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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival Verified by Imaging Techniques.

Outcome Description:

Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16

Outcome Time Frame:

Until disease progression

Safety Issue:

No

Principal Investigator

Steen Lisby, MD, PHD

Investigator Role:

Study Director

Investigator Affiliation:

Genmab employee

Authority:

United States: Food and Drug Administration

Study ID:

GEN204

NCT ID:

NCT00460551

Start Date:

April 2007

Completion Date:

October 2008

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Baltimore, Maryland  21287
Providence Portland Medical CenterPortland, Oregon  97213-3635