A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)

A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer

This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC).

Inclusion Criteria:

• Histologically or cytologically documented small cell carcinoma of the bronchus, classified as extensive-stage disease
• Measurable disease or lesions
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

• Life expectancy of < 12 weeks
• Current, recent, or planned participation in another experimental drug study
• Ongoing or active infection
• Active malignancy other than SCLC or superficial basal/squamous cell carcinoma within the previous 5 years
• Prior systemic therapy, radiation therapy, or surgery for SCLC
• Inadequate bone marrow function, renal function, or hepatic function
• Serum sodium of < 120 mg/dL
• Inadequately controlled hypertension
• History of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association Class II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 6 months prior to study enrollment
• History of stroke or transient ischemic attack within 6 months prior to study enrollment
• Known central nervous system disease, except for brain metastases treated with whole-brain radiotherapy
• Significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to study enrollment
• History of hemoptysis within 4 weeks prior to study enrollment
• Evidence of bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of a need for a major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, including placement of a vascular access device, within 7 days prior to Day 1
• History of abdominal fistula or gastrointestinal perforation within 6 months prior to study enrollment
• Serious, non-healing wound, active ulcer, or untreated bone fracture
• Known hypersensitivity to any component of bevacizumab
• Pregnant (positive pregnancy test) or lactating