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A RANDOMIZED, MULTICENTER, PHASE III, OPEN-LABEL STUDY OF ALECTINIB VERSUS CRIZOTINIB IN TREATMENT-NAIVE ANAPLASTIC LYMPHOMA KINASE-POSITIVE ADVANCED NON-SMALL CELL LUNG CANCER

Trial Profile

A RANDOMIZED, MULTICENTER, PHASE III, OPEN-LABEL STUDY OF ALECTINIB VERSUS CRIZOTINIB IN TREATMENT-NAIVE ANAPLASTIC LYMPHOMA KINASE-POSITIVE ADVANCED NON-SMALL CELL LUNG CANCER

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 May 2025

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At a glance

  • Drugs Alectinib (Primary) ; Crizotinib
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ALEX
  • Sponsors Roche

Most Recent Events

  • 22 Apr 2025 Status changed from active, no longer recruiting to completed.
  • 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
  • 12 Sep 2023 Results comparing efficacy and safety of lorlatinib vs alectinib and brigatinib using matching adjusted indirect comparisons using patient level data from lorlatinib RCT (CROWN) to match the aggregate baseline characteristics of the comparator RCTs (alectinib: ALEX, ALESIA; brigatinib: ALTA-1L), presented at the 24th World Conference on Lung Cancer.

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