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
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival Verified by Imaging Techniques.
Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16
Until disease progression
Steen Lisby, MD, PHD
United States: Food and Drug Administration
|Baltimore, Maryland 21287|
|Providence Portland Medical Center||Portland, Oregon 97213-3635|