drugset / Trial / NCT03329911

A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer

NCT03329911

Phase 3 Completed 651 enrolled Bio-Thera Solutions
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase III, randomized, double blind, multicenter, active comparator, parallel two arm study to compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1706 to EU Avastin® in patients with previously untreated advanced non-squamous non-small cell lung cancer (nsNSCLC) to demonstrate clinical equivalence of BAT1706 and EU Avastin®.

Timeline

Start
2017-10-20
Primary completion
2019-11-05
Completion
2021-05-27

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT1706 Unknown 15 mg/kg Intravenous
Comparator Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Paclitaxel Small molecule 200 mg/m2 Intravenous