Study of Daraxonrasib (RMC-6236) in Previously Treated Patients With RAS Mutated NSCLC (RASolve 301)
Sponsor: Revolution Medicines, Inc.
ClinicalTrials ID:NCT06881784
This Phase 3 study assesses daraxonrasib's impact on PFS and OS versus docetaxel in NSCLC patients. Eligible participants are adults with ECOG 0-1, confirmed RAS-mutated NSCLC, measurable disease, and prior therapy. Interventions include oral daraxonrasib and IV docetaxel. Participants must have adequate organ function and be able to take oral medications.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
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 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.
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.
- Histologically 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.
- Pregnancy and/or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Taylor Cancer Research Center | 43537 | Maumee | Ohio |
| SCRI Oncology Partners - Tennessee | 37203 | Nashville | Tennessee |
| Utah Cancer Specialists | 84106 | Salt Lake City | Utah |
| Virginia Cancer Specialists | 22031 | Fairfax | Virginia |
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