Clinical Trial

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

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2024-03-28; most recent amendment 2026-07-03.
Status change: Recruiting → Active, Not Recruiting 2025-11-13
Trial Details
NCT Number NCT06348199
Lead Sponsor Samsung Bioepis Co., Ltd.
Conditions Non-small Cell Lung Cancer Stage IV
Enrollment 555 participants
Start Date 2024-03-12
Primary Completion 2026-03-10 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-07