Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Matrix Metalloprotease Inhibitor Prinomastat (AG3340) in Combination With Gemcitabine and Cisplatin in Patients Having Advanced Non-Small Cell Lung Cancer

OBJECTIVES: I. Compare the overall survival, progression free survival, symptomatic
progression free survival, and one year survival of patients with metastatic or recurrent
non-small cell lung cancer treated with prinomastat (AG3340) or placebo in combination with
gemcitabine and cisplatin. II. Compare the disease response and duration of response in
these patients on these regimens. III. Compare the quality of life of these patients on
these regimens. IV. Evaluate the safety of these regimens in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
receive oral prinomastat or placebo twice daily beginning on day 1, followed by gemcitabine
IV on days 1 and 8 and cisplatin IV on day 1. Courses repeat every 3 weeks.

PROJECTED ACCRUAL: Approximately 420 patients will be accrued for this study.