NCT06268613 - A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy | Biotech Hunter

Enrollment

135

Participants

Timeline

Start Date

January 16, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

October 31, 2026

Conditions

Non-small Cell Lung Cancer Stage IINon-small Cell Lung Cancer Stage IIIA

Interventions

DRUG

SB27

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

DRUG

EU sourced Keytruda

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

DRUG

US sourced Keytruda

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

Trial Locations (22)

Unknown

RECRUITING

SB Investigative Site, Gdansk

RECRUITING

SB Investigative Site, Otwock

RECRUITING

SB Investigative Site, Szczecin

RECRUITING

SB Investigative Site, Ansan

RECRUITING

SB Investigative Site, Busan

RECRUITING

SB Investigative Site, Daegu

RECRUITING

SB Investigative Site, Hwasun

RECRUITING

SB Investigative Site, Incheon

RECRUITING

SB Investigative Site, Jinju

RECRUITING

SB Investigative Site, Seongnam

WITHDRAWN

SB Investigative Site, Seoul

RECRUITING

SB Investigative Site, Seoul

RECRUITING

SB Investigative Site, Suwon

RECRUITING

SB Investigative Site, Ulsan

RECRUITING

SB Investigative Site, Jaén

WITHDRAWN

SB Investigative Site, Leganés

RECRUITING

SB Investigative Site, A Coruña

RECRUITING

SB Investigative Site, Málaga

RECRUITING

SB Investigative Site, Adana

RECRUITING

SB Investigative Site, Ankara

RECRUITING

SB Investigative Site, Istanbul

RECRUITING

SB Investigative Site, Izmir

All Listed Sponsors

lead

Samsung Bioepis Co., Ltd.

INDUSTRY