A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumors

Trial Profile

A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumors

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2015

At a glance

  • Drugs Erlotinib (Primary) ; Cisplatin; Gemcitabine
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ENSURE
  • Sponsors Roche
  • Most Recent Events

    • 02 Jun 2015 Results from a meta-analysis of 6 trials showing impact on overall survival in patients with EGFR mutations presented at the 51st Annual Meeting of the American Society of Clinical Oncology.
    • 03 Nov 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 14 Mar 2014 Planned End Date changed from 1 Dec 2014 to 1 Dec 2015 as reported by ClinicalTrials.gov.
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