Open-label randomized PhaseIII Study of the Efficacy and Safety of CH5424802(AF802) in ALK-Positive Advanced or Recurrecnt Non-Small Cell Lung Cancer with Crizotinib control

Trial Profile

Open-label randomized PhaseIII Study of the Efficacy and Safety of CH5424802(AF802) in ALK-Positive Advanced or Recurrecnt Non-Small Cell Lung Cancer with Crizotinib control

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2017

At a glance

  • Drugs Alectinib (Primary) ; Crizotinib
  • Indications Non-small cell lung cancer
  • Focus Therapeutic Use
  • Acronyms J-ALEX
  • Sponsors Chugai Pharmaceutical
  • Most Recent Events

    • 03 Aug 2017 According to a Genentech media release, the US FDA has accepted the company's sNDA and granted Priority Review for Alecensa (alectinib) as an initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic NSCLC as detected by an FDA-approved test. The FDA will make a decision on approval by November 30, 2017. This sNDA submission for Alecensa is based on results from the Phase III ALEX and Phase III J-ALEX studies.
    • 06 Jun 2017 Results of population pharmakokinetics presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
    • 06 Jun 2017 Updated efficacy and safety results (Data cut off: Sep 2016), presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
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