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
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 13, 2026 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Amgen
- Interventions being studied
- Drug: Sotorasib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Alabama OncologyBirmingham, Alabama
- Arizona Oncology Associates Professional CorporationTucson, Arizona
- City of Hope at Long Beach ElmDuarte, California
- City of Hope National Medical CenterDuarte, California
- Baptist MD Anderson Cancer CenterJacksonville, Florida
- Northwest Georgia Oncology Centers PCMarietta, Georgia
- Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana
- Baptist Health LexingtonLexington, Kentucky
- Frederick Memorial HospitalFrederick, Maryland
- Englewood Hospital and Medical CenterEnglewood, New Jersey
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
- Laura and Isaac Perlmutter Cancer Center at New York University LangoneNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 13, 2026. Always confirm current availability with the study team.