Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
1차 비소세포폐암에 대한 화학요법 및 기타 조사 약물과 병용한 BNT327의 글로벌 시험을 위한 2상/3상, 다중 사이트, 무작위 마스터 프로토콜
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: BioNTech clinical trials patient information
- 전화번호: +49 6131 9084
- 이메일: patients@biontech.de
연구 장소
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Batumi, 그루지야, 6000
- 모병
- High Technology Hospital Medcenter LTD
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Tbilisi, 그루지야, 0144
- 모병
- LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
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Tbilisi, 그루지야, 0112
- 모병
- LLC Todua Clinic
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Tbilisi, 그루지야, 0162
- 모병
- New Hospitals
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Tbilisi, 그루지야, 0179
- 모병
- Cancer Research Centre
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-
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Cheongju-si, 대한민국, 28644
- 모병
- Chungbuk National University Hospital
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Daejeon, 대한민국, 35015
- 모병
- Chungnam National University Hospital (CNUH)
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Goyang-si, 대한민국, 10408
- 모병
- National Cancer Center
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Incheon, 대한민국, 21565
- 모병
- Gachon University Gil Medical Center
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Jinju, 대한민국, 52727
- 모병
- Gyeongsang National University Hospital (GNUH)
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Seongnam-si, 대한민국, 13620
- 모병
- Seoul National University Bundang Hospital (SNUBH)
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Seoul, 대한민국, 03722
- 모병
- Severance Hospital, Yonsei University Health System
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Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
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Seoul, 대한민국, 08308
- 모병
- Korea University Guro Hospital
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Seoul, 대한민국, 05505
- 모병
- Asan Medical Center (AMC)
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Suwon, 대한민국, 16499
- 모병
- Ajou University Hospital
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Suwon, 대한민국, 16247
- 모병
- The Catholic University Of Korea, St. Vincent's Hospital
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-
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Aachen, 독일, 52074
- 모병
- Uniklinik RWTH Aachen Medizinische Klinik IV
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Berlin, 독일, 13125
- 모병
- Evangelische Lungenklinik Berlin
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Chemnitz, 독일, 09116
- 모병
- Klinikum Chemnitz gGmbH
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Düsseldorf, 독일, 40489
- 모병
- Kaiserwerther Diakonie - Florence Nightingale Krankenhaus
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Erlangen, 독일, 91054
- 모병
- Universitätsklinikum Erlangen
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Esslingen am Neckar, 독일, 73730
- 모병
- Klinikum Esslingen GmbH
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Gauting, 독일, 82131
- 모병
- Asklepios Fachkliniken Muenchen Gauting
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Gera, 독일, 07548
- 모병
- SRH Wald-Kliniken Gera GmbH
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Hamburg, 독일, 21075
- 모병
- Asklepios Klinik Harburg
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Heidelberg, 독일, 69126
- 모병
- Thoraxklinik-Heidelberg Ggmbh
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Immenhausen, 독일, 34376
- 모병
- Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen
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Mainz, 독일, 55131
- 모병
- University Medical Center of Johannes Gutenberg-University Mainz
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Moers, 독일, 47441
- 모병
- Krankenhaus Bethanien Moers
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München, 독일, 81925
- 모병
- Staedtisches Klinikum Muenchen Bogenhausen
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Neuss, 독일, 41462
- 모병
- MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
-
Remscheid, 독일, 42853
- 모병
- Onkologische Tagesklinik Remscheid
-
Wesseling, 독일, 50389
- 모병
- Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
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Wuppertal, 독일, 42883
- 모병
- Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
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-
-
-
-
Bucharest, 루마니아, 030171
- 모병
- Coltea Clinical Hospital
-
Bucharest, 루마니아, 031424
- 모병
- SC Gral Medical SRL
-
Bucharest, 루마니아, 22328
- 모병
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB)
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Cluj-Napoca, 루마니아, 400015
- 모병
- Cardiomed
-
Cluj-Napoca, 루마니아, 400641
- 모병
- S.C. Medisprof S.R.L, Oncologie medicala
-
Cluj-Napoca, 루마니아, 407280
- 모병
- Radiotherapy Center Cluj
-
Cluj-Napoca, 루마니아, 400015
- 모병
- Oncology Institute Cluj-Napoca
-
Craiova, 루마니아, 200094
- 모병
- Onco Clinic Consult SA
-
Craiova, 루마니아, 200542
- 모병
- Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)
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Iași, 루마니아, 700106
- 모병
- Centrul de Oncologie Euroclinic srl
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Iași, 루마니아, 700483
- 모병
- Institutul Regional De Oncologie Iasi
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Ovidiu, 루마니아, 905900
- 빼는
- Ovidius Clinical Hospital
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Ploieşti, 루마니아, 100337
- 모병
- Municipal Hospital Ploiesti
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Timișoara, 루마니아, 300239
- 모병
- Oncomed
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-
-
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Alabama
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Birmingham, Alabama, 미국, 35223
- 모병
- Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology
-
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Alaska
-
Anchorage, Alaska, 미국, 99508
- 모병
- Alaska Oncology and Hematology, LLC
-
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California
-
Concord, California, 미국, 94520
- 모병
- John Muir Clinical Research Center
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La Jolla, California, 미국, 92093
- 모병
- University Of California - San Diego Moores Cancer Center
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Colorado
-
Vail, Colorado, 미국, 81657
- 모병
- Vail Health
-
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District of Columbia
-
Washington D.C., District of Columbia, 미국, 20007
- 모병
- MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
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Washington D.C., District of Columbia, 미국, 20010
- 모병
- MEDSTAR Washington Hospital Center (MedStar Health Research Institute)
-
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Florida
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Clermont, Florida, 미국, 34711
- 모병
- Clermont Oncology Center
-
Coral Springs, Florida, 미국, 33065
- 모병
- SSAK Partners, LLC.
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Jacksonville, Florida, 미국, 32207
- 모병
- Baptist Medical Center Jacksonville
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Orange City, Florida, 미국, 32763
- 모병
- Mid Florida Cancer Centers
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Stuart, Florida, 미국, 34994
- 모병
- Cleveland Clinic Florida - Martin North Hospital
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Tampa, Florida, 미국, 33612
- 모병
- H. Lee Moffit Cancer center and research institute
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Weston, Florida, 미국, 33331
- 모병
- Cleveland Clinic Weston Hospital
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Georgia
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Marietta, Georgia, 미국, 30060
- 모병
- Northwest Georgia Oncology Centers, P.C.
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Indiana
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Fort Wayne, Indiana, 미국, 46845
- 모병
- Fort Wayne Medical Oncology and Hematology, Inc.
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Indianapolis, Indiana, 미국, 46202
- 모병
- Indiana University Health University Hospital
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Iowa
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Cedar Rapids, Iowa, 미국, 52401-2112
- 모병
- Physicians Clinic of Iowa
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Iowa City, Iowa, 미국, 52242
- 모병
- Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
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Kentucky
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Elizabethtown, Kentucky, 미국, 42701
- 모병
- Baptist Health Hardin
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Lexington, Kentucky, 미국, 40503
- 모병
- Baptist Health Lexington
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Lexington, Kentucky, 미국, 40536
- 모병
- University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center)
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Maryland
-
Frederick, Maryland, 미국, 21704
- 모병
- Frederick Health Hospital- James M Stockman Cancer Institute
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Missouri
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Columbia, Missouri, 미국, 65201
- 모병
- Missouri Cancer Associates
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Fenton, Missouri, 미국, 63026
- 빼는
- SSM Health Cancer Care - St. Clare
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Nebraska
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Hastings, Nebraska, 미국, 68901-4470
- 모병
- Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)
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New Jersey
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East Brunswick, New Jersey, 미국, 08816
- 모병
- Astera Cancer Care
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Florham Park, New Jersey, 미국, 07932
- 모병
- Summit Medical Group PA
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Paramus, New Jersey, 미국, 07652
- 모병
- The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
-
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New York
-
Poughkeepsie, New York, 미국, 12601
- 모병
- Nuvance Health
-
Stony Brook, New York, 미국, 11794-9446
- 모병
- Suny-Stony Brook University Cancer Center
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White Plains, New York, 미국, 10601
- 모병
- White Plains Hospital
-
-
North Carolina
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Hendersonville, North Carolina, 미국, 28792
- 모병
- Fletcher Hospital, Inc. dba AdventHealth Hendersonville
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Ohio
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Canton, Ohio, 미국, 44718
- 모병
- Gabrail Cancer Center Research
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Cincinnati, Ohio, 미국, 45219
- 모병
- University of Cincinnati Medical Center
-
Cincinnati, Ohio, 미국, 45219
- 모병
- The Christ Hospital Cancer Center
-
Cleveland, Ohio, 미국, 44195-0001
- 모병
- Cleveland Clinic
-
Cleveland, Ohio, 미국, 44111
- 모병
- The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion
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Dayton, Ohio, 미국, 45415
- 모병
- Dayton Physicians Network
-
Kettering, Ohio, 미국, 45429
- 모병
- Kettering Medical Center
-
Mayfield Heights, Ohio, 미국, 44124
- 모병
- Cleveland Clinic - Hillcrest Hospital
-
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Oklahoma
-
Oklahoma City, Oklahoma, 미국, 73109
- 모병
- INTEGRIS Cancer Institute of Oklahoma
-
-
Tennessee
-
Knoxville, Tennessee, 미국, 37920
- 모병
- University of Tennessee Medical Center
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Memphis, Tennessee, 미국, 38120
- 빼는
- Baptist Cancer Center
-
Nashville, Tennessee, 미국, 37232
- 모병
- Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center
-
-
Texas
-
Houston, Texas, 미국, 77090
- 모집하지 않고 적극적으로
- Millennium Research and Clinical Development, LLC
-
-
Utah
-
Salt Lake City, Utah, 미국, 84106
- 모병
- Utah Cancer Specialists
-
-
Virginia
-
Fairfax, Virginia, 미국, 22031
- 모병
- Virginia Cancer Specialists
-
Fairfax, Virginia, 미국, 22031
- 모병
- Inova Schar Cancer
-
Richmond, Virginia, 미국, 23229
- 모병
- Virginia Cancer Institute
-
Richmond, Virginia, 미국, 23298
- 모병
- VCU Massey Cancer Center
-
Winchester, Virginia, 미국, 22601
- 모병
- Shenandoah Oncology
-
-
West Virginia
-
Morgantown, West Virginia, 미국, 26506-8110
- 모병
- West Virginia University Hospitals - Mary Babb Randolph Cancer Center
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Wisconsin
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La Crosse, Wisconsin, 미국, 54601-5467
- 모병
- Gundersen Lutheran Medical Center
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-
-
-
-
Ghent, 벨기에, 9000
- 모병
- Universitair Ziekenhuis Gent (Uz Gent)
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Leuven, 벨기에, 3000
- 모병
- Universitair Ziekenhuis Leuven
-
Mons, 벨기에, 7000
- 모병
- CHU HELORA, Hopital de Mons - Site Kennedy
-
Roeselare, 벨기에, 8800
- 모병
- Algemeen Ziekenhuis Delta
-
Sint-Niklaas, 벨기에, 9100
- 모병
- VITAZ
-
Woluwe-Saint-Lambert, 벨기에, 1200
- 모병
- Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
-
-
-
-
-
Plovdiv, 불가리아, 4000
- 모병
- Complex Oncology Center
-
Rousse, 불가리아, 7000
- 모병
- Complex Oncological Center Ruse Ltd
-
Sofia, 불가리아, 1527
- 모병
- University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
-
Sofia, 불가리아, 1373
- 모병
- MHAT for Womens Health - Nadezhda OOD
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-
-
-
-
Barretos, 브라질, 14784-400
- 모병
- Fundacao Pio XII - Hospital de Cancer de Barretos
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Curitiba, 브라질, 81480-580
- 모병
- CIONC - Centro Integrado de Oncologia de Curitiba
-
Fortaleza, 브라질, 60336-232
- 모병
- Centro Regional Integrado de Oncologia
-
Ijuí, 브라질, 98700-000
- 모병
- Oncosite Centro De Pesquisa Clinica Em Oncologia
-
Itajaí, 브라질, 88301-220
- 모병
- Clinica de Neoplasias Litoral LTDA / Catarina Pesquisa Clínica
-
Lajeado, 브라질, 95900-000
- 모병
- Bruno Born Hospital
-
Londrina, 브라질, 86015-520
- 모병
- Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL
-
Natal, 브라질, 59062-000
- 모병
- Liga Norte Riograndense Contra o Cancer - CECAN
-
Passo Fundo, 브라질, 99010-080
- 모병
- Hospital Sao Vicente de Paulo (HSVP)
-
Porto Alegre, 브라질, 91350-200
- 모병
- Hospital Nossa Senhora da Conceicao
-
Porto Alegre, 브라질, 90020-090
- 모병
- Irmandade Santa Casa de Misericordia de Porto Alegre
-
Porto Alegre, 브라질, 90110-270
- 모병
- Centro Gaucho Integrado de Oncologia e Hematologia - Hospital Mae de Deus/AESC
-
Porto Alegre, 브라질, 90610-000
- 모병
- Centro Clinico do Hospital Sao Lucas da PUCRS
-
Rio de Janeiro, 브라질, 22250-905
- 모병
- Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)
-
Salvador, 브라질, 40170-110
- 모병
- OC Oncoclínicas - Núcleo de Oncologia da Bahia-Ondina (OC Oncoclinicas-NOB Ondina)
-
São Caetano do Sul, 브라질, 09541-270
- 모병
- CEON Pesquisas
-
São José do Vale do Rio Preto, 브라질, 15090-000
- 모병
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do Rio Preto
-
São Paulo, 브라질, 01227-959
- 모병
- IEP São Lucas
-
São Paulo, 브라질, 01227-200
- 모병
- IEP Sao Lucas Instituto de Ensino e Pesquisa Sao Lucas
-
Vitória, 브라질, 29043-260
- 모병
- Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
-
-
-
-
-
Baden, 스위스, 5404
- 모병
- Kantonspital Baden
-
Lausanne, 스위스, 1011
- 모병
- Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) - Centre de transplantation d'organes (CTO)
-
Münsterlingen, 스위스, 8596
- 모병
- Kantonsspital Münsterlingen
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-
-
-
-
A Coruña, 스페인, 15006
- 모병
- CHUAC Hospital Teresa Herrera
-
Badajoz, 스페인, 6006
- 모병
- Hospital Universitario de Badajoz
-
Badalona, 스페인, 08916
- 모병
- Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
-
Barcelona, 스페인, 08035
- 모병
- Hospital Universitario Vall d'Hebron
-
Barcelona, 스페인, 8908
- 모병
- Instituto Catalan de Oncologia - Hospital Duran i Reynals
-
Castellon, 스페인, 12002
- 모병
- Consorcio Hospitalario Provincial de Castellón
-
Las Palmas de Gran Canaria, 스페인, 35016
- 모병
- Complejo Hospitalario Universitario Insular Materno Infantil
-
León, 스페인, 24080
- 모병
- Hospital Universitario De Leon
-
Lleida, 스페인, 25198
- 모병
- Hospital Universitari de Lleida Arnau de Villanova
-
Madrid, 스페인, 28041
- 모병
- Hospital Universitario 12 de Octubre
-
Madrid, 스페인, 28007
- 모병
- Hospital General Universitario Gregorio Maranon (HGUGM)
-
Madrid, 스페인, 28033
- 모병
- Clinica MD Anderson International
-
Madrid, 스페인, 28040
- 모병
- Hospital Universitario Fundacion Jimenez Diaz
-
Majadahonda, 스페인, 28222
- 모병
- Hospital Universitario Puerta de Hierro de Majadahonda
-
Santa Cruz de Tenerife, 스페인, 38320
- 모병
- Hospital Universitario de Canarias
-
Seville, 스페인, 41013
- 모병
- Hospital Universitario Virgen del Rocio
-
Seville, 스페인, 41014
- 모병
- Hospital Universitario Nuestra Senora De Valme
-
Valencia, 스페인, 46026
- 모병
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
-
Valencia, 스페인, 46009
- 모병
- Fundacion Instituto Valenciano de Oncologia
-
Valencia, 스페인, 46014
- 모병
- Hospital General Universitario De Valencia
-
Vigo, 스페인, 36312
- 모병
- Hospital Alvaro Cunqueiro
-
Zaragoza, 스페인, 50009
- 모병
- Hospital Universitario Miguel Servet de Zaragoza
-
-
-
-
-
Buenos Aires, 아르헨티나, C1199
- 모병
- Hospital Italiano de Buenos Aires
-
Buenos Aires, 아르헨티나, C1113
- 모병
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
-
Buenos Aires, 아르헨티나, C1122
- 모병
- Instituto Argentino de Diagnóstico y Tratamiento (IADT)
-
Córdoba, 아르헨티나, X5000JHQ
- 모병
- Sanatorio Allende
-
La Rioja, 아르헨티나, F5300
- 모병
- Centro Oncologico Riojano Integral (CORI)
-
San Miguel de Tucumán, 아르헨티나, 4000
- 모병
- Exelsus SRL
-
Viedma, 아르헨티나, R8500
- 모병
- Centro de Investigaciones Clinicas. Clinica Viedma S. A
-
-
-
-
-
Basildon, 영국, SS16 5NL
- 모병
- Basildon University Hospital - Basildon And Thurrock University Hospitals Nhs Foundation Trust
-
Bath, 영국, BA1 3NG
- 모병
- Royal United Hospital, Bath - Royal United Hospitals Bath NHS Foundation Trust
-
Brighton, 영국, BN2 5BE
- 모병
- Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
-
Cardiff, 영국, CF14 2TL
- 모병
- Velindre NHS Trust, Velindre Cancer Centre
-
Chelsea, 영국, SW3 6JJ
- 모병
- Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
-
Cottingham, 영국, HU16 5JQ
- 모병
- Hull University Teaching Hospitals NHS Trust
-
Glasgow, 영국, G12 0YN
- 모병
- Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
-
Liverpool, 영국, L7 8YA
- 모병
- Clatterbridge Cancer Centre
-
London, 영국, NW2 1PG
- 모병
- University College Hospital
-
London, 영국, SM2 5PT
- 모병
- Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
-
Manchester, 영국, M20 4BX
- 모병
- The Christie NHS Foundation Trust
-
Norwich, 영국, NR4 7UY
- 모병
- Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
-
Oxford, 영국, OX3 7LJ
- 모병
- Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals
-
Preston, 영국, PR2 9HT
- 모병
- Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
-
Sheffield, 영국, S10 2SJ
- 모병
- Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
-
Southampton, 영국, SO16 6YD
- 모병
- Southampton General Hospital
-
Taunton, 영국, TA1 5DA
- 모병
- Musgrove Park Hospital-Taunton & Somerset NHS Foundation Trust
-
Wolverhampton, 영국, WV10 0QP
- 모병
- New Cross Hospital
-
York, 영국, YO31 8HE
- 모병
- York Teaching Hospital NHS Foundation Trust - The York Hospital
-
-
-
-
-
Avellino, 이탈리아, 83100
- 모병
- Azienda Ospedaliera San Giuseppe Moscati
-
Aviano, 이탈리아, 33081
- 모병
- Centro di Riferimento Oncologico
-
Bologna, 이탈리아, 40138
- 모병
- Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi
-
Candiolo, 이탈리아, 10060
- 모병
- Istituto Candiolo IRCCS
-
Catania, 이탈리아, 95045
- 모병
- Humanitas Istituto Clinico Catanese S.p.A
-
Cona, 이탈리아, 44124
- 모병
- Azienda Ospedaliero - Universitaria di Ferrara
-
Cremona, 이탈리아, 26100
- 모병
- Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)
-
Lucca, 이탈리아, 55100
- 모병
- Ospedale San Luca
-
Meldola, 이탈리아, 47014
- 모병
- IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST)
-
Milan, 이탈리아, 20132
- 모병
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
-
Milan, 이탈리아, 20133
- 모병
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
Naples, 이탈리아, 80131
- 모병
- UOC Oncoematologia AOU Luigi Vanvitelli
-
Peschiera del Garda, 이탈리아, 37019
- 모병
- Casa Di Cura Polispecialistica Dott Pederzoli
-
Roma, 이탈리아, 00128
- 모병
- Fondazione Policlinico Universitario Campus Bio-Medico
-
Roma, 이탈리아, 00144
- 모병
- Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)
-
Rome, 이탈리아, 00186
- 모병
- Fondazione Ospedale Isola Tiberina - Gemelli Isola
-
Siena, 이탈리아, 53100
- 모병
- Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
-
-
-
-
-
Ageo, 일본, 362-8588
- 모병
- Ageo Central General Hospital
-
Akashi, 일본, 673-8558
- 모병
- Hyogo Cancer Center
-
Aomori, 일본, 030-8553
- 모병
- Aomori Prefectural Central Hospital
-
Bunkyō City, 일본, 113-8677
- 모병
- Tokyo Metropolitan Komagome Hospital
-
Chūōku, 일본, 431-3192
- 모병
- Hamamatsu University Hospital
-
Funabashi, 일본, 273-8588
- 모병
- Funabashi Municipal Medical Center
-
Himeji, 일본, 670-8520
- 모병
- National Hospital Organization Himeji Medical Center
-
Hiroshima, 일본, 734-8551
- 모병
- Hiroshima University Hospital
-
Hiroshima, 일본, 734-8530
- 모병
- Hiroshima Prefectural Hospital
-
Iizuka, 일본, 820-8505
- 모병
- Aso Iizuka Hospital
-
Iwakuni, 일본, 740-8510
- 모병
- National Hospital Organization Iwakuni Clinical Center
-
Kanagawa, 일본, 247-8533
- 모병
- Shonan Kamakura General Hospital
-
Kanazawa, 일본, 920-8530
- 모병
- Ishikawa Prefectural Central Hospital
-
Kumamoto, 일본, 861-4193
- 모병
- Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
-
Kurashiki, 일본, 710-8602
- 모병
- Kurashiki Central Hospital
-
Kurume, 일본, 830-0011
- 모병
- Kurume University Hospital
-
Matsusaka, 일본, 515-8544
- 모병
- Matsusaka Municipal Hospital
-
Matsuyama, 일본, 791-0280
- 모병
- National Hospital Organization Shikoku Cancer Center
-
Meguro City, 일본, 152-8902
- 모병
- National Hospital Organization Tokyo Medical Center
-
Mibu, 일본, 321-0293
- 모병
- Dokkyo Medical University Hospital
-
Morioka, 일본, 028-3695
- 모병
- Iwate Medical University Hospital
-
Nagaizumi-chō, 일본, 411-8777
- 모병
- Shizuoka Cancer Center
-
Nagasaki, 일본, 852-8501
- 모병
- Nagasaki University Hospital
-
Nagoya, 일본, 466-8560
- 모병
- Nagoya University Hospital
-
Nagoya, 일본, 460-0001
- 모병
- National Hospital Organization Nagoya Medical Center
-
Nagoya, 일본, 457-8510
- 모병
- Japan Community Healthcare Organization Chukyo Hospital
-
Niigata, 일본, 951-8566
- 모병
- Niigata Cancer Center Hospital
-
Nishinomiya, 일본, 663-8501
- 모병
- Hyogo Medical University Hospital
-
Osaka, 일본, 541-8567
- 모병
- Osaka Prefectural Hospital Organization Osaka International Cancer Institute
-
Saitama, 일본, 362-0806
- 모병
- Saitama Prefectural Cancer Center
-
Sakai, 일본, 591-8555
- 모병
- NHO Kinki Chuo Chest Medical Center
-
Sapporo, 일본, 006-8555
- 모병
- Teine Keijinkai Hospital
-
Sapporo, 일본, 060-0063
- 모병
- Sapporo Minamisanjo Hospital
-
Sendai, 일본, 981-0914
- 모병
- Sendai Kousei Hospital
-
Shibukawa, 일본, 377-0280
- 모병
- Shibukawa Medical Center
-
Toyama, 일본, 930-0194
- 모병
- Toyama University Hospital
-
Wakayama, 일본, 641-8510
- 모병
- Wakayama Medical University Hospital
-
Yokohama, 일본, 221-0855
- 모병
- Yokohama Municipal Citizen's Hospital
-
-
-
-
-
Baoding, 중국, 071000
- 모병
- Affiliated Hospital of Hebei University
-
Beijing, 중국, 100730
- 모병
- Peking Union Medical College Hospital
-
Beijing, 중국, 100730
- 모병
- Beijing Hospital
-
Beijing, 중국, 101149
- 모병
- Beijing Chest Hospital,Capital Medical University
-
Beijing, 중국, 100050
- 모병
- Beijing Friendship Hospital, Capital Medical University
-
Bengbu, 중국, 233004
- 모병
- The First Affiliated Hospital Of Bengbu Medical College
-
Changchun, 중국, 130000
- 모병
- Jilin Cancer Hospital
-
Changsha, 중국, 410013
- 모병
- Hunan Cancer Hospital
-
Changsha, 중국, 410013
- 모병
- The Third Xiangya Hospital of Central South University
-
Hangzhou, 중국, 310016
- 모병
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Hangzhou, 중국, 310022
- 모병
- Zhejiang Medical University, Zhejiang Cancer Hospital
-
Jiamusi, 중국, 154007
- 모병
- Jiamusi Cancer Hospital
-
Jinan, 중국, 250013
- 모병
- Shandong University - Jinan Central Hospital
-
Kunming, 중국, 650118
- 모병
- Yunnan Provincial Cancer Hospital
-
Nanjing, 중국, 210029
- 모병
- Jiangsu Peoples Hospital
-
Shanghai, 중국, 200433
- 모병
- Shanghai Pulmonary Hospital
-
Shanghai, 중국, 200030
- 모병
- Shanghai Chest Hospital
-
Shanghai, 중국, 200032
- 모병
- Fudan University - Shanghai Cancer Center (FUSCC)
-
Shantou, 중국, 515041
- 모병
- Cancer Hospital of Shantou University Medical College
-
Suzhou, 중국, 215006
- 모병
- The First Affiliated Hospital of Soochow University
-
Wanzhou, 중국, 404000
- 모병
- Chongqing University Three Gorges Hospital
-
Wuhan, 중국, 430071
- 모병
- Zhongnan Hospital of Wuhan University
-
Yangzhou, 중국, 225001
- 모병
- Northern Jiangsu Peoples Hospital (NJPH)
-
Zhejiang, 중국, 317000
- 모병
- Taizhou Hospital of Zhejiang Province
-
-
-
-
-
Antofagasta, 칠레, 1263521
- 모병
- Bradford Hill Norte
-
Lo Barnechea, 칠레, 7691236
- 모병
- Clinica MEDS
-
Recoleta, 칠레, 8420000
- 모병
- Centro De Investigacion Clinica Bradford Hill
-
Santiago, 칠레, 7500713
- 모병
- Orlandi Oncologia
-
Santiago, 칠레, 8331143
- 모병
- Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
-
-
-
-
-
Bangkok, 태국, 10330
- 모병
- Chulalongkorn University
-
Bangkok, 태국, 10300
- 모병
- Faculty of Medicine Vajira Hospital, Navamindradhiraj University
-
Chiang Rai, 태국, 57000
- 모병
- Chiangrai Prachanukroh Hospital
-
Lampang, 태국, 52000
- 모병
- Lampang Cancer Hospital
-
Nakhon Nayok, 태국, 26120
- 모병
- HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University
-
Ratchathewi, 태국, 10400
- 모병
- Rajavithi Hospital
-
-
-
-
-
Adana, 터키 (Türkiye), 1370
- 모병
- Adana City Training and Research Hospital
-
Adana, 터키 (Türkiye), 1120
- 모병
- Baskent Universitesi Tip Fakultesi Adana Hastanesi
-
Ankara, 터키 (Türkiye), 06010
- 모병
- Gulhane Training and Research Hospital
-
Ankara, 터키 (Türkiye), 06680
- 모병
- Liv Hospital Ankara
-
Ankara, 터키 (Türkiye), 06200
- 모병
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
Ankara, 터키 (Türkiye), 06520
- 모병
- Memorial Ankara Hospital
-
Ankara, 터키 (Türkiye), 06800
- 모병
- Ankara Bilkent City Hospital
-
Ankara, 터키 (Türkiye), 06230
- 모병
- Hacettepe University Medicine Faculty
-
Antalya, 터키 (Türkiye), 7985
- 모병
- Akdeniz University Hospital
-
Diyarbakır, 터키 (Türkiye), 21280
- 모병
- Dicle University Faculty of Medicine Hospital
-
Gaziantep, 터키 (Türkiye), 36020
- 모병
- Gaziantep Sanko University Medical Faculty
-
Istanbul, 터키 (Türkiye), 34093
- 모병
- Bezmialem Foundation University Medical Faculty
-
Istanbul, 터키 (Türkiye), 34517
- 모병
- Istinye University Bahcesehir Liv Hospital
-
Istanbul, 터키 (Türkiye), 34718
- 모병
- Yeditepe University Kosuyolu Hospital
-
Izmir, 터키 (Türkiye), 35325
- 모병
- Medical Point Izmir Hospital
-
Kadıköy, 터키 (Türkiye), 34722
- 모병
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Keçiören, 터키 (Türkiye), 06290
- 모병
- Ankara Ataturk Sanatoryum Saglik Uygulama ve Arastirma Merkezi
-
Kocaeli, 터키 (Türkiye), 41380
- 모병
- Kocaeli Universitesi Tip Fakultesi
-
Konya, 터키 (Türkiye), 42080
- 모병
- Necmettin Erbakan University Meram Medical Faculty
-
Küçükçekmece, 터키 (Türkiye), 34295
- 모병
- Medical Park Florya Hospital
-
Ordu, 터키 (Türkiye), 34752
- 모병
- Medicalpark Ordu Hospital
-
Ortahisar, 터키 (Türkiye), 61080
- 모병
- Karadeniz Technical University Faculty of Medicine
-
Sakarya, 터키 (Türkiye), 54290
- 모병
- Sakarya University - Faculty of Medicine
-
Samsun, 터키 (Türkiye), 55280
- 모병
- Ondokuz Mayis University Health Practice and Research Hospital
-
Seyhan, 터키 (Türkiye), 01130
- 빼는
- Acibadem Adana Hospital
-
Seyhan, 터키 (Türkiye), 01170
- 모병
- Medical Park Seyhan Hospital
-
Toroslar, 터키 (Türkiye), 33240
- 모병
- Mersin City Training and Research Hospital
-
Yenimahalle, 터키 (Türkiye), 06560
- 모병
- Gazi University Faculty of Medicine
-
Zeytinburnu, 터키 (Türkiye), 34010
- 모병
- Koc Universitesi Hastanesi (Koc University Hospital)
-
-
-
-
-
Bialystok, 폴란드, 15-540
- 모병
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
Bydgoszcz, 폴란드, 85-048
- 모병
- In- Vivo Sp. z o. o.
-
Gdansk, 폴란드, 80-211
- 모병
- Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
-
Gliwice, 폴란드, 44-102
- 모병
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach
-
Katowice, 폴란드, 40-074
- 모병
- Katowickie Centrum Onkologii
-
Kielce, 폴란드, 25-734
- 모병
- SPZOZ - Swietokrzyskie Centrum Onkologii
-
Koszalin, 폴란드, 75-581
- 모병
- Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
-
Krakow, 폴란드, 31-501
- 모병
- FutureMeds Krakow
-
Lodz, 폴란드, 90-302
- 모병
- Instytut MSF Sp. z o.o.
-
Lodz, 폴란드, 93-513
- 모병
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
Lublin, 폴란드, 20-954
- 모병
- Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
-
Olsztyn, 폴란드, 10-357
- 모병
- Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
-
Poznan, 폴란드, 60-693
- 모병
- NZOZ Medpolonia Sp. Z o.o.
-
Poznan, 폴란드, 60-101
- 모병
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
-
Przemyśl, 폴란드, 37-700
- 모병
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
-
Warsaw, 폴란드, 04-349
- 모병
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
-
Warsaw, 폴란드, 02-781
- 모병
- Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
-
Wroclaw, 폴란드, 53-413
- 모병
- Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
-
-
-
-
-
Angers, 프랑스, 49933
- 모병
- Centre Hospitalier Universitaire d'Angers (CHU Angers)
-
Angers, 프랑스, 49055
- 모병
- Institut de Cancerologie de l'Ouest Paul Papin
-
Bayonne, 프랑스, 64109
- 모병
- Centre Hospitalier de la Cote Basque
-
Bordeaux, 프랑스, 33000
- 모병
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
-
Bordeaux, 프랑스, 33076
- 모병
- Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
-
Bron, 프랑스, 69500
- 모병
- Hospices Civils de Lyon - Hopital Louis Pradel
-
Caen, 프랑스, 14033
- 모병
- CHU Caen Normandie
-
Caen, 프랑스, 14076
- 모병
- Centre Francois Baclesse
-
Clermont-Ferrand, 프랑스, 63003
- 모병
- Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
-
Créteil, 프랑스, 94010
- 모병
- Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
-
La Tronche, 프랑스, 38700
- 모병
- Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon
-
Limoges, 프랑스, 87042
- 모병
- Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
-
Lyon, 프랑스, 69004
- 모병
- Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
-
Marseille, 프랑스, 13009
- 모병
- Institut Paoli-Calmettes
-
Mulhouse, 프랑스, 68100
- 모병
- GHRMSA Hopital Emile Muller
-
Paris, 프랑스, 75013
- 모병
- Groupe Hospitalier Pitie-Salpetriere
-
Paris, 프랑스, 75005
- 모병
- Institut Curie - Centre de Recherche
-
Paris, 프랑스, 75014
- 모병
- CIC Cochin Pasteur, Hopital Cochin
-
Pierre-Bénite, 프랑스, 69310
- 모병
- Hopital Lyon Sud
-
Rennes, 프랑스, 35033
- 모병
- CHU de Rennes, Hopital de Pontchaillou
-
Saint-Herblain, 프랑스, 44805
- 모병
- Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
-
Strasbourg, 프랑스, 67200
- 모병
- Centre Regional Lutte Contre Le Cancer Paul Strauss
-
Suresnes, 프랑스, 92151
- 모병
- Hopital Foch
-
Toulon, 프랑스, 83000
- 모병
- Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
-
Villejuif, 프랑스, 94805
- 모병
- Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
-
-
-
-
-
Budapest, 헝가리, 1145
- 모병
- Budapesti Uzsoki Utcai Korhaz
-
Budapest, 헝가리, 1122
- 모병
- Orszagos Onkologiai Intezet (National Institute of Oncology)
-
Edelény, 헝가리, 3780
- 모병
- Edelenyi Koch Robert Korhaz es Rendelointezet
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Kecskemét, 헝가리, 6000
- 모병
- Bacs- Kiskun Varmegyei Oktatokorhaz Onkoradiologiai Kozpont
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Szolnok, 헝가리, 5000
- 모병
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet
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Adelaide, 호주, 5000
- 모병
- Royal Adelaide Hospital
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Adelaide, 호주, 5000
- 모병
- Cancer Research SA (CRSA)
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Bedford Park, 호주, 5042
- 모병
- Flinders Medical Centre
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Cairns, 호주, 4870
- 모병
- Cairns Hospital
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Dubbo, 호주, 2830
- 모병
- Dubbo Hospital
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Frankston, 호주, 3199
- 모병
- Peninsula & South Eastern Haematology and Oncology Group
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Joondalup, 호주, 6027
- 모병
- Joondalup Health campus
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Kurralta Park, 호주, 5037
- 모병
- Icon Cancer Centre Kurralta Park
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Melbourne, 호주, 3000
- 모병
- Peter MacCallum Cancer Centre
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Melbourne, 호주, 3168
- 모병
- Monash University - Monash Health -Monash Medical Centre
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Orange, 호주, 2800
- 모병
- Central West Cancer Care Centre
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Southport, 호주, 4216
- 모병
- Clinical Trial Center-Tasman Oncology Research Ltd
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St Albans, 호주, 3021
- 모병
- Western Health Sunshine Hospital
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Townsville, 호주, 4812
- 모병
- ICON Cancer Care - Townsville
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Wollongong, 호주, 2500
- 빼는
- Cancer Care Wollongong Pty Limited
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
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Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
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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.
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Participants with significant risk of hemorrhage (per investigator clinical judgment).
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Participants have superior vena cava syndrome or symptoms of spinal cord compression.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Substudy A Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
다른 이름들:
Intravenous infusion |
|
실험적: Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
다른 이름들:
Intravenous infusion |
|
실험적: Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
다른 이름들:
Intravenous infusion |
|
실험적: Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
다른 이름들:
Intravenous infusion |
|
활성 비교기: Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion Intravenous infusion |
|
실험적: Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Paclitaxel
|
Intravenous infusion Intravenous infusion
다른 이름들:
Intravenous infusion |
|
실험적: Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Paclitaxel
|
Intravenous infusion Intravenous infusion
다른 이름들:
Intravenous infusion |
|
실험적: Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + Paclitaxel
|
Intravenous infusion Intravenous infusion
다른 이름들:
Intravenous infusion |
|
실험적: Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Paclitaxel
|
Intravenous infusion Intravenous infusion
다른 이름들:
Intravenous infusion |
|
활성 비교기: Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Paclitaxel
|
Intravenous infusion Intravenous infusion Intravenous infusion |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit
|
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
|
|
Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)
기간: From the first dose of IMP to the 90-day Follow-Up Visit
|
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)
기간: Up to approximately 2 years
|
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
기간: Up to approximately 2 years
|
For substudies A and B. Based on investigator's tumor assessment according to RECIST v1.1. |
Up to approximately 2 years
|
|
Phase 3 - Progression free survival (PFS) assessed by BICR
기간: Up to approximately 5 years
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase 3 - Overall survival (OS)
기간: Up to approximately 5 years
|
For substudies A and B. OS defined as the time from randomization to death from any cause |
Up to approximately 5 years
|
|
Phase 2 - Duration of Response (DOR)
기간: Up to approximately 2 years
|
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
|
|
Phase 2 - Disease Control Rate (DCR)
기간: Up to approximately 2 years
|
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
기간: Up to approximately 5 years
|
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
|
|
Phase 3 - ORR
기간: Up to approximately 2 years
|
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
|
|
Phase 3 - PFS rate as assessed by BICR
기간: At 6, 12, and 18 months
|
For substudies A and B. |
At 6, 12, and 18 months
|
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Phase 3 - PFS rate as assessed by investigator
기간: At 6, 12, and 18 months
|
For substudies A and B. |
At 6, 12, and 18 months
|
|
Phase 3 - OS rate
기간: At 6, 12, 18, 24 months
|
For substudies A and B. |
At 6, 12, 18, 24 months
|
|
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)
기간: Up to approximately 5 years
|
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
|
|
Phase 3 - Change from baseline in EORTC QLQ-C30 physical functioning
기간: Up to approximately 5 years
|
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
|
|
Phase 3 - Change from baseline in coughing scale of the EORTC lung cancer-specific quality-of-life questionnaire (QLQ-LC29)
기간: 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
|
|
Phase 3 - Change from baseline in shortness of breath scale of the EORTC QLQ-LC29
기간: 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
|
|
Phase 3 - Change from baseline in coughed up blood item of the EORTC QLQ-LC29
기간: 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
|
|
Phase 3 - Change from baseline in fatigue domain score scale of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
기간: Up to approximately 5 years
|
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
|
|
Phase 3 - Change from baseline in pain domain score of the NSCLC-SAQ
기간: Up to approximately 5 years
|
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
|
|
Phase 3 - Change from baseline in Functional Assessment of Cancer Therapy-General item 5 overall bother item (FACT-GP5)
기간: Up to approximately 5 years
|
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
|
|
Phase 3 - Occurrence of TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship
기간: From the first dose of IMP to the 90-day Follow-Up Visit
|
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
|
|
Phase 3 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)
기간: From the first dose of IMP to the 90-day Follow-Up Visit
|
For substudies A and B. |
From the first dose of IMP to the 90-day Follow-Up Visit
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
- 부위별 신생물
- 신생물
- 호흡기 질환
- 폐 질환
- 호흡기 신생물
- 흉부 신생물
- 기관지 암종
- 기관지 신생물
- 폐 신생물
- 암종, 비소세포폐
- 아미노산, 펩티드 및 단백질
- 유기 화학 물질
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 탄화수소
- 사이클로 파라핀
- 탄화수소, alicyclic
- 탄화수소, 순환
- 테르펜
- 조정 복합체
- 구아닌
- Hypoxanthines
- 푸리 논
- 퓨린
- 글루타메이트
- 아미노산, 산성
- 아미노산
- 아미노산, 디카 르 복실
- 박습니다
- 사이클로 데카네
- Diterpenes
- 페메트렉시드
- 카르보플라틴
- 파클리탁셀
- 펨브 롤리 주맙
기타 연구 ID 번호
- BNT327-06
- 2024-515764-31-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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