Expanded Access of Sotorasib

August 11, 2025 updated by: Amgen

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

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5004FHP
        • Clínica Universitaria Privada Reina Fabiola
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1426ANZ
        • Instituto Medico Especializado Alexander Fleming
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
        • CEMIC
  • Brazil
      • Rio de Janeiro/RJ, Brazil, 22250-905
        • Oncoclinicas Rio de Janeiro S A
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • Hospital Sirio Libanes
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • PERSONAL Oncologia de Precisao e Personalizada
    • Paraná
      • Curitiba, Paraná, Brazil, 80040-170
        • Instituto de Oncologia do Parana
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Liga Norte-Riograndense Contra O Cancer
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88034-000
        • Ynova Pesquisa Clinica
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Fundacao Pio 12 Hospital de Cancer de Barretos
  • Israel
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Petah Tikva, Israel, 4941492
        • Shaare Zedek Medical Center
  • Saudi Arabia
      • Dammam, Saudi Arabia, 32253
        • King Fahad Specialist hospital
      • Riyadh, Saudi Arabia, 11426
        • King Abdulaziz Medical City - National Guard Hospital
      • Riyadh, Saudi Arabia, 12372
        • King Saud University Medical City-King Khalid University Hospital
      • Riyadh, Saudi Arabia, 12713
        • King Faisal Specialist Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Taichung, Taiwan, 40705
        • Veterans General Hospital - Taichung
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Institute
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Oncology and Hematology LLC
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer and Research Center
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology Associates Professional Corporation
    • Colorado
      • Alamosa, Colorado, United States, 81101
        • San Luis Valley Health Regional Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Kaiser Permanente
    • Florida
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Medical Oncology Group
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Central Illinois
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC
      • Des Moines, Iowa, United States, 50309
        • Des Moines Oncology Research Association
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Saint Joseph East
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Louisiana Hematology Oncology Associates
    • Maine
      • Brewer, Maine, United States, 04412
        • Northern Light Cancer Center
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • University of Pittsburgh Medical Center Western Maryland
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology, PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Midland, Michigan, United States, 48640
        • Mid Michigan Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Lukes Cancer Institute
      • Springfield, Missouri, United States, 65807
        • Oncology Hematology Associates
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
      • Summit, New Jersey, United States, 91010
        • Overlook Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Comprehensive Cancer Research Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Institute
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Scranton, Pennsylvania, United States, 18510
        • Scranton Hematology Oncology
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Erlanger East Hospital
      • Memphis, Tennessee, United States, 38120
        • Baptist Cancer Center
    • West Virginia
      • Huntington, West Virginia, United States, 25705
        • Saint Marys Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190436

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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