Study on AZD9291 for Treating Cancers with EGFR Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06303167
This clinical trial is testing the effectiveness of a drug called osimertinib (AZD9291) in treating cancers with specific genetic changes known as EGFR mutations. The study aims to see if this drug can help stop or slow down the growth of cancer cells.
Patient Parameters
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Program Overview
This study is exploring the use of osimertinib (AZD9291), a medication that targets specific genetic changes in cancer cells called EGFR mutations. These mutations can cause cancer cells to grow and spread. Osimertinib works by blocking the action of these mutant proteins, potentially leading to the death of cancer cells and slowing down tumor growth. The trial is focused on patients with advanced cancers that have not responded to other treatments.
Description
The main goal of this study is to see how many patients experience a reduction in their cancer after taking osimertinib. Researchers will also look at how long patients live without their cancer getting worse and how long they live overall. The study will explore other factors that might predict how well the treatment works, using various tests and imaging techniques.
Participants will take osimertinib by mouth once a day in 28-day cycles. These cycles will continue as long as the cancer does not progress and the treatment is tolerated well. Throughout the trial, patients will undergo regular scans and tests to monitor their health and the cancer's response to the treatment. 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 MATCH Master Protocol before joining this study.
- Must have a type of cancer with specific EGFR mutations, except for non-small cell lung cancer with EGFR T790M mutation.
- Must have a recent electrocardiogram (ECG) showing no significant heart issues.
- Must have a heart function test showing normal results.
- Must not be allergic to osimertinib or similar drugs.
- Must not have taken osimertinib or similar drugs before.
- Must not have certain lung diseases or active lung issues.
- Must not be taking certain medications that affect heart rhythm.
- Must agree not to donate sperm during and for four months after treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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