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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - At least 18 years old and has provided willing to sign a consent form. - 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. - tumors that can be measured on scans v1.1. - your organs (liver, kidneys, etc.) are working well enough based on blood tests (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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

daraxonrasib

oral tablets

DRUG

docetaxel

intravenous (IV) infusion

Locations (20)

Alabama Oncology
Birmingham, Alabama, United States
MemorialCare Long Beach Medical Center
Long Beach, California, United States
Yale University, Smillow Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists & Research Institute - South
Fort Myers, Florida, United States
BRCR Global
Plantation, Florida, United States
Cancer Care Centers of Breevard
Rockledge, Florida, United States
Florida Cancer Specialists & Research Institute - North
St. Petersburg, Florida, United States
Cleveland Clinic Martin North
Stuart, Florida, United States
Florida Cancer Specialists & Research Institute - East
West Palm Beach, Florida, United States
University Cancer and Blood Center
Athens, Georgia, United States
Center for Care and Discovery
Chicago, Illinois, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Johns Hopkins University of Medicine
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Morristown Medical Center (MMCORC)
Morristown, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States