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Brief Title: Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer
Official Title: 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
Study ID: NCT00460551
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Towson, Maryland, United States
Providence Portland Medical Center, Portland, Oregon, United States
UZ Gent, Gent, , Belgium
CHR La Citadelle, Liege, , Belgium
CHU Sart-Tilman Domaine Universitaire du Sart-Tilman, Liege, , Belgium
CHRU Reims, Hospital Maison Blanche, Reims, Cedex, France
VU Medisch Centrum (VUMC), Amsterdam, , Netherlands
The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust, Sutton, Surrey, , United Kingdom
Name: Steen Lisby, MD, PHD
Affiliation: Genmab employee
Role: STUDY_DIRECTOR