RATIONALE: Prinomastat may stop the growth of non-small cell lung cancer by stopping blood
flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop
growing or die.
PURPOSE: Randomized phase III trial to determine the effectiveness of prinomastat plus
cisplatin and gemcitabine in treating patients who have metastatic or recurrent 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.
DISEASE CHARACTERISTICS: Stage IV or recurrent or T4 lesion non-small cell lung cancer
Measurable or evaluable disease No brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for non-small cell lung cancer Endocrine therapy: Not specified Radiotherapy:
Not specified Surgery: Not specified