Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous 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