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Comparing SB27 and Keytruda for advanced lung cancer treatment

A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 (Proposed Pembrolizumab Biosimilar) and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

Phase 3 Interventional Samsung Bioepis Co., Ltd. · NCT06348199

This study is testing if a new treatment called SB27 works as well as Keytruda for people with advanced lung cancer when given with chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment616 (estimated)
Ages18 Years and up
SexAll
SponsorSamsung Bioepis Co., Ltd. Industry-sponsored
Drugs / interventionschemotherapy
Locations89 sites (Banja Luka and 88 other locations)
Trial IDNCT06348199 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of SB27 compared to Keytruda in patients with metastatic non-squamous non-small cell lung cancer (NSCLC). Participants will receive either SB27 or Keytruda along with chemotherapy every three weeks. The study seeks to determine if SB27 functions similarly to Keytruda in treating this advanced stage of lung cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with stage IV non-squamous NSCLC who have not previously received systemic anti-cancer therapy.

Not a fit: Patients with severe hypersensitivity to monoclonal antibodies or components of the treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment option for patients with metastatic non-squamous NSCLC.

How similar studies have performed: Other studies have shown success with similar immunotherapy approaches, indicating potential for positive outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Have been diagnosed with stage IV non-squamous NSCLC
* Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
* Agree to use adequate methods of contraception

Exclusion Criteria:

* Unable or unwilling to take folic acid and vitamin B12 supplementation
* Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.

Where this trial is running

Banja Luka and 88 other locations

+39 more sites — see ClinicalTrials.gov for the full list.

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 IV
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.