Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A)
NCT ID: NCT06385483
Last Updated: 2025-11-17
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
19 participants
INTERVENTIONAL
2018-02-28
2025-12-31
Brief Summary
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Detailed Description
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I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.
II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.
IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.
OUTLINE:
Patients receive afatinib orally (PO) once daily (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 computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo echocardiography (ECHO) or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
THE MATCH SCREENING TRIAL:
Please see NCT02465060 for information on the MATCH Screening Protocol and applicable documents.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (afatinib)
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.
Afatinib
Given PO
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Echocardiography Test
Undergo ECHO
Magnetic Resonance Imaging
Undergo MRI
Radionuclide Imaging
Undergo nuclear study
Interventions
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Afatinib
Given PO
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Echocardiography Test
Undergo ECHO
Magnetic Resonance Imaging
Undergo MRI
Radionuclide Imaging
Undergo nuclear study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must fulfill all eligibility criteria of MATCH Master Protocol at the time of registration to treatment step (Step 1, 3, 5, 7)
* Patient's tumor must have either of the below, or another aberration, as determined via the MATCH Master Protocol:
* Activating mutations of EGFR (del 19, L858R) OR
* Any malignancy harboring any of the following mutations: EGFR G719A, G719C, G719D, G719S EGFR L861Q, EGFR S768I
* Tumors with an exon 20 insertion alone without the above mutations will be excluded, with the exception of exon 20 insertions approved as inclusion variants as part of the dynamic actionable mutation of interest (aMOI) process
* Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
* Patients with known left ventricular dysfunction must have ECHO or a nuclear study (multigated acquisition scan \[MUGA\] or first pass) within 4 weeks prior to registration to treatment and must not have left ventricular ejection fraction (LVEF) \< institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be \> 50% for the patient to be eligible
* NOTE: Pre-treatment LVEF determination in patients without known left ventricular dysfunction is NOT otherwise required
* Patients must not have known hypersensitivity to afatinib or compounds of similar chemical or biologic composition
* Patients must have =\< grade 1 renal function as defined below:
* Creatinine =\< 1.5 x normal institutional limits OR
* Measured creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal or as calculated by the Cockcroft-Gault equation
* The above renal eligibility criteria should be strictly followed and will override the MATCH Master Protocol requirements
* Patients must not have had prior treatment with an EGFR tyrosine kinase inhibitor (TKI) (e.g. afatinib, erlotinib, gefitinib, neratinib, dacomitinib, AZD9291, cabertinib, CO-1686)
* Patients with non-small cell lung cancer and small cell lung cancer will be excluded
* Patients with a history of interstitial lung disease will be excluded
* Patients with glioblastoma multiforme (GBM) will be excluded
* Patients must have =\< grade 1 diarrhea at baseline
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Scott N Gettinger
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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NCI-2024-01125
Identifier Type: REGISTRY
Identifier Source: secondary_id
EAY131-A
Identifier Type: OTHER
Identifier Source: secondary_id
EAY131-A
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2024-01125
Identifier Type: -
Identifier Source: org_study_id
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