Expanded Access of Sotorasib

NO_LONGER_AVAILABLE

Conditions studied: Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC

In brief

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.

Key facts

Study ID

NCT04667234

Run by

Amgen

Last updated by the study team

2025-08-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Saint Joseph East — Lexington, Kentucky, United States
• Louisiana Hematology Oncology Associates — Baton Rouge, Louisiana, United States
• Northern Light Cancer Center — Brewer, Maine, United States
• University of Pittsburgh Medical Center Western Maryland — Cumberland, Maryland, United States
• Maryland Oncology Hematology, PA — Rockville, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Mid Michigan Medical Center — Midland, Michigan, United States
• Saint Lukes Cancer Institute — Kansas City, Missouri, United States
• Oncology Hematology Associates — Springfield, Missouri, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Englewood Hospital and Medical Center — Englewood, New Jersey, United States
• Overlook Medical Center — Summit, New Jersey, United States
• Wake Forest Baptist Comprehensive Cancer Research Center — Winston-Salem, North Carolina, United States
• Cleveland Clinic Taussig Cancer Institute — Cleveland, Ohio, United States
• LeHigh Valley Hospital — Allentown, Pennsylvania, United States
• Clearview Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.