Carcinoma, Non-Small-Cell Lung
Conditions
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.
Interventions
DRUGTRAIL-R1 mAb (TRM-1;HGS-ETR1)
Sponsors
Human Genome Sciences Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed