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
- Registration Number
- NCT04933695
- Lead Sponsor
- Amgen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sotorasib: 240 mg Daily Sotorasib 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: 960 mg Daily Sotorasib 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate (OR) Up to 6 years OR is defined as the total of Complete Response (CR) and Partial Response (PR).
- Secondary Outcome Measures
Name Time Method Number of Participants with a Treatment-emergent Adverse Event (TEAE) Day 1 up to Month 13 Number of Participants with a Treatment-related Adverse Event Day 1 up to Month 13 Number of Participants with a Clinically Significant Change from Baseline in Vital Signs Baseline (Screening; up to 28 days pre-dose) up to Month 13 Disease Control Rate Up to 6 years Duration of Reponse (DOR) Up to 6 years Time to Response (TTR) Up to 6 years Number of Participants with a Clinically Significant Change from Baseline in Electrocardiograms (ECGs) Baseline (Screening; up to 28 days pre-dose) up to Month 13 Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests Baseline (Screening; up to 28 days pre-dose) up to Month 13 Maximum Plasma Concentration (Cmax) of Sotorasib Day 1 up to Month 3 Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib Day 1 up to Month 3 Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib Day 1 up to Month 3 Progression-free Survival (PFS) Up to 6 years Overall Survival (OS) Up to 6 years
Trial Locations
- Locations (67)
Texas Oncology-Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Northport Veterans Affairs Medical Center
🇺🇸Northport, New York, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Texas Oncology - Flower Mound
🇺🇸Dallas, Texas, United States
Texas Oncology - Medical City Dallas
🇺🇸Dallas, Texas, United States
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Sahlgrenska Universitetssjukhuset
🇸🇪Goteborg, Sweden
Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo
🇮🇹Monza (MB), Italy
Hopital Cochin
🇫🇷Paris, France
Centre Hospitalier de Nantes - Hôpital Nord Laënnec
🇫🇷Saint Herblain, France
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
🇧🇪Bruxelles, Belgium
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Asklepios - Fachkliniken München-Gauting
🇩🇪Gauting, Germany
Jessa Ziekenhuis - Campus Virga Jesse
🇧🇪Hasselt, Belgium
Allegheny Health Network Cancer Institute at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Oncology-Denton
🇺🇸Denton, Texas, United States
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Comunidad Valenciana, Spain
Norrlands Universitetssjukhus
🇸🇪Umea, Sweden
Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano
🇮🇹Rome, Italy
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Gundersen Health System
🇺🇸La Crosse, Wisconsin, United States
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Texas Oncology - Baylor
🇺🇸Dallas, Texas, United States
Hospital del Mar
🇪🇸Barcelona, Cataluña, Spain
Gavle Sjukhus
🇸🇪Gavle, Sweden
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
🇮🇹Napoli, Italy
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
🇹🇷Ankara, Turkey
Hôpital Sainte Musse
🇫🇷Toulon Cedex, France
Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
🇫🇷Limoges Cedex, France
Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette
🇫🇷Lille Cedex, France
Texas Oncology - Northeast Texas
🇺🇸Paris, Texas, United States
Azienda Ospedaliera Universitaria San Luigi Gonzaga
🇮🇹Orbassano (TO), Italy
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
🇹🇷Edirne, Turkey
Centre Hospitalier Universitaire de Montpellier - Val d Aurelle
🇫🇷Montpellier Cedex 5, France
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
Universitetssjukhuset i Linkoping
🇸🇪Linkoping, Sweden
Centre Hospitalier Universitaire de Liege - Sart Tilman
🇧🇪Liege, Belgium
Skanes Universitetssjukhus
🇸🇪Lund, Sweden
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
🇫🇷Toulouse Cedex 9, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
🇫🇷Pessac Cedex, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
🇫🇷Rennes, France
Texas Oncology- Mckinney
🇺🇸McKinney, Texas, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center, Morris Cancer Clinic
🇺🇸Durham, North Carolina, United States
Oncology Consultants PA
🇺🇸Houston, Texas, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Arizona Oncology Associates Professional Corporation
🇺🇸Tucson, Arizona, United States
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
City of Hope at Long Beach Elm
🇺🇸Duarte, California, United States
Northwest Georgia Oncology Centers PC
🇺🇸Marietta, Georgia, United States
Frederick Memorial Hospital
🇺🇸Frederick, Maryland, United States
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States
James J Peters VA Medical Center
🇺🇸Bronx, New York, United States
Laura and Isaac Perlmutter Cancer Center at New York University Langone
🇺🇸New York, New York, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
University of Pittsburgh Medical Center Cancer Pavillion
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Oncology - Plano East
🇺🇸Dallas, Texas, United States
Odense Universitetshospital
🇩🇰Odense C, Denmark
Institut Sainte Catherine
🇫🇷Avignon cedex 9, France
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
🇩🇪Frankfurt am Main, Germany
Universitätsklinikum Köln
🇩🇪Koeln, Germany
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
🇳🇱Amsterdam, Netherlands
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Galicia, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Koc Universitesi Hastanesi
🇹🇷Istanbul, Turkey
Medical University of South Carolina, Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States