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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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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

  • 23 Mar 2018 Results (n=1312) assessing the value of early depth of response in predicting long-term outcome in EGFR-mutant lung cancer using data of patients those with either EGFR mutation exon 19 deletion or exon 21 L858R mutations from five phase III randomized trials EURTAC, IPASS, ENSURE, LUX-Lung , and LUX-Lung 6, published in the Journal of Thoracic Oncology.
  • 18 Oct 2017 Results assessing Overall survival Adjusting for Post-Progression Treatment Crossover in three phase III trials (EURTAC, ENSURE and OPTIMAL), presented at the 18th World Conference on Lung Cancer
  • 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.

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