Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06268613

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Non-small Cell Lung Cancer Stage II Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Stage IIIA Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SB Investigative Site, Gdansk, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SB27

Drug

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

EU sourced Keytruda

Drug

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

US sourced Keytruda

Drug

Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Samsung Bioepis Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.