A Phase II Study of Second-Line Therapy With Irinotecan or Gefitinib in Docetaxel Pretreated Patients With Non-Small Cell Lung Cancer: a New Treatment Strategy According to Clinical Predictors for Response
It has been suggested that some clinical parameters, including women, no smoking history and
a histologic diagnosis of adenocarcinoma, are associated with favorable outcomes of
gefitinib therapy. We will conduct a phase II study in docetaxel pretreated advanced NSCLC
patients treated with gefitinib or irinotecan according to these clinical parameters in
order to determine whether in patients with favorable clinical parameter(s) gefitinib will
produce difference outcomes from patients without favorable clinical parameter treated with
irinotecan.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Se Hoon Park, MD
Principal Investigator
Gachon University Gil Medical Center, Incheon, Korea
Korea: Food and Drug Administration
GMO-LU-62
NCT00319800
February 2006
March 2007
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