Study on Amivantamab and Olomorasib Combination Therapy for Metastatic Non-Small Cell Lung Cancer
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT07227025
This clinical trial is testing a new combination of drugs, amivantamab and olomorasib, to find the best dose and see how well it works in slowing down or stopping the growth of tumors in patients with a specific type of lung cancer that has spread to other parts of the body.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to determine the most effective dose of a new drug combination, amivantamab and olomorasib, and to evaluate how well this combination can slow down or stop the growth of tumors in patients with metastatic non-small cell lung cancer (NSCLC) that has a specific genetic mutation called KRAS G12C. This type of lung cancer is the most common and has spread to other parts of the body. The KRAS G12C mutation involves a change in the KRAS gene, which is important for cell growth.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.
- For Phase 1: Must have tried and not responded to, or cannot tolerate, platinum-based chemotherapy and PD-L1-targeted immunotherapy, either given together or one after the other. Additional previous treatments are allowed.
- For Phase 2: Must have tried and not responded to platinum-based chemotherapy and PD-L1-targeted immunotherapy, either given together or one after the other. No additional previous treatments are allowed.
- Must have at least one tumor that can be measured and has not been treated with radiation.
- Can have brain tumors only if they have been treated and are stable, with no symptoms for more than 2 weeks, and are on low-dose or no steroids for at least 2 weeks before starting the study.
- Can have another type of cancer if it is not expected to interfere with the study treatment.
- Must be in good overall health, with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have a history of uncontrolled illness.
- Have known allergies or intolerances to the ingredients in amivantamab or olomorasib.
- Have a history of lung diseases like interstitial lung disease (ILD) or pneumonitis, or currently have these conditions.
- Have other primary genetic mutations that drive cancer growth, such as EGFR, ALK, MET, HER2, ROS1, NTRK, BRAF, RET, NRAS, or other KRAS mutations besides G12C.
- Have previously been treated with any KRAS inhibitor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| New York University Langone Medical Center | 10016 | New York | New York |
| Virginia Cancer Specialists | 22031 | Fairfax | Virginia |
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