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A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Sponsor: Samsung Bioepis Co., Ltd.
Summary
The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is: • How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks. Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.
Official title: A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 (Proposed Pembrolizumab Biosimilar) and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
555
Start Date
2024-03-12
Completion Date
2026-09
Last Updated
2025-11-17
Healthy Volunteers
No
Conditions
Interventions
SB27
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
Keytruda
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
Locations (93)
SB Investigative Site
Banja Luka, Bosnia and Herzegovina
SB Investigative Site
Mostar, Bosnia and Herzegovina
SB Investigative Site
Sarajevo, Bosnia and Herzegovina
SB Investigative Site
Curitiba, Brazil
SB Investigative Site
Florianópolis, Brazil
SB Investigative Site
Ijuí, Brazil
SB Investigative Site
Natal, Brazil
SB Investigative Site
Pelotas, Brazil
SB Investigative Site 1
Porto Alegre, Brazil
SB Investigative Site 2
Porto Alegre, Brazil
SB Investigative Site
Rio de Janeiro, Brazil
SB Investigative Site
Santo André, Brazil
SB Investigative Site
Batumi, Georgia
SB Investigative Site 1
Tbilisi, Georgia
SB Investigative Site 2
Tbilisi, Georgia
SB Investigative Site 3
Tbilisi, Georgia
SB Investigative Site 4
Tbilisi, Georgia
SB Investigative Site 5
Tbilisi, Georgia
SB Investigative Site 6
Tbilisi, Georgia
SB Investigative Site
Düsseldorf, Germany
SB Investigative Site
Halle, Germany
SB Investigative Site
Moers, Germany
SB Investigative Site
Neuss, Germany
SB Investigative Site
Bangalore, India
SB Investigative Site
Bhubaneswar, India
SB Investigative Site
Erandwane, India
SB Investigative Site
Hyderabad, India
SB Investigative Site 1
Jaipur, India
SB Investigative Site 2
Jaipur, India
SB Investigative Site
Mumbai, India
SB Investigative Site
Sūrat, India
SB Investigative Site
Udaipur, India
SB Investigative Site
Himeji, Japan
SB Investigative Site
Iwakuni, Japan
SB Investigative Site
Izumi, Japan
SB Investigative Site
Kawachi-Nagano, Japan
SB Investigative Site
Kobe, Japan
SB Investigative Site
Kochi, Japan
SB Investigative Site
Sagamihara, Japan
SB Investigative Site
Tachikawa, Japan
SB Investigative Site
Takarazuka, Japan
SB Investigative Site
Toyonaka, Japan
SB Investigative Site
George Town, Malaysia
SB Investigative Site
Johor Bahru, Malaysia
SB Investigative Site
Kota Bharu, Malaysia
SB Investigative Site
Kuantan, Malaysia
SB Investigative Site
Lembah Pantai, Malaysia
SB Investigative Site
Putrajaya, Malaysia
SB Investigative Site
Aguascalientes, Mexico
SB Investigative Site
Guadalajara, Mexico
SB Investigative Site
Mexico City, Mexico
SB Investigative Site
Davao City, Philippines
SB Investigative Site
Makati City, Philippines
SB Investigative Site
Manila, Philippines
SB Investigative Site
Quezon City, Philippines
SB Investigative Site
San Juan City, Philippines
SB Investigative Site
Cluj-Napoca, Romania
SB Investigative Site 1
Craiova, Romania
SB Investigative Site 2
Craiova, Romania
SB Investigative Site
Craiova, Romania
SB Investigative Site
Iași, Romania
SB Investigative Site
Oradea, Romania
SB Investigative Site
Sibiu, Romania
SB Investigative Site
Suceava, Romania
SB Investigative Site 1
Belgrade, Serbia
SB Investigative Site 2
Belgrade, Serbia
SB Investigative Site
Kamenitz, Serbia
SB Investigative Site
Kragujevac, Serbia
SB Investigative Site
Niš, Serbia
SB Investigative Site
Leganés, Spain
SB Investigative Site
Málaga, Spain
SB Investigative Site
Ourense, Spain
SB Investigative Site
Oviedo, Spain
SB Investigative Site
Santiago de Compostela, Spain
SB Investigative Site
Seville, Spain
SB Investigative Site
Valencia, Spain
SB Investigative Site 1
Bangkok, Thailand
SB Investigative Site 2
Bangkok, Thailand
SB Investigative Site
Bangkok Noi, Thailand
SB Investigative Site
Khon Kaen, Thailand
SB Investigative Site
Adapazarı, Turkey (Türkiye)
SB Investigative Site 1
Ankara, Turkey (Türkiye)
SB Investigative Site 2
Ankara, Turkey (Türkiye)
SB Investigative Site
Bağcılar, Turkey (Türkiye)
SB Investigative Site
Balgat, Turkey (Türkiye)
SB Investigative Site
Çubuk, Turkey (Türkiye)
SB Investigative Site
Istanbul, Turkey (Türkiye)
SB Investigative Site
İzmit, Turkey (Türkiye)
SB Investigative Site
Kavaklıdere, Turkey (Türkiye)
SB Investigative Site
Konak, Turkey (Türkiye)
SB Investigative Site
Maltepe, Turkey (Türkiye)
SB Investigative Site
Seyhan, Turkey (Türkiye)
SB Investigative Site
Sivas, Turkey (Türkiye)