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

Non-small Cell Lung Cancer Stage II Clinical Trial

Official title:
A Phase I, Randomised, Double-blind, Three-arm, Parallel Group, Multicentre Study to Compare the Pharmacokinetics (PK), Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, European Union [EU] Sourced Keytruda, and the United States of America [US] Sourced Keytruda) in Subjects With Stage II-IIIA Non-small Cell Lung Cancer Following Complete Resection and Adjuvant Platinum-based Chemotherapy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer Stage IIIA

Clinical Trial Details

NCT number	NCT06268613
Study type	Interventional
Source	Samsung Bioepis Co., Ltd.
Contact	Samsung Bioepis
Phone	+82-32-728-0371
Email	sbregistry@samsung.com
Status	Recruiting
Phase	Phase 1
Start date	January 16, 2024
Completion date	December 2025

View Details

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