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
NCT ID: NCT04933695
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2022-01-28
2025-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sotorasib: 960 mg Daily
Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \< 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 960 mg daily. Participants will be stratified by known presence of STK11 mutation.
Sotorasib
Oral tablet
Sotorasib: 240 mg Daily
Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \< 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 240 mg daily. Participants will be stratified by known presence of STK11 mutation.
Sotorasib
Oral tablet
Interventions
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Sotorasib
Oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Napoli, , 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)
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2021-002638-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20190288
Identifier Type: -
Identifier Source: org_study_id
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