NCT00460551

Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer

A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

Detailed description

Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Zalutumumab	8 mg/kg
DRUG	Induction chemotherapy	Combination of cisplatin and docetaxel administered as two cycles given every three weeks
RADIATION	Radiotherapy	64 Gy in 32 fractions over 6.5 weeks

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-04-16
• Last updated: 2011-12-06
• Results posted: 2011-12-05

Locations

8 sites across 5 countries: United States, Belgium, France, Netherlands, United Kingdom