We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Expanded Access of Sotorasib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04667234
Expanded Access Status : Available
First Posted : December 14, 2020
Last Update Posted : February 16, 2023
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Non Small-cell Lung Cancer Locally Advanced Unresectable NSCLC Locally Advanced Metastatic NSCLC Drug: AMG 510

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
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

Resource links provided by the National Library of Medicine

Drug Information available for: Sotorasib

Intervention Details:
  • Drug: AMG 510
    Administered as an oral tablet.
    Other Names:
    • Sotorasib
    • Lumakras (US)
    • Lumykras (UK)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04667234

Layout table for location contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Show Show 55 study locations
Sponsors and Collaborators
Layout table for investigator information
Study Director: MD Amgen
Additional Information:
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04667234    
Other Study ID Numbers: 20190436
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: February 16, 2023
Last Verified: February 2023
Keywords provided by Amgen:
KRAS p.G12C Mutation
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases