NCT03329911

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

A Multicenter, Randomized, Double Blind, Phase III Study of BAT1706 Versus EU Avastin® Plus Chemotherapy in Patients With Advanced Non Squamous Non Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 651 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®.

Conditions

• Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	EU Avastin®	100 mg/4 mL
DRUG	BAT1706	100 mg/4 mL
DRUG	Paclitaxel	200 mg/m²
DRUG	carboplatin	target area under the curve \[AUC\] 6 mg/mL•minute

Timeline

• Start date: 2017-10-20
• Primary completion: 2019-11-05
• Completion: 2021-05-27
• First posted: 2017-11-06
• Last updated: 2021-09-14
• Results posted: 2021-09-13

Locations

5 sites across 5 countries: China, Mexico, South Africa, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study