Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
18 Years and older, Male and Female
RMC-6236-301 (primary)
NCI-2025-02939
Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON)
inhibitor compared to docetaxel.
Objectives
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
- 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.
Treatment Sites in Georgia
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