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

NCT ID: NCT00092924

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Completion Date

2005-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Human Genome Sciences Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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University of Colorado Cancer Center

Denver, Colorado, United States

Site Status

Rush Medical College

Chicago, Illinois, United States

Site Status

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Site Status

MD Anderson

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TRM1-ST03

Identifier Type: -

Identifier Source: org_study_id