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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

TRM1-ST03

NCT ID:

NCT00092924

Start Date:

Completion Date:

March 2005

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Sarah Cannon Cancer CenterNashville, Tennessee  37203
Rush Medical CollegeChicago, Illinois  60612
MD AndersonHouston, Texas  77230