Trial Outcomes & Findings for Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B) (NCT NCT04439136)

Last Updated: 2026-04-29

Results Overview

Overall response rate was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response 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 the detailed definitions of response criteria. The 90% two-sided binomial exact confidence interval was calculated for ORR.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

40 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

2026-04-29

Participant Flow

Subprotocol B was activated on August 12, 2015. Fifty-nine patients were assigned to Subprotocol B after screening, all from screening cohort. Of the 59 patients, 40 patients were enrolled in arm B between August 2015 and June 2017.

To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol B, patients had to have a qualifying ERBB2 actionable mutation.

Participant milestones

Participant milestones
Measure	Treatment (Afatinib Dimaleate) Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
Overall Study STARTED	40
Overall Study Eligible	39
Overall Study Eligible and Started Protocol Therapy	37
Overall Study Reported Adverse Events Data	37
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Afatinib Dimaleate) Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
Overall Study Ineligible	1
Overall Study Never Started Treatment	2
Overall Study Adverse Event	4
Overall Study Death	3
Overall Study Disease Progression	27
Overall Study Alternative Therapy	1
Overall Study Increased Tumor Burden	1
Overall Study Symptomatic Detrioration	1

Baseline Characteristics

Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Afatinib Dimaleate) n=37 Participants Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
Age, Continuous	62 years n=9 Participants
Sex: Female, Male Female	29 Participants n=9 Participants
Sex: Female, Male Male	8 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	1 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	4 Participants n=9 Participants
Race (NIH/OMB) White	30 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=9 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: Patients who were eligible and received protocol treatment

Outcome measures

Outcome measures
Measure	Treatment (Afatinib Dimaleate) n=37 Participants Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
Objective Response Rate (ORR)	2.7 percentage of participants Interval 0.14 to 12.2

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: Patients who were eligible and received protocol treatment

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 (Afatinib Dimaleate) n=37 Participants Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
6-month Progression-free Survival (PFS) Rate	12.0 percentage of participants Interval 5.6 to 25.8

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: Patients who were eligible and received protocol treatment

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 (Afatinib Dimaleate) n=37 Participants Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
Progression Free Survival (PFS)	1.7 months Interval 1.6 to 4.2

Adverse Events

Treatment (Afatinib Dimaleate)

Serious events: 18 serious events

Other events: 31 other events

Deaths: 37 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Afatinib Dimaleate) n=37 participants at risk Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
Blood and lymphatic system disorders Anemia	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
General disorders Fatigue	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Skin and subcutaneous tissue disorders Rash maculo-papular	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Gastrointestinal disorders Anal hemorrhage	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Gastrointestinal disorders Diarrhea	18.9% 7/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Gastrointestinal disorders Mucositis oral	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Gastrointestinal disorders Nausea	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Infections and infestations Sepsis	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Alkaline phosphatase increased	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Aspartate aminotransferase increased	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Creatinine increased	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Neutrophil count decreased	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Platelet count decreased	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations White blood cell decreased	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Anorexia	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Dehydration	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Hypokalemia	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Hypomagnesemia	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Hyponatremia	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Hypophosphatemia	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Renal and urinary disorders Acute kidney injury	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Vascular disorders Hypotension	2.7% 1/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).

Other adverse events

Other adverse events
Measure	Treatment (Afatinib Dimaleate) n=37 participants at risk Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
Blood and lymphatic system disorders Anemia	21.6% 8/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
General disorders Chills	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
General disorders Fatigue	35.1% 13/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
General disorders Fever	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Skin and subcutaneous tissue disorders Dry skin	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Skin and subcutaneous tissue disorders Pruritus	10.8% 4/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Skin and subcutaneous tissue disorders Rash acneiform	29.7% 11/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Skin and subcutaneous tissue disorders Rash maculo-papular	13.5% 5/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Gastrointestinal disorders Constipation	13.5% 5/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Gastrointestinal disorders Diarrhea	64.9% 24/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Gastrointestinal disorders Dry mouth	13.5% 5/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Gastrointestinal disorders Mucositis oral	35.1% 13/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Gastrointestinal disorders Nausea	27.0% 10/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Gastrointestinal disorders Vomiting	27.0% 10/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Infections and infestations Paronychia	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Alanine aminotransferase increased	10.8% 4/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Alkaline phosphatase increased	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Aspartate aminotransferase increased	10.8% 4/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Creatinine increased	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Lymphocyte count decreased	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Platelet count decreased	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Weight loss	10.8% 4/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations White blood cell decreased	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Investigations Investigations - Other, specify	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Anorexia	18.9% 7/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Dehydration	24.3% 9/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Hypoalbuminemia	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Hypokalemia	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Hypomagnesemia	10.8% 4/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Metabolism and nutrition disorders Hyponatremia	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, spe	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Nervous system disorders Dysgeusia	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Eye disorders Blurred vision	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Respiratory, thoracic and mediastinal disorders Cough	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Respiratory, thoracic and mediastinal disorders Dyspnea	5.4% 2/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).
Respiratory, thoracic and mediastinal disorders Epistaxis	8.1% 3/37 • 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-seven patients were included in the toxicity analysis (excluding two who did not receive afatinib treatment and one who was not assessed for toxicity).

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