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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. 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 : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date December 8, 2020
First Posted Date December 14, 2020
Last Update Posted Date November 15, 2022
 
Descriptive Information
Brief Title Expanded Access of Sotorasib
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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention Drug: AMG 510
Administered as an oral tablet.
Other Names:
  • Sotorasib
  • Lumakras (US)
  • Lumykras (UK)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries Argentina,   Brazil,   Israel,   Saudi Arabia,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04667234
Current Responsible Party Amgen
Original Responsible Party Same as current
Current Study Sponsor Amgen
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: MD Amgen
PRS Account Amgen
Verification Date November 2022