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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2023

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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

    • 24 Oct 2023 Results assessing baseline body mass index (BMI) associated with body weight gain from individual data of patients from J-ALEX, ALUR, ML29453 studies, presented at the 48th European Society for Medical Oncology Congress.
    • 24 Oct 2023 Results of a post-hoc patient-level pooled analysis at interim data cut-off of the randomized phase III trials ALEX (NCT02075840) and J-ALEX (JapicCTI-132316), exploring new prognostic factors presented at the 48th European Society for Medical Oncology Congress
    • 31 Mar 2022 Planned End Date changed from 1 Dec 2020 to 31 Dec 2020.

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