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

Revolution Medicines

Status and phase: Active, not recruiting; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: RMC-4630; Drug: Sotorasib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05054725

RMC-4630-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

RMC-4630 and sotorasib, Safety Run-in

Experimental group

Description:

Safety Run-In: RMC-4630 and sotorasib

Treatment:

Drug: Sotorasib

Drug: RMC-4630

RMC-4630 and sotorasib, Expansion

Experimental group

Description:

Dose Expansion: RMC-4630 and sotorasib

Treatment:

Drug: Sotorasib

Drug: RMC-4630