Trial Outcomes & Findings for Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma (NCT NCT04729959)

Last Updated: 2026-08-07

Results Overview

The maximum tolerated dose (MTD) was defined as the highest prespecified dose level with an observed dose-limiting toxicity (DLT) rate of ≤33% of participants. MTD was determined during the safety run-in by testing increasing prespecified dose levels of tocilizumab alone and in combination with atezolizumab in Arms 1-3, with cohorts of 3 to 6 participants enrolled at each dose level. Dose escalation began with tocilizumab 4 mg/kg (Dose Level 1 / Arm 1), followed by tocilizumab 8 mg/kg (Dose Level 2 / Arm 2), and then tocilizumab 8 mg/kg in combination with atezolizumab 1680 mg (Dose Level 3 / Arm 3).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

From first dose of study drug through completion of Cycle 1 (28 days).

Results posted on

2026-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Non Surgical Cohort: Arm 4 (Tocilizumab, Atezolizumab) The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Surgical Cohort: Arm A - Neoadjuvant Tocilizumab + Atezolizumab The surgical cohort is defined as patients with recurrent glioblastoma with a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. Within 3-7 days, patients undergo FSRT delivered in 3 fractions over 3-5 days, followed by surgical resection 7-14 days after completion of FSRT. Beginning 21-42 days after surgery, patients receive atezolizumab plus tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the study, and blood and tumor tissue are collected on study.	Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone Patients receive atezolizumab IV alone on Day 1 prior to FSRT and surgery. FSRT timing and fractionation, surgical timing, post operative treatment, MRI assessments, and biospecimen collection are performed as described in Arm A.	Non-Surgical Cohort: Arm 1 - Level 1 (Tocilizumab) The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo FSRT delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
Safety Run-in: Dose Level 1 STARTED	0	0	0	3	0	0
Safety Run-in: Dose Level 1 COMPLETED	0	0	0	3	0	0
Safety Run-in: Dose Level 1 NOT COMPLETED	0	0	0	0	0	0
Safety Run-in: Dose Level 2 STARTED	0	0	0	0	4	0
Safety Run-in: Dose Level 2 COMPLETED	0	0	0	0	3	0
Safety Run-in: Dose Level 2 NOT COMPLETED	0	0	0	0	1	0
Safety Run-in: Dose Level 3 STARTED	0	0	0	0	0	7
Safety Run-in: Dose Level 3 COMPLETED	0	0	0	0	0	6
Safety Run-in: Dose Level 3 NOT COMPLETED	0	0	0	0	0	1
Phase II STARTED	30	8	9	0	0	0
Phase II COMPLETED	29	8	8	0	0	0
Phase II NOT COMPLETED	1	0	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Non Surgical Cohort: Arm 4 (Tocilizumab, Atezolizumab) The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone Patients receive atezolizumab IV alone on Day 1 prior to FSRT and surgery. FSRT timing and fractionation, surgical timing, post operative treatment, MRI assessments, and biospecimen collection are performed as described in Arm A.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
Safety Run-in: Dose Level 2 Did not complete necessary treatment	0	0	1	0
Safety Run-in: Dose Level 3 Did not complete necessary treatment	0	0	0	1
Phase II Did not complete necessary treatment	1	1	0	0

Baseline Characteristics

Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Surgical Cohort: Arm 4 (Tocilizumab, Atezolizumab) n=29 Participants The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Surgical Cohort: Arm A - Neoadjuvant Tocilizumab + Atezolizumab n=8 Participants The surgical cohort is defined as patients with recurrent glioblastoma with a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. Within 3-7 days, patients undergo FSRT delivered in 3 fractions over 3-5 days, followed by surgical resection 7-14 days after completion of FSRT. Beginning 21-42 days after surgery, patients receive atezolizumab plus tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the study, and blood and tumor tissue are collected on study.	Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone n=8 Participants Patients receive atezolizumab IV alone on Day 1 prior to FSRT and surgery. FSRT timing and fractionation, surgical timing, post-operative treatment, MRI assessments, and biospecimen collection are performed as described in Arm A.	Non-Surgical Cohort: Arm 1 - Level 1 (Tocilizumab) n=3 Participants The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo FSRT delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 -Level 2 (Tocilizumab) n=3 Participants Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) n=6 Participants Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Total n=57 Participants Total of all reporting groups
Age, Continuous	61 years n=20 Participants	67.5 years n=20 Participants	58.5 years n=40 Participants	57 years n=6 Participants	76 years n=7 Participants	55.5 years n=13 Participants	72 years n=4 Participants
Sex: Female, Male Female	10 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=6 Participants	2 Participants n=7 Participants	2 Participants n=13 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=20 Participants	7 Participants n=20 Participants	7 Participants n=40 Participants	3 Participants n=6 Participants	1 Participants n=7 Participants	4 Participants n=13 Participants	41 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	2 Participants n=13 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=20 Participants	6 Participants n=20 Participants	6 Participants n=40 Participants	3 Participants n=6 Participants	2 Participants n=7 Participants	4 Participants n=13 Participants	47 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=6 Participants	1 Participants n=7 Participants	0 Participants n=13 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	28 Participants n=20 Participants	5 Participants n=20 Participants	7 Participants n=40 Participants	3 Participants n=6 Participants	3 Participants n=7 Participants	6 Participants n=13 Participants	52 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	3 Participants n=4 Participants
Karnofsky performance status 70	6 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	6 Participants n=4 Participants
Karnofsky performance status 80	5 Participants n=20 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=6 Participants	1 Participants n=7 Participants	2 Participants n=13 Participants	11 Participants n=4 Participants
Karnofsky performance status 90	14 Participants n=20 Participants	4 Participants n=20 Participants	5 Participants n=40 Participants	2 Participants n=6 Participants	2 Participants n=7 Participants	2 Participants n=13 Participants	29 Participants n=4 Participants
Karnofsky performance status 100	4 Participants n=20 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	2 Participants n=13 Participants	11 Participants n=4 Participants
Methyltransferase (MGMT) methylation status Methylated	10 Participants n=20 Participants	1 Participants n=20 Participants	5 Participants n=40 Participants	2 Participants n=6 Participants	2 Participants n=7 Participants	3 Participants n=13 Participants	23 Participants n=4 Participants
Methyltransferase (MGMT) methylation status Unmethylated	19 Participants n=20 Participants	7 Participants n=20 Participants	3 Participants n=40 Participants	1 Participants n=6 Participants	1 Participants n=7 Participants	3 Participants n=13 Participants	34 Participants n=4 Participants

PRIMARY outcome

Timeframe: From first dose of study drug through completion of Cycle 1 (28 days).

Population: The safety run-in population includes all participants who experience a dose-limiting toxicity (DLT) after starting study treatment. Participants without a DLT are included if they receive all planned pre-FSRT systemic therapy, at least one fraction of FSRT, and the first post-FSRT dose of all systemic therapy.

Outcome measures

Outcome measures
Measure	[Non-Surgical Cohort] All Safety-run Participants (Arms 1, 2, 3) n=12 Participants Participants from Arms 1, 2, and 3 combined (the non-surgical cohort safety run-in three dose levels). Arm 1: Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study. Arm 2 same as Arm 1 except has tocilizumab 8 mg/kg instead of 4mg/kg. Arm 3 same as Arm 2 except has atezolizumab administered intravenously (IV) over 30-60 minutes prior to the tocilizumab.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 1 - Level 1 (Tocilizumab) The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered intravenously (IV) over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
[Non-surgical Cohort] Maximum-tolerated Dose (Safety Run-In) Tocilizumab MTD (Monotherapy) [Dose Level 1 = 4 mg/kg, Dose Level 2 = 8 mg/kg]	8 mg/kg	—	—	—	—	—
[Non-surgical Cohort] Maximum-tolerated Dose (Safety Run-In) Tocilizumab MTD (with Atezolizumab) [Dose Level 3]	8 mg/kg	—	—	—	—	—

PRIMARY outcome

Timeframe: From first dose of study drug through completion of Cycle 1 (28 days).

Population: The safety run-in population includes all patients who experience a dose-limiting toxicity (DLT) after starting study treatment. Patients without a DLT are included if they receive all planned pre-FSRT systemic therapy, at least one fraction of FSRT, and the first post-FSRT dose of all systemic therapy.

DLTs per NCI CTCAE v5.0 include Grade ≥2 toxicity at least possibly related to study drug(s) that does not resolve to Grade ≤1 within 6 weeks of last dose with optimal management or prevents tapering corticosteroids to baseline (or pre-toxicity dose) within 6 weeks, excluding CNS toxicity due to intratumoral/peritumoral disease or edema that improves to Grade ≤2 within 7 days, cerebral edema improving per protocol, or endocrinopathy controlled by hormone replacement. Additional DLTs include Grade 4 immune-related AEs (excluding controlled endocrinopathy); Grade 3 hepatitis, pneumonitis, nephritis, myocarditis, pericarditis, encephalitis, myasthenia gravis, uveitis, episcleritis, peripheral neuropathy, autoimmune hemolytic anemia, acquired hemophilia, or autonomic neuropathy; recurrent Grade 2 pneumonitis; any-grade transverse myelitis; and hepatic or hematologic toxicity meeting protocol-specified criteria for dose modification or discontinuation.

Outcome measures

Outcome measures
Measure	[Non-Surgical Cohort] All Safety-run Participants (Arms 1, 2, 3) n=3 Participants Participants from Arms 1, 2, and 3 combined (the non-surgical cohort safety run-in three dose levels). Arm 1: Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study. Arm 2 same as Arm 1 except has tocilizumab 8 mg/kg instead of 4mg/kg. Arm 3 same as Arm 2 except has atezolizumab administered intravenously (IV) over 30-60 minutes prior to the tocilizumab.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) n=3 Participants Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) n=6 Participants Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 1 - Level 1 (Tocilizumab) The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered intravenously (IV) over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
[Non-surgical Cohort, Safety Run-In] Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	1 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Registration to 6 months

Population: The first 25 registered non-surgical cohort phase II participants.

Objective radiographic response rate (ORR) is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) on magnetic resonance imaging (MRI) using modified Response Assessment in Neuro-Oncology (RANO) criteria, compared with baseline MRI. CR is disappearance of all enhancing disease with no new lesions. PR is ≥50% decrease in enhancing tumor burden. Responses must be sustained for ≥4 weeks.

Outcome measures

Outcome measures
Measure	[Non-Surgical Cohort] All Safety-run Participants (Arms 1, 2, 3) n=25 Participants Participants from Arms 1, 2, and 3 combined (the non-surgical cohort safety run-in three dose levels). Arm 1: Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study. Arm 2 same as Arm 1 except has tocilizumab 8 mg/kg instead of 4mg/kg. Arm 3 same as Arm 2 except has atezolizumab administered intravenously (IV) over 30-60 minutes prior to the tocilizumab.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 1 - Level 1 (Tocilizumab) The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered intravenously (IV) over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
[Non-surgical Cohort] Objective Radiographic Response Rate (Phase II)	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Time from study enrollment to disease progression, death from any cause, or last evaluable MRI tumor assessment. Maximum follow-up time at time of analysis was 13.5 months.

Population: Phase II participants (non-surgical cohort Arm 4) who received at least one dose of any systemic therapy and at least one fraction of FSRT.

Disease progression is assessed by modified RANO criteria with iRANO adaptations. Progressive disease is defined as ≥25% increase in enhancing tumor burden compared with nadir, appearance of new enhancing lesions, clear clinical deterioration attributable to tumor progression, progression of non-measurable disease, or death. For patients receiving immunotherapy, suspected progression within 6 months may require confirmation on subsequent imaging to account for pseudoprogression; confirmed progression is back-dated to the initial scan. Median progression-free survival time was estimated using the Kaplan-Meier method, censoring participants alive without progression at date of the last evaluable MRI tumor assessment.

Outcome measures

Outcome measures
Measure	[Non-Surgical Cohort] All Safety-run Participants (Arms 1, 2, 3) n=29 Participants Participants from Arms 1, 2, and 3 combined (the non-surgical cohort safety run-in three dose levels). Arm 1: Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study. Arm 2 same as Arm 1 except has tocilizumab 8 mg/kg instead of 4mg/kg. Arm 3 same as Arm 2 except has atezolizumab administered intravenously (IV) over 30-60 minutes prior to the tocilizumab.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 1 - Level 1 (Tocilizumab) The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered intravenously (IV) over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
[Phase II Non-Surgical Cohort] Progression-free Survival	3.2 months Interval 2.0 to 4.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months.

Population: Phase II participants (non-surgical cohort Arm 4) who received at least one dose of any systemic therapy and at least one fraction of FSRT.

Median survival time was estimated using the Kaplan-Meier method in which participants alive at last known follow-up are censored.

Outcome measures

Outcome measures
Measure	[Non-Surgical Cohort] All Safety-run Participants (Arms 1, 2, 3) n=29 Participants Participants from Arms 1, 2, and 3 combined (the non-surgical cohort safety run-in three dose levels). Arm 1: Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study. Arm 2 same as Arm 1 except has tocilizumab 8 mg/kg instead of 4mg/kg. Arm 3 same as Arm 2 except has atezolizumab administered intravenously (IV) over 30-60 minutes prior to the tocilizumab.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 1 - Level 1 (Tocilizumab) The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered intravenously (IV) over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
[Phase II Non-Surgical Cohort] Overall Survival	10.2 months Interval 6.6 to 13.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Time from study enrollment to disease progression, death from any cause, or last evaluable MRI tumor assessment. Maximum follow-up time at time of analysis was 13.9 months.

Population: Enrolled surgical cohort participants who completed the planned treatment sequence of neoadjuvant systemic therapy, three fractions of FSRT, and surgery.

Outcome measures

Outcome measures
Measure	[Non-Surgical Cohort] All Safety-run Participants (Arms 1, 2, 3) n=8 Participants Participants from Arms 1, 2, and 3 combined (the non-surgical cohort safety run-in three dose levels). Arm 1: Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study. Arm 2 same as Arm 1 except has tocilizumab 8 mg/kg instead of 4mg/kg. Arm 3 same as Arm 2 except has atezolizumab administered intravenously (IV) over 30-60 minutes prior to the tocilizumab.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) n=8 Participants Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 1 - Level 1 (Tocilizumab) The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered intravenously (IV) over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
[Surgical Cohort] Progression-free Survival	3.5 months Interval 1.9 to 6.2	6.2 months Interval 2.5 to The upper confidence bound could not be estimated because there were insufficient events beyond the median survival time.	—	—	—	—

SECONDARY outcome

Timeframe: From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.9 months.

Population: Enrolled surgical cohort participants who complete the planned treatment sequence of neoadjuvant systemic therapy, three fractions of FSRT, and surgery.

Median survival time was estimated using the Kaplan-Meier method in which participants alive at last known follow-up are censored.

Outcome measures

Outcome measures
Measure	[Non-Surgical Cohort] All Safety-run Participants (Arms 1, 2, 3) n=8 Participants Participants from Arms 1, 2, and 3 combined (the non-surgical cohort safety run-in three dose levels). Arm 1: Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study. Arm 2 same as Arm 1 except has tocilizumab 8 mg/kg instead of 4mg/kg. Arm 3 same as Arm 2 except has atezolizumab administered intravenously (IV) over 30-60 minutes prior to the tocilizumab.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) n=8 Participants Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 1 - Level 1 (Tocilizumab) The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) Patients receive atezolizumab administered intravenously (IV) over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
[Surgical Cohort] Overall Survival	6.1 months Interval 1.9 to The upper confidence bound could not be estimated because there were insufficient events beyond the median survival time.	NA months Not estimable because no events occurred.	—	—	—	—

SECONDARY outcome

Timeframe: From study enrollment to last follow-up. Maximum follow-up time at time of analysis was 13.5 months for non-surgical cohort Arm 4, 13.9 months for surgical cohort Arms A and B, and 23.5 months for the non-surgical safety run-in Arms 1-3.

Population: Non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.

National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Outcome measures

Outcome measures
Measure	[Non-Surgical Cohort] All Safety-run Participants (Arms 1, 2, 3) n=29 Participants Participants from Arms 1, 2, and 3 combined (the non-surgical cohort safety run-in three dose levels). Arm 1: Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study. Arm 2 same as Arm 1 except has tocilizumab 8 mg/kg instead of 4mg/kg. Arm 3 same as Arm 2 except has atezolizumab administered intravenously (IV) over 30-60 minutes prior to the tocilizumab.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) n=8 Participants Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) n=8 Participants Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 1 - Level 1 (Tocilizumab) n=3 Participants The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Level 2 (Tocilizumab) n=3 Participants Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Level 3 (Tocilizumab, Atezolizumab) n=6 Participants Patients receive atezolizumab administered intravenously (IV) over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
Number of Participants by Highest Grade Adverse Event Reported Grade 5	2 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 1	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 4	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 2	7 Participants	1 Participants	3 Participants	1 Participants	1 Participants	2 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 3	16 Participants	1 Participants	4 Participants	2 Participants	1 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and cycle 2, day 1 (1 cycle = 4 weeks)

The primary integrated correlative study is to determine the impact of anti-IL6 therapy on the GBM tumor microenvironment, and the systemic immune milieu, specifically with regard to the effect on tumor-associated macrophages, tumor-infiltrating lymphocytes, and peripheral blood immune cells. Tumor samples from patients in the window-of-opportunity surgical cohort will be obtained by surgical resection following pre-operative doses of atezolizumab and SRS with or without tocilizumab.

Outcome measures

Outcome data not reported

Adverse Events

Non-Surgical Cohort: Arm 4 - Phase II Expansion (Tocilizumab Atezolizumab)

Serious events: 13 serious events

Other events: 29 other events

Deaths: 15 deaths

Surgical Cohort: Arm A - Neoadjuvant Tocilizumab + Atezolizumab

Serious events: 6 serious events

Other events: 8 other events

Deaths: 5 deaths

Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Non-Surgical Cohort: Arm 1 - Safety Run-In, Dose Level 1 (Tocilizumab)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Non-Surgical Cohort: Arm 2 - Safety Run-In, Dose Level 2 (Tocilizumab)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Non-Surgical Cohort: Arm 3 - Safety Run-In, Dose Level 3 (Tocilizumab, Atezolizumab)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Non-Surgical Cohort: Arm 4 - Phase II Expansion (Tocilizumab Atezolizumab) n=29 participants at risk The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Surgical Cohort: Arm A - Neoadjuvant Tocilizumab + Atezolizumab n=8 participants at risk The surgical cohort is defined as patients with recurrent glioblastoma with a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. Within 3-7 days, patients undergo FSRT delivered in 3 fractions over 3-5 days, followed by surgical resection 7-14 days after completion of FSRT. Beginning 21-42 days after surgery, patients receive atezolizumab plus tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the study, and blood and tumor tissue are collected on study.	Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone n=8 participants at risk Patients receive atezolizumab IV alone on Day 1 prior to FSRT and surgery. FSRT timing and fractionation, surgical timing, post-operative treatment, MRI assessments, and biospecimen collection are performed as described in Arm A.	Non-Surgical Cohort: Arm 1 - Safety Run-In, Dose Level 1 (Tocilizumab) n=3 participants at risk The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Safety Run-In, Dose Level 2 (Tocilizumab) n=3 participants at risk Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Safety Run-In, Dose Level 3 (Tocilizumab, Atezolizumab) n=6 participants at risk Patients receive atezolizumab administered intravenously (IV) over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cardiac disorders Cardiac arrest	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Eye disorders Vision decreased	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Colonic perforation	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders Disease progression	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Infections and infestations - Other	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Meningitis	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Skin infection	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hyponatremia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Ataxia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Dysarthria	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Dysphasia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Edema cerebral	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Encephalopathy	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Headache	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Lethargy	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Muscle weakness left-sided	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Seizure	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Stroke	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Syncope	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Confusion	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Delirium	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Aspiration	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Surgical and medical procedures Surgical and medical procedures - Other	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Vascular disorders Thromboembolic event	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.

Other adverse events

Other adverse events
Measure	Non-Surgical Cohort: Arm 4 - Phase II Expansion (Tocilizumab Atezolizumab) n=29 participants at risk The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Surgical Cohort: Arm A - Neoadjuvant Tocilizumab + Atezolizumab n=8 participants at risk The surgical cohort is defined as patients with recurrent glioblastoma with a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. Within 3-7 days, patients undergo FSRT delivered in 3 fractions over 3-5 days, followed by surgical resection 7-14 days after completion of FSRT. Beginning 21-42 days after surgery, patients receive atezolizumab plus tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the study, and blood and tumor tissue are collected on study.	Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone n=8 participants at risk Patients receive atezolizumab IV alone on Day 1 prior to FSRT and surgery. FSRT timing and fractionation, surgical timing, post-operative treatment, MRI assessments, and biospecimen collection are performed as described in Arm A.	Non-Surgical Cohort: Arm 1 - Safety Run-In, Dose Level 1 (Tocilizumab) n=3 participants at risk The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo fractionated stereotactic radiotherapy (FSRT) delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.	Non-Surgical Cohort: Arm 2 - Safety Run-In, Dose Level 2 (Tocilizumab) n=3 participants at risk Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.	Non-Surgical Cohort: Arm 3 - Safety Run-In, Dose Level 3 (Tocilizumab, Atezolizumab) n=6 participants at risk Patients receive atezolizumab administered intravenously (IV) over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	13.8% 4/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Blood and lymphatic system disorders Eosinophilia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Cardiac disorders Sinus bradycardia	17.2% 5/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Ear and labyrinth disorders Ear and labyrinth disorders - Other	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Ear and labyrinth disorders Hearing impaired	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Ear and labyrinth disorders Tinnitus	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Ear and labyrinth disorders Vertigo	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Ear and labyrinth disorders Vestibular disorder	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Endocrine disorders Cushingoid	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Endocrine disorders Hypoparathyroidism	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Endocrine disorders Hypothyroidism	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Eye disorders Blurred vision	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Eye disorders Dry eye	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Eye disorders Eye disorders - Other	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Eye disorders Eye pain	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Eye disorders Floaters	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Eye disorders Papilledema	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Eye disorders Vision decreased	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Abdominal pain	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Constipation	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Dental caries	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Diarrhea	20.7% 6/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Dry mouth	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Dyspepsia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Dysphagia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Fecal incontinence	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Flatulence	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Gastroesophageal reflux disease	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Stomach pain	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Gastrointestinal disorders - Other	13.8% 4/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Mucositis oral	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Nausea	27.6% 8/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Toothache	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Gastrointestinal disorders Vomiting	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders Chills	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders Disease progression	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders Edema limbs	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders Fatigue	58.6% 17/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	75.0% 6/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	66.7% 2/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders Flu like symptoms	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders Gait disturbance	24.1% 7/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders General disorders and administration site conditions - Other	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders Localized edema	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders Non-cardiac chest pain	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
General disorders Pain	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Immune system disorders Autoimmune disorder	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Bladder infection	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Bronchial infection	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Gum infection	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Infections and infestations - Other	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Lung infection	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Papulopustular rash	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Pharyngitis	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Sepsis	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Sinusitis	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Skin infection	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Thrush	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Upper respiratory infection	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Urinary tract infection	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Cholesterol high	17.2% 5/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 2/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Infections and infestations Wound infection	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Injury, poisoning and procedural complications Bruising	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Injury, poisoning and procedural complications Fall	20.7% 6/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Injury, poisoning and procedural complications Wound complication	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Injury, poisoning and procedural complications Wrist fracture	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Alanine aminotransferase increased	20.7% 6/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Alkaline phosphatase increased	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Aspartate aminotransferase increased	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Blood bilirubin increased	24.1% 7/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Blood lactate dehydrogenase increased	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Creatinine increased	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Hemoglobin increased	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Investigations - Other	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	50.0% 4/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Lymphocyte count decreased	27.6% 8/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Neutrophil count decreased	48.3% 14/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 2/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Platelet count decreased	34.5% 10/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	66.7% 2/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Serum amylase increased	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Thyroid stimulating hormone increased	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Weight gain	13.8% 4/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations Weight loss	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Investigations White blood cell decreased	55.2% 16/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	50.0% 3/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Anorexia	13.8% 4/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Dehydration	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Ataxia	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hyperglycemia	13.8% 4/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	50.0% 4/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hyperlipidemia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hyperphosphatemia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hypertriglyceridemia	17.2% 5/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hypoalbuminemia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hypocalcemia	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hypokalemia	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hypomagnesemia	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hyponatremia	20.7% 6/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Hypophosphatemia	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Arthralgia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Back pain	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Muscle cramp	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Myalgia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Musculoskeletal and connective tissue disorders Pain in extremity	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor hemorrhage	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Cognitive disturbance	13.8% 4/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Concentration impairment	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Dizziness	13.8% 4/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Dysesthesia	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Dysgeusia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Dysphasia	13.8% 4/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Edema cerebral	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Encephalopathy	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Facial muscle weakness	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Headache	44.8% 13/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Hydrocephalus	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Lethargy	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Memory impairment	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Muscle weakness left-sided	13.8% 4/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Muscle weakness right-sided	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Nervous system disorders - Other	27.6% 8/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Nystagmus	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Paresthesia	17.2% 5/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 2/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Peripheral sensory neuropathy	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Seizure	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	37.5% 3/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Spasticity	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Stroke	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Nervous system disorders Tremor	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Agitation	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Anxiety	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Confusion	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Delirium	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Depression	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Hallucinations	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Insomnia	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Irritability	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Libido decreased	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Psychiatric disorders Psychiatric disorders - Other	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Renal and urinary disorders Hematuria	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Renal and urinary disorders Renal and urinary disorders - Other	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Renal and urinary disorders Urinary frequency	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Renal and urinary disorders Urinary incontinence	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Renal and urinary disorders Urinary retention	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Renal and urinary disorders Urinary urgency	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Aspiration	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Cough	17.2% 5/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Hoarseness	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Sneezing	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Sore throat	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Skin and subcutaneous tissue disorders Dry skin	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Skin and subcutaneous tissue disorders Pruritus	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Skin and subcutaneous tissue disorders Scalp pain	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	13.8% 4/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	62.5% 5/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Surgical and medical procedures Surgical and medical procedures - Other	0.00% 0/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Vascular disorders Flushing	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Vascular disorders Hematoma	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	33.3% 1/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Vascular disorders Hot flashes	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Vascular disorders Hypertension	6.9% 2/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	16.7% 1/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Vascular disorders Hypotension	10.3% 3/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	12.5% 1/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.
Vascular disorders Vascular disorders - Other	3.4% 1/29 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	25.0% 2/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/8 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/3 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.	0.00% 0/6 • From study enrollment to death from any cause or last follow-up. Maximum follow-up time at time of analysis was 13.5 months for the non-surgical cohort expansion (Arm 4), 13.9 months for the surgical cohort (Arms A and B), and 23.5 months for the non-surgical safety run-in (Arms 1-3). All-cause mortality and adverse events are reported for non-surgical cohort participants who received at least one dose of systemic therapy and one fraction of FSRT (including safety run-in participants meeting protocol-specified DLT evaluability criteria) and surgical cohort participants who completed neoadjuvant systemic therapy, FSRT, and surgery.

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 215-574-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60