Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC
Sponsor: Revolution Medicines, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression free survival (PFS) per Blinded Independent Central Review (BICR) in the RAS G12X-C population (i.e RAS G12X excluding G12C)
Time frame: Up to approximately 4 years
Overall survival (OS) in the RAS G12X-C population
Time frame: Up to approximately 4 years
Secondary Endpoints
PFS in the RAS (MUT) population per BICR
OS in the RAS (MUT) population
Objective response per BICR in the RAS (G12X-C) and RAS (MUT) populations
Eligibility Criteria
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy. * Measurable disease per RECIST v1.1. * Adequate organ function (bone marrow, liver, kidney, coagulation). * One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy. * Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61). * Able to take oral medications. Exclusion Criteria: * Prior therapy with direct RAS-targeted therapy or docetaxel. * Untreated central nervous system (CNS) metastases. * Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function). * Ongoing anticancer therapy. * Pregnant or breastfeeding.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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