NCT00050973

Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 623 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

Detailed description

This study evaluates the use of Targretin capsules (bexarotene) in combination with Cisplatin and Vinorelbine for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	bexarotene

Timeline

• Primary completion: 2004-11-01
• Completion: 2005-03-01
• First posted: 2003-01-03
• Last updated: 2013-05-14

Locations

77 sites across 11 countries: United States, Australia, Canada, Czechia, France, Greece, Hungary, Israel, Poland, Russia, United Kingdom