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

Last updated: May 3, 2026
Sponsor: Samsung Bioepis Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

SB27

EU sourced Keytruda

US sourced Keytruda

Clinical Study ID

NCT06268613
SB27-1005
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Have received anti-cancer therapy before surgery

  • Have or had autoimmune disease in past 5 years

Study Design

Total Participants: 163
Treatment Group(s): 3
Primary Treatment: SB27
Phase: 1
Study Start date:
January 16, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • SB Investigative Site

    Ansan,
    Korea, Republic of

    Site Not Available

  • SB Investigative Site

    Busan,
    Korea, Republic of

    Site Not Available

  • SB Investigative Site

    Daegu,
    Korea, Republic of

    Site Not Available

  • SB Investigative Site

    Hwasun,
    Korea, Republic of

    Site Not Available

  • SB Investigative Site

    Incheon,
    Korea, Republic of

    Site Not Available

  • SB Investigative Site

    Jinju,
    Korea, Republic of

    Site Not Available

  • SB Investigative Site

    Seongnam,
    Korea, Republic of

    Site Not Available

  • SB Investigative Site

    Seoul,
    Korea, Republic of

    Site Not Available

  • SB Investigative Site

    Suwon,
    Korea, Republic of

    Site Not Available

  • SB Investigative Site

    Ulsan,
    Korea, Republic of

    Site Not Available

  • SB Investigative Site

    Gdansk,
    Poland

    Site Not Available

  • SB Investigative Site

    Gdansk 3099434,
    Poland

    Site Not Available

  • SB Investigative Site

    Gdańsk,
    Poland

    Site Not Available

  • SB Investigative Site

    Otwock,
    Poland

    Site Not Available

  • SB Investigative Site

    Otwock 762788,
    Poland

    Site Not Available

  • SB Investigative Site

    Szczecin,
    Poland

    Site Not Available

  • SB Investigative Site

    Szczecin 3083829,
    Poland

    Site Not Available

  • SB Investigative Site

    Ansan,
    South Korea

    Site Not Available

  • SB Investigative Site

    Ansan 6807803,
    South Korea

    Site Not Available

  • SB Investigative Site

    Ansan 6812607,
    South Korea

    Site Not Available

  • SB Investigative Site

    Busan,
    South Korea

    Site Not Available

  • SB Investigative Site

    Busan 1838524,
    South Korea

    Site Not Available

  • SB Investigative Site

    Daegu,
    South Korea

    Site Not Available

  • SB Investigative Site

    Daegu 1835329,
    South Korea

    Site Not Available

  • SB Investigative Site

    Hwasun,
    South Korea

    Site Not Available

  • SB Investigative Site

    Hwasun 1843841,
    South Korea

    Site Not Available

  • SB Investigative Site

    Incheon,
    South Korea

    Site Not Available

  • SB Investigative Site

    Incheon 1843564,
    South Korea

    Site Not Available

  • SB Investigative Site

    Jinju,
    South Korea

    Site Not Available

  • SB Investigative Site

    Jinju 1846052,
    South Korea

    Site Not Available

  • SB Investigative Site

    Seongnam,
    South Korea

    Site Not Available

  • SB Investigative Site

    Seongnam 6876792,
    South Korea

    Site Not Available

  • SB Investigative Site 3

    Seoul,
    South Korea

    Site Not Available

  • SB Investigative Site 4

    Seoul,
    South Korea

    Site Not Available

  • SB Investigative Site 5

    Seoul,
    South Korea

    Site Not Available

  • SB Investigative Site 6

    Seoul,
    South Korea

    Site Not Available

  • SB Investigative Site

    Seoul 1835848,
    South Korea

    Active - Recruiting

  • SB Investigative Site 3

    Seoul 1835848,
    South Korea

    Site Not Available

  • SB Investigative Site 4

    Seoul 1835848,
    South Korea

    Site Not Available

  • SB Investigative Site 5

    Seoul 1835848,
    South Korea

    Site Not Available

  • SB Investigative Site 6

    Seoul 1835848,
    South Korea

    Site Not Available

  • SB Investigative Site 1

    Suwon,
    South Korea

    Site Not Available

  • SB Investigative Site 2

    Suwon,
    South Korea

    Site Not Available

  • SB Investigative Site

    Suwon 1835553,
    South Korea

    Active - Recruiting

  • SB Investigative Site 1

    Suwon 1835553,
    South Korea

    Site Not Available

  • SB Investigative Site 2

    Suwon 1835553,
    South Korea

    Site Not Available

  • SB Investigative Site

    Ulsan,
    South Korea

    Site Not Available

  • SB Investigative Site

    Ulsan 1833747,
    South Korea

    Site Not Available

  • SB Investigative Site

    Jaén, Jaén
    Spain

    Site Not Available

  • SB Investigative Site

    Leganés, Madrid
    Spain

    Site Not Available

  • SB Investigative Site

    Leganés 3118594, Madrid 3117732
    Spain

    Site Not Available

  • SB Investigative Site

    A Coruña, Santiago de Compostela
    Spain

    Site Not Available

  • SB Investigative Site

    A Coruña 3119841, Santiago de Compostela
    Spain

    Site Not Available

  • SB Investigative Site

    Jaén 2516395,
    Spain

    Site Not Available

  • SB Investigative Site

    Madrid,
    Spain

    Site Not Available

  • SB Investigative Site

    Málaga,
    Spain

    Site Not Available

  • SB Investigative Site

    Málaga 2514256,
    Spain

    Site Not Available

  • SB Investigative Site

    Adana,
    Turkey

    Site Not Available

  • SB Investigative Site

    Ankara,
    Turkey

    Site Not Available

  • SB Investigative Site

    Istanbul,
    Turkey

    Site Not Available

  • SB Investigative Site

    Adana,
    Turkey (Türkiye)

    Site Not Available

  • SB Investigative Site

    Adana 325363,
    Turkey (Türkiye)

    Site Not Available

  • SB Investigative Site 1

    Ankara,
    Turkey (Türkiye)

    Site Not Available

  • SB Investigative Site 2

    Ankara,
    Turkey (Türkiye)

    Site Not Available

  • SB Investigative Site

    Ankara 323786,
    Turkey (Türkiye)

    Active - Recruiting

  • SB Investigative Site 1

    Ankara 323786,
    Turkey (Türkiye)

    Site Not Available

  • SB Investigative Site 2

    Ankara 323786,
    Turkey (Türkiye)

    Site Not Available

  • SB Investigative Site

    Istanbul,
    Turkey (Türkiye)

    Site Not Available

  • SB Investigative Site

    Istanbul 745044,
    Turkey (Türkiye)

    Site Not Available

  • SB Investigative Site

    Izmir,
    Turkey (Türkiye)

    Site Not Available

  • SB Investigative Site

    Izmir 311046,
    Turkey (Türkiye)

    Site Not Available

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