Revolution Medicines, Inc. announced on May 14, 2025, that the first patient has been dosed in RASolve 301, a global, randomized, open-label Phase 3 clinical trial. This study evaluates daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor, in patients with previously treated, locally advanced or metastatic RAS mutant non-small cell lung cancer (NSCLC) compared to docetaxel chemotherapy.
The RASolve 301 trial is anticipated to enroll approximately 420 patients worldwide who have received one to two prior lines of therapy, including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy. The study's dual primary endpoints are progression-free survival (PFS) and overall survival (OS) in the core patient population, which includes patients with NSCLC carrying RAS G12X mutations.
This pivotal trial represents a significant step in developing daraxonrasib for NSCLC, where RAS mutations drive tumor growth in 30% of cases and approved targeted drugs are lacking for most RAS cancer drivers. The decision to evaluate daraxonrasib as monotherapy in this setting was informed by early evidence of an acceptable safety profile and encouraging antitumor activity from a single-arm trial.
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