NCT00480831

A Study of PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer (APM4074g)

A Randomized, Double-Blind, Phase II Trial of Paclitaxel + Carboplatin + Bevacizumab With or Without PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab	Intravenous repeating dose
DRUG	carboplatin	Intravenous repeating dose
DRUG	paclitaxel	Intravenous repeating dose
DRUG	placebo	Intravenous repeating dose
DRUG	PRO95780	Intravenous repeating dose

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2007-05-31
• Last updated: 2017-05-18