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

This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.


Eligibility Criteria:
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