Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
Recruiting · NCT06881784 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 24 US states.
- 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
- Piedmont Healthcare, Inc - Atlanta, Georgia, United States
- Winship Cancer Institute - Atlanta, Georgia, United States
- Center for Care and Discovery - Chicago, Illinois, United States
- University of Iowa Health Care Cancer Services Quad Cities - Bettendorf, Iowa, United States
- University of Iowa Hospitals & Clinics - Iowa City, Iowa, United States
- University of Iowa Health Care, Mission Cancer + Blood - Waukee, Iowa, 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
- John Theurer Cancer Center at Hackensack UMC - Hackensack, New Jersey, United States
- Morristown Medical Center (MMCORC) - Morristown, New Jersey, United States
- Roswell Park Cancer Institute - Buffalo, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Montefiore Medical Center - The Bronx, New York, United States
- UNC Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, North Carolina, United States
- TriHealth Cancer & Blood Institute Research - Cincinnati, Ohio, United States
- Taylor Cancer Research Center - Maumee, Ohio, United States
- Oncology Associates of Oregon PC - Eugene, Oregon, United States
- Penn State Milton S. Hershey Medical Center - Hershey, Pennsylvania, United States
- Avera Saint Luke's Hospital - Aberdeen, South Dakota, United States
- Avera Cancer Institute - Sioux Falls, South Dakota, United States
- SCRI Oncology Partners - Tennessee - Nashville, Tennessee, United States
- Texas Oncology - South Austin - Austin, Texas, United States
- Texas Oncology Dallas - Dallas, Texas, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- Texas Oncology - Gulf Coast - The Woodlands, Texas, United States
- Utah Cancer Specialists - Salt Lake City, Utah, United States
- Huntsman Cancer Institute - Salt Lake City, Utah, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- Antoni van Leeuwenhoek - Amsterdam, Netherlands
- Klinikum Esslingen GmbH - Baden, Germany
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- Universitätsspital Basel - Basel, Switzerland
- Evangelische Lungenklinik Berlin - Berlin, Germany
- CHU Brest - Hôpital Morvan - Brest, France
- Chungbuk National University Hospital - Cheongju-si, South Korea
- Tallaght University Hospital - Dublin, Ireland
- Beaumont Hospital Cancer Clinical - Dublin, Ireland
- HFR Fribourg/Kantonsspital Fribourg - Fribourg, Switzerland
- Galway University Hospital - Galway, Ireland
- Klinika Onkologii I Radioterapii UCK - Gdansk, Poland
- Grand Hôpital de Charleroi - Les Viviers - Gilly, Belgium
- Institut Bergonie - Gironde, France
- Hong Kong United Oncology Centre - Hong Kong, Hong Kong
- Queen Mary Hospital - Hong Kong, Hong Kong
- Chonnam National University Hwasun Hospital - Hwasun, South Korea
Showing 60 of 153 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →