Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peregrine Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Bavituximab; Docetaxel

Criteria

Key Inclusion Criteria:

• Male or female at least 18 years of age

• Histologically or cytologically confirmed and documented stage IIIb/IV non-squamous NSCLC according to the American Joint Committee on Cancer Staging Manual (7th Edition)

• Radiographic disease recurrence or progression during or after front-line platinum-based doublet chemotherapy. For patients with known epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK) translocations, appropriate targeted treatment should have been used. Mutation testing is not required.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate hematologic, renal and hepatic function

Exclusion Criteria:

• Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC

• Known history of bleeding disorders, eg, von Willebrand disease or hemophilia

• Cavitary tumors or tumors invading or abutting large blood vessels

• Clinically significant bleeding such as gross hematuria, GI bleeding, and hemoptysis within the 6 months before screening

• Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening

• Grade 2 or higher peripheral neuropathy