NCT05054725CompletedPhase 2
Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 14 Sept 2021
- Start date
- 30 Dec 2021
- Primary completion date
- 3 Jul 2024
- Lead sponsor
- Revolution Medicines, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT05054725
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 47
- From 30 Dec 2021 to the primary completion date, 3 Jul 2024
- 60 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Primary central nervous system (CNS) tumors
- Known or suspected leptomeningeal or brain metastases or spinal cord compression
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (60)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blacktown Hospital Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| Goulburn Valley Health Coordinator of this site? Confirm its status | Shepparton | Australia | Unknown status |
| South West Oncology Coordinator of this site? Confirm its status | Warrnambool | Australia | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| William Osler Health System Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| Evangelische Lung Clinic Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Charite Benjamin Franklin Comprehensive Cancer center Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Klinikum Esslingen GmbH Coordinator of this site? Confirm its status | Esslingen am Neckar | Germany | Unknown status |
| Asklepios Fachkliniken Munchen Coordinator of this site? Confirm its status | Gauting | Germany | Unknown status |
| Hamato-Onkologie Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Lungenklinik Hemer Coordinator of this site? Confirm its status | Hemer | Germany | Unknown status |
| Comprehensive Cancer Center Mainfranken, University Wuerzburg Coordinator of this site? Confirm its status | Homburg | Germany | Unknown status |
| Lung Cancer Center, University of Saarland Coordinator of this site? Confirm its status | Homburg | Germany | Unknown status |
| POIS Sachsen GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Bethanien Hospital Moers Coordinator of this site? Confirm its status | Moers | Germany | Unknown status |
| Complejo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| APHM Hopital Nord, Service d'Oncologie Multidisciplinaire et innovations therapeutics Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hospital Larrey Universite Paul Sabatier Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| Istituto Europeo di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Sanitaria Ospedaliera S Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| E-DA Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| University of New Mexico Comprehensive Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Hematology/Oncology Clinic Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| American Oncology Partners of Maryland, PA Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| New Jersey Center for Cancer Research Coordinator of this site? Confirm its status | Brick | United States | Unknown status |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Charleston Oncology Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Tennessee Oncology Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Maryland Oncology Hematology P.A. Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Zangmeister Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| GenHarp Clinical Solutions Coordinator of this site? Confirm its status | Evergreen Park | United States | Unknown status |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Minnesota Oncology Hematology, P.A. Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Clinical Research Alliance, Inc. Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Nebraska Cancer Specialists Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| BRCR Medical Center Inc Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Cancer Specialists of North Florida Coordinator of this site? Confirm its status | Saint Augustine | United States | Unknown status |
| New England Cancer Specialists Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| CHRISTUS St. Michael-Colom and Carney Clinic P.A Coordinator of this site? Confirm its status | Texarkana | United States | Unknown status |
| Northwest Cancer Specialists, P.C. Coordinator of this site? Confirm its status | Vancouver | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.