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A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer

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Trial Profile

A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer

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

Latest Information Update: 24 Apr 2025

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At a glance

  • Drugs Alectinib (Primary) ; Carboplatin; Cisplatin; Gemcitabine; Pemetrexed; Vinorelbine
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ALINA
  • Sponsors Chugai Pharmaceutical; Roche

Most Recent Events

  • 16 Jul 2024 According to a Roche media release, company announced on June 27, 2024, Health Canada granted approval of Alecensaro (alectinib) monotherapy as adjuvant treatment following tumour resection for patients with stage IB to IIIA anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Data from the Phase III ALINA trial supported the Health Canada application and approval, which obtained Priority Review status by Health Canada.
  • 10 Jun 2024 According to a Roche Media Release, the European Commission has approved Alecensa (alectinib) monotherapy, as adjuvant treatment following tumour resection for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence (Stage IB [greater than or equal to 4 cm]-IIIA NSCLC [7 edition UICC/AJCC]), based on results form this trial.
  • 04 Jun 2024 Results presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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