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

NCT ID: NCT00460551

Last Updated: 2011-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zalutumumab 8 mg/kg

Group Type EXPERIMENTAL

Zalutumumab

Intervention Type BIOLOGICAL

8 mg/kg

Induction chemotherapy

Intervention Type DRUG

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

Radiotherapy

Intervention Type RADIATION

64 Gy in 32 fractions over 6.5 weeks

Interventions

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Zalutumumab

8 mg/kg

Intervention Type BIOLOGICAL

Induction chemotherapy

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

Intervention Type DRUG

Radiotherapy

64 Gy in 32 fractions over 6.5 weeks

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genmab

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steen Lisby, MD, PHD

Role: STUDY_DIRECTOR

Genmab employee

Locations

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Towson, Maryland, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

UZ Gent

Ghent, , Belgium

Site Status

CHR La Citadelle

Liège, , Belgium

Site Status

CHU Sart-Tilman Domaine Universitaire du Sart-Tilman

Liège, , Belgium

Site Status

CHRU Reims, Hospital Maison Blanche

Reims, Cedex, France

Site Status

VU Medisch Centrum (VUMC)

Amsterdam, , Netherlands

Site Status

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

Sutton, Surrey, , United Kingdom

Site Status

Countries

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United States Belgium France Netherlands United Kingdom

Other Identifiers

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GEN204

Identifier Type: -

Identifier Source: org_study_id