NCT06881784From ClinicalTrials.govRecruiting

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

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

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)

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Revolution Medicines, Inc.
Enrolment target: 590
Started: 6 May 2025
Main results due: 1 December 2027
Study sites: 158
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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.

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(158)

Alabama Oncology
Birmingham, Alabama, United States
Recruiting
MemorialCare Long Beach Medical Center
Long Beach, California, United States
Recruiting
Yale University, Smillow Cancer Center
New Haven, Connecticut, United States
Recruiting
Florida Cancer Specialists & Research Institute - South
Fort Myers, Florida, United States
Recruiting
BRCR Global
Plantation, Florida, United States
Recruiting
Cancer Care Centers of Breevard
Rockledge, Florida, United States
Recruiting
Florida Cancer Specialists & Research Institute - North
St. Petersburg, Florida, United States
Recruiting
Cleveland Clinic Martin North
Stuart, Florida, United States
Recruiting
Florida Cancer Specialists & Research Institute - East
West Palm Beach, Florida, United States
Recruiting
University Cancer and Blood Center
Athens, Georgia, United States
Recruiting
Piedmont Healthcare, Inc
Atlanta, Georgia, United States
Recruiting
Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
University of Illinois Cancer Center
Chicago, Illinois, United States
Recruiting
Center for Care and Discovery
Chicago, Illinois, United States
Recruiting
University of Iowa Health Care Cancer Services Quad Cities
Bettendorf, Iowa, United States
Recruiting
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Recruiting
University of Iowa Health Care, Mission Cancer + Blood
Waukee, Iowa, United States
Recruiting
The University of Kansas Cancer Center
Westwood, Kansas, United States
Recruiting
Johns Hopkins University of Medicine
Baltimore, Maryland, United States
Recruiting
Trinity Health Ann Arbor Hospital
Ann Arbor, Michigan, United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Recruiting
Henry Ford Health
Detroit, Michigan, United States
Recruiting
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
Recruiting
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Recruiting
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Recruiting
Morristown Medical Center (MMCORC)
Morristown, New Jersey, United States
Recruiting
Roswell Park Cancer Institute
Buffalo, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
UNC Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, United States
Recruiting
TriHealth Cancer & Blood Institute Research
Cincinnati, Ohio, United States
Recruiting
Taylor Cancer Research Center
Maumee, Ohio, United States
Recruiting
Oncology Associates of Oregon PC
Eugene, Oregon, United States
Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Recruiting
Avera Saint Luke's Hospital
Aberdeen, South Dakota, United States
Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Recruiting
SCRI Oncology Partners - Tennessee
Nashville, Tennessee, United States
Recruiting
Texas Oncology - South Austin
Austin, Texas, United States
Recruiting
Texas Oncology Dallas
Dallas, Texas, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States
Recruiting
Utah Cancer Specialists
Salt Lake City, Utah, United States
Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, United States
Recruiting
Blacktown Medical Oncology Research, Blacktown Hospital
Blacktown, New South Wales, Australia
Recruiting
Blacktown Medical Oncology Research
Blacktown, New South Wales, Australia
Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Recruiting
St. George Private Hospital Clinical Trials Unit
Kogarah, New South Wales, Australia
Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Recruiting
Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Recruiting
Alfred House
Melbourne, Victoria, Australia
Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Recruiting
Institut Jules Bordet
Anderlecht, Belgium, Belgium
Recruiting
Grand Hôpital de Charleroi - Les Viviers
Gilly, Belgium
Recruiting
AZ Groeninge
Kortrijk, Belgium
Recruiting
UZ Leuven-Campus Gasthuisberg
Leuven, Belgium
Recruiting
AZ Delta
Roeselare, Belgium
Recruiting
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, Bas Rhin, France
Recruiting
Hopital Nord - CHU Marseille
Marseille, Bouches-du-Rhône, France
Recruiting

Showing 60 of 158 sites — filter to narrow it down. 158 of the 158 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06881784. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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