NCT02754882

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

A Phase 3, Randomised, Double-blind Study to Compare the Efficacy, Safety, PK and Immunogenicity Between SB8 (Proposed Bevacizumab Biosimilar) and Avastin® in Subjects With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 763 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between SB8 and bevacizumab.

Conditions

• Lung Cancer
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Avastin® 15 mg/kg IV every 3 weeks on Day 1
DRUG	SB8	SB8 15 mg/kg IV every 3 weeks on Day 1
DRUG	Carboplatin	Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
DRUG	Paclitaxel	Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Timeline

• Start date: 2016-07-05
• Primary completion: 2018-01-24
• Completion: 2018-10-09
• First posted: 2016-04-28
• Last updated: 2024-12-16
• Results posted: 2024-12-16

Locations

105 sites across 13 countries: Belarus, Georgia, Germany, Hungary, Poland, Romania, Russia, Serbia, South Korea, Spain, Taiwan, Thailand, Ukraine