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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04667234
Expanded Access Status : No longer available
First Posted : December 14, 2020
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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

Study Design
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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

Interventions
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Intervention Details:
  • Drug: AMG 510
    Administered as an oral tablet.
    Other Names:
    • Sotorasib
    • Lumakras (US)
    • Lumykras (UK)
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04667234    
Other Study ID Numbers: 20190436
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Keywords provided by Amgen:
NSCLC
KRAS p.G12C Mutation
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Sotorasib
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents