An international, multicenter, randomized phase III study of first-line erlotinib followed by second-line cisplatin/gemcitabine versus first-line cisplatin/gemcitabine followed by second-line erlotinib in advanced non-small-cell lung cancer: Treatment rationale and protocol dynamics of the TORCH trial

Cesare Gridelli, Charles Butts, Fortunato Ciardiello, Ronald Feld, Ciro Gallo, Francesco Perrone

Research output: Contribution to journalArticlepeer-review

Abstract

Herein, we present a randomized phase III Italian-Canadian trial named TORCH (Tarceva or Chemotherapy). In TORCH, we are investigating whether erlotinib as first-line therapy until progression followed by chemotherapy with cisplatin/gemcitabine will not be inferior in terms of survival to the standard arm, consisting of first-line cisplatin/gemcitabine for 6 cycles, followed at progression by erlotinib until second progression. The primary objective is overall survival, and an adjunctive primary endpoint is activity of first-line treatment with erlotinib in terms of progression-free rate after 9 weeks of treatment. Secondary objectives include response rate, progression-free survival, toxicity, quality of life, and exploratory evaluations of tumor tissue and blood samples for biologic or genomic determinants of outcome. The study design is based on a noninferiority survival comparison with about 900 patients expected to be recruited. An early analysis of activity will be performed in the experimental arm (first-line erlotinib followed by chemotherapy).

Original languageEnglish
Pages (from-to)235-238
Number of pages4
JournalClinical Lung Cancer
Volume9
Issue number4
DOIs
Publication statusPublished - Jul 2008

Keywords

  • Epidermal growth factor receptor
  • Pyrimidine analogue
  • Targeted therapy
  • Tyrosine kinase inhibitor

ASJC Scopus subject areas

  • Cancer Research
  • Pulmonary and Respiratory Medicine

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