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

This study has been terminated.
(Due to considerations regarding the appropriate therapeutic regimen for these patients.)
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00460551
First received: April 12, 2007
Last updated: December 5, 2011
Last verified: December 2011
History of Changes

April 12, 2007
December 5, 2011
April 2007
October 2008   (final data collection date for primary outcome measure)
Progression Free Survival Verified by Imaging Techniques. [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16
Progression free survival time
Complete list of historical versions of study NCT00460551 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
Number of participants reporting at least one adverse event
Not Provided
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • 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
Experimental: Zalutumumab 8 mg/kg
Interventions:
  • Biological: Zalutumumab
  • Drug: Induction chemotherapy
  • Radiation: Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   France,   Netherlands,   United Kingdom
 
NCT00460551
GEN204
Yes
Genmab
Genmab
Not Provided
Study Director: Steen Lisby, MD, PHD Genmab employee
Genmab
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP