A Phase II Study of Gefitinib With Concurrent Thoracic Radiotherapy in Patients With Unresectable, Stage III Non-small-cell Lung Cancer Harboring EGFR Mutations (WJOG6911L)

Clin Lung Cancer. 2019 Jan;20(1):e25-e27. doi: 10.1016/j.cllc.2018.08.017. Epub 2018 Aug 30.

Abstract

Locally advanced non-small-cell lung cancer (NSCLC) is curable. Standard treatment is concurrent chemoradiotherapy, but its efficacy with cytotoxic agents seems to reach a plateau. Among patients with advanced NSCLC who have epidermal growth factor receptor (EGFR) mutation, EGFR-tyrosine kinase inhibitor is the key drug. Thus, a similar strategy should be tested in patients with locally advanced NSCLC who have EGFR mutation. This single arm, phase II study aims to explore the efficacy and tolerability of gefitinib with concurrent thoracic radiotherapy in patients with unresectable stage III NSCLC harboring EGFR mutations. The primary endpoint is progression-free survival rate at 2 years. The secondary endpoints are overall response rate, progression-free survival, overall survival, and safety. A total of 27 patients will be enrolled in this trial.

Keywords: Chemoradiation; EGFR mutation; Gefitinib; Thoracic radiotherapy.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antineoplastic Agents* / therapeutic use
  • Carcinoma, Non-Small-Cell Lung* / drug therapy
  • Carcinoma, Non-Small-Cell Lung* / genetics
  • Carcinoma, Non-Small-Cell Lung* / mortality
  • Chemoradiotherapy*
  • Clinical Trials, Phase II as Topic
  • ErbB Receptors / genetics
  • Female
  • Gefitinib* / therapeutic use
  • Humans
  • Lung Neoplasms* / drug therapy
  • Lung Neoplasms* / genetics
  • Lung Neoplasms* / mortality
  • Male
  • Mutation / genetics
  • Neoplasm Staging
  • Progression-Free Survival
  • Prospective Studies
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • EGFR protein, human
  • ErbB Receptors
  • Gefitinib