Study of TRM-1(TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
Phase 2
Completed
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT00092924
- Lead Sponsor
- Human Genome Sciences Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Rush Medical College
🇺🇸Chicago, Illinois, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
MD Anderson
🇺🇸Houston, Texas, United States
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States