Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC

A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy

The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy

Inclusion Criteria:

• Histologically Confirmed Non Small Cell Lung Cancer.
• Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
• Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
• Response to combined therapy

Exclusion Criteria:

• No previous treatment with ZD1839 or any other EGFR-targeted therapy
• No progressive disease after combined therapy for locally advanced NSCLC
• No presence of metastatic disease
• No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Any unresolved chronic toxicity from previous anticancer therapy.