NCT00434226

A Study of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (SABRE-L)

A Randomized, Controlled, Open-Label, Multicenter, Phase II Study of the Safety and Efficacy of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, randomized, controlled, open-label, multicenter trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced, recurrent or metastatic NSCLC who have not received prior systemic therapy for NSCLC. All patients will have advanced, histologically or cytologically confirmed NSCLC (Stage IIIb with pleural effusions, Stage IV, or recurrent).

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab	Intravenously at a dose of 15mg/kg on the first day of each 21-day cycle
DRUG	sunitinib	25 mg/day for 2 weeks, followed by 1 week of rest
DRUG	carboplatin	On the first day of each cycle for 4 cycles
DRUG	paclitaxel	On the first day of each cycle for 4 cycles

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-04-01
• First posted: 2007-02-13
• Last updated: 2009-08-21
• Results posted: 2009-08-21