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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00460551
• Other study ID #: GEN204
• Status: Terminated
• Phase: Phase 2
• First received: April 12, 2007
• Last updated: December 5, 2011
• Start date: April 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2011
• Source: Genmab
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Paul-Ehrlich-InstitutFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicines and Health Products, FAMHPNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Belgium	CHR La Citadelle	Liege
Belgium	CHU Sart-Tilman Domaine Universitaire du Sart-Tilman	Liege
France	CHRU Reims, Hospital Maison Blanche	Reims	Cedex
Netherlands	VU Medisch Centrum (VUMC)	Amsterdam
United Kingdom	The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust	Sutton, Surrey
United States	Providence Portland Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Genmab

Countries where clinical trial is conducted

United States,  Belgium,  France,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Until disease progression	No
Secondary	Adverse Events	Number of participants reporting at least one adverse event	Up to 3 months	No