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Expanded Access of Sotorasib | Clinical Trials | Clareo Health

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Expanded Access of Sotorasib

A Multicenter, Open-label, Single-arm, Expanded Access Protocol of Sotorasib for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation

NCT04667234•Amgen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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

Locations (55)

Clearview Cancer Institute

Huntsville, Alabama, United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Ironwood Cancer and Research Center

Chandler, Arizona, United States

Arizona Oncology Associates Professional Corporation

Tucson, Arizona, United States

San Luis Valley Health Regional Medical Center

Alamosa, Colorado, United States

Kaiser Permanente

Lone Tree, Colorado, United States

Sacred Heart Medical Oncology Group

Pensacola, Florida, United States

Cancer Care Specialists of Central Illinois

Decatur, Illinois, United States

McFarland Clinic PC

Ames, Iowa, United States

Des Moines Oncology Research Association

Des Moines, Iowa, United States

Key Dates

Last Updated

August 13, 2025

Conditions

Non Small-cell Lung CancerLocally Advanced Unresectable NSCLCLocally Advanced Metastatic NSCLC

Interventions

AMG 510

DRUG

Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK)

NCT01662635

Non Small-cell Lung Cancer

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COMPLETEDPHASE4

Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients

NCT01402089

Non Small-cell Lung CancerRenal-cell Cancer+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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