MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC

Status Completed

Clinical Trial Summary

Assess the Efficacy and Safety of MYL-1402O Compared with Avastin®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer

Clinical Trial Description

MYL-1402O is a monoclonal antibody currently being developed by Mylan GmbH, as a proposed biosimilar to European Union and US licensed Avastin (hereafter referred to as Avastin), which is approved as first line treatment in combination with carboplatin and paclitaxel (CP) for patients with Stage IV unresectable, recurrent or metastatic nsNSCLC. This randomized equivalence study is designed to meet the global regulatory requirement for approval of a biosimilar product. For this study, both MYL-1402O and Avastin are considered investigational medicinal products (IMP). ;

Study Design

Related Conditions & MeSH terms

NSCLC Stage IV

Clinical Trial Details

NCT number	NCT04633564
Study type	Interventional
Source	Viatris Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	January 21, 2017
Completion date	November 22, 2019

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