This randomized, multi-center, open-label Phase II study is designed to evaluate the efficacy and safety of HGS-ETR1 in combination with carboplatin and paclitaxel as first-line therapy in the treatment of advanced non-small cell lung cancer (Stage IIIB or IV). Approximately 105 patients will be randomly assigned among three treatment groups and treated with either the two-agent combination of carboplatin and paclitaxel or the three-agent combination of carboplatin, paclitaxel and HGS-ETR1 at either 10 mg/kg or 30 mg/kg.
HGS-ETR1 is a human monoclonal antibody to TRAIL receptor 1, a protein involved in programmed cell death (apoptosis). The first randomized Phase II trial of HGS-ETR1 is currently underway in combination with bortezomib (Velcade) in patients with advanced multiple myeloma. HGS expects to have data available from the multiple myeloma study by mid-2008.
David Stump, executive vice president, research & development at HGS, said: “The Trail-mediated apoptosis pathway is an exciting area of cancer research, and agonistic antibodies to this target offer great promise to patients with a wide variety of cancers. HGS-ETR1 is the most advanced of these antibodies, now with two randomized Phase II chemotherapy combination trials ongoing.”