Non Small Cell Lung Cancer Clinical Trial
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
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - NSCLC stage IIIA-IIIB - Performance status 0 or 1 (Zubrod or WHO Scale) Exclusion Criteria: - Evidence of metastases either in a separate lobe of the lung, or extra thoracic - Patients with high risk of radiation pneumonitis and or compromised lung function - Estimated life expectancy of less than 3 months - Prior chemotherapy for lung cancer - Prior radiotherapy to the chest - Prior surgery with curative intent for lung cancer |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Gent | Gent | |
Belgium | CHR La Citadelle | Liege | |
Belgium | CHU Sart-Tilman Domaine Universitaire du Sart-Tilman | Liege | |
France | CHRU Reims, Hospital Maison Blanche | Reims | Cedex |
Netherlands | VU Medisch Centrum (VUMC) | Amsterdam | |
United Kingdom | The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust | Sutton, Surrey | |
United States | Providence Portland Medical Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Genmab |
United States, Belgium, France, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Adverse Events | Number of participants reporting at least one adverse event | Up to 3 months | No |
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