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

• Status: Recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with each other.

The first two subprotocols include the following:

Subprotocol A: RMC-6291 + SOC Subprotocol B: RMC-6236 + SOC

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Revolution Medicines, Inc.
• Treatments: Carboplatin; Pembrolizumab; Pemetrexed

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)

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.