NCT00312377

ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer

A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,690 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy. This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone. All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer. In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent. Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients. Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.

Conditions

• Non-small Cell Lung Cancer
• Lung Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	infusion
DRUG	Vandetanib	oral

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-08-01
• Completion: 2014-03-01
• First posted: 2006-04-10
• Last updated: 2016-09-30
• Results posted: 2011-05-24

Locations

156 sites across 25 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, India, Indonesia, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Korea, Spain, Thailand, Turkey (Türkiye), Vietnam