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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC

Sponsor: Revolution Medicines, Inc. • ClinicalTrials.gov ID: NCT06162221

Registry updated: 2026-10-19
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Description

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other. The first four subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805

Interventions

  • RMC-6291 (Drug)
    Oral tablet
  • RMC-6236 (Drug)
    Oral tablet
  • Pembrolizumab (Drug)
    IV Infusion
  • Cisplatin (Drug)
    IV Infusion
  • Carboplatin (Drug)
    IV Infusion
  • Pemetrexed (Drug)
    IV infusion
  • RMC-9805 (Drug)
    Oral Tablet

Eligibility criteria

Inclusion criteria: All Patients (unless otherwise noted): * ≥ 18 years of age * ECOG PS is 0 to 1 * Adequate organ function as outlined by the study * Received prior standard therapy appropriate for tumor type and stage * Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A) * Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B) * Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C and Subprotocol D) Exclusion criteria: All Patients: * Primary central nervous system (CNS) tumors * Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs * Major surgery \< 28 days of first dose * Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids Other inclusion/exclusion criteria may apply.

Conditions

Non-Small Cell Lung Cancer, NSCLC KRAS, NRAS, HRAS-mutated NSCLC KRAS G12C-mutated Solid Tumors, Lung Cancer Lung Cancer Stage IV, Advanced Solid Tumor, Cancer RAS G12D-mutated NSCLC

Locations

  • Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
  • City of Hope - Duarte — Duarte, California, United States
  • City of Hope - Lennar — Irvine, California, United States
  • University of California Los Angeles — Los Angeles, California, United States
  • UC Davis, Davis Comprehensive Cancer Center — Sacramento, California, United States
  • University of California, San Diego Moores Cancer Center — San Diego, California, United States
  • UCSF Medical Center - Mission Bay — San Francisco, California, United States
  • Stanford University - Stanford Cancer Institute — Stanford, California, United States
  • Kaiser Permanente — Vallejo, California, United States
  • Georgetown University Medical Center — Washington D.C., District of Columbia, United States
  • Boca Raton Clinical Research Associates — Plantation, Florida, United States
  • Cancer Specialists of North Florida — Saint Augustine, Florida, United States
  • H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
  • Dana Farber Cancer Institute — Boston, Massachusetts, United States
  • Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) — Detroit, Michigan, United States
  • Intermountain Health - St. Vincent Frontier Cancer Center — Billings, Montana, United States
  • Nebraska Cancer Specialist — Grand Island, Nebraska, United States
  • New York University Langone Health — New York, New York, United States
  • Icahn School of Medicine at Mount Sinai — New York, New York, United States
  • Columbia University Medical Center — New York, New York, United States
  • Clinical Research Alliance — Westbury, New York, United States
  • University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • Baptist Medical Center — Memphis, Tennessee, United States
  • Tennessee Oncology — Nashville, Tennessee, United States
  • The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
  • NEXT Oncology Dallas — Irving, Texas, United States
  • NEXT Oncology Virginia — Fairfax, Virginia, United States
  • Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
  • Chris O'Brien Lifehouse Hosptial — Camperdown, New South Wales, Australia
  • Liverpool Hospital — Liverpool, New South Wales, Australia
  • Royal North Shore Hospital — St Leonards, New South Wales, Australia
  • Monash Health — Clayton, Victoria, Australia
  • Linear Clinical Research — Nedlands, Western Australia, Australia
  • Universitätsklinikum St. Pölten — Sankt Pölten, Austria, Austria
  • Wiener Gesundheitsverbund - Klinik Floridsdorf — Vienna, Austria
  • Nemocnice AGEL Novy Jicin a.s — Nový Jičín, Czech Republic, Czechia
  • Rigshospitalet — Copenhagen, Denmark
  • Odense University Hospital, Department of Oncology — Odense, Denmark
  • Hospices Civils de Lyon - Hôpital Louis Pradel — Bron, Auvergne-Rhône-Alpes, France
  • Centre Georges François Leclerc — Dijon, Bourgogne-Franche-Comté, France
  • CHU de Lille Institut Cœur Poumon — Lille, Hauts-de-France, France
  • CHU de Nantes — Nantes, Hauts-de-France, France
  • EDOG - Institut Bergonié — Bordeaux, New Aquitaine, France
  • Institut de Cancerologie de Ouest (ICO) - Angers — Angers, France
  • Ambroise-Paré Hospital — Boulogne, France
  • Centre François Baclesse — Caen, France
  • Hôpital Cochin — Paris, France
  • Hopital Tenon - AP-HP — Paris, France
  • Hopital Foch — Suresnes, France
  • Oncopole Claudius Regaud — Toulouse, France
  • Institut Gustave Roussy — Villejuif, France
  • Institut Curie — Paris, Île-de-France Region, France
  • Charite-Universitaetsmedizin Berlin - Campus Charite Mitte — Berlin, Germany
  • Uniklinik Köln — Cologne, Germany
  • Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Germany
  • Universitätsklinikum Frankfurt — Frankfurt am Main, Germany
  • Thoraxklinik Heidelberg gGmbH - Universitätsklinikum Heidelberg — Heidelberg, Germany
  • Lungenfachklinik Immenhausen — Immenhausen, Germany
  • Krankenhaus Bethanien Moers — Moers, Germany
  • Henry Dunant Hospital Center — Athens, Greece
  • Thoracic General Hospital of Athens "I SOTIRIA" — Athens, Greece
  • General Hospital of Thessaloniki — Thessaloniki, Greece
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l — Meldola, Emilia-Romagna, Italy
  • Fondazione IRCCS Istituto Nazionale dei tumori — Milan, Italy
  • Instituto Europeo Di Oncologia — Milan, Italy
  • ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
  • A.O.U. San Luigi Gonzaga-Orbassano - SCDU Oncologia Medica — Orbassano, Italy
  • Ospedale Santa Maria Delle Croci — Ravenna, Italy
  • IRCCS Instituto Nazionale tumori Ragina Elena — Rome, Italy
  • Fondazione Policlinico Universitario A Gemelli-Rome — Rome, Italy
  • The Netherlands Cancer Institute (NKI) — Amsterdam, Netherlands
  • University Medical Centre Groningen — Groningen, Netherlands
  • Leiden University Medical Center — Leiden, Netherlands
  • University Medical Center Utrecht — Utrecht, Netherlands
  • Samsung Medical Center — Seoul, Gangnam-gu, South Korea
  • National Cancer Center — Goyang-si, Gyeonggi-do, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggido, South Korea
  • Seoul St. Mary's Hospital, The Catholic University of Korea — Seoul, Seocho-gu, South Korea
  • Severance Hospital — Seoul, Seodaemun-Gu, South Korea
  • Hospital Clinico San Carlos — Madrid, Madrid, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain
  • Clinica Universidad de Navarra — Pamplona, Navarre, Spain
  • Hospital Universitari i Politecnic La Fe de Valencia — Valencia, Valencia, Spain
  • Complejo Hospitalario Universitario A Coruña — A Coruña, Spain
  • Hospital Universitari Vall D' Hebron — Barcelona, Spain
  • ICO Badalona - H.U. Germans Trias i Pujol — Barcelona, Spain
  • Hospital Universitario Ramon y Cajal — Madrid, Spain
  • Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain
  • Hospital Universitario Quironsalud - NEXT Oncology, Madrid — Madrid, Spain
  • Hospital Regional Universitario de Malaga - Hospital Civil — Málaga, Spain
  • Hospital Universitario Virgen del Rocio - PPDS — Seville, Spain
  • Fundacion Instituto Valenciano de Oncologia — Valencia, Spain
  • Taipei Municipal Wanfang Hospital — Taipei, Wenshan Dist, Taiwan
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
  • Taichung Veterans General Hospital — Taichung, Taiwan
  • Chi Mei Hospital, Liouying — Tainan, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record