NCT01519804

A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Placebo	Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle
DRUG	cisplatin/carboplatin	standard dose iv, Day 1 of each 21-day cycle, 4 cycles
DRUG	onartuzumab	15 mg/kg iv, Day 1 of each 21-day cycle
DRUG	paclitaxel	200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-01-01
• Completion: 2015-09-01
• First posted: 2012-01-27
• Last updated: 2016-09-02

Locations

69 sites across 9 countries: United States, Argentina, France, Germany, Israel, Italy, Latvia, Spain, United Kingdom