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

NCT05054725

CompletedPhase 2

Sponsor: Revolution Medicines, Inc.

Conditions: Non-Small Cell Lung Cancer

Interventions: RMC-4630, Sotorasib

Countries: United States, Australia, Canada, France, Germany, Italy, South Korea, Spain

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (60)
  • Fort Myers, Florida, United States
  • Plantation, Florida, United States
  • Saint Augustine, Florida, United States
  • Evergreen Park, Illinois, United States
  • Baton Rouge, Louisiana, United States
  • Scarborough, Maine, United States
  • Bethesda, Maryland, United States
  • Columbia, Maryland, United States
  • Minneapolis, Minnesota, United States
  • Omaha, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Brick, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • Columbus, Ohio, United States
  • Charleston, South Carolina, United States
  • Chattanooga, Tennessee, United States
  • Nashville, Tennessee, United States
  • Texarkana, Texas, United States
  • Fairfax, Virginia, United States
  • Norfolk, Virginia, United States
  • Vancouver, Washington, United States
  • Warrnambool, Victoria, Australia
  • Blacktown, Australia
  • Shepparton, Australia
  • Edmonton, Alberta, Canada
  • Mississauga, Ontario, Canada
  • Marseille, France
  • Toulouse, France
  • + 30 more on CT.gov