Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

• Status: Recruiting
• Trial end date: 2024-01-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC

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

Details

• Lead Sponsor: Revolution Medicines, Inc.
• Collaborators: Amgen; Sanofi

Criteria

Inclusion Criteria:

• Subject must be ≥18 years of age.

• Subject must have pathologically documented, locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed)

Exclusion Criteria

• Primary central nervous system (CNS) tumors

• Known or suspected leptomeningeal or brain metastases or spinal cord compression

• Clinically significant cardiac disease

• Known impairment of GI function that would alter the absorption

• Active autoimmune disease requiring systemic treatment within past 2 years

• History of severe allergic reactions to any of the study intervention components

• Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.

• Prior therapy with KRASG12C inhibitor and/or SHP2 inhibitor