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Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
RecruitingPhase 3
RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC
Who can join
Ages 18 and older · All sexes
Full 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.
* 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.
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.
* Pregnant or breastfeeding.
About the study
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
What is being tested
- daraxonrasib (drug)
- docetaxel (drug)
Sponsor: Revolution Medicines, Inc. · Participants: 590 · Started: May 6, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06881784
Locations in the U.S.
| Alabama | Alabama Oncology, Birmingham |
| California | MemorialCare Long Beach Medical Center, Long Beach |
| Connecticut | Yale University, Smillow Cancer Center, New Haven |
| Florida | Florida Cancer Specialists & Research Institute - South, Fort Myers BRCR Global, Plantation Cancer Care Centers of Breevard, Rockledge Florida Cancer Specialists & Research Institute - North, St. Petersburg Cleveland Clinic Martin North, Stuart Florida Cancer Specialists & Research Institute - East, West Palm Beach |
| Georgia | University Cancer and Blood Center, Athens Piedmont Healthcare, Inc, Atlanta Winship Cancer Institute, Atlanta |
| Illinois | Center for Care and Discovery, Chicago University of Illinois Cancer Center, Chicago |
| Iowa | University of Iowa Health Care Cancer Services Quad Cities, Bettendorf University of Iowa Hospitals & Clinics, Iowa City University of Iowa Health Care, Mission Cancer + Blood, Waukee |
| Kansas | The University of Kansas Cancer Center, Westwood |
| Maryland | Johns Hopkins University of Medicine, Baltimore |
| Michigan | Trinity Health Ann Arbor Hospital, Ann Arbor Henry Ford Health, Detroit Karmanos Cancer Institute, Detroit |
| Missouri | Washington University School of Medicine - Siteman Cancer Center, St Louis |
| Montana | St. Vincent Frontier Cancer Center, Billings |
| New Hampshire | Dartmouth-Hitchcock Medical Center, Lebanon |
| New Jersey | John Theurer Cancer Center at Hackensack UMC, Hackensack Morristown Medical Center (MMCORC), Morristown |
| New York | Roswell Park Cancer Institute, Buffalo Memorial Sloan Kettering Cancer Center, New York Montefiore Medical Center, The Bronx |
| North Carolina | UNC Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill |
| Ohio | TriHealth Cancer & Blood Institute Research, Cincinnati Taylor Cancer Research Center, Maumee |
| Oregon | Oncology Associates of Oregon PC, Eugene |
| Pennsylvania | Penn State Milton S. Hershey Medical Center, Hershey |
| South Dakota | Avera Saint Luke's Hospital, Aberdeen Avera Cancer Institute, Sioux Falls |
| Tennessee | SCRI Oncology Partners - Tennessee, Nashville |
| Texas | Texas Oncology - South Austin, Austin Texas Oncology Dallas, Dallas MD Anderson Cancer Center, Houston Texas Oncology - Gulf Coast, The Woodlands |
| Utah | Huntsman Cancer Institute, Salt Lake City Utah Cancer Specialists, Salt Lake City |
| Virginia | Virginia Cancer Specialists, Fairfax |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.