NCT04633564

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

Multicenter, Double-Blind, Randomized, Parallel-Group Study to 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 671 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• NSCLC Stage IV

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab as MYL-1402O	Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
BIOLOGICAL	Bevacizumab as Avastin	Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV

Timeline

• Start date: 2017-01-21
• Primary completion: 2019-06-05
• Completion: 2019-11-22
• First posted: 2020-11-18
• Last updated: 2022-03-16
• Results posted: 2021-02-01

Locations

102 sites across 17 countries: Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Georgia, Hungary, India, Italy, Philippines, Poland, Romania, Russia, Spain, Taiwan, Turkey (Türkiye), Ukraine, Vietnam