CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 627 enrolled
Drug / intervention
MB02 (Bevacizumab Biosimilar Drug) +3 moredrug
Likely dose
MB02 (Bevacizumab Biosimilar Drug) 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03296163
NCT03296163Phase 3Completed
CompareCT.gov

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)

mAbxience Research S.L.·interventional·Posted Sep 28, 2017·Updated Apr 26, 2021

In Brief

A Phase 3 clinical trial evaluating MB02 (Bevacizumab Biosimilar Drug), EU-approved Avastin®, and 2 other interventions for Non-small Cell Lung Cancer. Completed, enrolled 627 participants across 118 sites in 18 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesBrazil, Bulgaria, Chile, Georgia, Greece, Hungary, India, Lebanon, Malaysia, Mexico, Oman, Philippines, Russia, Serbia, Spain, Thailand, Turkey (Türkiye), Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 28, 2017
Enrollment StartFeb 6, 2018
Primary CompletionJul 3, 2019
Study CompletionFeb 27, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.8 years ago

Interventions

MB02 (Bevacizumab Biosimilar Drug)drug

15 mg/kg IV every 3 weeks on Day 1

EU-approved Avastin®drug

15 mg/kg IV every 3 weeks on Day 1

Carboplatindrug

Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles

Paclitaxeldrug

Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles