Expanded Access of Sotorasib

August 19, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
    • 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
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5004FHP
        • Clinica Universitaria Privada Reina Fabiola
  • Brazil
      • Rio de Janeiro/RJ, Brazil, 22250-905
        • Oncoclinicas Rio de Janeiro S A
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • Hospital Sirio Libanês
    • 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
      • Kaohsiung City, Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
    • Taichung
      • Taichung, Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Taichung, Taichung, Taiwan, 40705
        • Veterans General Hospital - Taichung
    • Tainan
      • Tainan, Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
    • Taipei
      • Taipei, Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taipei, Taiwan, 10002
        • National Taiwan University Hospital
    • Taoyuan
      • Taoyuan, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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