NCT03390686

A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients

A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Patients With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: Prestige Biopharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenicity.

Detailed description

This is a randomised, double-blind, parallel group, equivalence, multicentre Phase III study in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between HD204 and bevacizumab.

Conditions

• Lung Cancer
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	15 mg/kg IV every 3 weeks on Day 1
DRUG	HD204	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: 2019-11-15
• Primary completion: 2024-07-01
• Completion: 2025-12-01
• First posted: 2018-01-04
• Last updated: 2025-05-31

Locations

18 sites across 17 countries: Belarus, Bulgaria, Croatia, Georgia, Greece, Hungary, India, Latvia, Malaysia, Philippines, Poland, Russia, Serbia, Slovakia, Thailand, Turkey (Türkiye), Ukraine