Lung Cancer Clinical Trial
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
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.
Eligibility Criteria
Inclusion Criteria:
Adult (= or > 18 years old) with NSCLC
Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV disease
Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)
Programmed death-ligand 1 (PD-L1) TPS Score < 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
No active brain metastases
Measurable disease per investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Exclusion Criteria:
Mixed small-cell lung cancer and NSCLC histology
Myocardial Infarction within 6 months of study Day 1
Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonists (H2RA), strong inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) or known CYP3A4 sensitive substrates or P-gp substrates
Therapeutic or palliative radiation therapy within 2 weeks of study day 1
Unable to take oral medication
Unable to receive both iodinated contrast for computed tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans
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There are 63 Locations for this study
Birmingham Alabama, 35243, United States
Tucson Arizona, 85711, United States
Duarte California, 91010, United States
Duarte California, 91010, United States
Jacksonville Florida, 32207, United States
Marietta Georgia, 30060, United States
Indianapolis Indiana, 46202, United States
Lexington Kentucky, 40503, United States
Frederick Maryland, 21702, United States
Englewood New Jersey, 07631, United States
New Brunswick New Jersey, 08901, United States
Bronx New York, 10468, United States
New York New York, 10016, United States
Northport New York, 11768, United States
Syracuse New York, 13210, United States
Durham North Carolina, 27710, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Charleston South Carolina, 29425, United States
Dallas Texas, 75230, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Dallas Texas, 75234, United States
Dallas Texas, 75246, United States
Denton Texas, 76201, United States
Houston Texas, 77030, United States
McKinney Texas, 75071, United States
Paris Texas, 75460, United States
La Crosse Wisconsin, 54601, United States
Bruxelles , 1200, Belgium
Edegem , 2650, Belgium
Hasselt , 3500, Belgium
Liege , 4000, Belgium
Odense C , 5000, Denmark
Avignon cedex 9 , 84918, France
Limoges Cedex , 87042, France
Montpellier Cedex 5 , 34298, France
Paris , 75014, France
Pessac Cedex , 33604, France
Rennes , 35033, France
Saint Herblain , 44800, France
Toulon Cedex , 83056, France
Toulouse Cedex 9 , 31059, France
Frankfurt am Main , 60590, Germany
Gauting , 82130, Germany
Köln , 50937, Germany
Monza (MB) , 20900, Italy
Napoli , 80131, Italy
Orbassano (TO) , 10043, Italy
Rome , 00144, Italy
Amsterdam , 1066 , Netherlands
Barcelona Cataluña, 08003, Spain
Barcelona Cataluña, 08041, Spain
Valencia Comunidad Valenciana, 46026, Spain
Santiago de Compostela Galicia, 15706, Spain
Majadahonda Madrid, 28222, Spain
Madrid , 28046, Spain
Gavle , 801 8, Sweden
Goteborg , 413 4, Sweden
Linkoping , 581 8, Sweden
Lund , 221 8, Sweden
Umea , 901 8, Sweden
Ankara , 06560, Turkey
Edirne , 22030, Turkey
Istanbul , 34010, Turkey
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