Expanded Access of Sotorasib

NCT04667234 | Unknown

• 1 other identifier: 20190436
• Study Type: expanded_access
• Target: N/A
• Locations: 6 countries
• Sites: 55

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.

Conditions

Non Small-cell Lung Cancer; Locally Advanced Unresectable NSCLC; Locally Advanced Metastatic NSCLC

Keywords

NSCLC; KRAS p.G12C Mutation

Interventions

AMG 510 DRUG

Administered as an oral tablet.

Also known as: Sotorasib, Lumakras (US), Lumykras (UK)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Amgen: lead

Study Sites (55)

Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508, United States

Location

Ironwood Cancer and Research Center

Chandler, Arizona, 85224, United States

Location

Arizona Oncology Associates Professional Corporation

Tucson, Arizona, 85711, United States

Location

San Luis Valley Health Regional Medical Center

Alamosa, Colorado, 81101, United States

Location

Kaiser Permanente

Lone Tree, Colorado, 80124, United States

Location

Sacred Heart Medical Oncology Group

Pensacola, Florida, 32504, United States

Location

Cancer Care Specialists of Central Illinois

Decatur, Illinois, 62526, United States

Location

McFarland Clinic PC

Ames, Iowa, 50010, United States

Location

Des Moines Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

Saint Joseph East

Lexington, Kentucky, 40509, United States

Location

Louisiana Hematology Oncology Associates

Baton Rouge, Louisiana, 70809, United States

Location

Northern Light Cancer Center

Brewer, Maine, 04412, United States

Location

University of Pittsburgh Medical Center Western Maryland

Cumberland, Maryland, 21502, United States

Location

Maryland Oncology Hematology, PA

Rockville, Maryland, 20850, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mid Michigan Medical Center

Midland, Michigan, 48640, United States

Location

Saint Lukes Cancer Institute

Kansas City, Missouri, 64111, United States

Location

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Overlook Medical Center

Summit, New Jersey, 91010, United States

Location

Wake Forest Baptist Comprehensive Cancer Research Center

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

LeHigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Scranton Hematology Oncology

Scranton, Pennsylvania, 18510, United States

Location

Erlanger East Hospital

Chattanooga, Tennessee, 37421, United States

Location

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

Location

Saint Marys Medical Center

Huntington, West Virginia, 25705, United States

Location

Instituto Médico Especializado Alexander Fleming

Capital Federal, Buenos Aires, C1426ANZ, Argentina

Location

Hospital Aleman

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT, Argentina

Location

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina

Location

Clínica Universitaria Privada Reina Fabiola

Córdoba, X5004FHP, Argentina

Location

Hospital Sirio Libanes

Brasília, Federal District, 70200-730, Brazil

Location

Personal Oncologia de Precisao e Personalizada

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Instituto de Oncologia do Parana

Curitiba, Paraná, 80040-170, Brazil

Location

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

YNOVA Pesquisa Clinica

Florianópolis, Santa Catarina, 88034-000, Brazil

Location

Fundacao Pio 12 Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro/RJ, 22250-905, Brazil

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Shaare Zedek Medical Center

Petah Tikva, 4941492, Israel

Location

King Fahad Specialist Hospital

Dammam, 32253, Saudi Arabia

Location

King Abdulaziz Medical City - National Guard Hospital

Riyadh, 11426, Saudi Arabia

Location

King Saud University Medical City-King Khalid University Hospital

Riyadh, 12372, Saudi Arabia

Location

King Faisal Specialist Hospital

Riyadh, 12713, Saudi Arabia

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

Veterans General Hospital - Taichung

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sotorasib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

SA (4); IL (3); BR (7); TW (7); AR (4); US (30)