Expanded Access of Sotorasib

Study summary

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedAMG 510

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 20, 2026 · Source: ClinicalTrials.gov

Is enrollment open?No Longer Available

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Expanded Access

Where is it offered?55 U.S. locations

Locations may change over time.

Who runs it?Amgen

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Expanded Access
Phase: Not applicable
Sponsor: Amgen
Interventions being studied: Drug: AMG 510

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Locally advanced→Metastatic or stage IV→

Biomarkers

KRAS→

Treatment approach

Targeted therapy→

Study topics

After prior treatment→

Public criteria

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.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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