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Completed

NCT Number: NCT00583830

A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects with advanced non-small cell lung cancer (NSCLC).

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma
  • Age 18 years or older

Exclusion criteria

  • Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat Lung Cancer
  • Received radiation therapy within 4 weeks before randomization
  • Major surgery within 4 weeks before randomization
  • Minor surgery within 2 weeks before randomizaiton
  • Systemic steroids within 1 week before randomization
  • Any grade 2 or greater neuropathy
  • History of severe (Grade 4) hypersensitivity reaction to products containing Cremophor EL (cyclosporine, teniposide)
  • History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization
  • Known brain or spinal cord metastases
  • History of other cancers within 5 years before randomization
  • Known HIV, hepatitis-B or hepatitis-C infection
  • Pregnant or breast-feeding women
  • Previously treated with Mapatumumab

Treatment and study plan

Mapatumumab

Biological

30 mg/kg IV (in the vein), on day 1 of each 21 day cycle

paclitaxel

Drug

200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle

Other names: Tax01, Paxene

carboplatin

Drug

AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle

Other names: Paraplatin

Primary outcomes

  1. Objective response and Progression free survival

    Time frame: 6 cycles, or until disease progression or unacceptable toxicity develops

Secondary outcomes

  1. Disease control; Overall survival; Response duration and time to response in responders; Frequency and severity of treatment-emergent adverse events; Laboratory parameters; and Serum mapatumumab concentrations for use in a PK analysis.

    Time frame: 6 cycles, or until disease progression or unacceptable toxicity develops

Sponsors and collaborators

Lead sponsor

Human Genome Sciences Inc.

Industry

Registry information

Official study title

A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Mapatumumab in Combination With Carboplatin and Paclitaxel as First Line Therapy in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)

Acronym: NSCLC

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Dec 31, 2007
Registry last updated
Aug 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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