Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC

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

To determine whether in docetaxel pretreated advanced NSCLC patients with favorable clinical parameter(s) gefitinib can produce different outcomes from patients without favorable clinical parameter treated with irinotecan.

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.

Inclusion Criteria:

• aged 75 years or less
• histologically or cytologically confirmed non-small cell lung cancer
• advanced, metastatic or recurrent
• ECOG performance status 0 to 2
• one prior palliative chemotherapy including docetaxel
• measurable or evaluable indicator lesion(s)
• normal marrow, hepatic and renal function
• provision of written informed consent

Exclusion Criteria:

• active infection and/or severe comorbidities
• pregnant or breastfed women
• active CNS metastasis
• active bleeding in GI tract or elsewhere