A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects with advanced non-small cell lung cancer (NSCLC).

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

Details

• Lead Sponsor: Human Genome Sciences Inc.
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Carboplatin; Mapatumumab; Paclitaxel

Criteria

Inclusion Criteria:

• Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma

• Age 18 years or older

Exclusion Criteria:

• Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat Lung Cancer

• Received radiation therapy within 4 weeks before randomization

• Major surgery within 4 weeks before randomization

• Minor surgery within 2 weeks before randomizaiton

• Systemic steroids within 1 week before randomization

• Any grade 2 or greater neuropathy

• History of severe (Grade 4) hypersensitivity reaction to products containing Cremophor EL (cyclosporine, teniposide)

• History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization

• Known brain or spinal cord metastases

• History of other cancers within 5 years before randomization

• Known HIV, hepatitis-B or hepatitis-C infection

• Pregnant or breast-feeding women

• Previously treated with Mapatumumab