NCT00290953

Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 432 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lung Cancer
• Pulmonary Neoplasms
• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SR48692

Timeline

• Start date: 2002-10-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2006-02-13
• Last updated: 2008-12-23

Locations

14 sites across 14 countries: Argentina, Australia, Belgium, Brazil, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Russia, Spain, United Kingdom