Trial Outcomes & Findings for Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2) (NCT NCT06351371)

Last Updated: 2026-04-14

Results Overview

ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable (ie, eligible, treated and PIK3CA mutation status confirmed) 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

35 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

2026-04-14

Participant Flow

The study was activated on June 20, 2018. Thirty-five patients were enrolled between July 3, 2018, and July 15, 2019.

The FGFR Mutation or Fusion status was determined by assay performed in a NCI-MATCH approved laboratory for all patients in this arm. Mutation status was confirmed by central MATCH assay for 26 patients.

Participant milestones

Participant milestones
Measure	Subprotocol K2 (FGFR Mutation or Fusion) Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT or MRI, and tumor biopsy throughout the study. (CLOSED TO ACCRUAL 02/25/2022)
Overall Study STARTED	35
Overall Study Eligible	34
Overall Study Started Protocol Therapy	34
Overall Study Eligible and Treated	33
Overall Study Mutation Status Confirmed	26
Overall Study Eligible, Treated and Mutation Status Confirmed	25
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Subprotocol K2 (FGFR Mutation or Fusion) Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT or MRI, and tumor biopsy throughout the study. (CLOSED TO ACCRUAL 02/25/2022)
Overall Study Mutation Status Not Confirmed	9
Overall Study Ineligible	1
Overall Study Adverse Event	4
Overall Study Death	1
Overall Study Disease progression	14
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	3

Baseline Characteristics

Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subprotocol K2 (FGFR Mutation or Fusion) n=25 Participants Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT or MRI, and tumor biopsy throughout the study. (CLOSED TO ACCRUAL 02/25/2022)
Age, Continuous	61 years n=193 Participants
Sex: Female, Male Female	20 Participants n=193 Participants
Sex: Female, Male Male	5 Participants n=193 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=193 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=193 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=193 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=193 Participants
Race (NIH/OMB) Asian	2 Participants n=193 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=193 Participants
Race (NIH/OMB) Black or African American	3 Participants n=193 Participants
Race (NIH/OMB) White	18 Participants n=193 Participants
Race (NIH/OMB) More than one race	0 Participants n=193 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=193 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	Subprotocol K2 (FGFR Mutation or Fusion) n=25 Participants Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT or MRI, and tumor biopsy throughout the study. (CLOSED TO ACCRUAL 02/25/2022)
Objective Response Rate (ORR)	16 percentage of participants Interval 5.7 to 33.0

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, 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	Subprotocol K2 (FGFR Mutation or Fusion) n=25 Participants Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT or MRI, and tumor biopsy throughout the study. (CLOSED TO ACCRUAL 02/25/2022)
6-month Progression-free Survival (PFS) Rate	38.6 percentage of participants Interval 22.2 to 54.8

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

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	Subprotocol K2 (FGFR Mutation or Fusion) n=25 Participants Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT or MRI, and tumor biopsy throughout the study. (CLOSED TO ACCRUAL 02/25/2022)
Progression Free Survival	3.6 months Interval 1.8 to 7.6

Adverse Events

Subprotocol K2 (FGFR Mutation or Fusion)

Serious events: 11 serious events

Other events: 26 other events

Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure	Subprotocol K2 (FGFR Mutation or Fusion) n=34 participants at risk Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT or MRI, and tumor biopsy throughout the study. (CLOSED TO ACCRUAL 02/25/2022)
Gastrointestinal disorders Nausea	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Oral pain	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Infections and infestations Nail infection	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Infections and infestations Paronychia	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations Alkaline phosphatase increased	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations Lymphocyte count decreased	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Hypoalbuminemia	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Hyponatremia	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Hypophosphatemia	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Blood and lymphatic system disorders Anemia	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
General disorders Fatigue	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Lip pain	2.9% 1/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Mucositis oral	14.7% 5/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).

Other adverse events

Other adverse events
Measure	Subprotocol K2 (FGFR Mutation or Fusion) n=34 participants at risk Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT or MRI, and tumor biopsy throughout the study. (CLOSED TO ACCRUAL 02/25/2022)
Blood and lymphatic system disorders Anemia	32.4% 11/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	11.8% 4/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
General disorders Edema limbs	8.8% 3/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
General disorders Fatigue	47.1% 16/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Alopecia	23.5% 8/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Dry skin	29.4% 10/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Nail discoloration	29.4% 10/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Nail loss	17.6% 6/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Nail ridging	8.8% 3/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	17.6% 6/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Photosensitivity	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Rash acneiform	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Rash maculo-papular	8.8% 3/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	17.6% 6/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Abdominal pain	14.7% 5/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Constipation	20.6% 7/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Diarrhea	50.0% 17/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Dry mouth	52.9% 18/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Dysphagia	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Gastroesophageal reflux disease	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Mucositis oral	35.3% 12/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Nausea	23.5% 8/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Vomiting	8.8% 3/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	8.8% 3/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Infections and infestations Paronychia	17.6% 6/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Infections and infestations Infections and infestations - Other, specify	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations Alanine aminotransferase increased	11.8% 4/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations Alkaline phosphatase increased	26.5% 9/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations Aspartate aminotransferase increased	23.5% 8/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations Creatinine increased	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations Lymphocyte count decreased	17.6% 6/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations Platelet count decreased	20.6% 7/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations Weight loss	17.6% 6/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations White blood cell decreased	11.8% 4/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Investigations Investigations - Other, specify	20.6% 7/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Anorexia	29.4% 10/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Hypoalbuminemia	11.8% 4/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Hypocalcemia	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Hypokalemia	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Hypomagnesemia	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Hyponatremia	8.8% 3/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Hypophosphatemia	8.8% 3/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	32.4% 11/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Musculoskeletal and connective tissue disorders Arthralgia	17.6% 6/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Nervous system disorders Dizziness	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Nervous system disorders Dysgeusia	23.5% 8/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Nervous system disorders Headache	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Eye disorders Blurred vision	29.4% 10/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Eye disorders Dry eye	17.6% 6/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Eye disorders Watering eyes	8.8% 3/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Eye disorders Eye disorders - Other, specify	11.8% 4/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Psychiatric disorders Insomnia	8.8% 3/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Respiratory, thoracic and mediastinal disorders Cough	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Respiratory, thoracic and mediastinal disorders Epistaxis	8.8% 3/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	5.9% 2/34 • 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. Thirty-four patients were included in the toxicity analysis (excluding one never treated).

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60