Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
Purpose
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
Conditions
- 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)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- The central reader of the tumor scans will be masked to the patients' treatment arm.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental daraxonrasib |
study drug |
|
|
Active Comparator docetaxel |
Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy. |
|
Recruiting Locations
Alabama Oncology
Birmingham, Alabama 35243
Birmingham, Alabama 35243
Contact:
Stephanie (Sherbet) Abercrombie, CRC
205-803-4369
Stephanie.Abercrombie@alabamaoncology.com
Stephanie (Sherbet) Abercrombie, CRC
205-803-4369
Stephanie.Abercrombie@alabamaoncology.com
MemorialCare Long Beach Medical Center
Long Beach, California 90806
Long Beach, California 90806
Yale University, Smillow Cancer Center
New Haven, Connecticut 06519
New Haven, Connecticut 06519
Florida Cancer Specialists & Research Institute - South
Fort Myers, Florida 33901
Fort Myers, Florida 33901
BRCR Global
Plantation, Florida 33322
Plantation, Florida 33322
Cancer Care Centers of Breevard
Rockledge, Florida 32955
Rockledge, Florida 32955
Florida Cancer Specialists & Research Institute - North
St. Petersburg, Florida 33705
St. Petersburg, Florida 33705
Cleveland Clinic Martin North
Stuart, Florida 34994
Stuart, Florida 34994
Florida Cancer Specialists & Research Institute - East
West Palm Beach, Florida 33401
West Palm Beach, Florida 33401
University Cancer and Blood Center
Athens, Georgia 30607
Athens, Georgia 30607
Piedmont Healthcare, Inc
Atlanta, Georgia 30318
Atlanta, Georgia 30318
Winship Cancer Institute
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Center for Care and Discovery
Chicago, Illinois 60637
Chicago, Illinois 60637
University of Iowa Health Care Cancer Services Quad Cities
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University of Iowa Health Care, Mission Cancer + Blood
Waukee, Iowa 50263
Waukee, Iowa 50263
The University of Kansas Cancer Center
Westwood, Kansas 66205
Westwood, Kansas 66205
Johns Hopkins University of Medicine
Baltimore, Maryland 21224
Baltimore, Maryland 21224
Karmanos Cancer Institute
Detroit, Michigan 48201
Detroit, Michigan 48201
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri 63110
St Louis, Missouri 63110
St. Vincent Frontier Cancer Center
Billings, Montana 59102
Billings, Montana 59102
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Morristown Medical Center (MMCORC)
Morristown, New Jersey 07960
Morristown, New Jersey 07960
Roswell Park Cancer Institute
Buffalo, New York 14263
Buffalo, New York 14263
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Montefiore Medical Center
The Bronx, New York 10461
The Bronx, New York 10461
UNC Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
TriHealth Cancer & Blood Institute Research
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
Taylor Cancer Research Center
Maumee, Ohio 43537
Maumee, Ohio 43537
Oncology Associates of Oregon PC
Eugene, Oregon 97401
Eugene, Oregon 97401
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
Avera Saint Luke's Hospital
Aberdeen, South Dakota 57401
Aberdeen, South Dakota 57401
Avera Cancer Institute
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57105
SCRI Oncology Partners - Tennessee
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Texas Oncology - South Austin
Austin, Texas 78745
Austin, Texas 78745
Texas Oncology Dallas
Dallas, Texas 75251
Dallas, Texas 75251
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Texas Oncology - Gulf Coast
The Woodlands, Texas 77380
The Woodlands, Texas 77380
Utah Cancer Specialists
Salt Lake City, Utah 84106
Salt Lake City, Utah 84106
Huntsman Cancer Institute
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Virginia Cancer Specialists
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Pan American Center for Oncology Trials
San Juan, Puerto Rico, Puerto Rico 00909
San Juan, Puerto Rico, Puerto Rico 00909
More Details
- Status
- Recruiting
- Sponsor
- Revolution Medicines, Inc.
Detailed Description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated. Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.