Trial Outcomes & Findings for Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A) (NCT NCT06385483)

Last Updated: 2025-11-17

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

19 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

2025-11-17

Participant Flow

Subprotocol A was activated on August 12, 2015. Nineteen patients were enrolled between February 2018 and January 2020. All patients were enrolled though the outside laboratory and had their samples centrally confirmed.

EGFR variants allowing entry into subprotocol A included classic activating deletion 19 and L858R EGFR mutations, EGFR G719A, G719C, G719D, G719S, L861Q, and S768I. The mutation status was determined by a CLIA-approved assay performed in an NCI-MATCH approved laboratory, these cases had to be confirmed to be used in primary analysis.

Participant milestones

Participant milestones
Measure	Treatment (Afatinib) Patients receive afatinib 40 mg PO QD 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 may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Overall Study STARTED	19
Overall Study Started Protocol Therapy	17
Overall Study Eligible, Treated and Mutation Status Confirmed	17
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Afatinib) Patients receive afatinib 40 mg PO QD 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 may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Overall Study Withdrawal by Subject	2
Overall Study Never start protocol therapy	2
Overall Study Disease progression	15

Baseline Characteristics

Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Afatinib) n=17 Participants Patients receive afatinib PO QD 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 may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Age, Continuous	58 years n=202 Participants
Sex: Female, Male Female	8 Participants n=202 Participants
Sex: Female, Male Male	9 Participants n=202 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=202 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=202 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=202 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=202 Participants
Race (NIH/OMB) Asian	1 Participants n=202 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants
Race (NIH/OMB) Black or African American	1 Participants n=202 Participants
Race (NIH/OMB) White	15 Participants n=202 Participants
Race (NIH/OMB) More than one race	0 Participants n=202 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=202 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 (Afatinib) n=17 Participants Patients receive afatinib PO QD 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 may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Objective Response Rate (ORR)	11.8 percentage of participants Interval 2.1 to 32.6

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 (Afatinib) n=17 Participants Patients receive afatinib PO QD 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 may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
6-month Progression Free Survival (PFS)	15 percentage of participants Interval 0.0 to 30.7

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 (Afatinib) n=17 Participants Patients receive afatinib PO QD 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 may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Progression Free Survival	1.7 months Interval 1.35 to 1.94

Adverse Events

Treatment (Afatinib)

Serious events: 2 serious events

Other events: 15 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Afatinib) n=17 participants at risk Patients receive afatinib PO QD 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 may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Skin and subcutaneous tissue disorders Rash acneiform	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Gastrointestinal disorders Vomiting	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).

Other adverse events

Other adverse events
Measure	Treatment (Afatinib) n=17 participants at risk Patients receive afatinib PO QD 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 may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Blood and lymphatic system disorders Anemia	17.6% 3/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
General disorders Fatigue	29.4% 5/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Skin and subcutaneous tissue disorders Dry skin	11.8% 2/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Skin and subcutaneous tissue disorders Rash acneiform	35.3% 6/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Skin and subcutaneous tissue disorders Rash maculo-papular	35.3% 6/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Gastrointestinal disorders Diarrhea	70.6% 12/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Gastrointestinal disorders Dysphagia	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Gastrointestinal disorders Gingival pain	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Gastrointestinal disorders Nausea	35.3% 6/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Gastrointestinal disorders Oral hemorrhage	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Gastrointestinal disorders Oral pain	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Gastrointestinal disorders Vomiting	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Infections and infestations Paronychia	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Infections and infestations Urinary tract infection	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Investigations Lymphocyte count decreased	11.8% 2/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Investigations White blood cell decreased	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Metabolism and nutrition disorders Anorexia	17.6% 3/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Metabolism and nutrition disorders Dehydration	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Metabolism and nutrition disorders Hyperkalemia	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Metabolism and nutrition disorders Hypertriglyceridemia	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Metabolism and nutrition disorders Hypokalemia	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Metabolism and nutrition disorders Hyponatremia	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Musculoskeletal and connective tissue disorders Neck pain	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Nervous system disorders Headache	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Nervous system disorders Memory impairment	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Nervous system disorders Paresthesia	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Nervous system disorders Peripheral sensory neuropathy	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Eye disorders Conjunctivitis	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Eye disorders Dry eye	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Respiratory, thoracic and mediastinal disorders Epistaxis	11.8% 2/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Respiratory, thoracic and mediastinal disorders Hoarseness	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Respiratory, thoracic and mediastinal disorders Productive cough	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Respiratory, thoracic and mediastinal disorders Sore throat	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Respiratory, thoracic and mediastinal disorders Wheezing	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Renal and urinary disorders Cystitis noninfective	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Renal and urinary disorders Hematuria	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Renal and urinary disorders Proteinuria	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).
Reproductive system and breast disorders Erectile dysfunction	5.9% 1/17 • 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. Seventeen patients were included in the toxicity analysis (excluding two who did not receive treatment).

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