NCT06881784 Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
| NCT ID | NCT06881784 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Revolution Medicines, Inc. |
| Condition | NSCLC (Non-small Cell Lung Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 590 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 590 participants in total. It began in 2025-05-06 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06881784 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC (Non-small Cell Lung Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06881784 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 590 participants.
Is NCT06881784 currently recruiting?
Yes, NCT06881784 is actively recruiting participants. Contact the research team at medinfo@revmed.com for enrollment information.
Where is the NCT06881784 trial being conducted?
This trial is being conducted at Birmingham, United States, Long Beach, United States, New Haven, United States, Fort Myers, United States and 11 additional locations.
Who is sponsoring the NCT06881784 clinical trial?
NCT06881784 is sponsored by Revolution Medicines, Inc.. The trial plans to enroll 590 participants.
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