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

Sponsor
mAbxience Research S.L.
Study ID
NCT03296163
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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
  • Carboplatin — DRUG
    Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles
  • Paclitaxel — DRUG
    Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles

Study Details

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

Key Dates

First listed
Sep 28, 2017
Start date
Feb 6, 2018
Status verified
Mar 2021
Primary completion
Jul 3, 2019
Completion
Feb 27, 2020

Study Design

Enrollment
627 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MB02 (Bevacizumab Biosimilar Drug)
    MB02 (Bevacizumab Biosimilar Drug) + Carboplatin/Paclitaxel
  • Active Comparator: EU-approved Avastin®
    EU-approved Avastin® + Carboplatin/Paclitaxel

Primary Outcome Measure

Objective Response Rate (ORR) at Week 18 [ Time Frame: 18 weeks from randomisation ]

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