Testing Afatinib for Treating Cancers with EGFR Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06385483
This clinical trial is exploring how well the drug afatinib works in treating cancers with specific genetic changes in the EGFR gene. Afatinib is a type of medication that blocks signals that make cancer cells grow, potentially slowing or stopping the spread of cancer.
Patient Parameters
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Program Overview
This study is testing the effectiveness of afatinib, a medication that targets specific genetic changes in the EGFR gene found in some cancers. By blocking the action of the mutated EGFR, afatinib may help stop or slow down the growth of cancer cells. The trial aims to see how well patients respond to this treatment and how long they can live without the cancer getting worse.
Description
The main goal of this study is to see how many patients experience a reduction in their cancer with afatinib treatment. Researchers also want to know how many patients are still alive and have not seen their cancer progress after six months of treatment. They will also study how long it takes for the cancer to progress or for the patient to pass away. Additionally, the study will look for other markers that might predict how well the treatment works or why it might stop working.
Patients will take afatinib by mouth once a day in 28-day cycles. These cycles will continue as long as the cancer does not progress and the patient can tolerate the treatment. Patients will have CT or MRI scans and heart tests as needed. They will also have biopsies and blood samples taken during the study.
After finishing the treatment, patients will have follow-up visits every three months for two years, then every six months for one year.
Eligibility Criteria
Inclusion Criteria
- Must meet eligibility criteria from the main MATCH Protocol before joining this study.
- Must have a tumor with specific EGFR mutations, such as del 19, L858R, or other specified mutations.
- Must have a recent ECG showing no major heart issues.
- If known heart issues exist, must have a recent heart function test showing normal results.
- Must not be allergic to afatinib or similar drugs.
- Must have good kidney function as shown by specific tests.
- Must not have taken any EGFR inhibitors before.
- Cannot have non-small cell lung cancer, small cell lung cancer, interstitial lung disease, or glioblastoma multiforme.
- Must have mild or no diarrhea at the start of the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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