{"entity":{"id":"nct06348199","kind":"trial","name":"A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-s","aka":[],"tldr":"A phase 3 trial of Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Samsung Bioepis Co., Ltd., active and no longer recruiting.","summary":"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 is a phase 3 interventional study registered as NCT06348199 by Samsung Bioepis Co., Ltd., with 555 participants enrolled, started 2024-03-12 and due to reach its primary completion in 2026-03-10. Interventions recorded: SB27, Keytruda. Conditions listed: Non-small Cell Lung Cancer Stage IV. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06348199","url":"https://clinicaltrials.gov/study/NCT06348199"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["samsung-bioepis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06348199","phase":"3","setting":"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","sponsor":"Samsung Bioepis Co., Ltd.","participation":[{"nct":"NCT06348199","source":"https://clinicaltrials.gov/study/NCT06348199","fetchedAt":"2026-10-07T16:54:34.595Z","studySha256":"b908fa7127b6048b2782e99f1d2025e9058ab2b0a6f63eefd0b68ca01761d1f6","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-07-07","leadSponsor":"Samsung Bioepis Co., Ltd.","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":555,"enrolmentType":"ACTUAL","siteCount":93,"recruitingSiteCount":0,"countries":["Bosnia and Herzegovina","Brazil","Georgia","Germany","India","Japan","Malaysia","Mexico","Philippines","Romania","Serbia","Spain","Thailand","Turkey (Türkiye)"]}],"started":"2024-03-12","startedType":"actual","enrolled":555,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06348199/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"samsung-bioepis","kind":"company","name":"Samsung Bioepis","route":"/companies/samsung-bioepis/"}]}}