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

December 5, 2011 updated by: Genmab

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until disease progression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to 3 months
Number of participants reporting at least one adverse event
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Investigators

  • Study Director: Steen Lisby, MD, PHD, Genmab employee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

April 12, 2007

First Submitted That Met QC Criteria

April 13, 2007

First Posted (Estimate)

April 16, 2007

Study Record Updates

Last Update Posted (Estimate)

December 6, 2011

Last Update Submitted That Met QC Criteria

December 5, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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