Gefitinib Combined with Standard Chemoradiotherapy in EGFR-Mutant Locally Advanced Non-Small-Cell Lung Cancer: The LOGIK0902/OLCSG0905 Intergroup Study Protocol

Katsuyuki Hotta, Jiichiro Sasaki, Sho Saeki, Nagio Takigawa, Kuniaki Katsui, Koichi Takayama, Naoyuki Nogami, Yoshiyuki Shioyama, Akihiro Bessho, Junji Kishimoto, Mitsune Tanimoto, Katsuyuki Kiura, Yukito Ichinose

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Herein, we describe an ongoing phase II trial in patients with locally advanced non-small-cell lung cancer (NSCLC) with mutated epidermal growth factor receptor (EGFR). Patients with chemotherapy-naive locally advanced disease with active EGFR mutations will receive the induction treatment, specified as gefitinib monotherapy (250 mg/body) for 8 weeks. Patients whose disease has not progressed during the induction therapy will receive cisplatin and docetaxel (40 mg/m2) on days 1, 8, 29, and 36, and concurrent 3-dimensional conformal thoracic radiotherapy with a single daily fraction of 2 Gy, for 5 consecutive days each week to provide a total dose of 60 Gy. The primary end point is overall survival at 24 months. A target sample size of 21 evaluable patients is considered sufficient to validate an expected rate of 85%, and 60% would be the lower limit of interest, with 80% power and a 1-sided α of 5%. Secondary end points include toxicity, response rate, and overall survival. This study will clarify whether tyrosine kinase inhibitors targeted to EGFR can produce a maximal effect in selected NSCLC patients with the relevant driver mutation, even in the locally advanced setting.

Original languageEnglish
Pages (from-to)75-79
Number of pages5
JournalClinical Lung Cancer
Volume17
Issue number1
DOIs
Publication statusPublished - Jan 1 2016

Keywords

  • Chemoradiation
  • Cure
  • EGFR mutation
  • Locally advanced setting
  • Lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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