RecruitingNSCLC (Non-small Cell Lung Cancer)Non-Small Cell Lung CancerNSCLC

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

Eligible age

18+ yrs

Accepts

All genders

Locations

24 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

Sponsor: Revolution Medicines, Inc.

✓ 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.

✕ 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.