Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
NCT ID: NCT05054725
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2021-12-30
2024-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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RMC-4630 and sotorasib, Safety Run-in
Safety Run-In:
RMC-4630 and sotorasib
RMC-4630
RMC-4630 administered orally as a capsule
Sotorasib
Sotorasib administered orally as a tablet
RMC-4630 and sotorasib, Expansion
Dose Expansion:
RMC-4630 and sotorasib
RMC-4630
RMC-4630 administered orally as a capsule
Sotorasib
Sotorasib administered orally as a tablet
Interventions
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RMC-4630
RMC-4630 administered orally as a capsule
Sotorasib
Sotorasib administered orally as a tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must have pathologically documented, locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed)
Exclusion Criteria
* Known or suspected leptomeningeal or brain metastases or spinal cord compression
* Clinically significant cardiac disease
* Known impairment of GI function that would alter the absorption
* Active autoimmune disease requiring systemic treatment within past 2 years
* History of severe allergic reactions to any of the study intervention components
* Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
* Prior therapy with KRASG12C inhibitor and/or SHP2 inhibitor
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Amgen
INDUSTRY
Revolution Medicines, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Revolution Medicines, Inc.
Role: STUDY_DIRECTOR
Revolution Medicines, Inc.
Locations
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Florida Cancer Specialists
Fort Myers, Florida, United States
BRCR Medical Center Inc.
Plantation, Florida, United States
Cancer Specialists of North Florida
Saint Augustine, Florida, United States
GenHarp Clinical Solutions
Evergreen Park, Illinois, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
New England Cancer Specialists
Scarborough, Maine, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New Jersey Center for Cancer Research
Brick, New Jersey, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Roswell Park cancer Institute
Buffalo, New York, United States
Clinical Research Alliance, Inc.
New York, New York, United States
Zangmeister Cancer Center
Columbus, Ohio, United States
Charleston Oncology
Charleston, South Carolina, United States
Tennessee Oncology
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
CHRISTUS St. Michael-Colom and Carney Clinic P.A
Texarkana, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Northwest Cancer specialists, P.C.
Vancouver, Washington, United States
South West Oncology
Warrnambool, Victoria, Australia
Blacktown Hospital
Blacktown, , Australia
Goulburn Valley Health
Shepparton, , Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
William Osler Health System
Mississauga, Ontario, Canada
APHM Hopital Nord, Service d'Oncologie Multidisciplinaire et innovations therapeutics
Marseille, , France
Hospital Larrey Universite Paul Sabatier
Toulouse, , France
Klinikum Esslingen GmbH
Esslingen am Neckar, Baden-Wurttemberg, Germany
Asklepios Fachkliniken Munchen
Gauting, Bavaria, Germany
Lungenklinik Hemer
Hemer, North Rhine-Westphalia, Germany
Bethanien Hospital Moers
Moers, North Rhine-Westphalia, Germany
Comprehensive Cancer Center Mainfranken, University Wuerzburg
Homburg, Saarland, Germany
Lung Cancer Center, University of Saarland
Homburg, Saarland, Germany
POIS Sachsen GmbH
Leipzig, Saxony, Germany
Charite Benjamin Franklin Comprehensive Cancer center
Berlin, , Germany
Evangelische Lung Clinic
Berlin, , Germany
Hamato-Onkologie Hamburg
Hamburg, , Germany
Azienda Ospedaliera dei Colli
Napoli, Campania, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Piedmont, Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Chungbuk National University Hospital
Cheongju-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, Galicia, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Clinica Universidad de Navarra
Madrid, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
E-DA Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RMC-4630-03
Identifier Type: -
Identifier Source: org_study_id
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