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

Launched by REVOLUTION MEDICINES, INC. · Mar 10, 2025

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ClinConnect Summary

The RASolve 301 clinical trial is studying a new medication called Daraxonrasib (RMC-6236) to see how safe and effective it is for patients with a type of lung cancer known as non-small cell lung cancer (NSCLC) that has specific genetic changes called RAS mutations. This trial is aimed at patients who have already received one or two previous treatments for their cancer, including certain types of chemotherapy and immunotherapy. The study will compare the effects of Daraxonrasib to a standard treatment called docetaxel.

To be eligible for this trial, participants should be at least 18 years old, have confirmed NSCLC that cannot be cured with surgery or radiation, and have a measurable disease. They should also have good overall health and organ function. However, those who have received certain prior treatments or have serious health issues may not qualify. If you or a loved one participates in this trial, you can expect to take the study medication orally and attend regular check-ups to monitor your health and the effects of the treatment. This trial is currently recruiting participants, and it offers an opportunity to access a potentially promising new treatment for advanced lung cancer.

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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.