Back to resultsZalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zalutumumab
Induction chemotherapy
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Providence Portland Medical Center
- UZ Gent
- CHR La Citadelle
- CHU Sart-Tilman Domaine Universitaire du Sart-Tilman
- CHRU Reims, Hospital Maison Blanche
- VU Medisch Centrum (VUMC)
- The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zalutumumab 8 mg/kg
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Adverse Events
Number of participants reporting at least one adverse event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00460551
Brief Title
Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
Due to considerations regarding the appropriate therapeutic regimen for these patients.
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zalutumumab 8 mg/kg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Zalutumumab
Intervention Description
8 mg/kg
Intervention Type
Drug
Intervention Name(s)
Induction chemotherapy
Intervention Description
Combination of cisplatin and docetaxel administered as two cycles given every three weeks
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
64 Gy in 32 fractions over 6.5 weeks
Primary Outcome Measure Information:
Title
Progression Free Survival Verified by Imaging Techniques.
Description
Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16
Time Frame
Until disease progression
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number of participants reporting at least one adverse event
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steen Lisby, MD, PHD
Organizational Affiliation
Genmab employee
Official's Role
Study Director
Facility Information:
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHR La Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Sart-Tilman Domaine Universitaire du Sart-Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHRU Reims, Hospital Maison Blanche
City
Reims
State/Province
Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
VU Medisch Centrum (VUMC)
City
Amsterdam
ZIP/Postal Code
1004MB
Country
Netherlands
Facility Name
The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust
City
Sutton, Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer
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