Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
29. oktober 2026 opdateret af: BioNTech SE
En fase II/III, multisite, randomiseret masterprotokol for et globalt forsøg med BNT327 i kombination med kemoterapi og andre undersøgelsesmidler i førstelinjes ikke-småcellet lungekræft
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).
This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Each substudy contains a Phase 2 part followed by a Phase 3 part. In the Phase 2 part, participants will be randomized to one of two dose levels of pumitamig (also known as BNT327, BMS-986545, or PM8002) plus chemotherapy (Arm 1 and Arm 2). In the Phase 3 part, participants will be randomized to pumitamig plus chemotherapy (Arm 3) or pembrolizumab plus chemotherapy (Arm 4). In China, additional participants will be enrolled into the Phase 2 part of each substudy to receive pumitamig plus chemotherapy (Arm 1A) to further evaluate the selected Phase 3 dose.
For the Phase 3 part of both substudies, an independent data monitoring committee (IDMC) and a blinded Independent Central Review (BICR) will be established. The IDMC will provide independent review of the data during the study as needed and the BICR will review all available tumor assessment scans for all treated participants and will confirm the progression of disease, if applicable.
The planned study duration per study participant is up to 64 months.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1580
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: BioNTech clinical trials patient information
- Telefonnummer: +49 6131 9084
- E-mail: patients@biontech.de
Studiesteder
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Buenos Aires, Argentina, C1199
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- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina, C1113
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- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
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Buenos Aires, Argentina, C1122
- Rekruttering
- Instituto Argentino de Diagnóstico y Tratamiento (IADT)
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Córdoba, Argentina, X5000JHQ
- Rekruttering
- Sanatorio Allende
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La Rioja, Argentina, F5300
- Rekruttering
- Centro Oncologico Riojano Integral (CORI)
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San Miguel de Tucumán, Argentina, 4000
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- Exelsus SRL
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Viedma, Argentina, R8500
- Rekruttering
- Centro de Investigaciones Clinicas. Clinica Viedma S. A
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Adelaide, Australien, 5000
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- Royal Adelaide Hospital
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Adelaide, Australien, 5000
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- Cancer Research SA (CRSA)
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Bedford Park, Australien, 5042
- Rekruttering
- Flinders Medical Centre
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Cairns, Australien, 4870
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- Cairns Hospital
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Dubbo, Australien, 2830
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- Dubbo Hospital
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Frankston, Australien, 3199
- Rekruttering
- Peninsula & South Eastern Haematology and Oncology Group
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Joondalup, Australien, 6027
- Rekruttering
- Joondalup Health campus
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Kurralta Park, Australien, 5037
- Rekruttering
- Icon Cancer Centre Kurralta Park
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Melbourne, Australien, 3000
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- Peter MacCallum Cancer Centre
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Melbourne, Australien, 3168
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- Monash University - Monash Health -Monash Medical Centre
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Orange, Australien, 2800
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- Central West Cancer Care Centre
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Southport, Australien, 4216
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- Clinical Trial Center-Tasman Oncology Research Ltd
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St Albans, Australien, 3021
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- Western Health Sunshine Hospital
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Townsville, Australien, 4812
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- ICON Cancer Care - Townsville
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Wollongong, Australien, 2500
- Trukket tilbage
- Cancer Care Wollongong Pty Limited
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Ghent, Belgien, 9000
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- Universitair Ziekenhuis Gent (Uz Gent)
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Leuven, Belgien, 3000
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- Universitair Ziekenhuis Leuven
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Mons, Belgien, 7000
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- CHU HELORA, Hopital de Mons - Site Kennedy
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Roeselare, Belgien, 8800
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- Algemeen Ziekenhuis Delta
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Sint-Niklaas, Belgien, 9100
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- VITAZ
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Woluwe-Saint-Lambert, Belgien, 1200
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- Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
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Barretos, Brasilien, 14784-400
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- Fundacao Pio XII - Hospital de Cancer de Barretos
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Curitiba, Brasilien, 81480-580
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- CIONC - Centro Integrado de Oncologia de Curitiba
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Fortaleza, Brasilien, 60336-232
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- Centro Regional Integrado de Oncologia
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Ijuí, Brasilien, 98700-000
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- Oncosite Centro De Pesquisa Clinica Em Oncologia
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Itajaí, Brasilien, 88301-220
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- Clinica de Neoplasias Litoral LTDA / Catarina Pesquisa Clínica
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Lajeado, Brasilien, 95900-000
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- Bruno Born Hospital
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Londrina, Brasilien, 86015-520
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- Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL
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Natal, Brasilien, 59062-000
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- Liga Norte Riograndense Contra o Cancer - CECAN
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Passo Fundo, Brasilien, 99010-080
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- Hospital Sao Vicente de Paulo (HSVP)
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Porto Alegre, Brasilien, 91350-200
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- Hospital Nossa Senhora da Conceicao
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Porto Alegre, Brasilien, 90020-090
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- Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto Alegre, Brasilien, 90110-270
- Rekruttering
- Centro Gaucho Integrado de Oncologia e Hematologia - Hospital Mae de Deus/AESC
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Porto Alegre, Brasilien, 90610-000
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- Centro Clinico do Hospital Sao Lucas da PUCRS
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Rio de Janeiro, Brasilien, 22250-905
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- Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)
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Salvador, Brasilien, 40170-110
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- OC Oncoclínicas - Núcleo de Oncologia da Bahia-Ondina (OC Oncoclinicas-NOB Ondina)
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São Caetano do Sul, Brasilien, 09541-270
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- CEON Pesquisas
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São José do Vale do Rio Preto, Brasilien, 15090-000
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- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do Rio Preto
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São Paulo, Brasilien, 01227-959
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- IEP São Lucas
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São Paulo, Brasilien, 01227-200
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- IEP Sao Lucas Instituto de Ensino e Pesquisa Sao Lucas
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Vitória, Brasilien, 29043-260
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- Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
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Plovdiv, Bulgarien, 4000
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- Complex Oncology Center
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Rousse, Bulgarien, 7000
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- Complex Oncological Center Ruse Ltd
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Sofia, Bulgarien, 1527
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- University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
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Sofia, Bulgarien, 1373
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- MHAT for Womens Health - Nadezhda OOD
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Antofagasta, Chile, 1263521
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- Bradford Hill Norte
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Lo Barnechea, Chile, 7691236
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- Clinica MEDS
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Recoleta, Chile, 8420000
- Rekruttering
- Centro De Investigacion Clinica Bradford Hill
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Santiago, Chile, 7500713
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- Orlandi Oncologia
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Santiago, Chile, 8331143
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- Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
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Basildon, Det Forenede Kongerige, SS16 5NL
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- Basildon University Hospital - Basildon And Thurrock University Hospitals Nhs Foundation Trust
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Bath, Det Forenede Kongerige, BA1 3NG
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- Royal United Hospital, Bath - Royal United Hospitals Bath NHS Foundation Trust
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Brighton, Det Forenede Kongerige, BN2 5BE
- Rekruttering
- Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
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Cardiff, Det Forenede Kongerige, CF14 2TL
- Rekruttering
- Velindre NHS Trust, Velindre Cancer Centre
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Chelsea, Det Forenede Kongerige, SW3 6JJ
- Rekruttering
- Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
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Cottingham, Det Forenede Kongerige, HU16 5JQ
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- Hull University Teaching Hospitals NHS Trust
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Glasgow, Det Forenede Kongerige, G12 0YN
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- Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
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Liverpool, Det Forenede Kongerige, L7 8YA
- Rekruttering
- Clatterbridge Cancer Centre
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London, Det Forenede Kongerige, NW2 1PG
- Rekruttering
- University College Hospital
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London, Det Forenede Kongerige, SM2 5PT
- Rekruttering
- Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
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Manchester, Det Forenede Kongerige, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
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Norwich, Det Forenede Kongerige, NR4 7UY
- Rekruttering
- Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
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Oxford, Det Forenede Kongerige, OX3 7LJ
- Rekruttering
- Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals
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Preston, Det Forenede Kongerige, PR2 9HT
- Rekruttering
- Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
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Sheffield, Det Forenede Kongerige, S10 2SJ
- Rekruttering
- Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
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Southampton, Det Forenede Kongerige, SO16 6YD
- Rekruttering
- Southampton General Hospital
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Taunton, Det Forenede Kongerige, TA1 5DA
- Rekruttering
- Musgrove Park Hospital-Taunton & Somerset NHS Foundation Trust
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Wolverhampton, Det Forenede Kongerige, WV10 0QP
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- New Cross Hospital
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York, Det Forenede Kongerige, YO31 8HE
- Rekruttering
- York Teaching Hospital NHS Foundation Trust - The York Hospital
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Alabama
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Birmingham, Alabama, Forenede Stater, 35223
- Rekruttering
- Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Rekruttering
- Alaska Oncology and Hematology, LLC
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California
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Concord, California, Forenede Stater, 94520
- Rekruttering
- John Muir Clinical Research Center
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La Jolla, California, Forenede Stater, 92093
- Rekruttering
- University Of California - San Diego Moores Cancer Center
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Colorado
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Vail, Colorado, Forenede Stater, 81657
- Rekruttering
- Vail Health
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- Rekruttering
- MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
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Washington D.C., District of Columbia, Forenede Stater, 20010
- Rekruttering
- MEDSTAR Washington Hospital Center (MedStar Health Research Institute)
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Florida
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Clermont, Florida, Forenede Stater, 34711
- Rekruttering
- Clermont Oncology Center
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Coral Springs, Florida, Forenede Stater, 33065
- Rekruttering
- SSAK Partners, LLC.
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Jacksonville, Florida, Forenede Stater, 32207
- Rekruttering
- Baptist Medical Center Jacksonville
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Orange City, Florida, Forenede Stater, 32763
- Rekruttering
- Mid Florida Cancer Centers
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Stuart, Florida, Forenede Stater, 34994
- Rekruttering
- Cleveland Clinic Florida - Martin North Hospital
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Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- H. Lee Moffit Cancer center and research institute
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Weston, Florida, Forenede Stater, 33331
- Rekruttering
- Cleveland Clinic Weston Hospital
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Georgia
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Marietta, Georgia, Forenede Stater, 30060
- Rekruttering
- Northwest Georgia Oncology Centers, P.C.
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46845
- Rekruttering
- Fort Wayne Medical Oncology and Hematology, Inc.
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Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- Indiana University Health University Hospital
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Iowa
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Cedar Rapids, Iowa, Forenede Stater, 52401-2112
- Rekruttering
- Physicians Clinic of Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
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Kentucky
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Elizabethtown, Kentucky, Forenede Stater, 42701
- Rekruttering
- Baptist Health Hardin
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Lexington, Kentucky, Forenede Stater, 40503
- Rekruttering
- Baptist Health Lexington
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Lexington, Kentucky, Forenede Stater, 40536
- Rekruttering
- University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center)
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Maryland
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Frederick, Maryland, Forenede Stater, 21704
- Rekruttering
- Frederick Health Hospital- James M Stockman Cancer Institute
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Missouri
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Columbia, Missouri, Forenede Stater, 65201
- Rekruttering
- Missouri Cancer Associates
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Fenton, Missouri, Forenede Stater, 63026
- Trukket tilbage
- SSM Health Cancer Care - St. Clare
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Nebraska
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Hastings, Nebraska, Forenede Stater, 68901-4470
- Rekruttering
- Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)
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New Jersey
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East Brunswick, New Jersey, Forenede Stater, 08816
- Rekruttering
- Astera Cancer Care
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Florham Park, New Jersey, Forenede Stater, 07932
- Rekruttering
- Summit Medical Group PA
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Paramus, New Jersey, Forenede Stater, 07652
- Rekruttering
- The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
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New York
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Poughkeepsie, New York, Forenede Stater, 12601
- Rekruttering
- Nuvance Health
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Stony Brook, New York, Forenede Stater, 11794-9446
- Rekruttering
- Suny-Stony Brook University Cancer Center
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White Plains, New York, Forenede Stater, 10601
- Rekruttering
- White Plains Hospital
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North Carolina
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Hendersonville, North Carolina, Forenede Stater, 28792
- Rekruttering
- Fletcher Hospital, Inc. dba AdventHealth Hendersonville
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- Rekruttering
- Gabrail Cancer Center Research
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Cincinnati, Ohio, Forenede Stater, 45219
- Rekruttering
- University of Cincinnati Medical Center
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Cincinnati, Ohio, Forenede Stater, 45219
- Rekruttering
- The Christ Hospital Cancer Center
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Cleveland, Ohio, Forenede Stater, 44195-0001
- Rekruttering
- Cleveland Clinic
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Cleveland, Ohio, Forenede Stater, 44111
- Rekruttering
- The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion
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Dayton, Ohio, Forenede Stater, 45415
- Rekruttering
- Dayton Physicians Network
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Kettering, Ohio, Forenede Stater, 45429
- Rekruttering
- Kettering Medical Center
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Mayfield Heights, Ohio, Forenede Stater, 44124
- Rekruttering
- Cleveland Clinic - Hillcrest Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73109
- Rekruttering
- INTEGRIS Cancer Institute of Oklahoma
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37920
- Rekruttering
- University of Tennessee Medical Center
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Memphis, Tennessee, Forenede Stater, 38120
- Trukket tilbage
- Baptist Cancer Center
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Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center
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Texas
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Houston, Texas, Forenede Stater, 77090
- Aktiv, ikke rekrutterende
- Millennium Research and Clinical Development, LLC
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Utah
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Salt Lake City, Utah, Forenede Stater, 84106
- Rekruttering
- Utah Cancer Specialists
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Virginia Cancer Specialists
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Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Inova Schar Cancer
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Richmond, Virginia, Forenede Stater, 23229
- Rekruttering
- Virginia Cancer Institute
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Richmond, Virginia, Forenede Stater, 23298
- Rekruttering
- VCU Massey Cancer Center
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Winchester, Virginia, Forenede Stater, 22601
- Rekruttering
- Shenandoah Oncology
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26506-8110
- Rekruttering
- West Virginia University Hospitals - Mary Babb Randolph Cancer Center
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Wisconsin
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La Crosse, Wisconsin, Forenede Stater, 54601-5467
- Rekruttering
- Gundersen Lutheran Medical Center
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Angers, Frankrig, 49933
- Rekruttering
- Centre Hospitalier Universitaire d'Angers (CHU Angers)
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Angers, Frankrig, 49055
- Rekruttering
- Institut de Cancerologie de l'Ouest Paul Papin
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Bayonne, Frankrig, 64109
- Rekruttering
- Centre Hospitalier de la Cote Basque
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Bordeaux, Frankrig, 33000
- Rekruttering
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
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Bordeaux, Frankrig, 33076
- Rekruttering
- Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
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Bron, Frankrig, 69500
- Rekruttering
- Hospices Civils de Lyon - Hopital Louis Pradel
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Caen, Frankrig, 14033
- Rekruttering
- CHU Caen Normandie
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Caen, Frankrig, 14076
- Rekruttering
- Centre Francois Baclesse
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Clermont-Ferrand, Frankrig, 63003
- Rekruttering
- Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
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Créteil, Frankrig, 94010
- Rekruttering
- Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
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La Tronche, Frankrig, 38700
- Rekruttering
- Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon
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Limoges, Frankrig, 87042
- Rekruttering
- Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
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Lyon, Frankrig, 69004
- Rekruttering
- Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
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Marseille, Frankrig, 13009
- Rekruttering
- Institut Paoli-Calmettes
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Mulhouse, Frankrig, 68100
- Rekruttering
- GHRMSA Hopital Emile Muller
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Paris, Frankrig, 75013
- Rekruttering
- Groupe Hospitalier Pitie-Salpetriere
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Paris, Frankrig, 75005
- Rekruttering
- Institut Curie - Centre de Recherche
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Paris, Frankrig, 75014
- Rekruttering
- CIC Cochin Pasteur, Hopital Cochin
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Pierre-Bénite, Frankrig, 69310
- Rekruttering
- Hopital Lyon Sud
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Rennes, Frankrig, 35033
- Rekruttering
- CHU de Rennes, Hopital de Pontchaillou
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Saint-Herblain, Frankrig, 44805
- Rekruttering
- Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
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Strasbourg, Frankrig, 67200
- Rekruttering
- Centre Regional Lutte Contre Le Cancer Paul Strauss
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Suresnes, Frankrig, 92151
- Rekruttering
- Hopital Foch
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Toulon, Frankrig, 83000
- Rekruttering
- Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
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Villejuif, Frankrig, 94805
- Rekruttering
- Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
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-
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Batumi, Georgien, 6000
- Rekruttering
- High Technology Hospital Medcenter LTD
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Tbilisi, Georgien, 0144
- Rekruttering
- LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
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Tbilisi, Georgien, 0112
- Rekruttering
- LLC Todua Clinic
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Tbilisi, Georgien, 0162
- Rekruttering
- New Hospitals
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Tbilisi, Georgien, 0179
- Rekruttering
- Cancer Research Centre
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-
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-
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Avellino, Italien, 83100
- Rekruttering
- Azienda Ospedaliera San Giuseppe Moscati
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Aviano, Italien, 33081
- Rekruttering
- Centro di Riferimento Oncologico
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Bologna, Italien, 40138
- Rekruttering
- Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi
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Candiolo, Italien, 10060
- Rekruttering
- Istituto Candiolo IRCCS
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Catania, Italien, 95045
- Rekruttering
- Humanitas Istituto Clinico Catanese S.p.A
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Cona, Italien, 44124
- Rekruttering
- Azienda Ospedaliero - Universitaria di Ferrara
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Cremona, Italien, 26100
- Rekruttering
- Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)
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Lucca, Italien, 55100
- Rekruttering
- Ospedale San Luca
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Meldola, Italien, 47014
- Rekruttering
- IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST)
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Milan, Italien, 20132
- Rekruttering
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
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Milan, Italien, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Naples, Italien, 80131
- Rekruttering
- UOC Oncoematologia AOU Luigi Vanvitelli
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Peschiera del Garda, Italien, 37019
- Rekruttering
- Casa Di Cura Polispecialistica Dott Pederzoli
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Roma, Italien, 00128
- Rekruttering
- Fondazione Policlinico Universitario Campus Bio-Medico
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Roma, Italien, 00144
- Rekruttering
- Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)
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Rome, Italien, 00186
- Rekruttering
- Fondazione Ospedale Isola Tiberina - Gemelli Isola
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Siena, Italien, 53100
- Rekruttering
- Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
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-
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Ageo, Japan, 362-8588
- Rekruttering
- Ageo Central General Hospital
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Akashi, Japan, 673-8558
- Rekruttering
- Hyogo Cancer Center
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Aomori, Japan, 030-8553
- Rekruttering
- Aomori Prefectural Central Hospital
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Bunkyō City, Japan, 113-8677
- Rekruttering
- Tokyo Metropolitan Komagome Hospital
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Chūōku, Japan, 431-3192
- Rekruttering
- Hamamatsu University Hospital
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Funabashi, Japan, 273-8588
- Rekruttering
- Funabashi Municipal Medical Center
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Himeji, Japan, 670-8520
- Rekruttering
- National Hospital Organization Himeji Medical Center
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Hiroshima, Japan, 734-8551
- Rekruttering
- Hiroshima University Hospital
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Hiroshima, Japan, 734-8530
- Rekruttering
- Hiroshima Prefectural Hospital
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Iizuka, Japan, 820-8505
- Rekruttering
- Aso Iizuka Hospital
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Iwakuni, Japan, 740-8510
- Rekruttering
- National Hospital Organization Iwakuni Clinical Center
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Kanagawa, Japan, 247-8533
- Rekruttering
- Shonan Kamakura General Hospital
-
Kanazawa, Japan, 920-8530
- Rekruttering
- Ishikawa Prefectural Central Hospital
-
Kumamoto, Japan, 861-4193
- Rekruttering
- Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
-
Kurashiki, Japan, 710-8602
- Rekruttering
- Kurashiki Central Hospital
-
Kurume, Japan, 830-0011
- Rekruttering
- Kurume University Hospital
-
Matsusaka, Japan, 515-8544
- Rekruttering
- Matsusaka Municipal Hospital
-
Matsuyama, Japan, 791-0280
- Rekruttering
- National Hospital Organization Shikoku Cancer Center
-
Meguro City, Japan, 152-8902
- Rekruttering
- National Hospital Organization Tokyo Medical Center
-
Mibu, Japan, 321-0293
- Rekruttering
- Dokkyo Medical University Hospital
-
Morioka, Japan, 028-3695
- Rekruttering
- Iwate Medical University Hospital
-
Nagaizumi-chō, Japan, 411-8777
- Rekruttering
- Shizuoka Cancer Center
-
Nagasaki, Japan, 852-8501
- Rekruttering
- Nagasaki University Hospital
-
Nagoya, Japan, 466-8560
- Rekruttering
- Nagoya University Hospital
-
Nagoya, Japan, 460-0001
- Rekruttering
- National Hospital Organization Nagoya Medical Center
-
Nagoya, Japan, 457-8510
- Rekruttering
- Japan Community Healthcare Organization Chukyo Hospital
-
Niigata, Japan, 951-8566
- Rekruttering
- Niigata Cancer Center Hospital
-
Nishinomiya, Japan, 663-8501
- Rekruttering
- Hyogo Medical University Hospital
-
Osaka, Japan, 541-8567
- Rekruttering
- Osaka Prefectural Hospital Organization Osaka International Cancer Institute
-
Saitama, Japan, 362-0806
- Rekruttering
- Saitama Prefectural Cancer Center
-
Sakai, Japan, 591-8555
- Rekruttering
- NHO Kinki Chuo Chest Medical Center
-
Sapporo, Japan, 006-8555
- Rekruttering
- Teine Keijinkai Hospital
-
Sapporo, Japan, 060-0063
- Rekruttering
- Sapporo Minamisanjo Hospital
-
Sendai, Japan, 981-0914
- Rekruttering
- Sendai Kousei Hospital
-
Shibukawa, Japan, 377-0280
- Rekruttering
- Shibukawa Medical Center
-
Toyama, Japan, 930-0194
- Rekruttering
- Toyama University Hospital
-
Wakayama, Japan, 641-8510
- Rekruttering
- Wakayama Medical University Hospital
-
Yokohama, Japan, 221-0855
- Rekruttering
- Yokohama Municipal Citizen's Hospital
-
-
-
-
-
Baoding, Kina, 071000
- Rekruttering
- Affiliated Hospital of Hebei University
-
Beijing, Kina, 100730
- Rekruttering
- Peking Union Medical College Hospital
-
Beijing, Kina, 100730
- Rekruttering
- Beijing Hospital
-
Beijing, Kina, 101149
- Rekruttering
- Beijing Chest Hospital,Capital Medical University
-
Beijing, Kina, 100050
- Rekruttering
- Beijing Friendship Hospital, Capital Medical University
-
Bengbu, Kina, 233004
- Rekruttering
- The First Affiliated Hospital Of Bengbu Medical College
-
Changchun, Kina, 130000
- Rekruttering
- Jilin Cancer Hospital
-
Changsha, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital
-
Changsha, Kina, 410013
- Rekruttering
- The Third Xiangya Hospital of Central South University
-
Hangzhou, Kina, 310016
- Rekruttering
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Hangzhou, Kina, 310022
- Rekruttering
- Zhejiang Medical University, Zhejiang Cancer Hospital
-
Jiamusi, Kina, 154007
- Rekruttering
- Jiamusi Cancer Hospital
-
Jinan, Kina, 250013
- Rekruttering
- Shandong University - Jinan Central Hospital
-
Kunming, Kina, 650118
- Rekruttering
- Yunnan Provincial Cancer Hospital
-
Nanjing, Kina, 210029
- Rekruttering
- Jiangsu Peoples Hospital
-
Shanghai, Kina, 200433
- Rekruttering
- Shanghai Pulmonary Hospital
-
Shanghai, Kina, 200030
- Rekruttering
- Shanghai Chest Hospital
-
Shanghai, Kina, 200032
- Rekruttering
- Fudan University - Shanghai Cancer Center (FUSCC)
-
Shantou, Kina, 515041
- Rekruttering
- Cancer Hospital of Shantou University Medical College
-
Suzhou, Kina, 215006
- Rekruttering
- The First Affiliated Hospital of Soochow University
-
Wanzhou, Kina, 404000
- Rekruttering
- Chongqing University Three Gorges Hospital
-
Wuhan, Kina, 430071
- Rekruttering
- Zhongnan Hospital of Wuhan University
-
Yangzhou, Kina, 225001
- Rekruttering
- Northern Jiangsu Peoples Hospital (NJPH)
-
Zhejiang, Kina, 317000
- Rekruttering
- Taizhou Hospital of Zhejiang Province
-
-
-
-
-
Bialystok, Polen, 15-540
- Rekruttering
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
Bydgoszcz, Polen, 85-048
- Rekruttering
- In- Vivo Sp. z o. o.
-
Gdansk, Polen, 80-211
- Rekruttering
- Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
-
Gliwice, Polen, 44-102
- Rekruttering
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach
-
Katowice, Polen, 40-074
- Rekruttering
- Katowickie Centrum Onkologii
-
Kielce, Polen, 25-734
- Rekruttering
- SPZOZ - Swietokrzyskie Centrum Onkologii
-
Koszalin, Polen, 75-581
- Rekruttering
- Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
-
Krakow, Polen, 31-501
- Rekruttering
- FutureMeds Krakow
-
Lodz, Polen, 90-302
- Rekruttering
- Instytut MSF Sp. z o.o.
-
Lodz, Polen, 93-513
- Rekruttering
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
Lublin, Polen, 20-954
- Rekruttering
- Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
-
Olsztyn, Polen, 10-357
- Rekruttering
- Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
-
Poznan, Polen, 60-693
- Rekruttering
- NZOZ Medpolonia Sp. Z o.o.
-
Poznan, Polen, 60-101
- Rekruttering
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
-
Przemyśl, Polen, 37-700
- Rekruttering
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
-
Warsaw, Polen, 04-349
- Rekruttering
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
-
Warsaw, Polen, 02-781
- Rekruttering
- Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
-
Wroclaw, Polen, 53-413
- Rekruttering
- Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
-
-
-
-
-
Bucharest, Rumænien, 030171
- Rekruttering
- Coltea Clinical Hospital
-
Bucharest, Rumænien, 031424
- Rekruttering
- SC Gral Medical SRL
-
Bucharest, Rumænien, 22328
- Rekruttering
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB)
-
Cluj-Napoca, Rumænien, 400015
- Rekruttering
- Cardiomed
-
Cluj-Napoca, Rumænien, 400641
- Rekruttering
- S.C. Medisprof S.R.L, Oncologie medicala
-
Cluj-Napoca, Rumænien, 407280
- Rekruttering
- Radiotherapy Center Cluj
-
Cluj-Napoca, Rumænien, 400015
- Rekruttering
- Oncology Institute Cluj-Napoca
-
Craiova, Rumænien, 200094
- Rekruttering
- Onco Clinic Consult SA
-
Craiova, Rumænien, 200542
- Rekruttering
- Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)
-
Iași, Rumænien, 700106
- Rekruttering
- Centrul de Oncologie Euroclinic srl
-
Iași, Rumænien, 700483
- Rekruttering
- Institutul Regional De Oncologie Iasi
-
Ovidiu, Rumænien, 905900
- Trukket tilbage
- Ovidius Clinical Hospital
-
Ploieşti, Rumænien, 100337
- Rekruttering
- Municipal Hospital Ploiesti
-
Timișoara, Rumænien, 300239
- Rekruttering
- Oncomed
-
-
-
-
-
Baden, Schweiz, 5404
- Rekruttering
- Kantonspital Baden
-
Lausanne, Schweiz, 1011
- Rekruttering
- Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) - Centre de transplantation d'organes (CTO)
-
Münsterlingen, Schweiz, 8596
- Rekruttering
- Kantonsspital Münsterlingen
-
-
-
-
-
A Coruña, Spanien, 15006
- Rekruttering
- CHUAC Hospital Teresa Herrera
-
Badajoz, Spanien, 6006
- Rekruttering
- Hospital Universitario de Badajoz
-
Badalona, Spanien, 08916
- Rekruttering
- Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
-
Barcelona, Spanien, 08035
- Rekruttering
- Hospital Universitario Vall d'Hebron
-
Barcelona, Spanien, 8908
- Rekruttering
- Instituto Catalan de Oncologia - Hospital Duran i Reynals
-
Castellon, Spanien, 12002
- Rekruttering
- Consorcio Hospitalario Provincial de Castellón
-
Las Palmas de Gran Canaria, Spanien, 35016
- Rekruttering
- Complejo Hospitalario Universitario Insular Materno Infantil
-
León, Spanien, 24080
- Rekruttering
- Hospital Universitario De Leon
-
Lleida, Spanien, 25198
- Rekruttering
- Hospital Universitari de Lleida Arnau de Villanova
-
Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Madrid, Spanien, 28007
- Rekruttering
- Hospital General Universitario Gregorio Maranon (HGUGM)
-
Madrid, Spanien, 28033
- Rekruttering
- Clinica MD Anderson International
-
Madrid, Spanien, 28040
- Rekruttering
- Hospital Universitario Fundacion Jimenez Diaz
-
Majadahonda, Spanien, 28222
- Rekruttering
- Hospital Universitario Puerta de Hierro de Majadahonda
-
Santa Cruz de Tenerife, Spanien, 38320
- Rekruttering
- Hospital Universitario de Canarias
-
Seville, Spanien, 41013
- Rekruttering
- Hospital Universitario Virgen del Rocio
-
Seville, Spanien, 41014
- Rekruttering
- Hospital Universitario Nuestra Senora De Valme
-
Valencia, Spanien, 46026
- Rekruttering
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
-
Valencia, Spanien, 46009
- Rekruttering
- Fundacion Instituto Valenciano de Oncologia
-
Valencia, Spanien, 46014
- Rekruttering
- Hospital General Universitario De Valencia
-
Vigo, Spanien, 36312
- Rekruttering
- Hospital Alvaro Cunqueiro
-
Zaragoza, Spanien, 50009
- Rekruttering
- Hospital Universitario Miguel Servet de Zaragoza
-
-
-
-
-
Cheongju-si, Sydkorea, 28644
- Rekruttering
- Chungbuk National University Hospital
-
Daejeon, Sydkorea, 35015
- Rekruttering
- Chungnam National University Hospital (CNUH)
-
Goyang-si, Sydkorea, 10408
- Rekruttering
- National Cancer Center
-
Incheon, Sydkorea, 21565
- Rekruttering
- Gachon University Gil Medical Center
-
Jinju, Sydkorea, 52727
- Rekruttering
- Gyeongsang National University Hospital (GNUH)
-
Seongnam-si, Sydkorea, 13620
- Rekruttering
- Seoul National University Bundang Hospital (SNUBH)
-
Seoul, Sydkorea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System
-
Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Seoul, Sydkorea, 08308
- Rekruttering
- Korea University Guro Hospital
-
Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center (AMC)
-
Suwon, Sydkorea, 16499
- Rekruttering
- Ajou University Hospital
-
Suwon, Sydkorea, 16247
- Rekruttering
- The Catholic University Of Korea, St. Vincent's Hospital
-
-
-
-
-
Bangkok, Thailand, 10330
- Rekruttering
- Chulalongkorn University
-
Bangkok, Thailand, 10300
- Rekruttering
- Faculty of Medicine Vajira Hospital, Navamindradhiraj University
-
Chiang Rai, Thailand, 57000
- Rekruttering
- Chiangrai Prachanukroh Hospital
-
Lampang, Thailand, 52000
- Rekruttering
- Lampang Cancer Hospital
-
Nakhon Nayok, Thailand, 26120
- Rekruttering
- HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University
-
Ratchathewi, Thailand, 10400
- Rekruttering
- Rajavithi Hospital
-
-
-
-
-
Adana, Tyrkiet (Türkiye), 1370
- Rekruttering
- Adana City Training and Research Hospital
-
Adana, Tyrkiet (Türkiye), 1120
- Rekruttering
- Baskent Universitesi Tip Fakultesi Adana Hastanesi
-
Ankara, Tyrkiet (Türkiye), 06010
- Rekruttering
- Gulhane Training and Research Hospital
-
Ankara, Tyrkiet (Türkiye), 06680
- Rekruttering
- Liv Hospital Ankara
-
Ankara, Tyrkiet (Türkiye), 06200
- Rekruttering
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
Ankara, Tyrkiet (Türkiye), 06520
- Rekruttering
- Memorial Ankara Hospital
-
Ankara, Tyrkiet (Türkiye), 06800
- Rekruttering
- Ankara Bilkent City Hospital
-
Ankara, Tyrkiet (Türkiye), 06230
- Rekruttering
- Hacettepe University Medicine Faculty
-
Antalya, Tyrkiet (Türkiye), 7985
- Rekruttering
- Akdeniz University Hospital
-
Diyarbakır, Tyrkiet (Türkiye), 21280
- Rekruttering
- Dicle University Faculty of Medicine Hospital
-
Gaziantep, Tyrkiet (Türkiye), 36020
- Rekruttering
- Gaziantep Sanko University Medical Faculty
-
Istanbul, Tyrkiet (Türkiye), 34093
- Rekruttering
- Bezmialem Foundation University Medical Faculty
-
Istanbul, Tyrkiet (Türkiye), 34517
- Rekruttering
- Istinye University Bahcesehir Liv Hospital
-
Istanbul, Tyrkiet (Türkiye), 34718
- Rekruttering
- Yeditepe University Kosuyolu Hospital
-
Izmir, Tyrkiet (Türkiye), 35325
- Rekruttering
- Medical Point Izmir Hospital
-
Kadıköy, Tyrkiet (Türkiye), 34722
- Rekruttering
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Keçiören, Tyrkiet (Türkiye), 06290
- Rekruttering
- Ankara Ataturk Sanatoryum Saglik Uygulama ve Arastirma Merkezi
-
Kocaeli, Tyrkiet (Türkiye), 41380
- Rekruttering
- Kocaeli Universitesi Tip Fakultesi
-
Konya, Tyrkiet (Türkiye), 42080
- Rekruttering
- Necmettin Erbakan University Meram Medical Faculty
-
Küçükçekmece, Tyrkiet (Türkiye), 34295
- Rekruttering
- Medical Park Florya Hospital
-
Ordu, Tyrkiet (Türkiye), 34752
- Rekruttering
- Medicalpark Ordu Hospital
-
Ortahisar, Tyrkiet (Türkiye), 61080
- Rekruttering
- Karadeniz Technical University Faculty of Medicine
-
Sakarya, Tyrkiet (Türkiye), 54290
- Rekruttering
- Sakarya University - Faculty of Medicine
-
Samsun, Tyrkiet (Türkiye), 55280
- Rekruttering
- Ondokuz Mayis University Health Practice and Research Hospital
-
Seyhan, Tyrkiet (Türkiye), 01130
- Trukket tilbage
- Acibadem Adana Hospital
-
Seyhan, Tyrkiet (Türkiye), 01170
- Rekruttering
- Medical Park Seyhan Hospital
-
Toroslar, Tyrkiet (Türkiye), 33240
- Rekruttering
- Mersin City Training and Research Hospital
-
Yenimahalle, Tyrkiet (Türkiye), 06560
- Rekruttering
- Gazi University Faculty of Medicine
-
Zeytinburnu, Tyrkiet (Türkiye), 34010
- Rekruttering
- Koc Universitesi Hastanesi (Koc University Hospital)
-
-
-
-
-
Aachen, Tyskland, 52074
- Rekruttering
- Uniklinik RWTH Aachen Medizinische Klinik IV
-
Berlin, Tyskland, 13125
- Rekruttering
- Evangelische Lungenklinik Berlin
-
Chemnitz, Tyskland, 09116
- Rekruttering
- Klinikum Chemnitz gGmbH
-
Düsseldorf, Tyskland, 40489
- Rekruttering
- Kaiserwerther Diakonie - Florence Nightingale Krankenhaus
-
Erlangen, Tyskland, 91054
- Rekruttering
- Universitätsklinikum Erlangen
-
Esslingen am Neckar, Tyskland, 73730
- Rekruttering
- Klinikum Esslingen GmbH
-
Gauting, Tyskland, 82131
- Rekruttering
- Asklepios Fachkliniken Muenchen Gauting
-
Gera, Tyskland, 07548
- Rekruttering
- SRH Wald-Kliniken Gera GmbH
-
Hamburg, Tyskland, 21075
- Rekruttering
- Asklepios Klinik Harburg
-
Heidelberg, Tyskland, 69126
- Rekruttering
- Thoraxklinik-Heidelberg Ggmbh
-
Immenhausen, Tyskland, 34376
- Rekruttering
- Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen
-
Mainz, Tyskland, 55131
- Rekruttering
- University Medical Center of Johannes Gutenberg-University Mainz
-
Moers, Tyskland, 47441
- Rekruttering
- Krankenhaus Bethanien Moers
-
München, Tyskland, 81925
- Rekruttering
- Staedtisches Klinikum Muenchen Bogenhausen
-
Neuss, Tyskland, 41462
- Rekruttering
- MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
-
Remscheid, Tyskland, 42853
- Rekruttering
- Onkologische Tagesklinik Remscheid
-
Wesseling, Tyskland, 50389
- Rekruttering
- Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
-
Wuppertal, Tyskland, 42883
- Rekruttering
- Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
-
-
-
-
-
Budapest, Ungarn, 1145
- Rekruttering
- Budapesti Uzsoki Utcai Korhaz
-
Budapest, Ungarn, 1122
- Rekruttering
- Orszagos Onkologiai Intezet (National Institute of Oncology)
-
Edelény, Ungarn, 3780
- Rekruttering
- Edelenyi Koch Robert Korhaz es Rendelointezet
-
Kecskemét, Ungarn, 6000
- Rekruttering
- Bacs- Kiskun Varmegyei Oktatokorhaz Onkoradiologiai Kozpont
-
Szolnok, Ungarn, 5000
- Rekruttering
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Key Inclusion Criteria:
- Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition.
- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Adequate organ function as defined in the protocol.
Key Exclusion Criteria:
-
Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component.
-
Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
- Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting.
- Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody.
- Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
-
Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
-
Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
-
Participants with significant risk of hemorrhage (per investigator clinical judgment).
-
Participants have superior vena cava syndrome or symptoms of spinal cord compression.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Substudy A Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
Andre navne:
Intravenous infusion |
|
Eksperimentel: Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
Andre navne:
Intravenous infusion |
|
Eksperimentel: Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
Andre navne:
Intravenous infusion |
|
Eksperimentel: Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
Andre navne:
Intravenous infusion |
|
Aktiv komparator: Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion Intravenous infusion |
|
Eksperimentel: Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Paclitaxel
|
Intravenous infusion Intravenous infusion
Andre navne:
Intravenous infusion |
|
Eksperimentel: Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Paclitaxel
|
Intravenous infusion Intravenous infusion
Andre navne:
Intravenous infusion |
|
Eksperimentel: Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + Paclitaxel
|
Intravenous infusion Intravenous infusion
Andre navne:
Intravenous infusion |
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Eksperimentel: Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Paclitaxel
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Intravenous infusion Intravenous infusion
Andre navne:
Intravenous infusion |
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Aktiv komparator: Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Paclitaxel
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Intravenous infusion Intravenous infusion Intravenous infusion |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs
Tidsramme: From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit
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For substudies A and B. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) in the combination treatment regimen. |
From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit
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Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)
Tidsramme: From the first dose of IMP to the 90-day Follow-Up Visit
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For substudies A and B. |
From the first dose of IMP to the 90-day Follow-Up Visit
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Phase 2 - Objective response rate (ORR)
Tidsramme: Up to approximately 2 years
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For substudies A and B. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator's assessment) is observed as best overall response. |
Up to approximately 2 years
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Phase 2 - Best percentage change from baseline in tumor size
Tidsramme: Up to approximately 2 years
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For substudies A and B. Based on investigator's tumor assessment according to RECIST v1.1. |
Up to approximately 2 years
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Phase 3 - Progression free survival (PFS) assessed by BICR
Tidsramme: Up to approximately 5 years
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For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first. |
Up to approximately 5 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Phase 3 - Overall survival (OS)
Tidsramme: Up to approximately 5 years
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For substudies A and B. OS defined as the time from randomization to death from any cause |
Up to approximately 5 years
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Phase 2 - Duration of Response (DOR)
Tidsramme: Up to approximately 2 years
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For substudies A and B. DOR defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 2 years
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Phase 2 - Disease Control Rate (DCR)
Tidsramme: Up to approximately 2 years
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For substudies A and B. DCR defined as the proportion of participants in whom a confirmed CR or confirmed PR or stable disease (per RECIST v1.1, stable disease assessed at least 6 weeks after randomization) is observed as best overall response. |
Up to approximately 2 years
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Phase 3 - PFS assessed by investigator
Tidsramme: Up to approximately 5 years
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For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first. |
Up to approximately 5 years
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Phase 3 - ORR
Tidsramme: Up to approximately 2 years
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For substudies A and B. ORR defined as the proportion of participants in whom a confirmed CR or confirmed PR (per RECIST v1.1) is observed as best overall response. |
Up to approximately 2 years
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Phase 3 - PFS rate as assessed by BICR
Tidsramme: At 6, 12, and 18 months
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For substudies A and B. |
At 6, 12, and 18 months
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Phase 3 - PFS rate as assessed by investigator
Tidsramme: At 6, 12, and 18 months
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For substudies A and B. |
At 6, 12, and 18 months
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Phase 3 - OS rate
Tidsramme: At 6, 12, 18, 24 months
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For substudies A and B. |
At 6, 12, 18, 24 months
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Phase 3 - Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life-score 30 Questionnaire (QLQ-C30) global health status/Quality-of-Life (QoL) score (Items 29 and 30)
Tidsramme: Up to approximately 5 years
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For substudies A and B. The EORTC QLQ-C30 is the most widely used cancer-specific, health related QoL instrument containing a total of 30 items and measures 5 functional scales (physical, role, emotional, cognitive, and social), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status/QoL scale. All the scales and single-item measures range in score from 0 to 100 with a high scale score representing a higher response level (i.e., high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems). |
Up to approximately 5 years
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Phase 3 - Change from baseline in EORTC QLQ-C30 physical functioning
Tidsramme: Up to approximately 5 years
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For substudies A and B. The EORTC QLQ-C30 is the most widely used cancer-specific, health related QoL instrument containing a total of 30 items and measures 5 functional scales (physical, role, emotional, cognitive, and social), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status/QoL scale. All the scales and single-item measures range in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for functional scale is high/healthy level of functioning. |
Up to approximately 5 years
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Phase 3 - Change from baseline in coughing scale of the EORTC lung cancer-specific quality-of-life questionnaire (QLQ-LC29)
Tidsramme: Up to approximately 5 years
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For substudies A and B. The EORTC QLQ-LC29 is a disease-specific supplementary health-related quality-of-life (HRQoL) questionnaire module to be employed in conjunction with the QLQ-C30. It comprises 29 items and measures five multi-item scales (coughing, shortness of breath, side effects, tumor progression/existential issues, surgery-related symptoms) and five single items (coughing up blood, pain in chest, arm/shoulder and other parts of the body, and weight loss). All the scales and single-item measures range in score from 0 to 100 with a high score for the scales and single items representing a high level of symptomatology or problems. |
Up to approximately 5 years
|
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Phase 3 - Change from baseline in shortness of breath scale of the EORTC QLQ-LC29
Tidsramme: Up to approximately 5 years
|
For substudies A and B. The EORTC QLQ-LC29 is a disease-specific supplementary health-related quality-of-life (HRQoL) questionnaire module to be employed in conjunction with the QLQ-C30. It comprises 29 items and measures five multi-item scales (coughing, shortness of breath, side effects, tumor progression/existential issues, surgery-related symptoms) and five single items (coughing up blood, pain in chest, arm/shoulder and other parts of the body, and weight loss). All the scales and single-item measures range in score from 0 to 100 with a high score for the scales and single items representing a high level of symptomatology or problems. |
Up to approximately 5 years
|
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Phase 3 - Change from baseline in coughed up blood item of the EORTC QLQ-LC29
Tidsramme: Up to approximately 5 years
|
For substudies A and B. The EORTC QLQ-LC29 is a disease-specific supplementary health-related quality-of-life (HRQoL) questionnaire module to be employed in conjunction with the QLQ-C30. It comprises 29 items and measures five multi-item scales (coughing, shortness of breath, side effects, tumor progression/existential issues, surgery-related symptoms) and five single items (coughing up blood, pain in chest, arm/shoulder and other parts of the body, and weight loss). All the scales and single-item measures range in score from 0 to 100 with a high score for the scales and single items representing a high level of symptomatology or problems. |
Up to approximately 5 years
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Phase 3 - Change from baseline in fatigue domain score scale of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
Tidsramme: Up to approximately 5 years
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For substudies A and B. The NSCLC-SAQ is a 7-item patient-reported outcome (PRO) measure for use in adults to assess symptoms of advanced non-small cell lung cancer. It contains five domains and accompanying items that were identified as symptoms of non- small cell lung cancer: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1). The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms. |
Up to approximately 5 years
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Phase 3 - Change from baseline in pain domain score of the NSCLC-SAQ
Tidsramme: Up to approximately 5 years
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For substudies A and B. The NSCLC-SAQ is a 7-item PRO measure for use in adults to assess symptoms of advanced non-small cell lung cancer. It contains five domains and accompanying items that were identified as symptoms of non-small cell lung cancer: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1). The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms. |
Up to approximately 5 years
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Phase 3 - Change from baseline in Functional Assessment of Cancer Therapy-General item 5 overall bother item (FACT-GP5)
Tidsramme: Up to approximately 5 years
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For substudies A and B. The FACT-G - Item GP5 (Version 4) is a single-item summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of AEs in clinical studies. The single-item GP5 ("I am bothered by side effects of treatment") is rated on a 5-point Likert scale ("not at all" to "very much") with a recall period of past 7 days. |
Up to approximately 5 years
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Phase 3 - Occurrence of TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship
Tidsramme: From the first dose of IMP to the 90-day Follow-Up Visit
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For substudies A and B. AEs graded according to CTCAE v5.0. |
From the first dose of IMP to the 90-day Follow-Up Visit
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Phase 3 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)
Tidsramme: From the first dose of IMP to the 90-day Follow-Up Visit
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For substudies A and B. |
From the first dose of IMP to the 90-day Follow-Up Visit
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: BioNTech Responsible Person, BioNTech SE
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. januar 2025
Primær færdiggørelse (Anslået)
1. januar 2029
Studieafslutning (Anslået)
1. december 2031
Datoer for studieregistrering
Først indsendt
11. november 2024
Først indsendt, der opfyldte QC-kriterier
26. november 2024
Først opslået (Faktiske)
2. december 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Immunterapi
- Lungekræft
- Carboplatin
- Pemetrexed
- Paclitaxel
- Bispecifikt antistof
- Første linje behandling
- Programmeret dødsligand 1 (PD-L1)
- Programmerede Death-1 monoklonale antistoffer
- Kombination med kemoterapi
- Kombination med andre undersøgelsesmidler
- Vaskulær endotelvækstfaktor (VEGF) A
- Bnt327
- Pumitamig
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Luftvejssygdomme
- Lungesygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Aminosyrer, peptider og proteiner
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Kulbrinter
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Terpenes
- Koordinationskomplekser
- Guanine
- Hypoxanthines
- Purinoner
- Puriner
- Glutamater
- Aminosyrer, sur
- Aminosyrer
- Aminosyrer, dicarboxylic
- Taxoider
- Cyclodecanes
- Diterpenes
- Pemetrexed
- Carboplatin
- Paclitaxel
- pembrolizumab
Andre undersøgelses-id-numre
- BNT327-06
- 2024-515764-31-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Ingen
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