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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

NCT06348199 — Phase 3, Active not recruiting, 555 participants, Samsung Bioepis Co., Ltd.

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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

RegistryNCT06348199
StatusActive not recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment555 (Actual)
SponsorSamsung Bioepis Co., Ltd. (Industry)
ConditionsNon-small Cell Lung Cancer Stage IV
InterventionsSB27, Keytruda (Drug)
Datesstart 2024-03-12, primary completion 2026-03-10, completion 2026-09-01 (estimated), first posted 2024-04-04, last updated 2026-07-07
Locations93 sites in Bosnia and Herzegovina, Brazil, Georgia, Germany, India, Japan, Malaysia, Mexico and 6 more countries

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-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
SB27ExperimentalDrug: SB27SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).
KeytrudaActive comparatorDrug: KeytrudaKeytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).
  • SB27 (Drug): Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
  • Keytruda (Drug): Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

+Outcome measures

Primary outcomes

  • Objective response rate (ORR) at Week 24 [At Week 24]: Defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) at Week 24 according to RECIST v1.1

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (93)

FacilityCityCountryStatus
SB Investigative SiteBanja LukaBosnia and Herzegovina
SB Investigative SiteMostarBosnia and Herzegovina
SB Investigative SiteSarajevoBosnia and Herzegovina
SB Investigative SiteCuritibaBrazil
SB Investigative SiteFlorianópolisBrazil
SB Investigative SiteIjuíBrazil
SB Investigative SiteNatalBrazil
SB Investigative SitePelotasBrazil
SB Investigative Site 1Porto AlegreBrazil
SB Investigative Site 2Porto AlegreBrazil
SB Investigative SiteRio de JaneiroBrazil
SB Investigative SiteSanto AndréBrazil
SB Investigative SiteBatumiGeorgia
SB Investigative Site 1TbilisiGeorgia
SB Investigative Site 2TbilisiGeorgia
SB Investigative Site 3TbilisiGeorgia
SB Investigative Site 4TbilisiGeorgia
SB Investigative Site 5TbilisiGeorgia
SB Investigative Site 6TbilisiGeorgia
SB Investigative SiteDüsseldorfGermany
SB Investigative SiteHalleGermany
SB Investigative SiteMoersGermany
SB Investigative SiteNeussGermany
SB Investigative SiteBangaloreIndia
SB Investigative SiteBhubaneswarIndia
SB Investigative SiteErandwaneIndia
SB Investigative SiteHyderabadIndia
SB Investigative Site 1JaipurIndia
SB Investigative Site 2JaipurIndia
SB Investigative SiteMumbaiIndia
SB Investigative SiteSūratIndia
SB Investigative SiteUdaipurIndia
SB Investigative SiteHimejiJapan
SB Investigative SiteIwakuniJapan
SB Investigative SiteIzumiJapan
SB Investigative SiteKawachi-NaganoJapan
SB Investigative SiteKobeJapan
SB Investigative SiteKochiJapan
SB Investigative SiteSagamiharaJapan
SB Investigative SiteTachikawaJapan
SB Investigative SiteTakarazukaJapan
SB Investigative SiteToyonakaJapan
SB Investigative SiteGeorge TownMalaysia
SB Investigative SiteJohor BahruMalaysia
SB Investigative SiteKota BharuMalaysia
SB Investigative SiteKuantanMalaysia
SB Investigative SiteLembah PantaiMalaysia
SB Investigative SitePutrajayaMalaysia
SB Investigative SiteAguascalientesMexico
SB Investigative SiteGuadalajaraMexico
SB Investigative SiteMexico CityMexico
SB Investigative SiteDavao CityPhilippines
SB Investigative SiteMakati CityPhilippines
SB Investigative SiteManilaPhilippines
SB Investigative SiteQuezon CityPhilippines
SB Investigative SiteSan Juan CityPhilippines
SB Investigative SiteCluj-NapocaRomania
SB Investigative Site 1CraiovaRomania
SB Investigative Site 2CraiovaRomania
SB Investigative SiteCraiovaRomania
SB Investigative SiteIașiRomania
SB Investigative SiteOradeaRomania
SB Investigative SiteSibiuRomania
SB Investigative SiteSuceavaRomania
SB Investigative Site 1BelgradeSerbia
SB Investigative Site 2BelgradeSerbia
SB Investigative SiteKamenitzSerbia
SB Investigative SiteKragujevacSerbia
SB Investigative SiteNišSerbia
SB Investigative SiteLeganésSpain
SB Investigative SiteMálagaSpain
SB Investigative SiteOurenseSpain
SB Investigative SiteOviedoSpain
SB Investigative SiteSantiago de CompostelaSpain
SB Investigative SiteSevilleSpain
SB Investigative SiteValenciaSpain
SB Investigative Site 1BangkokThailand
SB Investigative Site 2BangkokThailand
SB Investigative SiteBangkok NoiThailand
SB Investigative SiteKhon KaenThailand
SB Investigative SiteAdapazarıTurkey (Türkiye)
SB Investigative Site 1AnkaraTurkey (Türkiye)
SB Investigative Site 2AnkaraTurkey (Türkiye)
SB Investigative SiteBağcılarTurkey (Türkiye)
SB Investigative SiteBalgatTurkey (Türkiye)
SB Investigative SiteÇubukTurkey (Türkiye)
SB Investigative SiteIstanbulTurkey (Türkiye)
SB Investigative SiteİzmitTurkey (Türkiye)
SB Investigative SiteKavaklıdereTurkey (Türkiye)
SB Investigative SiteKonakTurkey (Türkiye)
SB Investigative SiteMaltepeTurkey (Türkiye)
SB Investigative SiteSeyhanTurkey (Türkiye)
SB Investigative SiteSivasTurkey (Türkiye)

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