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
Public ClinicalTrials.gov record NCT04933695. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04933695
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 28, 2022 (Actual)
- Primary completion
- May 28, 2025 (Actual)
- Completion
- May 28, 2025 (Actual)
- Last update posted
- Jul 13, 2026
2022 – 2025
United States locations
- U.S. sites
- 30
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 35243 | — |
| Arizona Oncology Associates Professional Corporation | Tucson | Arizona | 85711 | — |
| City of Hope at Long Beach Elm | Duarte | California | 91010 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | — |
| Northwest Georgia Oncology Centers PC | Marietta | Georgia | 30060 | — |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Frederick Memorial Hospital | Frederick | Maryland | 21702 | — |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Laura and Isaac Perlmutter Cancer Center at New York University Langone | New York | New York | 10016 | — |
| Northport Veterans Affairs Medical Center | Northport | New York | 11768 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| James J Peters VA Medical Center | The Bronx | New York | 10468 | — |
| Duke University Medical Center, Morris Cancer Clinic | Durham | North Carolina | 27710 | — |
| Allegheny Health Network Cancer Institute at Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center Cancer Pavillion | Pittsburgh | Pennsylvania | 15232 | — |
| Medical University of South Carolina, Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| Texas Oncology - Medical City Dallas | Dallas | Texas | 75230-2510 | — |
| Texas Oncology - Plano East | Dallas | Texas | 75230-2510 | — |
| Texas Oncology-Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| Texas Oncology - Flower Mound | Dallas | Texas | 75234 | — |
| Texas Oncology - Baylor | Dallas | Texas | 75246 | — |
| Texas Oncology-Denton | Denton | Texas | 76201 | — |
| Oncology Consultants PA | Houston | Texas | 77030 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Texas Oncology- Mckinney | McKinney | Texas | 75071 | — |
| Texas Oncology - Northeast Texas | Paris | Texas | 75460-5004 | — |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04933695, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04933695 live on ClinicalTrials.gov.