Study on Amivantamab and Capmatinib Combination Therapy for Advanced Non-Small Cell Lung Cancer
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT05488314
This clinical trial is testing a combination of two drugs, amivantamab and capmatinib, to find the best dose and evaluate their effectiveness in treating advanced non-small cell lung cancer (NSCLC) with specific genetic changes.
Patient Parameters
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Program Overview
The aim of this study is to determine the most effective dose of a combination treatment using amivantamab and capmatinib for patients with advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed. The study will also assess how well this combination works in shrinking tumors in patients with specific genetic mutations in their cancer cells.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed.
- May have brain metastases that have been treated and are stable without symptoms for more than 2 weeks, and are either not on steroids or on a low dose (10 mg or less of prednisone or equivalent) for at least 2 weeks before starting the study.
- May have had another type of cancer in the past, as long as it does not interfere with the study treatment.
- Have a good overall health status, with an ECOG performance score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Women of childbearing potential must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study.
Exclusion Criteria
- Have a history of lung diseases like interstitial lung disease (ILD) or pneumonitis, or currently have these conditions.
- Have digestive issues that could affect how the body absorbs capmatinib, or cannot swallow tablets.
- Have brain metastases that are causing symptoms or require increasing doses of steroids (more than 10 mg of prednisone or equivalent) within 2 weeks before starting the study.
- Have uncontrolled pain from tumors that could be treated with radiation therapy, such as bone metastases or tumors pressing on nerves, and have not been treated at least 7 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham, Comprehensive Cancer Center | 35233 | Birmingham | Alabama |
| The Oncology Institute of Hope and Innovation | 90703 | Cerritos | California |
| UCLA | 90095 | Los Angeles | California |
| Montefiore Einstein Center for Cancer Care | 10467 | The Bronx | New York |
| Virginia Cancer Specialists | 22031 | Fairfax | Virginia |
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