A Randomized, Double Blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA) in Combination With Gemcitabine and Cisplatin Versus Placebo in Combination With Gemcitabine and Cisplatin in Chemotherapy Naive Patients With Advanced (Stage III or IV) Non-Small Cell Lung Cancer
OBJECTIVES: I. Compare the 1 year survival rate, time to worsening of disease related
symptoms, and progression free survival in chemotherapy naive patients with stage IIIB or IV
non-small cell lung cancer treated with one of two doses of ZD 1839 or placebo combined with
gemcitabine and cisplatin.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are randomized to one of three treatment arms. Patients receive gemcitabine and cisplatin
combined with lower dose oral ZD 1839 (arm I), higher dose oral ZD 1839 (arm II), or placebo
PROJECTED ACCRUAL: A total of 1,029 patients (343 per arm) will be accrued for this study.
Primary Purpose: Treatment
United States: Federal Government
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