Targeted Treatment for Advanced Non-Small Cell Lung Cancer with Extra MET Gene Copies
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT06116682
This study is testing a new drug, amivantamab-SC, to see if it can help control advanced non-small cell lung cancer (NSCLC) that has extra copies of the MET gene. The drug aims to slow down or stop the cancer from growing or spreading.
Patient Parameters
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Program Overview
This clinical trial is exploring how well a new drug, amivantamab-SC, works for patients with advanced non-small cell lung cancer (NSCLC) that has extra copies of the MET gene. The drug is given under the skin and is designed to target and reduce these extra gene copies, which may help control the cancer's growth and spread. Patients will receive the drug in cycles and undergo regular scans and blood tests to monitor their progress. The study will follow participants for up to three years after treatment to assess long-term effects.
Description
The main goal of this study is to see how well the drug amivantamab-SC works in shrinking tumors in patients with advanced non-small cell lung cancer (NSCLC) that has extra copies of the MET gene. Researchers will also look at how long patients live without the cancer getting worse and overall survival rates. They will monitor any side effects and collect blood samples to study the cancer's genetic material.
Participants will receive the drug through an injection under the skin on specific days of each treatment cycle. These cycles repeat every 28 days as long as the cancer does not progress and side effects are manageable. Throughout the study, patients will have regular CT or MRI scans and blood tests to track their response to the treatment.
After finishing the treatment, participants will be followed for up to three years to monitor their health and any long-term effects of the drug.
Eligibility Criteria
Inclusion Criteria
- Must be part of the S1900J study group.
- Have non-small cell lung cancer (NSCLC) with extra copies of the MET gene.
- Have measurable cancer that can be seen on a CT or MRI scan.
- Have a brain scan to check for cancer spread to the brain.
- Be stable if there is cancer in the brain, with no symptoms for at least 14 days.
- Not have other known genetic changes that affect cancer treatment.
- Have tried at least one other treatment for advanced NSCLC.
- Be recovered from any side effects of previous treatments.
- Not have used certain cancer drugs before, like MET inhibitors.
- Not have had any cancer treatment in the last 21 days.
- Not have had major surgery or significant injury in the last 28 days.
- Have good blood counts and organ function based on recent tests.
- Be in good general health with a performance status of 0-2.
- Not have any other active cancer that could interfere with this study.
- Agree to use effective birth control if of reproductive potential.
- Agree to provide blood samples for research purposes.
- Understand the study and agree to participate by signing a consent form.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Sutter Auburn Faith Hospital | 95602 | Auburn | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
| Palo Alto Medical Foundation-Fremont | 94538 | Fremont | California |
| Memorial Medical Center | 95355 | Modesto | California |
| Palo Alto Medical Foundation Health Care | 94301 | Palo Alto | California |
| Sutter Roseville Medical Center | 95661 | Roseville | California |
| California Pacific Medical Center-Pacific Campus | 94115 | San Francisco | California |
| Sutter Pacific Medical Foundation | 95403 | Santa Rosa | California |
| Palo Alto Medical Foundation-Sunnyvale | 94086 | Sunnyvale | California |
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