Phase II Iressa + Irradiation Followed by Chemo in NSCLC

A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer

The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.

Inclusion Criteria:

• Signed informed consent.
• 18 to 75 years inclusive.
• At least one measurable lesions histologically confirmed inoperable stage III NSCLC.
• WHO performance status of 0 to 2 inclusive.
• Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %.
• Life expectancy of at least 6 months.
• Using secure contraceptives precautions.

Exclusion Criteria:

• Any previous anti cancer therapy for NSCLC.
• Known severe hypersensitivity to these products
• Any evidence of clinically active interstitial lung disease
• Other co-existing malignancies, symptomatic metastases.
• Abnormal blood test
• Weight loss of over 15% in the 3 months before the start of the study.
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.