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Expanded Access to Ensartinib for Participants With ALK+ NSCLC

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. Identifier: NCT04146571
Expanded Access Status : Available
First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Information provided by (Responsible Party):
Xcovery Holding Company, LLC

Tracking Information
First Submitted Date October 28, 2019
First Posted Date October 31, 2019
Last Update Posted Date October 31, 2019
Descriptive Information
Brief Title Expanded Access to Ensartinib for Participants With ALK+ NSCLC
Brief Summary This is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396). The treatment plan is designed to provide ensartinib to participants with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC).
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention Drug: Ensartinib
Oral, ALK inhibitor
Other Names:
  • X-396
  • X396
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Contact: Allison K Holzhausen 5618359356 ext 206
Contact: Kimberly Harrow 5618359356 ext 200
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT04146571
Responsible Party Xcovery Holding Company, LLC
Study Sponsor Xcovery Holding Company, LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account Xcovery Holding Company, LLC
Verification Date October 2019