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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer Stage IIIA; Non-small Cell Lung Cancer Stage II
• Intervention / Treatment: Drug: SB27; Drug: EU sourced Keytruda; Drug: US sourced Keytruda

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 1

Contacts and Locations

Study Locations

• Poland
  • Gdansk, Poland
    • SB Investigative Site
  • Otwock, Poland
    • SB Investigative Site
• South Korea
  • Ansan, South Korea
    • SB Investigative Site
  • Busan, South Korea
    • SB Investigative Site
  • Daegu, South Korea
    • SB Investigative Site
  • Hwasun, South Korea
    • SB Investigative Site
  • Incheon, South Korea
    • SB Investigative Site
  • Jinju, South Korea
    • SB Investigative Site
  • Seongnam, South Korea
    • SB Investigative Site
  • Seoul, South Korea
    • SB Investigative Site 3
  • Seoul, South Korea
    • SB Investigative Site 4
  • Seoul, South Korea
    • SB Investigative Site 5
  • Seoul, South Korea
    • SB Investigative Site 6
  • Suwon, South Korea
    • SB Investigative Site 1
  • Suwon, South Korea
    • SB Investigative Site 2
  • Ulsan, South Korea
    • SB Investigative Site
• Spain
  • Málaga, Spain
    • SB Investigative Site
  • Jaén
    • Jaén, Jaén, Spain
      • SB Investigative Site
  • Santiago de Compostela
    • A Coruña, Santiago de Compostela, Spain
      • SB Investigative Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
    • SB Investigative Site
  • Ankara, Turkey (Türkiye)
    • SB Investigative Site 1
  • Ankara, Turkey (Türkiye)
    • SB Investigative Site 2
  • Istanbul, Turkey (Türkiye)
    • SB Investigative Site
  • Izmir, Turkey (Türkiye)
    • SB Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female aged 18 years or older
• Diagnosed as NSCLC stage II-IIIA (staging should be confirmed after surgery)
• Have completely removed all of the cancer from the body surgically
• Have been received 3 or 4 cycles of platinum-based chemotherapy after surgery

Exclusion Criteria:

• Have received anti-cancer therapy before surgery
• Have or had autoimmune disease in past 5 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB27; SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks	Drug: SB27; Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Active Comparator: EU sourced Keytruda; EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks	Drug: EU sourced Keytruda; Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Active Comparator: US sourced Keytruda; EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks	Drug: US sourced Keytruda; Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1	Defined as AUC calculated in Cycle 1 based on intensive PK assessment	At the end of Cycle 1 (each cycle is 21 days)
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6	Defined as AUC calculated in Cycle 6 based on intensive PK assessment	At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival	Defined as the time from the date of randomization until the date of disease recurrence, occurrence of new primary NSCLC, or death of any cause, whichever occurs first.	From the date of randomization until the date of disease recurrence, occurrence of new primary NSCLC, or death of any cause, whichever occurs first, assessed up to Week 55
Overall Survival	Defined as the time from the date of randomization until the date of death of any cause.	From the date of randomization until the date of death of any cause, assessed up to Week 55

Collaborators and Investigators

• Sponsor: Samsung Bioepis Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Actual): February 19, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Pembrolizumab
• Other Study ID Numbers: SB27-1005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes