Status:
RECRUITING
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
Lead Sponsor:
Revolution Medicines, Inc.
Conditions:
NSCLC (Non-small Cell Lung Cancer)
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Detailed Description
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 docet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06881784
Start Date
May 6 2025
End Date
December 1 2030
Last Update
December 24 2025
Active Locations (101)
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1
Alabama Oncology
Birmingham, Alabama, United States, 35243
2
MemorialCare Long Beach Medical Center
Long Beach, California, United States, 90806
3
Yale University, Smillow Cancer Center
New Haven, Connecticut, United States, 06519
4
Florida Cancer Specialists & Research Institute - South
Fort Myers, Florida, United States, 33901