Trial Outcomes & Findings for Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E) (NCT NCT06303167)

Last Updated: 2025-09-16

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

2025-09-16

Participant Flow

Subprotocol E was activated on August 12, 2015. Nineteen patients were enrolled between January 2016 and November 2021. Three patients were enrolled on the basis of the results from the NCI-MATCH assay and 16 on the basis of the outside assay results.

Patients with an EGFR T790M mutation in any histology except lung cancer and patients with a rare activating mutation (EGFR G719A, G719C, G719D, G719S, L861Q, S786I, or an exon 19 in frame insertion mutations) in any histology were offered participation in this subprotocol. The mutation status was determined by a CLIA-approved assay performed in an NCI-MATCH approved laboratory for 16 patients in this arm, these cases had to be confirmed to be used in primary analysis.

Participant milestones

Participant milestones
Measure	Treatment (Osimertinib) Patients receive osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment.
Overall Study STARTED	19
Overall Study Started Protocol Therapy	17
Overall Study Eligible and Treated	16
Overall Study Eligible, Treated and Mutation Status Confirmed	13
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Osimertinib) Patients receive osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment.
Overall Study Ineligible	1
Overall Study Never start protocol therapy	2
Overall Study Disease progression	16

Baseline Characteristics

Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Osimertinib) n=13 Participants Patients receive osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment.
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 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 (Osimertinib) n=13 Participants Patients receive osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment.
Objective Response Rate	15.4 percentage of participants Interval 2.8 to 41.0

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	Treatment (Osimertinib) n=13 Participants Patients receive osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment.
6-month Progression-Free Survival (PFS) Rate	16.7 percentage of participants Interval 0.0 to 34.4

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 (Osimertinib) n=13 Participants Patients receive osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment.
Progression Free Survival	2.7 months Interval 1.74 to 4.04

Adverse Events

Treatment (Osimertinib)

Serious events: 2 serious events

Other events: 13 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Osimertinib) n=17 participants at risk Patients receive osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment.
Investigations Electrocardiogram QT corrected interval prolonged	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	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).

Other adverse events

Other adverse events
Measure	Treatment (Osimertinib) n=17 participants at risk Patients receive osimertinib (AZD9291) 80 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO or MUGA during screening, and biopsy and collection of blood samples on trial and at end of treatment.
Blood and lymphatic system disorders Anemia	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).
Cardiac disorders Palpitations	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).
General disorders Fatigue	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).
Skin and subcutaneous tissue disorders Dry skin	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).
Skin and subcutaneous tissue disorders Photosensitivity	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).
Skin and subcutaneous tissue disorders Pruritus	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	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).
Skin and subcutaneous tissue disorders Rash maculo-papular	23.5% 4/17 • 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 Bloating	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	23.5% 4/17 • 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 Dyspepsia	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 Gastroesophageal reflux disease	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).
Gastrointestinal disorders Mucositis oral	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	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).
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).
Gastrointestinal disorders Gastrointestinal 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).
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 Skin 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 Aspartate aminotransferase increased	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 Creatinine increased	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	23.5% 4/17 • 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 Neutrophil count 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).
Investigations Platelet count decreased	23.5% 4/17 • 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 Weight loss	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	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 Investigations - 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).
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 Hyponatremia	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).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	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 Muscle weakness right-sided	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 Dysgeusia	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	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).
Vascular disorders Hypertension	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