Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

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.

Inclusion Criteria:

• Adults over age 18 years of age with a life expectancy of at least 3 months.
• Histologically or cytologically confirmed stage IIIB or stage IV non squamous non-small-cell lung cancer (NSCLC) who have progressed after 1 chemotherapy regimen.
• Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
• Adequate hematologic, renal, and hepatic function.
• PT/INR ≤ 1.5 × ULN; aPTT time ≤ 1.5 × ULN.
• New York Heart Association classification I or II

Exclusion Criteria:

• Squamous, small cell, or mixed histology.
• Known history of bleeding diathesis or coagulopathy.
• Cavitary tumors or tumors invading or abutting large blood vessels.
• Bleeding: Clinically significant bleeding such as gross hematuria, GI bleeding and hemoptysis within 12 months of Screening.
• Venous thromboembolic events within 6 months of screening.
• Ongoing therapy with oral or parenteral anticoagulants.
• Concurrent estrogens, anti-estrogens or progesterone compounds.
• Radiotherapy within 2 weeks or major surgery within 4 weeks preceding Study Day 1.
• Symptomatic or clinically active brain metastases.
• Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris within 6 months of screening.
• Grade 2 or higher peripheral neuropathy