Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects

Subjects with measurable disease will be assessed for response after every 2 cycles of
therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall
survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be
evaluated.

Inclusion Criteria:

- Greater than or equal to 18

- Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously
treated with systemic chemotherapy

- Evaluable disease by clinical or radiographic parameters

- No history or concomitant malignancy

- Adequate organ and marrow function

- Female subjects with negative urine or serum pregnancy

- ECOG must be 0 or 1

Exclusion Criteria:

- Squamous cell, small cell, or mixed histology

- Known history of bleeding diathesis or coagulopathy

- Cavitary tumors or tumors invading or abutting large blood vessels

- Any history of thromboembolic events

- Ongoing therapy with oral or parenteral anticoagulants

- Major surgery within 4 weeks of Day 1 of treatment

- Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease)

- any history of significant vascular disease

- Congestive heart failure

- History of any condition requiring anti-platelet therapy

- Serious non healing wound

- Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis

- Unable or unwilling to discontinue use of prohibited medications

- D-dimers >2 x ULN as measured on 2 separate occasions at least 1 day apart