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Status:

RECRUITING

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

Lead Sponsor:

Revolution Medicines, Inc.

Conditions:

Non-Small Cell Lung Cancer, NSCLC

KRAS, NRAS, HRAS-mutated NSCLC

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

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 Stan...

Detailed Description

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. T...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 18 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2028

    Estimated Enrollment :

    616 Patients enrolled

    Trial Details

    Trial ID

    NCT06162221

    Start Date

    January 18 2024

    End Date

    December 1 2028

    Last Update

    December 16 2025

    Active Locations (74)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 19 (74 locations)

    1

    Banner MD Anderson Cancer Center

    Gilbert, Arizona, United States, 85234

    2

    City of Hope - Duarte

    Duarte, California, United States, 91010

    3

    City of Hope - Lennar

    Irvine, California, United States, 92618

    4

    UC Davis, Davis Comprehensive Cancer Center

    Sacramento, California, United States, 95817