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
Status: Recruiting
Location: See all (91) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female ≥ 18 years of age
• Have been diagnosed with stage IV non-squamous NSCLC
• Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
• Agree to use adequate methods of contraception
Locations
Other Locations
Bosnia and Herzegovina
SB Investigative Site
ACTIVE_NOT_RECRUITING
Banja Luka
SB Investigative Site
ACTIVE_NOT_RECRUITING
Mostar
SB Investigative Site
ACTIVE_NOT_RECRUITING
Sarajevo
Brazil
SB Investigative Site
ACTIVE_NOT_RECRUITING
Curitiba
SB Investigative Site
ACTIVE_NOT_RECRUITING
Florianópolis
SB Investigative Site
ACTIVE_NOT_RECRUITING
Ijuí
SB Investigative Site
ACTIVE_NOT_RECRUITING
Natal
SB Investigative Site
ACTIVE_NOT_RECRUITING
Pelotas
SB Investigative Site
ACTIVE_NOT_RECRUITING
Porto Alegre
SB Investigative Site
ACTIVE_NOT_RECRUITING
Rio De Janeiro
SB Investigative Site
RECRUITING
Santo André
Georgia
SB Investigative Site
ACTIVE_NOT_RECRUITING
Batumi
SB Investigative Site
ACTIVE_NOT_RECRUITING
Tbilisi
SB Investigative Site
RECRUITING
Tbilisi
Germany
SB Investigative Site
ACTIVE_NOT_RECRUITING
Düsseldorf
SB Investigative Site
WITHDRAWN
Giessen
SB Investigative Site
ACTIVE_NOT_RECRUITING
Halle
SB Investigative Site
WITHDRAWN
Kassel
SB Investigative Site
ACTIVE_NOT_RECRUITING
Moers
SB Investigative Site
ACTIVE_NOT_RECRUITING
Neuss
India
SB Investigative Site
ACTIVE_NOT_RECRUITING
Bangalore
SB Investigative Site
ACTIVE_NOT_RECRUITING
Bhubaneshwar
SB Investigative Site
ACTIVE_NOT_RECRUITING
Bhubaneswar
SB Investigative Site
ACTIVE_NOT_RECRUITING
Erandwane
SB Investigative Site
ACTIVE_NOT_RECRUITING
Hyderabad
SB Investigative Site
ACTIVE_NOT_RECRUITING
Jaipur
SB Investigative Site
RECRUITING
Jaipur
SB Investigative Site
ACTIVE_NOT_RECRUITING
Mumbai
SB Investigative Site
RECRUITING
Sūrat
SB Investigative Site
ACTIVE_NOT_RECRUITING
Udaipur
Japan
SB Investigative Site
ACTIVE_NOT_RECRUITING
Himeji
SB Investigative Site
ACTIVE_NOT_RECRUITING
Iwakuni
SB Investigative Site
ACTIVE_NOT_RECRUITING
Izumi
SB Investigative Site
ACTIVE_NOT_RECRUITING
Kawachi-nagano
SB Investigative Site
ACTIVE_NOT_RECRUITING
Kobe
SB Investigative Site
ACTIVE_NOT_RECRUITING
Kochi
SB Investigative Site
WITHDRAWN
Okayama
SB Investigative Site
ACTIVE_NOT_RECRUITING
Sagamihara
SB Investigative Site
ACTIVE_NOT_RECRUITING
Tachikawa
SB Investigative Site
ACTIVE_NOT_RECRUITING
Takarazuka
SB Investigative Site
ACTIVE_NOT_RECRUITING
Toyonaka
Malaysia
SB Investigative Site
ACTIVE_NOT_RECRUITING
George Town
SB Investigative Site
ACTIVE_NOT_RECRUITING
Johor Bahru
SB Investigative Site
ACTIVE_NOT_RECRUITING
Kota Bharu
SB Investigative Site
ACTIVE_NOT_RECRUITING
Kuantan
SB Investigative Site
ACTIVE_NOT_RECRUITING
Lembah Pantai
SB Investigative Site
ACTIVE_NOT_RECRUITING
Putrajaya
Mexico
SB Investigative Site
ACTIVE_NOT_RECRUITING
Aguascalientes
SB Investigative Site
RECRUITING
Guadalajara
SB Investigative Site
ACTIVE_NOT_RECRUITING
Mexico City
Philippines
SB Investigative Site
ACTIVE_NOT_RECRUITING
Davao City
SB Investigative Site
ACTIVE_NOT_RECRUITING
Makati City
SB Investigative Site
ACTIVE_NOT_RECRUITING
Manila
SB Investigative Site
ACTIVE_NOT_RECRUITING
Quezon City
SB Investigative Site
ACTIVE_NOT_RECRUITING
San Juan City
Romania
SB Investigative Site
ACTIVE_NOT_RECRUITING
Cluj-napoca
SB Investigative Site
ACTIVE_NOT_RECRUITING
Craiova
SB Investigative Site
ACTIVE_NOT_RECRUITING
Iași
SB Investigative Site
ACTIVE_NOT_RECRUITING
Oradea
SB Investigative Site
ACTIVE_NOT_RECRUITING
Sibiu
SB Investigative Site
ACTIVE_NOT_RECRUITING
Suceava
SB Investigative Site
WITHDRAWN
Târgu Mureş
SB Investigative Site
WITHDRAWN
Timișoara
Serbia
SB Investigative Site
ACTIVE_NOT_RECRUITING
Belgrade
SB Investigative Site
ACTIVE_NOT_RECRUITING
Kamenitz
SB Investigative Site
ACTIVE_NOT_RECRUITING
Kragujevac
SB Investigative Site
ACTIVE_NOT_RECRUITING
Niš
Spain
SB Investigative Site
ACTIVE_NOT_RECRUITING
Leganés
SB Investigative Site
WITHDRAWN
Madrid
SB Investigative Site
ACTIVE_NOT_RECRUITING
Málaga
SB Investigative Site
ACTIVE_NOT_RECRUITING
Ourense
SB Investigative Site
ACTIVE_NOT_RECRUITING
Oviedo
SB Investigative Site
WITHDRAWN
Pamplona
SB Investigative Site
ACTIVE_NOT_RECRUITING
Santiago De Compostela
SB Investigative Site
ACTIVE_NOT_RECRUITING
Seville
SB Investigative Site
ACTIVE_NOT_RECRUITING
Valencia
Thailand
SB Investigative Site
ACTIVE_NOT_RECRUITING
Bangkok
SB Investigative Site
ACTIVE_NOT_RECRUITING
Bangkok Noi
SB Investigative Site
ACTIVE_NOT_RECRUITING
Khon Kaen
Turkey
SB Investigative Site
ACTIVE_NOT_RECRUITING
Adapazarı
SB Investigative Site
ACTIVE_NOT_RECRUITING
Ankara
SB Investigative Site
ACTIVE_NOT_RECRUITING
Bağcılar
SB Investigative Site
ACTIVE_NOT_RECRUITING
Balgat
SB Investigative Site
ACTIVE_NOT_RECRUITING
Çubuk
SB Investigative Site
ACTIVE_NOT_RECRUITING
Istanbul
SB Investigative Site
ACTIVE_NOT_RECRUITING
İzmit
SB Investigative Site
ACTIVE_NOT_RECRUITING
Kavaklıdere
SB Investigative Site
ACTIVE_NOT_RECRUITING
Konak
SB Investigative Site
ACTIVE_NOT_RECRUITING
Maltepe
SB Investigative Site
ACTIVE_NOT_RECRUITING
Seyhan
SB Investigative Site
ACTIVE_NOT_RECRUITING
Sivas
Contact Information
Primary
Samsung Bioepis
sbregistry@samsung.com
+82-32-728-0371
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2027-03
Participants
Target number of participants: 616
Treatments
Experimental: SB27
SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).
Active_comparator: Keytruda
Keytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).
Related Therapeutic Areas
Sponsors
Leads: Samsung Bioepis Co., Ltd.