NCT03296163

A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

A Randomized, Multicenter, Multinational, Double-Blind Study to Assess the Efficacy and Safety of MB02 (Bevacizumab Biosimilar Drug) Versus Avastin® in Combination With Carboplatin and Paclitaxel for the Treatment of Subjects With Stage IIIB/IV Non-squamous Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 627 (actual)
• Sponsor: mAbxience Research S.L. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC

Detailed description

Efficacy parameters, safety profiles and immunogenicity will be compared between MB02 (Bevacizumab Biosimilar Drug) and European (EU)-approved Avastin®

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	MB02 (Bevacizumab Biosimilar Drug)	15 mg/kg IV every 3 weeks on Day 1
DRUG	EU-approved Avastin®	15 mg/kg IV every 3 weeks on Day 1
DRUG	Carboplatin	Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles
DRUG	Paclitaxel	Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles

Timeline

• Start date: 2018-02-06
• Primary completion: 2019-07-03
• Completion: 2020-02-27
• First posted: 2017-09-28
• Last updated: 2021-04-26
• Results posted: 2021-03-26

Locations

118 sites across 18 countries: Brazil, Bulgaria, Chile, Georgia, Greece, Hungary, India, Lebanon, Malaysia, Mexico, Oman, Philippines, Russia, Serbia, Spain, Thailand, Turkey (Türkiye), Ukraine