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

Revolution Medicines, Inc.47 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

RMC-4630DRUG

RMC-4630 administered orally as a capsule

SotorasibDRUG

Sotorasib administered orally as a tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (60)

Outcomes

Primary Outcomes

Objective Response Rate (ORR) as Assessed Per RECIST v1.1

Evaluation of the antitumor effects of RMC-4630 and sotorasib in locally advanced or metastatic NSCLC patients with KRASG12C mutation with and without co-existing genetic aberrations in specific genes such as STK11/LKB1, KEAP1, and PIK3CA after failure of prior standard therapy. Objective Response Rate (%) is defined as the proportion of patients with Best Overall Response of confirmed CR, or PR. Response was confirmed by a repeat assessment no less than 28 days.

Time frame: 31 months

Secondary Outcomes

Clinically Significant Changes in Vital Signs

Characterization of the safety, tolerability of RMC-4630 in combination with sotorasib for subjects with KRASG12C mutant NSCLC after failure of prior standard therapy

Time frame: 31 months

Clinically Significant Changes in Laboratory Tests

Characterization of the safety, tolerability of RMC-4630 in combination with sotorasib for subjects with KRASG12C mutant NSCLC after failure of prior standard therapy

Time frame: 31 months

Clinically Significant Changes in ECGs

Characterization of the safety, tolerability of RMC-4630 in combination with sotorasib for subjects with KRASG12C mutant NSCLC after failure of prior standard therapy

Time frame: 31 months

Trough and Approximate Peak Concentrations of RMC-4630

Characterization of PK of RMC-4630 in combination with sotorasib for subjects with KRASG12C mutant NSCLC.

Time frame: 31 months

Trough and Approximate Peak Concentrations of Sotorasib

Characterization of PK of RMC-4630 in combination with Sotorasib for subjects with KRASG12C mutant NSCLC

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Florida Cancer Specialists

Fort Myers, Florida, United States

BRCR Medical Center Inc.

Plantation, Florida, United States

Cancer Specialists of North Florida

Saint Augustine, Florida, United States

GenHarp Clinical Solutions

Evergreen Park, Illinois, United States

Hematology Oncology Clinic

Baton Rouge, Louisiana, United States

New England Cancer Specialists

Scarborough, Maine, United States

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States

Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

...and 50 more locations