A Phase I, Randomised, Double-blind, Three-arm, Parallel Group, Multicentre Study to Compare the Pharmacokinetics (PK), Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, European Union [EU] Sourced Keytruda, and the United States of America [US] Sourced Keytruda) in Subjects With Stage II-IIIA Non-small Cell Lung Cancer Following Complete Resection and Adjuvant Platinum-based Chemotherapy
Status: Active_not_recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is: • What the body does to the study drug, which is called pharmacokinetic Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected. Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female aged 18 years or older
• Diagnosed as NSCLC stage II-IIIA (staging should be confirmed after surgery)
• Have completely removed all of the cancer from the body surgically
• Have been received 3 or 4 cycles of platinum-based chemotherapy after surgery
Locations
Other Locations
Poland
SB Investigative Site
Gdansk
SB Investigative Site
Otwock
Republic of Korea
SB Investigative Site
Ansan
SB Investigative Site
Busan
SB Investigative Site
Daegu
SB Investigative Site
Hwasun
SB Investigative Site
Incheon
SB Investigative Site
Jinju
SB Investigative Site
Seongnam
SB Investigative Site 3
Seoul
SB Investigative Site 4
Seoul
SB Investigative Site 5
Seoul
SB Investigative Site 6
Seoul
SB Investigative Site 1
Suwon
SB Investigative Site 2
Suwon
SB Investigative Site
Ulsan
Spain
SB Investigative Site
A Coruña
SB Investigative Site
Jaén
SB Investigative Site
Málaga
Turkey
SB Investigative Site
Adana
SB Investigative Site 1
Ankara
SB Investigative Site 2
Ankara
SB Investigative Site
Istanbul
SB Investigative Site
Izmir
Time Frame
Start Date:2024-01-16
Completion Date:2026-11
Participants
Target number of participants:163
Treatments
Experimental: SB27
SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Active_comparator: EU sourced Keytruda
EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Active_comparator: US sourced Keytruda
EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks