Phase 3 Study Comparing Daraxonrasib Tablets to Docetaxel Infusions in Adults With Previously Treated RAS-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new oral drug called daraxonrasib compared to the chemotherapy drug docetaxel in patients with non-small cell lung cancer NSCLC that has a specific RAS mutation. This Phase 3, randomized, open-label study aims to see if daraxonrasib can improve progression-free survival or overall survival in patients who have already received prior treatments. The study focuses on patients with locally advanced or metastatic NSCLC who cannot be cured with surgery or radiation. Participants will be randomly assigned in equal groups to receive either daraxonrasib tablets or docetaxel by intravenous infusion. The treatments will be given according to the study plan, and participants will be monitored over about four years. The study includes careful assessment of response to treatment, safety, quality of life, and drug characteristics during this period. During the trial, participants will undergo regular evaluations including imaging scans to measure tumor size, assessments of side effects, blood tests to check organ function, and questionnaires about quality of life. Researchers will track how long patients live without disease progression and overall survival, along with treatment effects and tolerability. This follow-up and monitoring will continue for up to approximately four years, ensuring comprehensive data collection throughout the study duration.

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)