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

Launched by REVOLUTION MEDICINES, INC. · Nov 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying new treatments for patients with advanced non-small cell lung cancer (NSCLC) that has specific mutations in genes called RAS. The goal is to test the safety and effectiveness of two new drugs, RMC-6291 and RMC-6236, when combined with standard cancer care. Researchers want to see how well these drugs work together and how they are absorbed by the body.

To participate in this trial, patients should be at least 18 years old, have good overall health with few limitations, and have already received standard treatments for their cancer. They must also have a specific type of advanced lung cancer that cannot be surgically removed. Participants can expect to receive either the new drug combined with standard treatments or the new drug combined with each other, and they will be closely monitored for any side effects or changes in their cancer. It's important to know that certain health conditions, like major surgeries recently or serious lung problems, may prevent someone from joining this study.

Gender

ALL

Eligibility 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)
• • Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C)
• 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.