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

Recruiting now · Phase 1/Phase 2

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT06162221

Run by

Revolution Medicines, Inc.

People needed

616

Starts

2024-01-18

Expected to finish

2028-12-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• City of Hope - Duarte — Duarte, California, United States (enrolling)
• City of Hope - Lennar — Irvine, California, United States (enrolling)
• UC Davis, Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• University of California, San Diego Moores Cancer Center — San Diego, California, United States (enrolling)
• UCSF Medical Center - Mission Bay — San Francisco, California, United States (enrolling)
• Stanford University - Stanford Cancer Institute — Stanford, California, United States (enrolling)
• Colorado Health Medical Group - Medical Oncology & Hematology — Colorado Springs, Colorado, United States (enrolling)
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Boca Raton Clinical Research Associates — Plantation, Florida, United States (enrolling)
• Cancer Specialists of North Florida — Saint Augustine, Florida, United States (enrolling)
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) — Detroit, Michigan, United States (enrolling)
• Intermountain Health - St. Vincent Frontier Cancer Center — Billings, Montana, United States (enrolling)
• Nebraska Cancer Specialist — Grand Island, Nebraska, United States (enrolling)
• New York University Langone Health — New York, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Clinical Research Alliance — Westbury, New York, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Baptist Medical Center — Memphis, Tennessee, United States (enrolling)
• Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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