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Phase 3Recruiting

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

Sponsored by Revolution Medicines, Inc.

About this study

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated. Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.

Where this study is enrolling (43)

Show all 43 locations
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.