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NCT06348199Active, not recruitingPhase 3

A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

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: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is: • How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks. Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
555 (actual)
First submitted
28 Mar 2024
Start date
12 Mar 2024
Primary completion date
10 Mar 2026
Lead sponsor
Samsung Bioepis Co., Ltd.
Diseases
Lung cancer
NCT number
NCT06348199

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 555
  • From 12 Mar 2024 to the primary completion date, 10 Mar 2026
  • 93 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.

Other

  • Unable or unwilling 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

Full criteria on ClinicalTrials.gov

Sites (93)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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CuritibaBrazilUnknown status
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FlorianópolisBrazilUnknown status
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IjuíBrazilUnknown status
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NatalBrazilUnknown status
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PelotasBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Rio de JaneiroBrazilUnknown status
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Santo AndréBrazilUnknown status
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DüsseldorfGermanyUnknown status
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HalleGermanyUnknown status
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MoersGermanyUnknown status
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NeussGermanyUnknown status
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LeganésSpainUnknown status
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MálagaSpainUnknown status
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OurenseSpainUnknown status
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OviedoSpainUnknown status
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Santiago de CompostelaSpainUnknown status
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SevilleSpainUnknown status
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ValenciaSpainUnknown status
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BatumiGeorgiaUnknown status
SB Investigative Site 1
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TbilisiGeorgiaUnknown status
SB Investigative Site 5
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TbilisiGeorgiaUnknown status
SB Investigative Site 6
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TbilisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
SB Investigative Site 2
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TbilisiGeorgiaUnknown status
SB Investigative Site 3
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TbilisiGeorgiaUnknown status
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BangaloreIndiaUnknown status
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BhubaneswarIndiaUnknown status
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ErandwaneIndiaUnknown status
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HyderabadIndiaUnknown status
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JaipurIndiaUnknown status
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JaipurIndiaUnknown status
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MumbaiIndiaUnknown status
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SūratIndiaUnknown status
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UdaipurIndiaUnknown status
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HimejiJapanUnknown status
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IwakuniJapanUnknown status
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IzumiJapanUnknown status
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Kawachi-NaganoJapanUnknown status
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KobeJapanUnknown status
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KochiJapanUnknown status
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SagamiharaJapanUnknown status
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TachikawaJapanUnknown status
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TakarazukaJapanUnknown status
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ToyonakaJapanUnknown status
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AguascalientesMexicoUnknown status
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GuadalajaraMexicoUnknown status
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Mexico CityMexicoUnknown status
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George TownMalaysiaUnknown status
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Johor BahruMalaysiaUnknown status
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Kota BharuMalaysiaUnknown status
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KuantanMalaysiaUnknown status
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Lembah PantaiMalaysiaUnknown status
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PutrajayaMalaysiaUnknown status
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Davao CityPhilippinesUnknown status
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Makati CityPhilippinesUnknown status
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ManilaPhilippinesUnknown status
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Quezon CityPhilippinesUnknown status
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San Juan CityPhilippinesUnknown status
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Cluj-NapocaRomaniaUnknown status
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CraiovaRomaniaUnknown status
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CraiovaRomaniaUnknown status
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CraiovaRomaniaUnknown status
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IașiRomaniaUnknown status
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OradeaRomaniaUnknown status
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SibiuRomaniaUnknown status
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SuceavaRomaniaUnknown status
SB Investigative Site 1
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BelgradeSerbiaUnknown status
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BelgradeSerbiaUnknown status
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KamenitzSerbiaUnknown status
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KragujevacSerbiaUnknown status
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NišSerbiaUnknown status
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BangkokThailandUnknown status
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BangkokThailandUnknown status
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Bangkok NoiThailandUnknown status
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Khon KaenThailandUnknown status
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AdapazarıTurkey (Türkiye)Unknown status
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AnkaraTurkey (Türkiye)Unknown status
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AnkaraTurkey (Türkiye)Unknown status
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BağcılarTurkey (Türkiye)Unknown status
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BalgatTurkey (Türkiye)Unknown status
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Banja LukaBosnia and HerzegovinaUnknown status
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ÇubukTurkey (Türkiye)Unknown status
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IstanbulTurkey (Türkiye)Unknown status
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İzmitTurkey (Türkiye)Unknown status
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KavaklıdereTurkey (Türkiye)Unknown status
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KonakTurkey (Türkiye)Unknown status
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MaltepeTurkey (Türkiye)Unknown status
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MostarBosnia and HerzegovinaUnknown status
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SarajevoBosnia and HerzegovinaUnknown status
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SeyhanTurkey (Türkiye)Unknown status
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SivasTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.