Multicenter, Open-Ended, Double-Blind, Placebo-Controlled, Phase III Study of AE-941 in Addition to Combined Modality Treatment (Chemotherapy/Radiotherapy) for Locally Advanced Unresectable Non-Small Cell Lung Cancer
I. Determine the overall survival of patients with unresectable stage IIIA or IIIB non-small
cell lung cancer treated with induction platinum-based chemotherapy and radiotherapy with or
without AE-941 (Neovastat).
II. Determine the progression-free survival, tumor response, tumor response duration, and
metastasis-free survival of patients treated with these regimens.
III. Determine the tolerability of this regimen in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to stage (IIIA vs IIIB), type of platinum-based induction
chemotherapy to be received (cisplatin and vinorelbine vs carboplatin and paclitaxel), and
gender. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral AE-941 (Neovastat) twice daily beginning on day 1 or within 10
days of initiation of chemotherapy.
Arm II: Patients receive oral placebo twice daily beginning on day 1 or within 10 days of
initiation of chemotherapy.
All patients receive induction chemotherapy with 1 of the following platinum-based regimens:
cisplatin IV on days 1, 22, 50, and 71 and vinorelbine IV on days 1, 8, 22, 29, 50, 57, 71,
and 78 carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on days 1, 22, 50, 57,
64, 71, 78, and 85.
All patients receive radiotherapy beginning on day 50 for 6 weeks. Treatment in both arms
continues in the absence of unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 756 patients (378 per treatment arm) will be accrued for this
study within 36 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Survival distributions will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted to illustrate the comparative survival experience of both groups over the entire study period.
From randomization until date of death or last follow-up, assessed up to 7 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|