Lung Cancer Clinical Trial
Official title:
A Double Blind, Randomized, Phase II-III Maintenance Study of SR48692 Versus Placebo in Patients With Extensive Stage Small Cell Lung Cancer Following a First Line Chemotherapy With Cisplatin + Etoposide
To demonstrate an increase in overall survival for patients with newly diagnosed extended
stage small cell lung cancer when treated with SR48692 versus placebo, after an initial
response (complete or partial response or stable) to first line cisplatin plus etoposide.
Primary objective: comparison of overall survival between patients in the control arm and
the meclinertant arm.
Secondary objectives: comparison of the progression free survival, the time to progression,
the clinical benefit, the quality of life, the toxicity and safety between patients in the
control arm and the meclinertant arm.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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