Official Title
A Multicenter, Open-label, Single-arm, Expanded Access Protocol of AMG 510 (Sotorasib) for the Treatment of Subjects With Previously Treated Locally Advanced Unresectable/Metastatic NSCLC With KRAS p.G12C Mutation
Brief Summary

The primary objective of this study is to provide expanded access to and characterize the safety profile of AMG 510 (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.

Available
Treatment IND/Protocol
Non Small-cell Lung Cancer
Locally Advanced Unresectable NSCLC
Locally Advanced Metastatic NSCLC

Drug: AMG 510
Administered as an oral tablet.
Other Name: Sotorasib

Eligibility Criteria

Inclusion Criteria - Age ≥ 18 years - Ineligibility for participation in any 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 disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless contraindicated) - Performance Status ≤ 2

Exclusion Criteria - Active brain metastases - Active hepatitis B or hepatitis C virus - Current active malignancy other than NSCLC - Participants previously enrolled in sotorasib Study 20190009 (CodeBreaK 200) - Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 99 Years
Countries
Brazil
Israel
United States
Locations

Clearview Cancer Institute
Huntsville, Alabama, 35805

Available

Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508

Available

Ironwood Cancer and Research Center
Chandler, Arizona, 85224

Available

Arizona Oncology Associates Professional Corporation
Tucson, Arizona, 85711

Available

San Luis Valley Health Regional Medical Center
Alamosa, Colorado, 81101

Available

Kaiser Permanente
Lone Tree, Colorado, 80124

Available

Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504

Available

Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526

Available

McFarland Clinic PC
Ames, Iowa, 50010

Available

Des Moines Oncology Research Association
Des Moines, Iowa, 50309

Available

Saint Joseph East
Lexington, Kentucky, 40509

Available

Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, 70809

Available

Northern Light Cancer Center
Brewer, Maine, 04412

Available

University of Pittsburgh Medical Center Western Maryland
Cumberland, Maryland, 21502

Available

Maryland Oncology Hematology, PA
Rockville, Maryland, 20850

Available

Dana Farber Cancer Institute
Boston, Massachusetts, 02215

Available

Mid Michigan Medical Center
Midland, Michigan, 48640

Available

Saint Lukes Cancer Institute
Saint Louis, Missouri, 63110

Available

Oncology Hematology Associates
Springfield, Missouri, 65807

Available

Nebraska Cancer Specialists
Omaha, Nebraska, 68130

Available

Englewood Hospital and Medical Center
Englewood, New Jersey, 07631

Available

Overlook Medical Center
Summit, New Jersey, 07901

Available

Wake Forest Baptist Comprehensive Cancer Research Center
Winston-Salem, North Carolina, 27157

Available

Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195

Available

LeHigh Valley Hospital
Allentown, Pennsylvania, 18103

Available

Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111

Available

Scranton Hematology Oncology
Scranton, Pennsylvania, 18510

Available

Erlanger East Hospital
Chattanooga, Tennessee, 37421

Available

Baptist Cancer Center
Memphis, Tennessee, 38120

Available

Saint Marys Medical Center
Huntington, West Virginia, 25705

Available

Contacts

Amgen Call Center
866-572-6436
medinfo@amgen.com

MD
Study Director
Amgen

NCT Number
Keywords
NSCLC
KRAS p.G12C Mutation
MeSH Terms
Carcinoma, Non-Small-Cell Lung
Intervention Name
AMG 510