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

Recruiting now · Phase 3

Conditions studied: NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma), NSCLC (Advanced Non-small Cell Lung Cancer)

In brief

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

Key facts

Study ID

NCT06881784

Run by

Revolution Medicines, Inc.

People needed

590

Starts

2025-05-06

Expected to finish

2030-12-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• MemorialCare Long Beach Medical Center — Long Beach, California, United States (enrolling)
• Yale University, Smillow Cancer Center — New Haven, Connecticut, United States (enrolling)
• Florida Cancer Specialists & Research Institute - South — Fort Myers, Florida, United States (enrolling)
• BRCR Global — Plantation, Florida, United States (enrolling)
• Cancer Care Centers of Breevard — Rockledge, Florida, United States (enrolling)
• Florida Cancer Specialists & Research Institute - North — St. Petersburg, Florida, United States (enrolling)
• Cleveland Clinic Martin North — Stuart, Florida, United States (enrolling)
• Florida Cancer Specialists & Research Institute - East — West Palm Beach, Florida, United States (enrolling)
• University Cancer and Blood Center — Athens, Georgia, United States (enrolling)
• Piedmont Healthcare, Inc — Atlanta, Georgia, United States (enrolling)
• Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Center for Care and Discovery — Chicago, Illinois, United States (enrolling)
• University of Iowa Health Care Cancer Services Quad Cities — Bettendorf, Iowa, United States (enrolling)
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (enrolling)
• University of Iowa Health Care, Mission Cancer + Blood — Waukee, Iowa, United States (enrolling)
• The University of Kansas Cancer Center — Westwood, Kansas, United States (enrolling)
• Johns Hopkins University of Medicine — Baltimore, Maryland, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
• St. Vincent Frontier Cancer Center — Billings, Montana, United States (enrolling)
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• John Theurer Cancer Center at Hackensack UMC — Hackensack, New Jersey, United States (enrolling)
• Morristown Medical Center (MMCORC) — Morristown, New Jersey, United States (enrolling)
• Alabama Oncology — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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