Trial Outcomes & Findings for Testing LOXO-101 as Potentially Targeted Treatment in Cancers With NTRK Genetic Changes (MATCH - Subprotocol Z1E) (NCT NCT06390852)

Last Updated: 2026-08-11

Results Overview

ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Results posted on

2026-08-11

Participant Flow

Subprotocol Z1E was activated on March 13, 2017. Between August 21, 2017, and July 8, 2021, 16 patients were enrolled in subprotocol Z1E. All were enrolled on the basis of the outside assay results.

Patients were assigned to subprotocol Z1E if an NTRK fusion-positive tumor was identified. The mutation status was determined by an NCI-MATCH approved laboratory for all 16 patients in this arm. These cases had to be confirmed to be used in primary analysis.

Participant milestones

Participant milestones
Measure	Treatment (Larotrectinib [LOXO-101]) Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
Overall Study STARTED	16
Overall Study Started Protocol Therapy	16
Overall Study Eligible	15
Overall Study Eligible, Treated and Mutation Status Confirmed	12
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Larotrectinib [LOXO-101]) Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
Overall Study Ineligible	1
Overall Study Mutation Status Not Confirmed	3
Overall Study Adverse Event	1
Overall Study Disease Progression	8
Overall Study Still on Therapy	3

Baseline Characteristics

Testing LOXO-101 as Potentially Targeted Treatment in Cancers With NTRK Genetic Changes (MATCH - Subprotocol Z1E)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Larotrectinib [LOXO-101]) n=12 Participants Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
Age, Continuous	69 years n=54 Participants
Sex: Female, Male Female	9 Participants n=54 Participants
Sex: Female, Male Male	3 Participants n=54 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=54 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	3 Participants n=54 Participants
Race (NIH/OMB) White	9 Participants n=54 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants

PRIMARY outcome

Timeframe: Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Population: Eligible, treated and mutation status confirmed

Outcome measures

Outcome measures
Measure	Treatment (Larotrectinib [LOXO-101]) n=12 Participants Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
Objective Response Rate (ORR)	75 percentage of participants Interval 47.3 to 92.8

SECONDARY outcome

Timeframe: Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined

Population: Eligible, treated and mutation status confirmed

Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.

Outcome measures

Outcome measures
Measure	Treatment (Larotrectinib [LOXO-101]) n=12 Participants Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
6-month Progression Free Survival (PFS)	83.3 percentage of participants Interval 65.6 to 100.0

SECONDARY outcome

Timeframe: Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Population: Eligible, treated and mutation status confirmed

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.

Outcome measures

Outcome measures
Measure	Treatment (Larotrectinib [LOXO-101]) n=12 Participants Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
Progression Free Survival	14.4 months Interval 8.5 to 90% CI upper bound not reached

Adverse Events

Treatment (Larotrectinib [LOXO-101])

Serious events: 5 serious events

Other events: 13 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Larotrectinib [LOXO-101]) n=16 participants at risk Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.2% 1/16 • Number of events 5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Injury, poisoning and procedural complications Fall	6.2% 1/16 • Number of events 5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Alanine aminotransferase increased	6.2% 1/16 • Number of events 5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Neutrophil count decreased	6.2% 1/16 • Number of events 5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Weight gain	6.2% 1/16 • Number of events 5 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.

Other adverse events

Other adverse events
Measure	Treatment (Larotrectinib [LOXO-101]) n=16 participants at risk Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
Ear and labyrinth disorders Ear pain	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Blood and lymphatic system disorders Anemia	18.8% 3/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
General disorders Edema limbs	18.8% 3/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
General disorders Fatigue	25.0% 4/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
General disorders Gait disturbance	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
General disorders Malaise	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
General disorders Non-cardiac chest pain	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
General disorders Pain	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
General disorders General disorders and administration site conditions - Other, specify	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Skin and subcutaneous tissue disorders Dry skin	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Skin and subcutaneous tissue disorders Pruritus	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Skin and subcutaneous tissue disorders Rash acneiform	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Gastrointestinal disorders Abdominal pain	18.8% 3/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Gastrointestinal disorders Bloating	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Gastrointestinal disorders Constipation	25.0% 4/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Gastrointestinal disorders Diarrhea	31.2% 5/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Gastrointestinal disorders Dyspepsia	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Gastrointestinal disorders Fecal incontinence	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Gastrointestinal disorders Gastroesophageal reflux disease	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Gastrointestinal disorders Nausea	37.5% 6/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Gastrointestinal disorders Vomiting	31.2% 5/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Psychiatric disorders Depression	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Alanine aminotransferase increased	31.2% 5/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Alkaline phosphatase increased	18.8% 3/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Aspartate aminotransferase increased	31.2% 5/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Creatinine increased	18.8% 3/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Neutrophil count decreased	18.8% 3/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Weight gain	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Weight loss	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations White blood cell decreased	18.8% 3/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Investigations Investigations - Other, specify	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Anorexia	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Hyperglycemia	18.8% 3/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Hyperkalemia	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Hypermagnesemia	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Hypernatremia	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Hyperuricemia	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Hypoalbuminemia	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Hypocalcemia	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Hypokalemia	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Hypophosphatemia	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Musculoskeletal and connective tissue disorders Back pain	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Musculoskeletal and connective tissue disorders Myalgia	37.5% 6/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	18.8% 3/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Nervous system disorders Dizziness	31.2% 5/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Nervous system disorders Dysgeusia	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Nervous system disorders Headache	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Nervous system disorders Neuralgia	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Nervous system disorders Paresthesia	18.8% 3/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Nervous system disorders Nervous system disorders - Other, specify	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Eye disorders Blurred vision	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Eye disorders Dry eye	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Eye disorders Eye disorders - Other, specify	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Psychiatric disorders Anxiety	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Psychiatric disorders Confusion	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Psychiatric disorders Insomnia	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 2/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Respiratory, thoracic and mediastinal disorders Sore throat	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Renal and urinary disorders Renal and urinary disorders - Other, specify	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Vascular disorders Hypertension	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.
Vascular disorders Hypotension	6.2% 1/16 • Number of events 13 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis and in the toxicity analysis.

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60