Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
- Registration Number
- NCT05054725
- Lead Sponsor
- Revolution Medicines, Inc.
- Brief Summary
The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC
- Detailed Description
This is a phase 2 multicenter, open-label study evaluating the efficacy, safety, tolerability, and pharmacokinetics (PK) of RMC-4630 in combination with sotorasib in subjects with KRASG12C mutant NSCLC after failure of prior standard therapies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- Subject must be ≥18 years of age.
- 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
- Primary central nervous system (CNS) tumors
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description RMC-4630 and sotorasib, Safety Run-in RMC-4630 Safety Run-In: RMC-4630 and sotorasib RMC-4630 and sotorasib, Safety Run-in Sotorasib Safety Run-In: RMC-4630 and sotorasib RMC-4630 and sotorasib, Expansion RMC-4630 Dose Expansion: RMC-4630 and sotorasib RMC-4630 and sotorasib, Expansion Sotorasib Dose Expansion: RMC-4630 and sotorasib
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) approximately 12 months ORR as assessed per RECIST v1.1
- Secondary Outcome Measures
Name Time Method Concentration of sotorasib approximately 12 months Trough Concentration of sotorasib
Vital signs approximately 12 months Number of subjects with clinically significant changes in vital signs
ECGs Measurements approximately 12 months Number of subjects with clinically significant changes in ECGs Measurements
Serious Adverse Events approximately 12 months Number of Participants with Serious Adverse Events
Overall survival (OS) approximately 12 months Overall survival (OS)
Clinical laboratory test values approximately 12 months Number of subjects with clinically significant changes in clinical laboratory test values
Duration of response (DOR) approximately 12 months DOR as assessed by RECIST v1.1
Adverse Events approximately 12 months Number of Participants with Adverse Events
Concentration of RMC-4630 approximately 12 months Trough Concentration of RMC-4630
Progression-free survival (PFS) approximately 12 months PFS as assessed by RECIST v1.1
Disease Control Rate (DCR) approximately 12 months DCR as assessed by RECIST v1.1
Trial Locations
- Locations (59)
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
BRCR Medical Center Inc.
🇺🇸Plantation, Florida, United States
Hematology Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
New England Cancer Specialists
🇺🇸Scarborough, Maine, United States
Cancer Specialists of North Florida
🇺🇸Saint Augustine, Florida, United States
Maryland Oncology Hematology, P.A.
🇺🇸Columbia, Maryland, United States
New Jersey Center for Cancer Research
🇺🇸Brick, New Jersey, United States
Charleston Oncology
🇺🇸Charleston, South Carolina, United States
Tennessee Oncology
🇺🇸Chattanooga, Tennessee, United States
South West Oncology
🇦🇺Warrnambool, Victoria, Australia
William Osler Health System
🇨🇦Mississauga, Ontario, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
APHM Hopital Nord, Service d'Oncologie Multidisciplinaire et innovations therapeutics
🇫🇷Marseille, France
Asklepios Fachkliniken Munchen
🇩🇪Gauting, Bavaria, Germany
Lungenklinik Hemer
🇩🇪Hemer, North Rhine- Westphalia, 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
Istituto Europeo Di Oncologia
🇮🇹Milano, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
The Royal Marsden NHS Foundation Trust
🇬🇧Sutton, Surrey, United Kingdom
Bethanien Hospital Moers
🇩🇪Moers, North Rhine-Westphalia, Germany
Lung Cancer Center, University of Saarland
🇩🇪Homburg, Saarland, Germany
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
American Oncology Partners of Maryland, PA
🇺🇸Bethesda, Maryland, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
GenHarp Clinical Solutions
🇺🇸Evergreen Park, Illinois, United States
University of New Mexico Comprehensive Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Clinical Research Alliance, Inc.
🇺🇸New York, New York, United States
Roswell Park cancer Institute
🇺🇸Buffalo, New York, United States
Zangmeister Cancer Center
🇺🇸Columbus, Ohio, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
CHRISTUS St. Michael-Colom and Carney Clinic P.A
🇺🇸Texarkana, Texas, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Blacktown Hospital
🇦🇺Blacktown, Australia
Goulburn Valley Health
🇦🇺Shepparton, Australia
Northwest Cancer specialists, P.C.
🇺🇸Vancouver, Washington, United States
Hospital Larrey Universite Paul Sabatier
🇫🇷Toulouse, France
Klinikum Esslingen GmbH
🇩🇪Esslingen, Baden-Wurttemberg, Germany
Comprehensive Cancer Center Mainfranken, University Wuerzburg
🇩🇪Homburg, Saarland, Germany
POIS Sachsen GmbH
🇩🇪Leipzig, Sachsen, Germany
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
🇮🇹Orbassano, Piedmont, Italy
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Galicia, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Andalucia, Spain
Clinica Universidad de Navarra
🇪🇸Madrid, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Catalonia, Spain
Hospital Universitario y Politecnico La Fe
🇪🇸Valencia, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
E-DA Hospital
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
The Christie NHS Foundation Trust
🇬🇧Manchester, Greater Manchester, United Kingdom