Expanded Access of Sotorasib
The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.
Checked against the public recordLast updated Aug 20, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Expanded Access
- Phase
- Not applicable
- Sponsor
- Amgen
- Interventions being studied
- Drug: AMG 510
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria * Age ≥ 18 years * Ineligibility for participation in any Amgen-sponsored ongoing clinical study of the investigational product * Pathologically documented, locally-advanced and unresectable or metastatic Non Small-Cell Lung Cancer (NSCLC) with KRAS p.G12C mutation confirmed through molecular testing * Exhausted other standard of care options for locally advanced and unresectable or metastatic NSCLC disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless medically contraindicated) * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 Exclusion Criteria * Mixed small-cell lung cancer or mixed NSCLC histology * Active brain metastases * Active hepatitis B or hepatitis C virus * Current active malignancy other than NSCLC * Currently or previously enrolled in a prior sotorasib study unless radiographic disease progression confirmed, able to remain on long term follow up of their original protocol and receives medical monitor approval * Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Clearview Cancer InstituteHuntsville, Alabama
- Alaska Oncology and Hematology LLCAnchorage, Alaska
- Ironwood Cancer and Research CenterChandler, Arizona
- Arizona Oncology Associates Professional CorporationTucson, Arizona
- San Luis Valley Health Regional Medical CenterAlamosa, Colorado
- Kaiser PermanenteLone Tree, Colorado
- Sacred Heart Medical Oncology GroupPensacola, Florida
- Cancer Care Specialists of Central IllinoisDecatur, Illinois
- McFarland Clinic PCAmes, Iowa
- Des Moines Oncology Research AssociationDes Moines, Iowa
- Saint Joseph EastLexington, Kentucky
- Louisiana Hematology Oncology AssociatesBaton Rouge, Louisiana
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 20, 2026. Always confirm current availability with the study team.