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Brief Title: A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer
Official Title: A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination With Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) and BRAF-Mutant (BRAF-MT) Non-Small Cell Lung Cancer (NSCLC) (RAMP 202)
Study ID: NCT04620330
Brief Summary: This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.
Detailed Description: This is a multicenter, open-label Phase 2 study designed to evaluate safety and tolerability and efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with KRAS and BRAF mutant NSCLC following treatment with an appropriate platinum-based regimen and an approved immune checkpoint inhibitor (CPI).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Emory University School of Medicine, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Medical Center-Duchossois Center for Advanced Medicine, Chicago, Illinois, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Hematology/Oncology Clinic, LLP, Baton Rouge, Louisiana, United States
Maryland Oncology Hematology P.A, Columbia, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Cancer Institute/Henry Ford Health System, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Northwell Health-Monter Cancer Center, Lake Success, New York, United States
Zangmeister Cancer Center, Columbus, Ohio, United States
Northwest Cancer Specialists, P.C., Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Univ. of Pittsburgh Med Center, Pittsburgh, Pennsylvania, United States
Chattanooga Oncology Hematology Assoc., Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Texas Oncology, Dallas, Texas, United States
Texas Oncology Ft Worth Cancer Center, Fort Worth, Texas, United States
Texas Oncology, Grapevine, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Centre Leon Berard, Lyon, , France
Hopital Nord Marseille, Marseille, , France
Hopital Cochin, Paris, , France
Institute De Cancerologie De L'Ouest Site Paul Papin Oncologie Medicale, Saint-Herblain, , France
Cancerologie Gustave Roussy - Cancer Medicine, Villejuif, , France
Klinikum Chemnitz gGmbH, Chemnitz, , Germany
Universitatsklinkum Leipzig, Leipzig, , Germany
Evangelisches Klinkum Bethel, Straße, , Germany
Azienda Ospedaliera Universitaria, Orbassano, Torino, Italy
Irccs, Irts, Meldola, , Italy
UOC di Oncologia Medica, Parma, , Italy
Centro Ricerche Cliniche di Verona, Verona, , Italy
Hospital Clinic de Barcelona, Barcelona, , Spain
Complejo Hospitalario Universiario a Coruna Teresa, Coruña, , Spain
Hospital 12 de Octubre, Córdoba, , Spain
Universitario de Teatinos, Málaga, , Spain
Hospital Universitario Virgen de la Macarena, Sevilla, , Spain
Name: Ross Camidge, MD, PhD
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR
Name: MD Verastem
Affiliation: Verastem, Inc.
Role: STUDY_DIRECTOR