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

NCT00460551 | Terminated Phase 2 Results DMC

• 1 other identifier: GEN204
• Study Type: interventional
• Target: 13
• Locations: 5 countries
• Sites: 8

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Adverse Events

  Up to 3 months

Study Arms (1)

Zalutumumab 8 mg/kg

EXPERIMENTAL

Biological: Zalutumumab; Drug: Induction chemotherapy; Radiation: Radiotherapy

Interventions

Zalutumumab BIOLOGICAL

8 mg/kg

Zalutumumab 8 mg/kg

Induction chemotherapy DRUG

Combination of cisplatin and docetaxel administered as two cycles given every three weeks

Zalutumumab 8 mg/kg

Radiotherapy RADIATION

64 Gy in 32 fractions over 6.5 weeks

Zalutumumab 8 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NSCLC stage IIIA-IIIB
• Performance status 0 or 1 (Zubrod or WHO Scale)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genmab: lead

Study Sites (8)

Unknown Facility

Towson, Maryland, 21204, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

UZ Gent

Ghent, 9000, Belgium

Location

CHR La Citadelle

Liège, 4000, Belgium

Location

CHU Sart-Tilman Domaine Universitaire du Sart-Tilman

Liège, 4000, Belgium

Location

CHRU Reims, Hospital Maison Blanche

Reims, Cedex, 51092, France

Location

VU Medisch Centrum (VUMC)

Amsterdam, 1004MB, Netherlands

Location

The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

zalutumumab; Induction Chemotherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction

Limitations and Caveats

The trial was prematurely closed. The original protocol contained Part 1A, followed by Part 1B and Part 2. The trial was terminated when 13 patients were enrolled in Part 1A. Scans for efficacy were planned for Part 1B and Part 2.

Results Point of Contact

• Title: Eva Järlid Westerberg PhD
• Organization: Genmab A/S

E.Westerberg@genmab.com

+45 7020 2728

Study Officials

• Steen Lisby, MD, PHD

  Genmab employee

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2007
• First Posted: April 16, 2007
• Study Start: April 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 6, 2011
• Results First Posted: December 5, 2011

Record last verified: 2011-12

Locations

NL (1); FR (1); BE (3); US (2); GB (1)