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OpenTrials
Completed

NCT Number: NCT00092924

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic 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

University of Colorado Cancer Center, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

TRAIL-R1 mAb (TRM-1;HGS-ETR1)

Drug

Sponsors and collaborators

Lead sponsor

Human Genome Sciences Inc.

Industry

Registry information

Official study 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

Important dates

Primary completion
2005
Study completion
2005
First posted
Sep 28, 2004
Registry last updated
Aug 2, 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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