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

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT05054725

Run by

Revolution Medicines, Inc.

People needed

47

Starts

2021-12-30

Expected to finish

2024-08-29

Last updated by the study team

2026-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• New Jersey Center for Cancer Research — Brick, New Jersey, United States
• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States
• Roswell Park cancer Institute — Buffalo, New York, United States
• Clinical Research Alliance, Inc. — New York, New York, United States
• Zangmeister Cancer Center — Columbus, Ohio, United States
• Charleston Oncology — Charleston, South Carolina, United States
• Tennessee Oncology — Chattanooga, Tennessee, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• CHRISTUS St. Michael-Colom and Carney Clinic P.A — Texarkana, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Northwest Cancer specialists, P.C. — Vancouver, Washington, United States
• South West Oncology — Warrnambool, Victoria, Australia
• Blacktown Hospital — Blacktown, Australia
• Florida Cancer Specialists — Fort Myers, Florida, United States

Full record on ClinicalTrials.gov

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