A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

Key

Inclusion Criteria:

- Adults over 18 years of age with a life expectancy of at least 3 months.

- Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC
that has not been previously treated with systemic chemotherapy.

- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version
1.1).

- Adequate hematologic, renal and hepatic function.

- PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.

Key Exclusion Criteria:

- Squamous cell, small cell, or mixed histology.

- Known history of bleeding diathesis or coagulopathy.

- Cavitary tumors or tumors abutting large blood vessels.

- Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and
hemoptysis, within 12 months of Screening.

- Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary
thromboembolism) within 6 months of Screening.

- Ongoing therapy with oral or parenteral anticoagulants.

- Concurrent estrogens, anti-estrogens or progesterone compounds.

- Grade 2 or higher peripheral neuropathy.

- Radiotherapy within 2 weeks preceding Study Day 1.

- Symptomatic or clinically active brain metastases.

- Major surgery within 4 weeks of Study Day 1.

- Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).

- Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic
attack, myocardial infarction, or unstable angina pectoris within 6 months of
Screening.