Iressa v BSC (Best Supportive Care) in First Line NSCLC

A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status

The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.

Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC
• NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
• Not suitable for chemotherapy
• WHO Performance status 2 or 3

Exclusion Criteria:

• Newly diagnosed CNS mets
• Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity
• Other co-existing malignancies
• ALT/AST greater than 5 x upper limit of normal
• ANC less than 1.0 x 109/L or platelets less than 100 x 109/L