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Phase 1Recruiting

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

Sponsored by Revolution Medicines, Inc.

About this study

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

The platform study design allows combinations of RAS(ON) inhibitors with other anticancer agents or as a monotherapy to be evaluated in patients with RAS-mutated solid tumors with a focus on NSCLC. This is an open-label platform Phase 1b/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard of Care (SOC), or as a monotherapy and to define the Recommended Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with KRAS or RAS mutations will be specified in each subprotocol. Subprotocol A is an open-label, multicenter, Phase 1b/2 study of RMC-6291, with or without RMC-6236, in combination with pembrolizumab, with or without chemotherapy, in patients with KRAS G12C-mutated advanced solid …

Where this study is enrolling (23)

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona

    Call +1 480-256-6444

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  • UCSF Medical Center - Mission Bay

    San Francisco, California

    I'm interested
  • UC Davis, Davis Comprehensive Cancer Center

    Sacramento, California

    I'm interested
  • Stanford University - Stanford Cancer Institute

    Stanford, California

    I'm interested
  • City of Hope - Duarte

    Duarte, California

    I'm interested
Show all 23 locations
  • City of Hope - Lennar

    Irvine, California

    I'm interested
  • University of California, San Diego Moores Cancer Center

    San Diego, California

    I'm interested
  • Georgetown University Medical Center

    Washington D.C., District of Columbia

    I'm interested
  • Boca Raton Clinical Research Associates

    Plantation, Florida

    I'm interested
  • Cancer Specialists of North Florida

    Saint Augustine, Florida

    I'm interested
  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida

    I'm interested
  • Dana Farber Cancer Institute

    Boston, Massachusetts

    I'm interested
  • Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

    Detroit, Michigan

    I'm interested
  • Intermountain Health - St. Vincent Frontier Cancer Center

    Billings, Montana

    I'm interested
  • Icahn School of Medicine at Mount Sinai

    New York, New York

    I'm interested
  • Clinical Research Alliance

    Westbury, New York

    Call 516-488-2918

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  • Columbia University Medical Center

    New York, New York

    I'm interested
  • New York University Langone Health

    New York, New York

    I'm interested
  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio

    Call 216-844-3951

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  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania

    I'm interested
  • The University of Texas MD Anderson Cancer Center

    Houston, Texas

    I'm interested
  • NEXT Oncology Dallas

    Irving, Texas

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  • NEXT Oncology Virginia

    Fairfax, Virginia

    I'm interested
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.