NCT06348199

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 555 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer Stage IV

Interventions

Type	Name	Description
DRUG	SB27	Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
DRUG	Keytruda	Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

Timeline

• Start date: 2024-03-12
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2024-04-04
• Last updated: 2025-11-17

Locations

93 sites across 14 countries: Bosnia and Herzegovina, Brazil, Georgia, Germany, India, Japan, Malaysia, Mexico, Philippines, Romania, Serbia, Spain, Thailand, Turkey (Türkiye)