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: November 28, 2024
Sponsor: Samsung Bioepis Co., Ltd.
Overall Status: Active - 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: 135
Treatment Group(s): 3
Primary Treatment: SB27
Phase: 1
Study Start date:
January 16, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • SB Investigative Site

    Ansan,
    Korea, Republic of

    Active - Recruiting

  • SB Investigative Site

    Busan,
    Korea, Republic of

    Active - Recruiting

  • SB Investigative Site

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • SB Investigative Site

    Hwasun,
    Korea, Republic of

    Active - Recruiting

  • SB Investigative Site

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • SB Investigative Site

    Jinju,
    Korea, Republic of

    Active - Recruiting

  • SB Investigative Site

    Seongnam,
    Korea, Republic of

    Active - Recruiting

  • SB Investigative Site

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • SB Investigative Site

    Suwon,
    Korea, Republic of

    Active - Recruiting

  • SB Investigative Site

    Ulsan,
    Korea, Republic of

    Active - Recruiting

  • SB Investigative Site

    Gdańsk,
    Poland

    Active - Recruiting

  • SB Investigative Site

    Otwock,
    Poland

    Active - Recruiting

  • SB Investigative Site

    Szczecin,
    Poland

    Active - Recruiting

  • SB Investigative Site

    Leganés, Madrid
    Spain

    Site Not Available

  • SB Investigative Site

    A Coruña, Santiago De Compostela
    Spain

    Active - Recruiting

  • SB Investigative Site

    Jaén,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Madrid,
    Spain

    Site Not Available

  • SB Investigative Site

    Málaga,
    Spain

    Active - Recruiting

  • SB Investigative Site

    Adana,
    Turkey

    Active - Recruiting

  • SB Investigative Site

    Ankara,
    Turkey

    Active - Recruiting

  • SB Investigative Site

    Istanbul,
    Turkey

    Active - Recruiting

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