NCT00850577

Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer

A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Paclitaxel	Solution, IV, 200 mg/m2, Q21days, 6 cycles
DRUG	Carboplatin	Solution, IV, AUC=6, Q21days, 6 cycles
DRUG	CT-322	Solution, IV, 2 mg/kg, Q7days, Until PD
DRUG	Bevacizumab	Solution, IV, 15 mg/kg, Q21days, Until PD
DRUG	Bevacizumab placebo (ie saline solution)	Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2009-02-25
• Last updated: 2015-10-12

Locations

55 sites across 8 countries: United States, Brazil, France, Italy, Poland, Russia, South Africa, United Kingdom