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
Stopped early · Phase 2
Conditions studied: Non-small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT04933695
- Run by
- Amgen
- People needed
- 42
- Starts
- 2022-01-28
- Expected to finish
- 2025-05-28
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Alabama Oncology — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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