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Phase 3, Randomized Study Comparing Ensartinib to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

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Trial Profile

Phase 3, Randomized Study Comparing Ensartinib to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Dec 2024

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At a glance

  • Drugs Ensartinib (Primary) ; Crizotinib
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms eXalt3
  • Sponsors Xcovery Holdings

Most Recent Events

  • 18 Dec 2024 According to a Food and Drug Administration media release, based on results from this trial the the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.
  • 20 Aug 2024 Planned primary completion date changed from 30 Jun 2024 to 30 Dec 2025.
  • 06 May 2024 Planned End Date changed from 31 Dec 2023 to 31 Dec 2025.

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