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

Phase 2TerminatedNCT00460551

Genmab13 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Small Cell Lung Cancer

Interventions

ZalutumumabBIOLOGICAL

8 mg/kg

Induction chemotherapyDRUG

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

RadiotherapyRADIATION

64 Gy in 32 fractions over 6.5 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Towson, Maryland, United States

Providence Portland Medical Center

Portland, Oregon, United States

UZ Gent

Ghent, Belgium

CHR La Citadelle

Liège, Belgium

Outcomes

Primary Outcomes

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

Time frame: Until disease progression

Secondary Outcomes

Adverse Events

Number of participants reporting at least one adverse event

Time frame: Up to 3 months

Data from ClinicalTrials.gov

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