Phase 12 Study of Amivantamab and Olomorasib Combination Therapy for Metastatic Non-Small Cell Lung Cancer with KRAS G12C Mutation

What this Trial Is About

Researchers are evaluating the combination of amivantamab and olomorasib in participants with metastatic non-small cell lung cancer NSCLC that has a specific KRAS G12C mutation. This study aims to find the recommended phase 2 combination dose RP2CD and assess how well the treatment slows or prevents tumor growth. The study includes participants who have progressed after platinum-based chemotherapy and PD-L1-targeted immunotherapy. Participants first receive amivantamab combined with olomorasib to determine the best dose in Phase 1. In Phase 2, they receive the combination therapy at the determined dose until the disease progresses, significant side effects occur, or other reasons require stopping treatment. Eligible participants may join a long-term extension phase for continued access to the study treatments. During the study, participants are monitored for side effects and tumor response for up to approximately 3 years and 2 months. Assessments include measuring adverse events, dose-limiting toxicities, objective response rate, duration of response, disease control rate, progression-free survival, and overall survival. Participants attend regular visits for treatment and evaluations, with safety and efficacy carefully tracked throughout the study.

A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer