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A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients
Sponsor: Prestige Biopharma Limited
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
650
Start Date
2019-11-15
Completion Date
2025-12
Last Updated
2025-05-31
Healthy Volunteers
No
Conditions
Interventions
Bevacizumab
15 mg/kg IV every 3 weeks on Day 1
HD204
15 mg/kg IV every 3 weeks on Day 1
Carboplatin
Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
Paclitaxel
Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Locations (18)
Alexandrov Cancer Center
Minsk, Minsk City, Belarus
MHAT "Dr. Tota Venkova", AD
Gabrovo, Bulgaria
CHC Osijek
Osijek, Osijecko-baranjska, Croatia
LTD "High Technology Hospital Medcenter"
Batumi, Georgia
Institute of Clinical Oncology
Tbilisi, Georgia
Interbalkan Hospital
Thessaloniki, Asklipiou 10, Greece
Tudogyogyintezet Torokbalint
Törökbálint, Hungary
HCG Manavata Cancer Centre
Nashik, Maharashtra, India
Riga East University Hospital Latvian Oncology centre
Riga, Latvia
HRPZ II
Kota Bharu, Kelantan, Malaysia
Asian Hospital and Medical Center
City of Muntinlupa, Philippines
Magodend Szpital Elblaska
Warsaw, Poland
MEDSI
Moscow, Otradnoye, Russia
IPD of Vojvodina
Kamenitz, Serbia
Nemocnica na okraji mesta, n.o.
Partizánske, Slovakia
Maharaj Nakorn Chiang Mai
Chiang Mai, Muang, Thailand
Acibadem Adana Hospital
Adana, Turkey (Türkiye)
Oncology Dispensary
Odesa, Ukraine