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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00460551
Recruitment Status : Terminated (Due to considerations regarding the appropriate therapeutic regimen for these patients.)
First Posted : April 16, 2007
Results First Posted : December 5, 2011
Last Update Posted : December 6, 2011
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: Zalutumumab Drug: Induction chemotherapy Radiation: Radiotherapy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Zalutumumab 8 mg/kg 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

Primary Outcome Measures :
  1. Progression Free Survival Verified by Imaging Techniques. [ Time Frame: Until disease progression ]
    Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 3 months ]
    Number of participants reporting at least one adverse event

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00460551

United States, Maryland
Towson, Maryland, United States, 21204
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
UZ Gent
Gent, Belgium, 9000
CHR La Citadelle
Liege, Belgium, 4000
CHU Sart-Tilman Domaine Universitaire du Sart-Tilman
Liege, Belgium, 4000
CHRU Reims, Hospital Maison Blanche
Reims, Cedex, France, 51092
VU Medisch Centrum (VUMC)
Amsterdam, Netherlands, 1004MB
United Kingdom
The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Study Director: Steen Lisby, MD, PHD Genmab employee

Responsible Party: Genmab Identifier: NCT00460551     History of Changes
Other Study ID Numbers: GEN204
First Posted: April 16, 2007    Key Record Dates
Results First Posted: December 5, 2011
Last Update Posted: December 6, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs