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

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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.

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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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

46

Study ID:

NCT05054725

Recruitment Status:

Recruiting

Sponsor:

Revolution Medicines, Inc.

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There are 50 Locations for this study

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Florida Cancer Specialists
Fort Myers Florida, 33901, United States
BRCR Medical Center Inc.
Plantation Florida, 33322, United States
Cancer Specialists of North Florida
Saint Augustine Florida, 32086, United States
GenHarp Clinical Solutions
Evergreen Park Illinois, 60805, United States
Hematology Oncology Clinic
Baton Rouge Louisiana, 70809, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Minnesota Oncology Hematology, P.A.
Minneapolis Minnesota, 55404, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
New Jersey Center for Cancer Research
Brick New Jersey, 08724, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque New Mexico, 87131, United States
Roswell Park cancer Institute
Buffalo New York, 14263, United States
Clinical Research Alliance, Inc.
New York New York, 10021, United States
Zangmeister Cancer Center
Columbus Ohio, 43219, United States
Charleston Oncology
Charleston South Carolina, 29414, United States
Tennessee Oncology
Chattanooga Tennessee, 37404, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
CHRISTUS St. Michael-Colom and Carney Clinic P.A
Texarkana Texas, 75503, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Northwest Cancer specialists, P.C.
Vancouver Washington, 98684, United States
South West Oncology
Warrnambool Victoria, 3280, Australia
Blacktown Hospital
Blacktown , 2148, Australia
Goulburn Valley Health
Shepparton , 3630, Australia
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Hospital Larrey Universite Paul Sabatier
Toulouse , 31059, France
Klinikum Esslingen GmbH
Esslingen Baden-Wurttemberg, 73730, Germany
Asklepios Fachkliniken Munchen
Gauting Bavaria, 82131, Germany
Lungenklinik Hemer
Hemer North Rhine- Westphalia, 58675, Germany
Bethanien Hospital Moers
Moers North Rhine-Westphalia, 47441, Germany
Comprehensive Cancer Center Mainfranken, University Wuerzburg
Homburg Saarland, 66421, Germany
Lung Cancer Center, University of Saarland
Homburg Saarland, 66421, Germany
POIS Sachsen GmbH
Leipzig Sachsen, 04347, Germany
Charite Benjamin Franklin Comprehensive Cancer center
Berlin , 12200, Germany
Evangelische Lung Clinic
Berlin , 13125, Germany
Hamato-Onkologie Hamburg
Hamburg , 20251, Germany
Azienda Ospedaliera dei Colli
Napoli Campania, 80131, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano Piedmont, 10043, Italy
Istituto Europeo Di Oncologia
Milano , 20141, Italy
Chungbuk National University Hospital
Cheongju-si , 28644, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Hospital Clinic de Barcelona
Barcelona Catalonia, 08036, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung , 807, Taiwan
E-DA Hospital
Kaohsiung , 824, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
The Christie NHS Foundation Trust
Manchester Greater Manchester, M20 4, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton Surrey, SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

46

Study ID:

NCT05054725

Recruitment Status:

Recruiting

Sponsor:


Revolution Medicines, Inc.

How clear is this clinincal trial information?

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