Phase II Iressa & Carbo/Gem in NSCLC

A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2

The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.

Inclusion Criteria:

• Advanced Non Small cell Lung Cell Lung cancer
• Never received chemotherapy
• Up and about 50% of waking hours

Exclusion Criteria:

• Spread of lung cancer to the brain
• Low level of white blood cells
• Radiotherapy within 4 weeks

Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.