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

Research Site
Huntsville, Alabama, 35805

Available

Research Site
Anchorage, Alaska, 99508

Available

Research Site
Chandler, Arizona, 85224

Available

Research Site
Tucson, Arizona, 85711

Available

Research Site
Pensacola, Florida, 32504

Available

Research Site
Decatur, Illinois, 62526

Available

Research Site
Ames, Iowa, 50010

Available

Research Site
Des Moines, Iowa, 50314

Available

Research Site
Lexington, Kentucky, 40509

Available

Research Site
Baton Rouge, Louisiana, 70809

Available

Research Site
Brewer, Maine, 04412

Available

Research Site
Cumberland, Maryland, 21502

Available

Research Site
Rockville, Maryland, 20850

Available

Research Site
Boston, Massachusetts, 02215

Available

Research Site
Kansas City, Missouri, 64111

Available

Research Site
Springfield, Missouri, 65807

Available

Research Site
Omaha, Nebraska, 68130

Available

Research Site
Englewood, New Jersey, 07631

Available

Research Site
Summit, New Jersey, 07901

Available

Research Site
Winston-Salem, North Carolina, 27157

Available

Research Site
Cleveland, Ohio, 44195

Available

Research Site
Allentown, Pennsylvania, 18103

Available

Research Site
Philadelphia, Pennsylvania, 19111

Available

Research Site
Scranton, Pennsylvania, 18510

Available

Research Site
Chattanooga, Tennessee, 37421

Available

Research Site
Memphis, Tennessee, 38120

Available

Research Site
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