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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

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: 15 Mar 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

    • 13 Mar 2024 According to a Xcovery Holdings media release, results of the eXalt3 were originally published in JAMA Oncology in September 2021.
    • 13 Mar 2024 According to a Xcovery Holdings media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib or the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) based on the results of the eXalt3. The FDA granted the application Standard Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.
    • 17 Nov 2023 Planned number of patients changed from 398 to 290.
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