Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
第一選択の非小細胞肺がんにおける化学療法および他の治験薬と併用したBNT327の世界的試験のための第II/III相、マルチサイト、ランダム化マスタープロトコル
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：BioNTech clinical trials patient information
- 電話番号：+49 6131 9084
- メール：patients@biontech.de
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35223
- 募集
- Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology
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-
Alaska
-
Anchorage、Alaska、アメリカ、99508
- 募集
- Alaska Oncology and Hematology, LLC
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-
California
-
Concord、California、アメリカ、94520
- 募集
- John Muir Clinical Research Center
-
La Jolla、California、アメリカ、92093
- 募集
- University Of California - San Diego Moores Cancer Center
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-
Colorado
-
Vail、Colorado、アメリカ、81657
- 募集
- Vail Health
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-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20007
- 募集
- MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
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Washington D.C.、District of Columbia、アメリカ、20010
- 募集
- MEDSTAR Washington Hospital Center (MedStar Health Research Institute)
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-
Florida
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Clermont、Florida、アメリカ、34711
- 募集
- Clermont Oncology Center
-
Coral Springs、Florida、アメリカ、33065
- 募集
- SSAK Partners, LLC.
-
Jacksonville、Florida、アメリカ、32207
- 募集
- Baptist Medical Center Jacksonville
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Orange City、Florida、アメリカ、32763
- 募集
- Mid Florida Cancer Centers
-
Stuart、Florida、アメリカ、34994
- 募集
- Cleveland Clinic Florida - Martin North Hospital
-
Tampa、Florida、アメリカ、33612
- 募集
- H. Lee Moffit Cancer center and research institute
-
Weston、Florida、アメリカ、33331
- 募集
- Cleveland Clinic Weston Hospital
-
-
Georgia
-
Marietta、Georgia、アメリカ、30060
- 募集
- Northwest Georgia Oncology Centers, P.C.
-
-
Indiana
-
Fort Wayne、Indiana、アメリカ、46845
- 募集
- Fort Wayne Medical Oncology and Hematology, Inc.
-
Indianapolis、Indiana、アメリカ、46202
- 募集
- Indiana University Health University Hospital
-
-
Iowa
-
Cedar Rapids、Iowa、アメリカ、52401-2112
- 募集
- Physicians Clinic of Iowa
-
Iowa City、Iowa、アメリカ、52242
- 募集
- Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
-
-
Kentucky
-
Elizabethtown、Kentucky、アメリカ、42701
- 募集
- Baptist Health Hardin
-
Lexington、Kentucky、アメリカ、40503
- 募集
- Baptist Health Lexington
-
Lexington、Kentucky、アメリカ、40536
- 募集
- University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center)
-
-
Maryland
-
Frederick、Maryland、アメリカ、21704
- 募集
- Frederick Health Hospital- James M Stockman Cancer Institute
-
-
Missouri
-
Columbia、Missouri、アメリカ、65201
- 募集
- Missouri Cancer Associates
-
Fenton、Missouri、アメリカ、63026
- 引きこもった
- SSM Health Cancer Care - St. Clare
-
-
Nebraska
-
Hastings、Nebraska、アメリカ、68901-4470
- 募集
- Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)
-
-
New Jersey
-
East Brunswick、New Jersey、アメリカ、08816
- 募集
- Astera Cancer Care
-
Florham Park、New Jersey、アメリカ、07932
- 募集
- Summit Medical Group PA
-
Paramus、New Jersey、アメリカ、07652
- 募集
- The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
-
-
New York
-
Poughkeepsie、New York、アメリカ、12601
- 募集
- Nuvance Health
-
Stony Brook、New York、アメリカ、11794-9446
- 募集
- Suny-Stony Brook University Cancer Center
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White Plains、New York、アメリカ、10601
- 募集
- White Plains Hospital
-
-
North Carolina
-
Hendersonville、North Carolina、アメリカ、28792
- 募集
- Fletcher Hospital, Inc. dba AdventHealth Hendersonville
-
-
Ohio
-
Canton、Ohio、アメリカ、44718
- 募集
- Gabrail Cancer Center Research
-
Cincinnati、Ohio、アメリカ、45219
- 募集
- University of Cincinnati Medical Center
-
Cincinnati、Ohio、アメリカ、45219
- 募集
- The Christ Hospital Cancer Center
-
Cleveland、Ohio、アメリカ、44195-0001
- 募集
- Cleveland Clinic
-
Cleveland、Ohio、アメリカ、44111
- 募集
- The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion
-
Dayton、Ohio、アメリカ、45415
- 募集
- Dayton Physicians Network
-
Kettering、Ohio、アメリカ、45429
- 募集
- Kettering Medical Center
-
Mayfield Heights、Ohio、アメリカ、44124
- 募集
- Cleveland Clinic - Hillcrest Hospital
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73109
- 募集
- INTEGRIS Cancer Institute of Oklahoma
-
-
Tennessee
-
Knoxville、Tennessee、アメリカ、37920
- 募集
- University of Tennessee Medical Center
-
Memphis、Tennessee、アメリカ、38120
- 引きこもった
- Baptist Cancer Center
-
Nashville、Tennessee、アメリカ、37232
- 募集
- Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center
-
-
Texas
-
Houston、Texas、アメリカ、77090
- 積極的、募集していない
- Millennium Research and Clinical Development, LLC
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84106
- 募集
- Utah Cancer Specialists
-
-
Virginia
-
Fairfax、Virginia、アメリカ、22031
- 募集
- Virginia Cancer Specialists
-
Fairfax、Virginia、アメリカ、22031
- 募集
- Inova Schar Cancer
-
Richmond、Virginia、アメリカ、23229
- 募集
- Virginia Cancer Institute
-
Richmond、Virginia、アメリカ、23298
- 募集
- VCU Massey Cancer Center
-
Winchester、Virginia、アメリカ、22601
- 募集
- Shenandoah Oncology
-
-
West Virginia
-
Morgantown、West Virginia、アメリカ、26506-8110
- 募集
- West Virginia University Hospitals - Mary Babb Randolph Cancer Center
-
-
Wisconsin
-
La Crosse、Wisconsin、アメリカ、54601-5467
- 募集
- Gundersen Lutheran Medical Center
-
-
-
-
-
Buenos Aires、アルゼンチン、C1199
- 募集
- Hospital Italiano de Buenos Aires
-
Buenos Aires、アルゼンチン、C1113
- 募集
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
-
Buenos Aires、アルゼンチン、C1122
- 募集
- Instituto Argentino de Diagnóstico y Tratamiento (IADT)
-
Córdoba、アルゼンチン、X5000JHQ
- 募集
- Sanatorio Allende
-
La Rioja、アルゼンチン、F5300
- 募集
- Centro Oncologico Riojano Integral (CORI)
-
San Miguel de Tucumán、アルゼンチン、4000
- 募集
- Exelsus SRL
-
Viedma、アルゼンチン、R8500
- 募集
- Centro de Investigaciones Clinicas. Clinica Viedma S. A
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-
-
-
-
Basildon、イギリス、SS16 5NL
- 募集
- Basildon University Hospital - Basildon And Thurrock University Hospitals Nhs Foundation Trust
-
Bath、イギリス、BA1 3NG
- 募集
- Royal United Hospital, Bath - Royal United Hospitals Bath NHS Foundation Trust
-
Brighton、イギリス、BN2 5BE
- 募集
- Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
-
Cardiff、イギリス、CF14 2TL
- 募集
- Velindre NHS Trust, Velindre Cancer Centre
-
Chelsea、イギリス、SW3 6JJ
- 募集
- Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
-
Cottingham、イギリス、HU16 5JQ
- 募集
- Hull University Teaching Hospitals NHS Trust
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Glasgow、イギリス、G12 0YN
- 募集
- Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
-
Liverpool、イギリス、L7 8YA
- 募集
- Clatterbridge Cancer Centre
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London、イギリス、NW2 1PG
- 募集
- University College Hospital
-
London、イギリス、SM2 5PT
- 募集
- Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
-
Manchester、イギリス、M20 4BX
- 募集
- The Christie NHS Foundation Trust
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Norwich、イギリス、NR4 7UY
- 募集
- Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
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Oxford、イギリス、OX3 7LJ
- 募集
- Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals
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Preston、イギリス、PR2 9HT
- 募集
- Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
-
Sheffield、イギリス、S10 2SJ
- 募集
- Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
-
Southampton、イギリス、SO16 6YD
- 募集
- Southampton General Hospital
-
Taunton、イギリス、TA1 5DA
- 募集
- Musgrove Park Hospital-Taunton & Somerset NHS Foundation Trust
-
Wolverhampton、イギリス、WV10 0QP
- 募集
- New Cross Hospital
-
York、イギリス、YO31 8HE
- 募集
- York Teaching Hospital NHS Foundation Trust - The York Hospital
-
-
-
-
-
Avellino、イタリア、83100
- 募集
- Azienda Ospedaliera San Giuseppe Moscati
-
Aviano、イタリア、33081
- 募集
- Centro di Riferimento Oncologico
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Bologna、イタリア、40138
- 募集
- Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi
-
Candiolo、イタリア、10060
- 募集
- Istituto Candiolo IRCCS
-
Catania、イタリア、95045
- 募集
- Humanitas Istituto Clinico Catanese S.p.A
-
Cona、イタリア、44124
- 募集
- Azienda Ospedaliero - Universitaria di Ferrara
-
Cremona、イタリア、26100
- 募集
- Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)
-
Lucca、イタリア、55100
- 募集
- Ospedale San Luca
-
Meldola、イタリア、47014
- 募集
- IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST)
-
Milan、イタリア、20132
- 募集
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
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Milan、イタリア、20133
- 募集
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Naples、イタリア、80131
- 募集
- UOC Oncoematologia AOU Luigi Vanvitelli
-
Peschiera del Garda、イタリア、37019
- 募集
- Casa Di Cura Polispecialistica Dott Pederzoli
-
Roma、イタリア、00128
- 募集
- Fondazione Policlinico Universitario Campus Bio-Medico
-
Roma、イタリア、00144
- 募集
- Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)
-
Rome、イタリア、00186
- 募集
- Fondazione Ospedale Isola Tiberina - Gemelli Isola
-
Siena、イタリア、53100
- 募集
- Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
-
-
-
-
-
Adelaide、オーストラリア、5000
- 募集
- Royal Adelaide Hospital
-
Adelaide、オーストラリア、5000
- 募集
- Cancer Research SA (CRSA)
-
Bedford Park、オーストラリア、5042
- 募集
- Flinders Medical Centre
-
Cairns、オーストラリア、4870
- 募集
- Cairns Hospital
-
Dubbo、オーストラリア、2830
- 募集
- Dubbo Hospital
-
Frankston、オーストラリア、3199
- 募集
- Peninsula & South Eastern Haematology and Oncology Group
-
Joondalup、オーストラリア、6027
- 募集
- Joondalup Health campus
-
Kurralta Park、オーストラリア、5037
- 募集
- Icon Cancer Centre Kurralta Park
-
Melbourne、オーストラリア、3000
- 募集
- Peter MacCallum Cancer Centre
-
Melbourne、オーストラリア、3168
- 募集
- Monash University - Monash Health -Monash Medical Centre
-
Orange、オーストラリア、2800
- 募集
- Central West Cancer Care Centre
-
Southport、オーストラリア、4216
- 募集
- Clinical Trial Center-Tasman Oncology Research Ltd
-
St Albans、オーストラリア、3021
- 募集
- Western Health Sunshine Hospital
-
Townsville、オーストラリア、4812
- 募集
- ICON Cancer Care - Townsville
-
Wollongong、オーストラリア、2500
- 引きこもった
- Cancer Care Wollongong Pty Limited
-
-
-
-
-
Batumi、グルジア、6000
- 募集
- High Technology Hospital Medcenter LTD
-
Tbilisi、グルジア、0144
- 募集
- LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
-
Tbilisi、グルジア、0112
- 募集
- LLC Todua Clinic
-
Tbilisi、グルジア、0162
- 募集
- New Hospitals
-
Tbilisi、グルジア、0179
- 募集
- Cancer Research Centre
-
-
-
-
-
Baden、スイス、5404
- 募集
- Kantonspital Baden
-
Lausanne、スイス、1011
- 募集
- Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) - Centre de transplantation d'organes (CTO)
-
Münsterlingen、スイス、8596
- 募集
- Kantonsspital Münsterlingen
-
-
-
-
-
A Coruña、スペイン、15006
- 募集
- CHUAC Hospital Teresa Herrera
-
Badajoz、スペイン、6006
- 募集
- Hospital Universitario de Badajoz
-
Badalona、スペイン、08916
- 募集
- Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
-
Barcelona、スペイン、08035
- 募集
- Hospital Universitario Vall d'Hebron
-
Barcelona、スペイン、8908
- 募集
- Instituto Catalan de Oncologia - Hospital Duran i Reynals
-
Castellon、スペイン、12002
- 募集
- Consorcio Hospitalario Provincial de Castellón
-
Las Palmas de Gran Canaria、スペイン、35016
- 募集
- Complejo Hospitalario Universitario Insular Materno Infantil
-
León、スペイン、24080
- 募集
- Hospital Universitario De Leon
-
Lleida、スペイン、25198
- 募集
- Hospital Universitari de Lleida Arnau de Villanova
-
Madrid、スペイン、28041
- 募集
- Hospital Universitario 12 de Octubre
-
Madrid、スペイン、28007
- 募集
- Hospital General Universitario Gregorio Maranon (HGUGM)
-
Madrid、スペイン、28033
- 募集
- Clinica MD Anderson International
-
Madrid、スペイン、28040
- 募集
- Hospital Universitario Fundacion Jimenez Diaz
-
Majadahonda、スペイン、28222
- 募集
- Hospital Universitario Puerta de Hierro de Majadahonda
-
Santa Cruz de Tenerife、スペイン、38320
- 募集
- Hospital Universitario de Canarias
-
Seville、スペイン、41013
- 募集
- Hospital Universitario Virgen del Rocio
-
Seville、スペイン、41014
- 募集
- Hospital Universitario Nuestra Senora De Valme
-
Valencia、スペイン、46026
- 募集
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
-
Valencia、スペイン、46009
- 募集
- Fundacion Instituto Valenciano de Oncologia
-
Valencia、スペイン、46014
- 募集
- Hospital General Universitario De Valencia
-
Vigo、スペイン、36312
- 募集
- Hospital Alvaro Cunqueiro
-
Zaragoza、スペイン、50009
- 募集
- Hospital Universitario Miguel Servet de Zaragoza
-
-
-
-
-
Bangkok、タイ、10330
- 募集
- Chulalongkorn University
-
Bangkok、タイ、10300
- 募集
- Faculty of Medicine Vajira Hospital, Navamindradhiraj University
-
Chiang Rai、タイ、57000
- 募集
- Chiangrai Prachanukroh Hospital
-
Lampang、タイ、52000
- 募集
- Lampang Cancer Hospital
-
Nakhon Nayok、タイ、26120
- 募集
- HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University
-
Ratchathewi、タイ、10400
- 募集
- Rajavithi Hospital
-
-
-
-
-
Antofagasta、チリ、1263521
- 募集
- Bradford Hill Norte
-
Lo Barnechea、チリ、7691236
- 募集
- Clinica MEDS
-
Recoleta、チリ、8420000
- 募集
- Centro De Investigacion Clinica Bradford Hill
-
Santiago、チリ、7500713
- 募集
- Orlandi Oncologia
-
Santiago、チリ、8331143
- 募集
- Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
-
-
-
-
-
Adana、トルコ（Türkiye）、1370
- 募集
- Adana City Training and Research Hospital
-
Adana、トルコ（Türkiye）、1120
- 募集
- Baskent Universitesi Tip Fakultesi Adana Hastanesi
-
Ankara、トルコ（Türkiye）、06010
- 募集
- Gulhane Training and Research Hospital
-
Ankara、トルコ（Türkiye）、06680
- 募集
- Liv Hospital Ankara
-
Ankara、トルコ（Türkiye）、06200
- 募集
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
Ankara、トルコ（Türkiye）、06520
- 募集
- Memorial Ankara Hospital
-
Ankara、トルコ（Türkiye）、06800
- 募集
- Ankara Bilkent City Hospital
-
Ankara、トルコ（Türkiye）、06230
- 募集
- Hacettepe University Medicine Faculty
-
Antalya、トルコ（Türkiye）、7985
- 募集
- Akdeniz University Hospital
-
Diyarbakır、トルコ（Türkiye）、21280
- 募集
- Dicle University Faculty of Medicine Hospital
-
Gaziantep、トルコ（Türkiye）、36020
- 募集
- Gaziantep Sanko University Medical Faculty
-
Istanbul、トルコ（Türkiye）、34093
- 募集
- Bezmialem Foundation University Medical Faculty
-
Istanbul、トルコ（Türkiye）、34517
- 募集
- Istinye University Bahcesehir Liv Hospital
-
Istanbul、トルコ（Türkiye）、34718
- 募集
- Yeditepe University Kosuyolu Hospital
-
Izmir、トルコ（Türkiye）、35325
- 募集
- Medical Point Izmir Hospital
-
Kadıköy、トルコ（Türkiye）、34722
- 募集
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Keçiören、トルコ（Türkiye）、06290
- 募集
- Ankara Ataturk Sanatoryum Saglik Uygulama ve Arastirma Merkezi
-
Kocaeli、トルコ（Türkiye）、41380
- 募集
- Kocaeli Universitesi Tip Fakultesi
-
Konya、トルコ（Türkiye）、42080
- 募集
- Necmettin Erbakan University Meram Medical Faculty
-
Küçükçekmece、トルコ（Türkiye）、34295
- 募集
- Medical Park Florya Hospital
-
Ordu、トルコ（Türkiye）、34752
- 募集
- Medicalpark Ordu Hospital
-
Ortahisar、トルコ（Türkiye）、61080
- 募集
- Karadeniz Technical University Faculty of Medicine
-
Sakarya、トルコ（Türkiye）、54290
- 募集
- Sakarya University - Faculty of Medicine
-
Samsun、トルコ（Türkiye）、55280
- 募集
- Ondokuz Mayis University Health Practice and Research Hospital
-
Seyhan、トルコ（Türkiye）、01130
- 引きこもった
- Acibadem Adana Hospital
-
Seyhan、トルコ（Türkiye）、01170
- 募集
- Medical Park Seyhan Hospital
-
Toroslar、トルコ（Türkiye）、33240
- 募集
- Mersin City Training and Research Hospital
-
Yenimahalle、トルコ（Türkiye）、06560
- 募集
- Gazi University Faculty of Medicine
-
Zeytinburnu、トルコ（Türkiye）、34010
- 募集
- Koc Universitesi Hastanesi (Koc University Hospital)
-
-
-
-
-
Aachen、ドイツ、52074
- 募集
- Uniklinik RWTH Aachen Medizinische Klinik IV
-
Berlin、ドイツ、13125
- 募集
- Evangelische Lungenklinik Berlin
-
Chemnitz、ドイツ、09116
- 募集
- Klinikum Chemnitz gGmbH
-
Düsseldorf、ドイツ、40489
- 募集
- Kaiserwerther Diakonie - Florence Nightingale Krankenhaus
-
Erlangen、ドイツ、91054
- 募集
- Universitätsklinikum Erlangen
-
Esslingen am Neckar、ドイツ、73730
- 募集
- Klinikum Esslingen GmbH
-
Gauting、ドイツ、82131
- 募集
- Asklepios Fachkliniken Muenchen Gauting
-
Gera、ドイツ、07548
- 募集
- SRH Wald-Kliniken Gera GmbH
-
Hamburg、ドイツ、21075
- 募集
- Asklepios Klinik Harburg
-
Heidelberg、ドイツ、69126
- 募集
- Thoraxklinik-Heidelberg Ggmbh
-
Immenhausen、ドイツ、34376
- 募集
- Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen
-
Mainz、ドイツ、55131
- 募集
- University Medical Center of Johannes Gutenberg-University Mainz
-
Moers、ドイツ、47441
- 募集
- Krankenhaus Bethanien Moers
-
München、ドイツ、81925
- 募集
- Staedtisches Klinikum Muenchen Bogenhausen
-
Neuss、ドイツ、41462
- 募集
- MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
-
Remscheid、ドイツ、42853
- 募集
- Onkologische Tagesklinik Remscheid
-
Wesseling、ドイツ、50389
- 募集
- Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
-
Wuppertal、ドイツ、42883
- 募集
- Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
-
-
-
-
-
Budapest、ハンガリー、1145
- 募集
- Budapesti Uzsoki Utcai Korhaz
-
Budapest、ハンガリー、1122
- 募集
- Orszagos Onkologiai Intezet (National Institute of Oncology)
-
Edelény、ハンガリー、3780
- 募集
- Edelenyi Koch Robert Korhaz es Rendelointezet
-
Kecskemét、ハンガリー、6000
- 募集
- Bacs- Kiskun Varmegyei Oktatokorhaz Onkoradiologiai Kozpont
-
Szolnok、ハンガリー、5000
- 募集
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet
-
-
-
-
-
Angers、フランス、49933
- 募集
- Centre Hospitalier Universitaire d'Angers (CHU Angers)
-
Angers、フランス、49055
- 募集
- Institut de Cancerologie de l'Ouest Paul Papin
-
Bayonne、フランス、64109
- 募集
- Centre Hospitalier de la Cote Basque
-
Bordeaux、フランス、33000
- 募集
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
-
Bordeaux、フランス、33076
- 募集
- Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
-
Bron、フランス、69500
- 募集
- Hospices Civils de Lyon - Hopital Louis Pradel
-
Caen、フランス、14033
- 募集
- CHU Caen Normandie
-
Caen、フランス、14076
- 募集
- Centre Francois Baclesse
-
Clermont-Ferrand、フランス、63003
- 募集
- Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
-
Créteil、フランス、94010
- 募集
- Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
-
La Tronche、フランス、38700
- 募集
- Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon
-
Limoges、フランス、87042
- 募集
- Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
-
Lyon、フランス、69004
- 募集
- Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
-
Marseille、フランス、13009
- 募集
- Institut Paoli-Calmettes
-
Mulhouse、フランス、68100
- 募集
- GHRMSA Hopital Emile Muller
-
Paris、フランス、75013
- 募集
- Groupe Hospitalier Pitie-Salpetriere
-
Paris、フランス、75005
- 募集
- Institut Curie - Centre de Recherche
-
Paris、フランス、75014
- 募集
- CIC Cochin Pasteur, Hopital Cochin
-
Pierre-Bénite、フランス、69310
- 募集
- Hopital Lyon Sud
-
Rennes、フランス、35033
- 募集
- CHU de Rennes, Hopital de Pontchaillou
-
Saint-Herblain、フランス、44805
- 募集
- Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
-
Strasbourg、フランス、67200
- 募集
- Centre Regional Lutte Contre Le Cancer Paul Strauss
-
Suresnes、フランス、92151
- 募集
- Hopital Foch
-
Toulon、フランス、83000
- 募集
- Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
-
Villejuif、フランス、94805
- 募集
- Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
-
-
-
-
-
Barretos、ブラジル、14784-400
- 募集
- Fundacao Pio XII - Hospital de Cancer de Barretos
-
Curitiba、ブラジル、81480-580
- 募集
- CIONC - Centro Integrado de Oncologia de Curitiba
-
Fortaleza、ブラジル、60336-232
- 募集
- Centro Regional Integrado de Oncologia
-
Ijuí、ブラジル、98700-000
- 募集
- Oncosite Centro De Pesquisa Clinica Em Oncologia
-
Itajaí、ブラジル、88301-220
- 募集
- Clinica de Neoplasias Litoral LTDA / Catarina Pesquisa Clínica
-
Lajeado、ブラジル、95900-000
- 募集
- Bruno Born Hospital
-
Londrina、ブラジル、86015-520
- 募集
- Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL
-
Natal、ブラジル、59062-000
- 募集
- Liga Norte Riograndense Contra o Cancer - CECAN
-
Passo Fundo、ブラジル、99010-080
- 募集
- Hospital Sao Vicente de Paulo (HSVP)
-
Porto Alegre、ブラジル、91350-200
- 募集
- Hospital Nossa Senhora da Conceicao
-
Porto Alegre、ブラジル、90020-090
- 募集
- Irmandade Santa Casa de Misericordia de Porto Alegre
-
Porto Alegre、ブラジル、90110-270
- 募集
- Centro Gaucho Integrado de Oncologia e Hematologia - Hospital Mae de Deus/AESC
-
Porto Alegre、ブラジル、90610-000
- 募集
- Centro Clinico do Hospital Sao Lucas da PUCRS
-
Rio de Janeiro、ブラジル、22250-905
- 募集
- Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)
-
Salvador、ブラジル、40170-110
- 募集
- OC Oncoclínicas - Núcleo de Oncologia da Bahia-Ondina (OC Oncoclinicas-NOB Ondina)
-
São Caetano do Sul、ブラジル、09541-270
- 募集
- CEON Pesquisas
-
São José do Vale do Rio Preto、ブラジル、15090-000
- 募集
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do Rio Preto
-
São Paulo、ブラジル、01227-959
- 募集
- IEP São Lucas
-
São Paulo、ブラジル、01227-200
- 募集
- IEP Sao Lucas Instituto de Ensino e Pesquisa Sao Lucas
-
Vitória、ブラジル、29043-260
- 募集
- Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita
-
-
-
-
-
Plovdiv、ブルガリア、4000
- 募集
- Complex Oncology Center
-
Rousse、ブルガリア、7000
- 募集
- Complex Oncological Center Ruse Ltd
-
Sofia、ブルガリア、1527
- 募集
- University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
-
Sofia、ブルガリア、1373
- 募集
- MHAT for Womens Health - Nadezhda OOD
-
-
-
-
-
Ghent、ベルギー、9000
- 募集
- Universitair Ziekenhuis Gent (Uz Gent)
-
Leuven、ベルギー、3000
- 募集
- Universitair Ziekenhuis Leuven
-
Mons、ベルギー、7000
- 募集
- CHU HELORA, Hopital de Mons - Site Kennedy
-
Roeselare、ベルギー、8800
- 募集
- Algemeen Ziekenhuis Delta
-
Sint-Niklaas、ベルギー、9100
- 募集
- VITAZ
-
Woluwe-Saint-Lambert、ベルギー、1200
- 募集
- Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
-
-
-
-
-
Bialystok、ポーランド、15-540
- 募集
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
Bydgoszcz、ポーランド、85-048
- 募集
- In- Vivo Sp. z o. o.
-
Gdansk、ポーランド、80-211
- 募集
- Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
-
Gliwice、ポーランド、44-102
- 募集
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach
-
Katowice、ポーランド、40-074
- 募集
- Katowickie Centrum Onkologii
-
Kielce、ポーランド、25-734
- 募集
- SPZOZ - Swietokrzyskie Centrum Onkologii
-
Koszalin、ポーランド、75-581
- 募集
- Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
-
Krakow、ポーランド、31-501
- 募集
- FutureMeds Krakow
-
Lodz、ポーランド、90-302
- 募集
- Instytut MSF Sp. z o.o.
-
Lodz、ポーランド、93-513
- 募集
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
Lublin、ポーランド、20-954
- 募集
- Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
-
Olsztyn、ポーランド、10-357
- 募集
- Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
-
Poznan、ポーランド、60-693
- 募集
- NZOZ Medpolonia Sp. Z o.o.
-
Poznan、ポーランド、60-101
- 募集
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
-
Przemyśl、ポーランド、37-700
- 募集
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
-
Warsaw、ポーランド、04-349
- 募集
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
-
Warsaw、ポーランド、02-781
- 募集
- Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
-
Wroclaw、ポーランド、53-413
- 募集
- Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
-
-
-
-
-
Bucharest、ルーマニア、030171
- 募集
- Coltea Clinical Hospital
-
Bucharest、ルーマニア、031424
- 募集
- SC Gral Medical SRL
-
Bucharest、ルーマニア、22328
- 募集
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB)
-
Cluj-Napoca、ルーマニア、400015
- 募集
- Cardiomed
-
Cluj-Napoca、ルーマニア、400641
- 募集
- S.C. Medisprof S.R.L, Oncologie medicala
-
Cluj-Napoca、ルーマニア、407280
- 募集
- Radiotherapy Center Cluj
-
Cluj-Napoca、ルーマニア、400015
- 募集
- Oncology Institute Cluj-Napoca
-
Craiova、ルーマニア、200094
- 募集
- Onco Clinic Consult SA
-
Craiova、ルーマニア、200542
- 募集
- Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)
-
Iași、ルーマニア、700106
- 募集
- Centrul de Oncologie Euroclinic srl
-
Iași、ルーマニア、700483
- 募集
- Institutul Regional De Oncologie Iasi
-
Ovidiu、ルーマニア、905900
- 引きこもった
- Ovidius Clinical Hospital
-
Ploieşti、ルーマニア、100337
- 募集
- Municipal Hospital Ploiesti
-
Timișoara、ルーマニア、300239
- 募集
- Oncomed
-
-
-
-
-
Baoding、中国、071000
- 募集
- Affiliated Hospital of Hebei University
-
Beijing、中国、100730
- 募集
- Peking Union Medical College Hospital
-
Beijing、中国、100730
- 募集
- Beijing Hospital
-
Beijing、中国、101149
- 募集
- Beijing Chest Hospital,Capital Medical University
-
Beijing、中国、100050
- 募集
- Beijing Friendship Hospital, Capital Medical University
-
Bengbu、中国、233004
- 募集
- The First Affiliated Hospital Of Bengbu Medical College
-
Changchun、中国、130000
- 募集
- Jilin Cancer Hospital
-
Changsha、中国、410013
- 募集
- Hunan Cancer Hospital
-
Changsha、中国、410013
- 募集
- The Third Xiangya Hospital of Central South University
-
Hangzhou、中国、310016
- 募集
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Hangzhou、中国、310022
- 募集
- Zhejiang Medical University, Zhejiang Cancer Hospital
-
Jiamusi、中国、154007
- 募集
- Jiamusi Cancer Hospital
-
Jinan、中国、250013
- 募集
- Shandong University - Jinan Central Hospital
-
Kunming、中国、650118
- 募集
- Yunnan Provincial Cancer Hospital
-
Nanjing、中国、210029
- 募集
- Jiangsu Peoples Hospital
-
Shanghai、中国、200433
- 募集
- Shanghai Pulmonary Hospital
-
Shanghai、中国、200030
- 募集
- Shanghai Chest Hospital
-
Shanghai、中国、200032
- 募集
- Fudan University - Shanghai Cancer Center (FUSCC)
-
Shantou、中国、515041
- 募集
- Cancer Hospital of Shantou University Medical College
-
Suzhou、中国、215006
- 募集
- The First Affiliated Hospital of Soochow University
-
Wanzhou、中国、404000
- 募集
- Chongqing University Three Gorges Hospital
-
Wuhan、中国、430071
- 募集
- Zhongnan Hospital of Wuhan University
-
Yangzhou、中国、225001
- 募集
- Northern Jiangsu Peoples Hospital (NJPH)
-
Zhejiang、中国、317000
- 募集
- Taizhou Hospital of Zhejiang Province
-
-
-
-
-
Ageo、日本、362-8588
- 募集
- Ageo Central General Hospital
-
Akashi、日本、673-8558
- 募集
- Hyogo Cancer Center
-
Aomori、日本、030-8553
- 募集
- Aomori Prefectural Central Hospital
-
Bunkyō City、日本、113-8677
- 募集
- Tokyo Metropolitan Komagome Hospital
-
Chūōku、日本、431-3192
- 募集
- Hamamatsu University Hospital
-
Funabashi、日本、273-8588
- 募集
- Funabashi Municipal Medical Center
-
Himeji、日本、670-8520
- 募集
- National Hospital Organization Himeji Medical Center
-
Hiroshima、日本、734-8551
- 募集
- Hiroshima University Hospital
-
Hiroshima、日本、734-8530
- 募集
- Hiroshima Prefectural Hospital
-
Iizuka、日本、820-8505
- 募集
- Aso Iizuka Hospital
-
Iwakuni、日本、740-8510
- 募集
- National Hospital Organization Iwakuni Clinical Center
-
Kanagawa、日本、247-8533
- 募集
- Shonan Kamakura General Hospital
-
Kanazawa、日本、920-8530
- 募集
- Ishikawa Prefectural Central Hospital
-
Kumamoto、日本、861-4193
- 募集
- Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
-
Kurashiki、日本、710-8602
- 募集
- Kurashiki Central Hospital
-
Kurume、日本、830-0011
- 募集
- Kurume University Hospital
-
Matsusaka、日本、515-8544
- 募集
- Matsusaka Municipal Hospital
-
Matsuyama、日本、791-0280
- 募集
- National Hospital Organization Shikoku Cancer Center
-
Meguro City、日本、152-8902
- 募集
- National Hospital Organization Tokyo Medical Center
-
Mibu、日本、321-0293
- 募集
- Dokkyo Medical University Hospital
-
Morioka、日本、028-3695
- 募集
- Iwate Medical University Hospital
-
Nagaizumi-chō、日本、411-8777
- 募集
- Shizuoka Cancer Center
-
Nagasaki、日本、852-8501
- 募集
- Nagasaki University Hospital
-
Nagoya、日本、466-8560
- 募集
- Nagoya University Hospital
-
Nagoya、日本、460-0001
- 募集
- National Hospital Organization Nagoya Medical Center
-
Nagoya、日本、457-8510
- 募集
- Japan Community Healthcare Organization Chukyo Hospital
-
Niigata、日本、951-8566
- 募集
- Niigata Cancer Center Hospital
-
Nishinomiya、日本、663-8501
- 募集
- Hyogo Medical University Hospital
-
Osaka、日本、541-8567
- 募集
- Osaka Prefectural Hospital Organization Osaka International Cancer Institute
-
Saitama、日本、362-0806
- 募集
- Saitama Prefectural Cancer Center
-
Sakai、日本、591-8555
- 募集
- NHO Kinki Chuo Chest Medical Center
-
Sapporo、日本、006-8555
- 募集
- Teine Keijinkai Hospital
-
Sapporo、日本、060-0063
- 募集
- Sapporo Minamisanjo Hospital
-
Sendai、日本、981-0914
- 募集
- Sendai Kousei Hospital
-
Shibukawa、日本、377-0280
- 募集
- Shibukawa Medical Center
-
Toyama、日本、930-0194
- 募集
- Toyama University Hospital
-
Wakayama、日本、641-8510
- 募集
- Wakayama Medical University Hospital
-
Yokohama、日本、221-0855
- 募集
- Yokohama Municipal Citizen's Hospital
-
-
-
-
-
Cheongju-si、韓国、28644
- 募集
- Chungbuk National University Hospital
-
Daejeon、韓国、35015
- 募集
- Chungnam National University Hospital (CNUH)
-
Goyang-si、韓国、10408
- 募集
- National Cancer Center
-
Incheon、韓国、21565
- 募集
- Gachon University Gil Medical Center
-
Jinju、韓国、52727
- 募集
- Gyeongsang National University Hospital (GNUH)
-
Seongnam-si、韓国、13620
- 募集
- Seoul National University Bundang Hospital (SNUBH)
-
Seoul、韓国、03722
- 募集
- Severance Hospital, Yonsei University Health System
-
Seoul、韓国、06351
- 募集
- Samsung Medical Center
-
Seoul、韓国、08308
- 募集
- Korea University Guro Hospital
-
Seoul、韓国、05505
- 募集
- Asan Medical Center (AMC)
-
Suwon、韓国、16499
- 募集
- Ajou University Hospital
-
Suwon、韓国、16247
- 募集
- The Catholic University Of Korea, St. Vincent's Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Substudy A Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
他の名前：
Intravenous infusion |
|
実験的：Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
他の名前：
Intravenous infusion |
|
実験的：Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
他の名前：
Intravenous infusion |
|
実験的：Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion
他の名前：
Intravenous infusion |
|
アクティブコンパレータ：Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Pemetrexed
|
Intravenous infusion Intravenous infusion Intravenous infusion |
|
実験的：Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Paclitaxel
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Intravenous infusion Intravenous infusion
他の名前：
Intravenous infusion |
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実験的：Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Paclitaxel
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Intravenous infusion Intravenous infusion
他の名前：
Intravenous infusion |
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実験的：Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + Paclitaxel
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Intravenous infusion Intravenous infusion
他の名前：
Intravenous infusion |
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実験的：Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Paclitaxel
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Intravenous infusion Intravenous infusion
他の名前：
Intravenous infusion |
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アクティブコンパレータ：Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Paclitaxel
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Intravenous infusion Intravenous infusion Intravenous infusion |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
|
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Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 3 - Overall survival (OS)
時間枠：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)
時間枠：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)
時間枠：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
|
|
Phase 3 - PFS assessed by investigator
時間枠：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
時間枠：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
時間枠：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
時間枠：At 6, 12, and 18 months
|
For substudies A and B. |
At 6, 12, and 18 months
|
|
Phase 3 - OS rate
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- BNT327-06
- 2024-515764-31-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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