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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Genome Sciences Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Mapatumumab

Criteria

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