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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

170

Study ID:

NCT04933695

Recruitment Status:

Active, not recruiting

Sponsor:

Amgen

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There are 63 Locations for this study

See Locations Near You

Alabama Oncology
Birmingham Alabama, 35243, United States
Arizona Oncology Associates Professional Corporation
Tucson Arizona, 85711, United States
City of Hope at Long Beach Elm
Duarte California, 91010, United States
City of Hope National Medical Center
Duarte California, 91010, United States
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States
Northwest Georgia Oncology Centers PC
Marietta Georgia, 30060, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Frederick Memorial Hospital
Frederick Maryland, 21702, United States
Englewood Hospital and Medical Center
Englewood New Jersey, 07631, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
James J Peters VA Medical Center
Bronx New York, 10468, United States
Laura and Isaac Perlmutter Cancer Center at New York University Langone
New York New York, 10016, United States
Northport Veterans Affairs Medical Center
Northport New York, 11768, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
Duke University Medical Center, Morris Cancer Clinic
Durham North Carolina, 27710, United States
Allegheny Health Network Cancer Institute at Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh Pennsylvania, 15232, United States
Medical University of South Carolina, Hollings Cancer Center
Charleston South Carolina, 29425, United States
Texas Oncology - Medical City Dallas
Dallas Texas, 75230, United States
Texas Oncology - Plano East
Dallas Texas, 75230, United States
Texas Oncology-Dallas Presbyterian Hospital
Dallas Texas, 75231, United States
Texas Oncology - Flower Mound
Dallas Texas, 75234, United States
Texas Oncology Baylor
Dallas Texas, 75246, United States
Texas Oncology-Denton
Denton Texas, 76201, United States
Oncology Consultants PA
Houston Texas, 77030, United States
Texas Oncology- Mckinney
McKinney Texas, 75071, United States
Texas Oncology - Northeast Texas
Paris Texas, 75460, United States
Gundersen Health System
La Crosse Wisconsin, 54601, United States
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Bruxelles , 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt , 3500, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liege , 4000, Belgium
Odense Universitetshospital
Odense C , 5000, Denmark
Institut Sainte Catherine
Avignon cedex 9 , 84918, France
Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
Limoges Cedex , 87042, France
Centre Hospitalier Universitaire de Montpellier - Val d Aurelle
Montpellier Cedex 5 , 34298, France
Hopital Cochin
Paris , 75014, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac Cedex , 33604, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes , 35033, France
Centre Hospitalier de Nantes - Hôpital Nord Laënnec
Saint Herblain , 44800, France
Hôpital Sainte Musse
Toulon Cedex , 83056, France
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse Cedex 9 , 31059, France
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main , 60590, Germany
Asklepios - Fachkliniken München-Gauting
Gauting , 82130, Germany
Universitätsklinikum Köln
Köln , 50937, Germany
Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo
Monza (MB) , 20900, Italy
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
Napoli , 80131, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO) , 10043, Italy
Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano
Rome , 00144, Italy
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam , 1066 , Netherlands
Hospital del Mar
Barcelona Cataluña, 08003, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona Cataluña, 08041, Spain
Hospital Universitari i Politecnic La Fe
Valencia Comunidad Valenciana, 46026, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela Galicia, 15706, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, 28222, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Gavle Sjukhus
Gavle , 801 8, Sweden
Sahlgrenska Universitetssjukhuset
Goteborg , 413 4, Sweden
Universitetssjukhuset i Linkoping
Linkoping , 581 8, Sweden
Skanes Universitetssjukhus
Lund , 221 8, Sweden
Norrlands Universitetssjukhus
Umea , 901 8, Sweden
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara , 06560, Turkey
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edirne , 22030, Turkey
Koc Universitesi Hastanesi
Istanbul , 34010, Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

170

Study ID:

NCT04933695

Recruitment Status:

Active, not recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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