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

NCT03296163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 627

Last updated 2021-04-26

Study results available
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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

Conditions

Interventions

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

Sponsors & Collaborators

  • mAbxience Research S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2019-07-03
Completion
2020-02-27

Countries

  • Brazil
  • Bulgaria
  • Chile
  • Georgia
  • Greece
  • Hungary
  • India
  • Lebanon
  • Malaysia
  • Mexico
  • Oman
  • Philippines
  • Russia
  • Serbia
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03296163 on ClinicalTrials.gov