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Comparing different sources of Keytruda for lung cancer treatment

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

Phase 1 Interventional Samsung Bioepis Co., Ltd. · NCT06268613

This study is testing if a European version of Keytruda works as well and is safe for people with early-stage lung cancer compared to the US version.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment135 (estimated)
Ages18 Years and up
SexAll
SponsorSamsung Bioepis Co., Ltd. Industry-sponsored
Drugs / interventionschemotherapy
Locations20 sites (Ansan and 19 other locations)
Trial IDNCT06268613 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the pharmacokinetics, efficacy, safety, and immunogenicity of SB27, a European-sourced version of Keytruda, with US-sourced Keytruda in patients with stage II-IIIA non-small cell lung cancer (NSCLC) who have undergone complete surgical resection and received adjuvant platinum-based chemotherapy. Participants will receive the investigational product every three weeks for a maximum of 18 cycles over approximately 51 weeks, with blood samples collected to assess how the body processes the drug. The study seeks to confirm that SB27 functions similarly to the other two versions of Keytruda in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older diagnosed with stage II-IIIA NSCLC who have undergone complete surgical resection and received adjuvant chemotherapy.

Not a fit: Patients who have received anti-cancer therapy prior to surgery or have a history of autoimmune disease in the past five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for patients with early-stage non-small cell lung cancer.

How similar studies have performed: Other studies have shown success with similar approaches in evaluating different formulations of cancer therapies, suggesting potential for this study's success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Ansan and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung Cancer Stage IINon-small Cell Lung Cancer Stage IIIA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.