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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092924
• Other study ID #: TRM1-ST03
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2004
• Last updated: August 1, 2013
• Est. completion date: March 2005

Study information

• Verified date: August 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• TRAIL-R1 mAb (TRM-1;HGS-ETR1)

Locations

Country	Name	City	State
United States	Rush Medical College	Chicago	Illinois
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	MD Anderson	Houston	Texas
United States	Sarah Cannon Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.

Country where clinical trial is conducted

United States,