protocolSection identificationModule nctId: NCT06268613, orgStudyIdInfo id: SB27-1005, briefTitle: 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Samsung Bioepis Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Non-small Cell Lung Cancer Stage II, conditions: Non-small Cell Lung Cancer Stage IIIA, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: SB27, interventions name: EU sourced Keytruda, interventions name: US sourced Keytruda, outcomesModule primaryOutcomes measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1, primaryOutcomes measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6, secondaryOutcomes measure: Disease-free Survival, secondaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SB Investigative Site, status: RECRUITING, city: Busan, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: SB Investigative Site, status: RECRUITING, city: Daegu, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: SB Investigative Site, status: RECRUITING, city: Hwasun, country: Korea, Republic of, geoPoint lat: 35.06125, lon: 126.98746, locations facility: SB Investigative Site, status: RECRUITING, city: Jinju, country: Korea, Republic of, geoPoint lat: 35.19278, lon: 128.08472, locations facility: SB Investigative Site, status: RECRUITING, city: Seongnam, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, locations facility: SB Investigative Site, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: SB Investigative Site, status: RECRUITING, city: Suwon, country: Korea, Republic of, geoPoint lat: 37.29111, lon: 127.00889, locations facility: SB Investigative Site, status: RECRUITING, city: Szczecin, country: Poland, geoPoint lat: 53.42894, lon: 14.55302, locations facility: SB Investigative Site, status: RECRUITING, city: Leganés, state: Madrid, country: Spain, geoPoint lat: 40.32718, lon: -3.7635, locations facility: SB Investigative Site, status: RECRUITING, city: A Coruña, state: Santiago De Compostela, country: Spain, geoPoint lat: 43.37135, lon: -8.396, locations facility: SB Investigative Site, status: RECRUITING, city: Jaén, country: Spain, geoPoint lat: 37.76922, lon: -3.79028, locations facility: SB Investigative Site, status: RECRUITING, city: Málaga, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, hasResults: False