RecruitingPhase 3NCT06881784
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.
Enrollment
420 participants
Start Date
May 6, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria5
- 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.
Interventions
DRUGdaraxonrasib
oral tablets
DRUGdocetaxel
intravenous (IV) infusion
Locations(129)
View Full Details on ClinicalTrials.gov
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NCT06881784
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