NCT00111839

Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer

Randomized, Phase II, Open-Label Controlled Study of Two Different Doses and Schedules of EMD 72000 (Matuzumab) in Combination With Pemetrexed, or Pemetrexed Alone, as Second-Line Treatment for Stage IIIB/IV Non-Small Cell Lung Cancer and Progressive Disease on or After First-Line Treatment With a Platinum in Combination With Taxanes, Gemcitabine and Vinorelbine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multicenter, randomized, controlled, Phase II study is planned to answer questions about how the drug, matuzumab (EMD 72000), works and is part of an effort aimed to develop better treatment for advanced lung cancer by combining matuzumab, a monoclonal antibody, with a chemotherapy treatment, called pemetrexed.

Conditions

• Lung Cancer
• Non Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Pemetrexed	Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.
DRUG	Matuzumab	Matuzumab will be administered IV until PD or the occurrence of unacceptable toxicity.

Timeline

• Start date: 2005-05-31
• Primary completion: 2007-07-31
• Completion: 2009-03-31
• First posted: 2005-05-27
• Last updated: 2018-04-06
• Results posted: 2018-04-06

Locations

58 sites across 3 countries: United States, Austria, Germany