Phase II Iressa + Irradiation Followed by Chemo in NSCLC

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gefitinib; Vinorelbine

Criteria

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.