Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

Trial Profile

Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2018

At a glance

  • Drugs Crizotinib (Primary) ; Carboplatin; Cisplatin; Pemetrexed
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PROFILE-1014
  • Sponsors Pfizer
  • Most Recent Events

    • 13 Jul 2018 Results assessing Crizotinib efficacy in three prospective studies ((PROFILE 1005, PROFILE 1007, and PROFILE 1014), were published in the Annals of Oncology.
    • 16 May 2018 Results of final overall survival a key secondary endpoint data published in the Journal of Clinical Oncology.
    • 18 Oct 2017 Results of analysis assessing the effect of dexamethasone on steady-state crizotinib exposure using patient data from PROFILE-1001, PROFILE-1005, PROFILE-1007, PROFILE-1014 trials presented at the 18th World Conference on Lung Cancer
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