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A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
Sponsor: Amgen
Summary
The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) \< 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 \< 1% and in a subgroup of participants with STK11 co-mutation.
Official title: A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2022-01-28
Completion Date
2025-05-28
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
Sotorasib
Oral tablet
Locations (67)
Alabama Oncology
Birmingham, Alabama, United States
Arizona Oncology Associates Professional Corporation
Tucson, Arizona, United States
City of Hope at Long Beach Elm
Duarte, California, United States
City of Hope National Medical Center
Duarte, California, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Northwest Georgia Oncology Centers PC
Marietta, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Frederick Memorial Hospital
Frederick, Maryland, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center at New York University Langone
New York, New York, United States
Northport Veterans Affairs Medical Center
Northport, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
James J Peters VA Medical Center
The Bronx, New York, United States
Duke University Medical Center, Morris Cancer Clinic
Durham, North Carolina, United States
Allegheny Health Network Cancer Institute at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Hollings Cancer Center
Charleston, South Carolina, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Texas Oncology - Plano East
Dallas, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States
Texas Oncology - Flower Mound
Dallas, Texas, United States
Texas Oncology - Baylor
Dallas, Texas, United States
Texas Oncology-Denton
Denton, Texas, United States
Oncology Consultants PA
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology- Mckinney
McKinney, Texas, United States
Texas Oncology - Northeast Texas
Paris, Texas, United States
Gundersen Health System
La Crosse, Wisconsin, United States
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, Belgium
Odense Universitetshospital
Odense C, Denmark
Institut Sainte Catherine
Avignon, France
Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette
Lille, France
Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
Limoges, France
Centre Hospitalier Universitaire de Montpellier - Val d Aurelle
Montpellier, France
Hopital Cochin
Paris, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, France
Centre Hospitalier de Nantes - Hôpital Nord Laënnec
Saint-Herblain, France
Hôpital Sainte Musse
Toulon, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, France
Universitätsklinikum Köln
Cologne, Germany
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, Germany
Asklepios - Fachkliniken München-Gauting
Gauting, Germany
Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo
Monza (MB), Italy
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
Naples, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO), Italy
Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano
Rome, Italy
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam, Netherlands
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario La Paz
Madrid, Spain
Gavle Sjukhus
Gävle, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Universitetssjukhuset i Linkoping
Linköping, Sweden
Skanes Universitetssjukhus
Lund, Sweden
Norrlands Universitetssjukhus
Umeå, Sweden
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, Turkey (Türkiye)
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edirne, Turkey (Türkiye)
Koc Universitesi Hastanesi
Istanbul, Turkey (Türkiye)