drugset / Trial / NCT02879097

Efficacy-Safety-Immunogenicity Study of CBT124&EU-sourced Avastin® in Stage 4 NSCLC

NCT02879097 ↗

Phase 3 Unknown 200 enrolled Cipla BioTec Pvt. Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether CBT124 and Avastin® are comparable in terms of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124 matches that of Avastin® (pharmacokinetics is nested in this study for Indian patients).

Timeline

Start
2016-12
Primary completion
2017-12
Completion
2018-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject CBT124 Unknown 15 mg/kg Intravenous
Background Carboplatin Small molecule 6 unknown —
Background Paclitaxel Small molecule 200 mg/m2 —