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

Human Genome Sciences

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: TRAIL-R1 mAb (TRM-1;HGS-ETR1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092924

TRM1-ST03

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)