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Expanded Access of AMG 510 (Sotorasib)

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ClinicalTrials.gov Identifier: NCT04667234
Expanded Access Status : Available
First Posted : December 14, 2020
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The primary objective of this study is to provide expanded access to and characterize the safety profile of AMG 510 (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

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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 AMG 510 (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



Intervention Details:
  • Drug: AMG 510
    Administered as an oral tablet.
    Other Name: Sotorasib

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 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 disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless contraindicated)
  • Performance Status ≤ 2

Exclusion Criteria

  • Active brain metastases
  • Active hepatitis B or hepatitis C virus
  • Current active malignancy other than NSCLC
  • Participants previously enrolled in sotorasib Study 20190009 (CodeBreaK 200)
  • 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


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
Show Show 38 study locations
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
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: June 18, 2021
Last Verified: June 2021
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