Official Title
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
Brief 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.

No longer 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: Array

Eligibility Criteria

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

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

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

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

Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States

Scranton Hematology Oncology
Scranton, Pennsylvania, United States

Erlanger East Hospital
Chattanooga, Tennessee, United States

Baptist Cancer Center
Memphis, Tennessee, United States

Saint Marys Medical Center
Huntington, West Virginia, United States

Instituto Médico Especializado Alexander Fleming
Capital Federal, Buenos Aires, Argentina

Hospital Aleman
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Cemic
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Clínica Universitaria Privada Reina Fabiola
Córdoba, Argentina

Hospital Sirio Libanes
Brasilia, Distrito Federal, Brazil

Personal Oncologia de Precisao e Personalizada
Belo Horizonte, Minas Gerais, Brazil

Instituto de Oncologia do Parana
Curitiba, Paraná, Brazil

Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande Do Norte, Brazil

YNOVA Pesquisa Clinica
Florianopolis, Santa Catarina, Brazil

Fundacao Pio 12 Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil

Oncoclinicas Rio de Janeiro S A
Rio De Janeiro/RJ, Brazil

Meir Medical Center
Kfar Saba, Israel

Shaare Zedek Medical Center
Petach Tikva, Israel

Rabin Medical Center
Petah Tikva, Israel

King Fahad Specialist Hospital
Dammam, Saudi Arabia

King Abdulaziz Medical City - National Guard Hospital
Riyadh, Saudi Arabia

King Saud University Medical City-King Khalid University Hospital
Riyadh, Saudi Arabia

King Faisal Specialist Hospital
Riyadh, Saudi Arabia

Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan

Chung Shan Medical University Hospital
Taichung, Taiwan

Veterans General Hospital - Taichung
Taichung, Taiwan

National Cheng Kung University Hospital
Tainan, Taiwan

National Taiwan University Hospital
Taipei, Taiwan

Taipei Veterans General Hospital
Taipei, Taiwan

Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan

MD, Study Director
Amgen

NCT Number
Keywords
NSCLC
KRAS p.G12C Mutation
MeSH Terms
Carcinoma, Non-Small-Cell Lung
Sotorasib