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

Phase 2

Terminated

• Conditions: Non Small Cell Lung Cancer
• Interventions: Biological: Zalutumumab; Drug: Induction chemotherapy; Radiation: Radiotherapy

• Registration Number: NCT00460551
• Lead Sponsor: Genmab

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-12
• Study First Submitted QC: 2007-04-13
• Study First Posted: 2007-04-16
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2011-09-12
• Results First Submitted QC: 2011-10-28
• Status Verified: 2011-12
• Results First Posted: 2011-12-05
• Last Update Submitted: 2011-12-05
• Last Update Posted: 2011-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zalutumumab 8 mg/kg	Induction chemotherapy	-
Zalutumumab 8 mg/kg	Zalutumumab	-
Zalutumumab 8 mg/kg	Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival Verified by Imaging Techniques.	Until disease progression	Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Up to 3 months	Number of participants reporting at least one adverse event

Trial Locations

Locations (7)

CHR La Citadelle; 🇧🇪 Liege, Belgium

VU Medisch Centrum (VUMC); 🇳🇱 Amsterdam, Netherlands

CHRU Reims, Hospital Maison Blanche; 🇫🇷 Reims, Cedex, France

The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom

UZ Gent; 🇧🇪 Gent, Belgium

CHU Sart-Tilman Domaine Universitaire du Sart-Tilman; 🇧🇪 Liege, Belgium

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States