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.
Drug: AMG 510
Administered as an oral tablet.
Other Name: Sotorasib
Other Name: Lumakras (US)
Other Name: Lumykras (UK)
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
Clearview Cancer Institute
Huntsville, Alabama, 35805
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Ironwood Cancer and Research Center
Chandler, Arizona, 85224
Arizona Oncology Associates Professional Corporation
Tucson, Arizona, 85711
San Luis Valley Health Regional Medical Center
Alamosa, Colorado, 81101
Kaiser Permanente
Lone Tree, Colorado, 80124
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526
McFarland Clinic PC
Ames, Iowa, 50010
Des Moines Oncology Research Association
Des Moines, Iowa, 50309
Saint Joseph East
Lexington, Kentucky, 40509
Louisiana Hematology Oncology Associates
Baton Rouge, Louisiana, 70809
Northern Light Cancer Center
Brewer, Maine, 04412
University of Pittsburgh Medical Center Western Maryland
Cumberland, Maryland, 21502
Maryland Oncology Hematology, PA
Rockville, Maryland, 20850
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Mid Michigan Medical Center
Midland, Michigan, 48640
Saint Lukes Cancer Institute
Kansas City, Missouri, 64111
Oncology Hematology Associates
Springfield, Missouri, 65807
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Overlook Medical Center
Summit, New Jersey, 07901
Wake Forest Baptist Comprehensive Cancer Research Center
Winston-Salem, North Carolina, 27157
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195
LeHigh Valley Hospital
Allentown, Pennsylvania, 18103
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Scranton Hematology Oncology
Scranton, Pennsylvania, 18510
Erlanger East Hospital
Chattanooga, Tennessee, 37421
Baptist Cancer Center
Memphis, Tennessee, 38120
Saint Marys Medical Center
Huntington, West Virginia, 25705
Amgen Call Center
866-572-6436
medinfo@amgen.com
MD
Study Director
Amgen