Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC
A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
Revolution Medicines, Inc.
616 participants
Jan 18, 2024
INTERVENTIONAL
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 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
Eligibility
Inclusion Criteria8
- 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 Criteria5
- 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
Interventions
Oral tablet
Oral tablet
IV Infusion
IV Infusion
IV Infusion
IV infusion
Oral Tablet
Locations(89)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06162221