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NCT05565378Active, not recruitingPhase 2

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 15 Jun 2026

Brief summary (registry, in English)

This study will monitor the safety of novel immunotherapy combinations in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells \[TC\]/ Tumor proportion score \[TPS\] \>= 50%), previously untreated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
351 (actual)
First submitted
30 Sept 2022
Start date
14 Oct 2022
Primary completion date
9 Nov 2026
Lead sponsor
GlaxoSmithKline
Diseases
Lung cancer
NCT number
NCT05565378
EU CT number
2023-505057-40-00
EudraCT number
2021-005115-32

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 351
  • From 14 Oct 2022 to the primary completion date, 9 Nov 2026
  • 86 sites in 22 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

  • Had major surgery within 4 weeks or lung radiation of \>30 Gy therapy within 6 months prior to the first dose of study intervention
  • Received prior therapy with any immune checkpoint inhibitors
  • Receiving systemic steroid therapy \<= 3 days prior to first dose of study intervention or any form of immunosuppressive medication
  • Received any live vaccine \<= 30 days prior to first dose of study intervention
  • Severe infection within 4 weeks prior to the first dose of study intervention
  • Is currently participating in or has participated in a study of an investigational therapy within 4 weeks prior to the first dose of study intervention

Other illness

  • Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years (clinical exceptions apply as per protocol)
  • Symptomatic, untreated, or actively progressing, brain metastases or any leptomeningeal disease (regardless of symptomatology, treatment status, or stability)
  • Autoimmune disease or syndrome that required systemic treatment within the past 2 years
  • Any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
  • History or evidence of cardiac abnormalities
  • Current unstable liver or biliary disease
  • Positive for tuberculosis, human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or hepatitis C
  • Has a history of allogeneic tissue/stem cell transplant or solid organ transplant

Lab values

  • Has NSCLC with a tumor that harbors any of the following molecular alterations: EGFR and /or ALK translocations mutations that are sensitive to available targeted inhibitor therapy, Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC.

Other

  • Never smoked, defined as smoking \<100 tobacco cigarettes in a lifetime
  • Has advanced, symptomatic, or visceral spread and is considered to be at imminent risk of life-threatening complications (including, but not limited to, massive uncontrolled effusions \[e.g., pleural, pericardial, peritoneal\])

Who the study is looking for

  • Histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or non squamous)
  • No prior systemic therapy for their locally advanced or metastatic NSCLC
  • Provides a fresh tumor tissue sample or archival sample collected within 2 years prior to screening
  • PD-L1-high (TC/TPS \>= 50%) tumor
  • Measurable disease based on RECIST 1.1, as determined by the investigator
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Adequate Baseline organ function
  • Female participants of childbearing potential must use adequate contraception

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (86)

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

SiteCityCountrySite status
GSK Investigational Site
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Abu DhabiUnited Arab EmiratesUnknown status
GSK Investigational Site
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Buenos AiresArgentinaUnknown status
GSK Investigational Site
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Cipoletti Rio NegroArgentinaUnknown status
GSK Investigational Site
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Ciudad Autonoma de Buenos AireArgentinaUnknown status
GSK Investigational Site
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FloridaArgentinaUnknown status
GSK Investigational Site
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Mar del PlataArgentinaUnknown status
GSK Investigational Site
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San JuanArgentinaUnknown status
GSK Investigational Site
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Santa FeArgentinaUnknown status
University Of Antwerp
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EdegemBelgiumCompleted
GSK Investigational Site
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BarretosBrazilUnknown status
GSK Investigational Site
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Porto AlegreBrazilUnknown status
GSK Investigational Site
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São PauloBrazilUnknown status
GSK Investigational Site
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VitóriaBrazilUnknown status
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
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BerlinGermanyActive, not recruiting
Technische Universitaet Dresden
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
LungenClinic Grosshansdorf GmbH
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GrosshansdorfGermanyActive, not recruiting
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Oulu University Hospital
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OuluFinlandCompleted
Pirkanmaan hyvinvointialue
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TampereFinlandCompleted
Turku University Hospital
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TurkuFinlandCompleted
Vaasa Central Hospital
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VaasaFinlandCompleted
Institut Bergonie
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BordeauxFranceActive, not recruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
Centre Hospitalier Intercommunal De Cornouaille
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Quimper CedexFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceActive, not recruiting
GSK Investigational Site
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MiddlesbroughUnited KingdomUnknown status
GSK Investigational Site
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MiddlesexUnited KingdomUnknown status
GSK Investigational Site
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WolverhamptonUnited KingdomUnknown status
University General Hospital Attikon
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AthensGreeceActive, not recruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceActive, not recruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceActive, not recruiting
Athens Medical Center S.A.
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ThessalonikiGreeceActive, not recruiting
Koranyi National Institute For Pulmonology
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Budapest XIIHungaryCompleted
Farkasgyepui Tudogyogyintezet
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FarkasgyepűHungaryCompleted
Matrai Gyogyintezet
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GyöngyösHungaryCompleted
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
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TatabányaHungaryCompleted
Református Pulmonológiai Centrum
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TörökbálintHungaryCompleted
Cliniche Gavazzeni S.p.A.
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BergamoItalyActive, not recruiting
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
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LeghornItalyActive, not recruiting
GSK Investigational Site
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ChibaJapanUnknown status
GSK Investigational Site
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FukuokaJapanUnknown status
GSK Investigational Site
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HyōgoJapanUnknown status
GSK Investigational Site
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KanagawaJapanUnknown status
GSK Investigational Site
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OsakaJapanUnknown status
GSK Investigational Site
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SaitamaJapanUnknown status
GSK Investigational Site
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IncheonSouth KoreaUnknown status
GSK Investigational Site
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SeoulSouth KoreaUnknown status
GSK Investigational Site
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Suwon Gyeonggi-doSouth KoreaUnknown status
GSK Investigational Site
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GuadajalaraMexicoUnknown status
GSK Investigational Site
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San Luis Potosí CityMexicoUnknown status
Frisius MC
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LeeuwardenNetherlandsCompleted
St Antonius Ziekenhuis
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UtrechtNetherlandsCompleted
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandActive, not recruiting
Szpital Specjalistyczny w Prabutach Sp. z o.o.
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PrabutyPolandActive, not recruiting
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
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SiedlcePolandActive, not recruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandActive, not recruiting
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalActive, not recruiting
Hospital Cuf Descobertas S.A.
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LisbonPortugalActive, not recruiting
Hospital da Luz, S.A
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LisbonPortugalActive, not recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalActive, not recruiting
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalActive, not recruiting
GSK Investigational Site
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BangkokThailandUnknown status
GSK Investigational Site
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Chiang MaiThailandUnknown status
GSK Investigational Site
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Kho Hong Hat YaiThailandUnknown status
GSK Investigational Site
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Khon KaenThailandUnknown status
GSK Investigational Site
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Pathum ThaniThailandUnknown status
GSK Investigational Site
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AlbuquerqueUnited StatesUnknown status
GSK Investigational Site
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ChattanoogaUnited StatesUnknown status
GSK Investigational Site
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MorgantownUnited StatesUnknown status
GSK Investigational Site
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PlantationUnited StatesUnknown status
GSK Investigational Site
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Cape TownSouth AfricaUnknown status
GSK Investigational Site
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ParktownSouth AfricaUnknown status
GSK Investigational Site
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AnkaraTurkey (Türkiye)Unknown status
GSK Investigational Site
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AntalyaTurkey (Türkiye)Unknown status
GSK Investigational Site
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IstanbulTurkey (Türkiye)Unknown status
GSK Investigational Site
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SamsunTurkey (Türkiye)Unknown status

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