2023-507448-36-00Active, not recruitingPhase 3
Study which tests 2 medications (SB27, Keytruda) to compare how effective, safe and well tolerated in a large number of metastatic non-squamous non-small cell lung cancer patients
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Oct 2026
Brief summary (registry, in English)
"To demonstrate the equivalence in efficacy of SB27 to Keytruda, in terms of objective response rate (ORR) in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC)"
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 22 Sept 2023
- Start date
- 16 Feb 2024
- Lead sponsor
- Samsung Bioepis Co. Ltd.
- Diseases
- Lung cancer
- EU CT number
- 2023-507448-36-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 96
- 12 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable to receive chemotherapy during the study
Other
- Unable to take folic acid and vitamin B12 supplementation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers | Moers | Germany | Active, not recruiting |
| MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH | Neuss | Germany | Active, not recruiting |
| Hospital Universitario Severo Ochoa | Leganés | Spain | Active, not recruiting |
| Hospital Quironsalud Malaga | Málaga | Spain | Active, not recruiting |
| Complejo Hospitalario Universitario de Ourense | Ourense | Spain | Active, not recruiting |
| Hospital Universitario Central De Asturias | Oviedo | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Active, not recruiting |
| Oncolab S.R.L. | Craiova | Romania | Active, not recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. | Craiova | Romania | Active, not recruiting |
| Centrul De Oncologie-Euroclinic S.R.L. | Iasi | Romania | Active, not recruiting |
| Sigmedical Services S.R.L. | Suceava | Romania | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.