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Study of TRM-1(TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092924
First Posted: September 28, 2004
Last Update Posted: August 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Human Genome Sciences Inc.
  Purpose
The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with relapsed or refractory non-small cell lung cancer.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung Drug: TRAIL-R1 mAb (TRM-1;HGS-ETR1) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of TRM-1 (Fully Human Monoclonal Antibody To TRAIL-R1) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Human Genome Sciences Inc.:

Study Completion Date: March 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Primary Inclusion Criteria:

  • Relapsed or refractory histologically or cytologically confirmed Stage IIIB, IV, or recurrent NSCLC
  • Previously treated and failed to respond to standard therapy or progressed after standard therapy
  • 18 years of age or older

Primary Exclusion Criteria:

  • Received a non-FDA approved investigational agent within the last 4 weeks.
  • Previous cancer therapies (chemotherapy, hormonal therapy, monoclonal antibodies or radiation therapy) within the last 3 weeks, 8 weeks for fully human or humanized monoclonal antibodies
  • Infection requiring antibiotics or hospitalization within the last 2 weeks
  • HIV, Hepatitis-B, Hepatitis-C
  • Pregnant or breast-feeding women
  • Major surgery within the last 4 weeks
  • History of other cancers within the past 5 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092924


Locations
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80220
United States, Illinois
Rush Medical College
Chicago, Illinois, United States, 60612
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson
Houston, Texas, United States, 77230
Sponsors and Collaborators
Human Genome Sciences Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

ClinicalTrials.gov Identifier: NCT00092924     History of Changes
Other Study ID Numbers: TRM1-ST03
First Submitted: September 24, 2004
First Posted: September 28, 2004
Last Update Posted: August 2, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs