Lung Cancer Clinical Trial
Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
Summary
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.
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
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There are 50 Locations for this study
Fort Myers Florida, 33901, United States
Plantation Florida, 33322, United States
Saint Augustine Florida, 32086, United States
Evergreen Park Illinois, 60805, United States
Baton Rouge Louisiana, 70809, United States
Scarborough Maine, 04074, United States
Minneapolis Minnesota, 55404, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89169, United States
Brick New Jersey, 08724, United States
Albuquerque New Mexico, 87131, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
Columbus Ohio, 43219, United States
Charleston South Carolina, 29414, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Texarkana Texas, 75503, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Vancouver Washington, 98684, United States
Warrnambool Victoria, 3280, Australia
Blacktown , 2148, Australia
Shepparton , 3630, Australia
Edmonton Alberta, T6G 1, Canada
Toulouse , 31059, France
Esslingen Baden-Wurttemberg, 73730, Germany
Gauting Bavaria, 82131, Germany
Hemer North Rhine- Westphalia, 58675, Germany
Moers North Rhine-Westphalia, 47441, Germany
Homburg Saarland, 66421, Germany
Homburg Saarland, 66421, Germany
Leipzig Sachsen, 04347, Germany
Berlin , 12200, Germany
Berlin , 13125, Germany
Hamburg , 20251, Germany
Napoli Campania, 80131, Italy
Orbassano Piedmont, 10043, Italy
Milano , 20141, Italy
Cheongju-si , 28644, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Barcelona Catalonia, 08036, Spain
Kaohsiung , 807, Taiwan
Kaohsiung , 824, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Taipei , 10002, Taiwan
Manchester Greater Manchester, M20 4, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
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