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

Summary

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.

Timeline

Start

2024-01-16

Primary completion

2026-02-19

Completion

2026-11

Outcome

Met primary endpoint

release “한국을 포함한 글로벌 4개국 163명의 환자를 대상으로 한 임상 1상에서, 1차 평가 변수인 약동학 분석을 위해 체내 약물이 머무는 정도를 의미하는 '혈중 농도-시간 곡선 아래 면적(AUC: Area Under the Curve)'을 측정했으며, 그 결과 사전에 수립한 기준을 충족하며 오리지널 의약품과의 약동학적 동등성을 입증했다.” samsungbioepis.com ↗

Drugs

Indications