NCT00418886

Efficacy Study Comparing ZD6474 in Combination With Pemetrexed and Pemetrexed Alone in 2nd Line NSCLC Patients

A Phase III, Randomized, Double-blinded, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of ZD6474 (ZACTIMA™) in Combination With Pemetrexed (Alimta®) Versus Pemetrexed Alone in Patients With Locally-Advanced or Metastatic NSCLC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 698 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Non-small cell lung cancer (NSCLC) can be treated with drugs that kill tumour cells, stop them from dividing, or stop the growth of the blood supply that cancers need to grow and spread. Clinical research has shown that drugs that inhibit vascular endothelial growth factor receptor (VEGFR) or epidermal growth factor receptor (EGFR) signalling can increase overall survival in patients with advanced non-small cell lung cancer (NSCLC). Preclinical studies have shown that vandetanib (ZD6474) is an inhibitor of both VEGFR and EGFR signalling. Giving vandetanib may therefore inhibit the growth of cancer cells by blocking their blood supply and by stopping them from dividing. This lung cancer study is to investigate if adding vandetanib to Alimta (pemetrexed) is more effective than Alimta (pemetrexed) alone.

Detailed description

This randomized phase III non-small cell lung cancer clinical trial is studying the effect of Alimta (pemetrexed) plus vandetanib to see how well the combination works compared to Alimta (pemetrexed) alone in patients who have previously been treated for non-small cell lung cancer (NSCLC).

Conditions

• Non Small Cell Lung Cancer
• Lung Cancer

Interventions

Type	Name	Description
DRUG	Vandetanib	oral once daily tablet
DRUG	Pemetrexed	intravenous infusion

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-09-01
• Completion: 2023-02-14
• First posted: 2007-01-05
• Last updated: 2024-12-31
• Results posted: 2012-03-26

Locations

110 sites across 21 countries: United States, Argentina, Australia, Belgium, Colombia, France, Germany, Greece, Hong Kong, India, Israel, Italy, Mexico, Philippines, Portugal, South Africa, Spain, Sweden, Taiwan, United Kingdom, Venezuela