A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer

Inclusion Criteria:

- Signed written informed consent

- Cytologically or histologically confirmed NSCLC

- Clinical or radiographic progression during or after first-line chemotherapy or
chemoradiotherapy for NSCLC

- Consent to provide archival tissue for analysis is required for participation in this
study

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Age ≥ 18 years

- Use of an acceptable means of contraception for men and women of childbearing
potential

- International normalized ratio (INR) no greater than 1.3 and an aPTT no greater than
the upper limits of normal within 28 days prior to enrollment for patients not on
low‑molecular‑weight heparin or fondaparinux

Exclusion Criteria:

- Squamous cell carcinoma

- Prior treatment with an investigational or marketed inhibitor of the Epidermal Growth
Factor Receptor (EGFR) pathway or anti-angiogenesis agent

- Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior
to randomization

- Local palliative radiotherapy within 14 days prior to randomization or persistent
adverse effects from radiotherapy that have not resolved to Grade 2 or less following
completion of treatment

- Whole brain radiotherapy or stereotactic radiosurgery for brain metastases within 4
weeks of Day 0

- Neurosurgery for brain metastases within 24 weeks of Day 0

- Brain biopsy within 12 weeks of Day 0

- Current use of dexamethasone for treatment associated with brain metastases

- History of gross hemoptysis within 3 months prior to randomization unless definitively
treated with surgery or radiation

- History of any of the following within 6 months prior to Day 0: serious systemic
disease, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA)
Grade 2 or greater Congestive Heart Failure (CHF), unstable symptomatic arrhythmia
requiring medication, clinically significant peripheral vascular disease, abdominal
fistula, gastrointestinal perforation, or intra-abdominal abscess

- Evidence of bleeding diathesis or coagulopathy or other serious or acute internal
bleeding within 6 months prior to randomization

- Central Nervous System (CNS) bleeding; history or clinical evidence of CNS stroke
(hemorrhagic or thrombotic) within the last 6 months

- Progressive neurologic symptoms in patients with a history of brain metastases

- Full-dose anticoagulation with warfarin

- Chronic daily use of aspirin or other full-dose nonsteroidal anti-inflammatory drugs
(NSAIDs) with anti-platelet activity

- In-patient surgical procedure, open biopsy, or significant traumatic injury within 28
days prior to randomization

- Minor surgical procedure, fine needle aspirations or core biopsy within 7 days prior
to randomization

- Anticipation of need for a major surgical procedure during the course of the study

- Serious, non-healing wound, ulcer, or bone fracture

- Inability to take oral medication or requirement for intravenous (IV) alimentation or
total parenteral nutrition with lipids, or prior surgical procedures affecting
absorption

- Pregnancy or breast-feeding

- Presence of another invasive cancer within 5 years prior to randomization

- Evidence of confusion or disorientation, or history of major psychiatric illness that
may impair the patient's understanding of the Informed Consent Form or their ability
to comply with study requirements