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

May 3, 2026 updated by: Samsung Bioepis Co., Ltd.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
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
Time Frame: At the end of Cycle 6 (each cycle is 21 days)
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
Time Frame: 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
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
Time Frame: From the date of randomization until the date of death of any cause, assessed up to Week 55
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

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Bioepis Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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