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Clinical Trials in the UK / NCT06881784
Recruiting Phase 3

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

NCT06881784 · tracked via the Priya Life Science UK tracker
Sponsor
Revolution Medicines, Inc.
Phase
Phase 3
Started
2025-05-06
Last updated
2026-08-27

Condition(s) studied

NSCLC (Non-small Cell Lung Cancer)Non-Small Cell Lung CancerNSCLCNSCLC (Non-small Cell Lung Carcinoma)NSCLC (Advanced Non-small Cell Lung Cancer)

Investigational drug(s) / intervention(s)

daraxonrasibdocetaxel

daraxonrasib: oral tablets

docetaxel: intravenous (IV) infusion

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (153)

FacilityCityRegionStatus
Alabama Oncology Birmingham Alabama Recruiting
MemorialCare Long Beach Medical Center Long Beach California Recruiting
Yale University, Smillow Cancer Center New Haven Connecticut Recruiting
Florida Cancer Specialists & Research Institute - South Fort Myers Florida Recruiting
BRCR Global Plantation Florida Recruiting
Cancer Care Centers of Breevard Rockledge Florida Recruiting
Florida Cancer Specialists & Research Institute - North St. Petersburg Florida Recruiting
Cleveland Clinic Martin North Stuart Florida Recruiting
Florida Cancer Specialists & Research Institute - East West Palm Beach Florida Recruiting
University Cancer and Blood Center Athens Georgia Recruiting
Piedmont Healthcare, Inc Atlanta Georgia Recruiting
Winship Cancer Institute Atlanta Georgia Recruiting
Center for Care and Discovery Chicago Illinois Recruiting
University of Iowa Health Care Cancer Services Quad Cities Bettendorf Iowa Recruiting
University of Iowa Hospitals & Clinics Iowa City Iowa Recruiting
University of Iowa Health Care, Mission Cancer + Blood Waukee Iowa Recruiting
The University of Kansas Cancer Center Westwood Kansas Recruiting
Johns Hopkins University of Medicine Baltimore Maryland Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Henry Ford Health Detroit Michigan Recruiting
Washington University School of Medicine - Siteman Cancer Center St Louis Missouri Recruiting
St. Vincent Frontier Cancer Center Billings Montana Recruiting
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire Recruiting
John Theurer Cancer Center at Hackensack UMC Hackensack New Jersey Recruiting
Morristown Medical Center (MMCORC) Morristown New Jersey Recruiting
Roswell Park Cancer Institute Buffalo New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
UNC Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill North Carolina Recruiting
TriHealth Cancer & Blood Institute Research Cincinnati Ohio Recruiting
Taylor Cancer Research Center Maumee Ohio Recruiting
Oncology Associates of Oregon PC Eugene Oregon Recruiting
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania Recruiting
Avera Saint Luke's Hospital Aberdeen South Dakota Recruiting
Avera Cancer Institute Sioux Falls South Dakota Recruiting
SCRI Oncology Partners - Tennessee Nashville Tennessee Recruiting
Texas Oncology - South Austin Austin Texas Recruiting
Texas Oncology Dallas Dallas Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Texas Oncology - Gulf Coast The Woodlands Texas Recruiting

+ 113 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06881784 on ClinicalTrials.gov ↗ ← All trials in the UK