drugset / Trial / NCT02754882

A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

NCT02754882 ↗

Phase 3 Completed 763 enrolled Samsung Bioepis Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

Timeline

Start
2016-07-05
Primary completion
2018-01-24
Completion
2018-10-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject SB8 Unknown 15 mg/kg Intravenous
Background Carboplatin Small molecule — Intravenous
Background Paclitaxel Small molecule 200 mg/m2 Intravenous