NCT05054725

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

A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Revolution Medicines, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a phase 2 multicenter, open-label study evaluating the efficacy, safety, tolerability, and pharmacokinetics (PK) of RMC-4630 in combination with sotorasib in subjects with KRASG12C mutant NSCLC after failure of prior standard therapies.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	RMC-4630	RMC-4630 administered orally as a capsule
DRUG	Sotorasib	Sotorasib administered orally as a tablet

Timeline

• Start date: 2021-12-30
• Primary completion: 2024-07-03
• Completion: 2024-08-29
• First posted: 2021-09-23
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

60 sites across 10 countries: United States, Australia, Canada, France, Germany, Italy, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study