En studie av Ifinatamab Deruxtecan versus behandling av legens valg hos personer med tilbakefall av småcellet lungekreft (IDeate-Lung02)
4. august 2026 oppdatert av: Daiichi Sankyo
En fase 3, multisenter, randomisert, åpen studie av Ifinatamab Deruxtecan (I-DXd), et B7-H3-antistoffkonjugat (ADC), versus behandling av leges valg (TPC) hos pasienter med residiverende småcellet lungekreft (SCLC) ) (IDeate-2)
Denne studien ble designet for å sammenligne effektiviteten og sikkerheten til I-DXd med behandling etter legens valg hos deltakere med residiverende småcellet lungekreft (SCLC).
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Hovedmålet med denne studien er å vurdere om behandling med I-DXd forbedrer objektiv responsrate (ORR) og forlenger total overlevelse (OS) sammenlignet med behandling etter legens valg blant deltakere med residiverende SCLC.
De sekundære målene for studien er å ytterligere evaluere effektiviteten/sikkerheten til I-DXd, helseøkonomi og resultatforskningsmål (inkludert pasientrapporterte utfall), immunogenisitet til I-DXd og B7-H3-proteinekspresjon.
Studietype
Intervensjonell
Registrering (Antatt)
540
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Daiichi Sankyo Contact for Clinical Trial Information
- Telefonnummer: 9089926400
- E-post: CTRinfo@dsi.com
Studiesteder
-
-
-
Ballarat, Australia, 3350
- Rekruttering
- Ballarat Base Hospital
-
Ta kontakt med:
- Principal Investigator
-
Bedford Park, Australia, 5042
- Rekruttering
- Flinders Medical Centre (Fmc)
-
Ta kontakt med:
- Principal Investigator
-
Camperdown, Australia, 2050
- Rekruttering
- Chris O Brien Lifehouse
-
Ta kontakt med:
- Principal Investigator
-
St Albans, Australia, 3021
- Rekruttering
- Sunshine Hospital
-
Ta kontakt med:
- Principal Investigator
-
Subiaco, Australia, 6008
- Rekruttering
- St John of God Subiaco Hospital
-
Townsville, Australia, 4814
- Rekruttering
- Townsville Cancer Centre
-
Ta kontakt med:
- Principal Investigator
-
Woolloongabba, Australia, 4102
- Rekruttering
- Princess Alexandra Hospital
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Brussels, Belgia, 1200
- Har ikke rekruttert ennå
- Cliniques universitaires Saint-Luc
-
Ta kontakt med:
- Principal Investigator
-
Edegem, Belgia, 2650
- Rekruttering
- Universitair Ziekenhuis Antwerpen
-
Ta kontakt med:
- Principal Investigator
-
Hasselt, Belgia, 3500
- Rekruttering
- Jessa Ziekenhuis Hospital
-
Ta kontakt med:
- Principal Investigator
-
Liège, Belgia, 4000
- Rekruttering
- Centre Hospitalier Universitaire de Liege
-
Ta kontakt med:
- Principal Investigator
-
Roeselare, Belgia, 8800
- Har ikke rekruttert ennå
- AZ Delta
-
Ta kontakt med:
- Principal Investigator
-
Yvoir, Belgia, 5530
- Rekruttering
- CHU UCL Namur
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Barretos, Brasil, 14784-400
- Rekruttering
- Departmento de Pesquisa Clinica- Hospital de Amor de Barretos
-
Ta kontakt med:
- Principal Investigator
-
Florianópolis, Brasil, 88034-000
- Rekruttering
- Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
-
Ta kontakt med:
- Principal Investigator
-
Itajaí, Brasil, 88301-220
- Rekruttering
- Clinica de Neoplasias Litoral
-
Ta kontakt med:
- Principal Investigator
-
Porto Alegre, Brasil, 90610-000
- Rekruttering
- Hospital Sao Lucas da PUCRS
-
Ta kontakt med:
- Principal Investigator
-
Santo André, Brasil, 09060-650
- Rekruttering
- Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
-
Ta kontakt med:
- Principal Investigator
-
São José do Rio Preto, Brasil, 15090-000
- Rekruttering
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
-
Ta kontakt med:
- Principal Investigator
-
São Paulo, Brasil, 01327-001
- Rekruttering
- Hospital Alemao Oswaldo Cruz
-
Ta kontakt med:
- Principal Investigator
-
São Paulo, Brasil, 01308-050
- Har ikke rekruttert ennå
- Hospital Sírio-Libanês
-
Ta kontakt med:
- Principal Investigator
-
São Paulo, Brasil, 01509-900
- Har ikke rekruttert ennå
- A. C. Camargo Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
São Paulo, Brasil, 01246-000
- Rekruttering
- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
-
Ta kontakt med:
- Principal Investigator
-
São Paulo, Brasil, 01321-001
- Rekruttering
- Hospital Beneficăncia Portuguesa de Săo Paulo
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Brampton, Canada, L6R 3J7
- Rekruttering
- William Osler Health System - Brampton Civic Hospital
-
Edmonton, Canada, T6G 1Z2
- Rekruttering
- Cross Cancer Institute
-
Ta kontakt med:
- Principal Investigator
-
Québec, Canada, G1V 4G5
- Rekruttering
- Institut Universitaire de cardiologie et de pneumologie de Quebec
-
Ta kontakt med:
- Principal Investigator
-
Toronto, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
Winnipeg, Canada, R3E0V9
- Rekruttering
- CancerCare Manitoba
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
Arkansas
-
Springdale, Arkansas, Forente stater, 72762
- Rekruttering
- Highlands Oncology Group
-
Ta kontakt med:
- Principal Investigator
-
-
California
-
Fullerton, California, Forente stater, 92835
- Rekruttering
- Clinical Research Providence Medical Foundation
-
Ta kontakt med:
- Principal Investigator
-
Los Angeles, California, Forente stater, 90095
- Rekruttering
- UCLA Hematology-Oncology
-
Ta kontakt med:
- Principal Investigator
-
San Francisco, California, Forente stater, 94115
- Rekruttering
- UCSF Mission Bay Mission Hall
-
Ta kontakt med:
- Principal Investigator
-
-
Florida
-
Miami, Florida, Forente stater, 33136
- Rekruttering
- University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
Orlando, Florida, Forente stater, 32804
- Rekruttering
- AdventHealth Orlando, Cancer Institute
-
Ta kontakt med:
- Principal Investigator
-
Tampa, Florida, Forente stater, 33612
- Har ikke rekruttert ennå
- H. Lee Moffitt Cancer Center and Research Institute, Inc
-
Ta kontakt med:
- Principal Investigator
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60612
- Rekruttering
- Rush MD Anderson Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40503
- Rekruttering
- Baptist Health Lexington
-
Ta kontakt med:
- Principal Investigator
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21201
- Rekruttering
- University of Maryland Greenebaum Comprehensive Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
Baltimore, Maryland, Forente stater, 21287
- Rekruttering
- John Hopkins School of Medicine
-
Ta kontakt med:
- Principal Investigator
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02216
- Rekruttering
- Dana-Farber Cancer Institute
-
Ta kontakt med:
- Principal Investigator
-
-
Michigan
-
Detroit, Michigan, Forente stater, 48202
- Har ikke rekruttert ennå
- Henry Ford Health System
-
Ta kontakt med:
- Principal Investigator
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63128
- Rekruttering
- Mercy Clinic Oncology and Hematology Sindelar Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
-
Nebraska
-
Omaha, Nebraska, Forente stater, 68198-6811
- Rekruttering
- University of Nebraska Medical Center
-
Ta kontakt med:
- Principal Investigator
-
-
New Hampshire
-
Lebanon, New Hampshire, Forente stater, 03766
- Rekruttering
- Dartmouth-Hitchcock Medical Center
-
Ta kontakt med:
- Principal Investigator
-
-
New Jersey
-
East Brunswick, New Jersey, Forente stater, 08816
- Rekruttering
- Astera Cancer Care
-
Ta kontakt med:
- Principal Investigator
-
Neptune City, New Jersey, Forente stater, 07753
- Rekruttering
- Hackensack Meridian Health Jsumc
-
Ta kontakt med:
- Principal Investigator
-
-
New York
-
Lake Success, New York, Forente stater, 11042
- Rekruttering
- Clinical Research Alliance, Inc
-
Ta kontakt med:
- Principal Investigator
-
New York, New York, Forente stater, 10016
- Rekruttering
- New York University Cancer Center - Laura and Isaac
-
New York, New York, Forente stater, 10016
- Rekruttering
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long Island
-
Ta kontakt med:
- Principal Investigator
-
The Bronx, New York, Forente stater, 10461
- Har ikke rekruttert ennå
- Montefiore Medical Center PRIME
-
Ta kontakt med:
- Principal Investigator
-
-
Ohio
-
Canton, Ohio, Forente stater, 44708
- Rekruttering
- Cleveland Clinic Mercy Hospital
-
Ta kontakt med:
- Principal Investigator
-
Cincinnati, Ohio, Forente stater, 45236
- Rekruttering
- Oncology/Hematology Care Clinical Trials, Llc
-
Ta kontakt med:
- Principal Investigator
-
-
Oregon
-
Portland, Oregon, Forente stater, 97213
- Har ikke rekruttert ennå
- Providence Portland Medical Center
-
Ta kontakt med:
- Principal Investigator
-
-
Tennessee
-
Germantown, Tennessee, Forente stater, 38138
- Rekruttering
- The West Clinic, PLLC dba West Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- Rekruttering
- University of Texas MD Anderson Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
Houston, Texas, Forente stater, 77030
- Rekruttering
- Houston Methodist Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
Tyler, Texas, Forente stater, 75702
- Rekruttering
- Texas Oncology, P.A. - Tyler
-
Ta kontakt med:
- Principal Investigator
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forente stater, 53226
- Har ikke rekruttert ennå
- Medical College of Wisconsin
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Avignon, Frankrike, 84000
- Rekruttering
- Institut Sainte Catherine
-
Ta kontakt med:
- Principal Investigator
-
Bordeaux, Frankrike, 33075
- Har ikke rekruttert ennå
- CHU Bordeaux
-
Ta kontakt med:
- Principal Investigator
-
Créteil, Frankrike, 94010
- Rekruttering
- Centre Hospitalier Intercommunal de Crăteil
-
Ta kontakt med:
- Principal Investigator
-
Lille, Frankrike, 69037
- Rekruttering
- Institut Cœur Poumon CHU de Lille
-
Limoges, Frankrike, 87042
- Rekruttering
- Chu Limoges - Hopital Du Cluzeau
-
Ta kontakt med:
- Principal Investigator
-
Lyon, Frankrike, 69008
- Har ikke rekruttert ennå
- Centre Léon Bérard
-
Ta kontakt med:
- Principal Investigator
-
Marseille, Frankrike, 13005
- Rekruttering
- Assistance Publique-Hăpitaux de Marseille
-
Ta kontakt med:
- Principal Investigator
-
Montpellier, Frankrike, 34295
- Rekruttering
- Hopital Arnaud de Villeneuve
-
Ta kontakt med:
- Principal Investigator
-
Montpellier, Frankrike, 34298
- Rekruttering
- Institut régional du Cancer de Montpellier
-
Ta kontakt med:
- Principal Investigator
-
Mulhouse, Frankrike, 68100
- Rekruttering
- Ch de Mulhouse - Hăpital Emile Muller
-
Ta kontakt med:
- Principal Investigator
-
Paris, Frankrike, 75020
- Rekruttering
- Hôpital Tenon
-
Ta kontakt med:
- Principal Investigator
-
Paris, Frankrike, 75005
- Rekruttering
- Institut Curie - Site de Paris
-
Ta kontakt med:
- Principal Investigator
-
Rennes, Frankrike, 35033
- Rekruttering
- CHU Rennes - Hôpital Pontchaillou
-
Saint-Etienne, Frankrike, 42055
- Rekruttering
- CHU de Saint Etienne
-
Ta kontakt med:
- Principal Investigator
-
Saint-Herblain, Frankrike, 44805
- Har ikke rekruttert ennå
- Chu Nantes - Hăpital Guillaume Et Renă Laănnec
-
Ta kontakt med:
- Principal Investigator
-
Saint-Priest-en-Jarez, Frankrike, 42270
- Rekruttering
- Institut de Cancérologie de la Loire
-
Ta kontakt med:
- Principal Investigator
-
Suresnes, Frankrike, 92151
- Har ikke rekruttert ennå
- Hăpital Foch
-
Ta kontakt med:
- Principal Investigator
-
Villejuif, Frankrike, 94805
- Har ikke rekruttert ennå
- Institut Gustave Roussy
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Athens, Hellas, 11528
- Har ikke rekruttert ennå
- General Hospital of Athens Alexandra
-
Ta kontakt med:
- Principal Investigator
-
Athens, Hellas, 11526
- Har ikke rekruttert ennå
- 'Henry Dynant' Hospital Center
-
Ta kontakt med:
- Principal Investigator
-
Athens, Hellas, 11527
- Rekruttering
- General Hospital of Athens of Chest Diseases 'Sotiria'
-
Ta kontakt med:
- Principal Investigator
-
Chaïdári, Hellas, 124 62
- Har ikke rekruttert ennå
- University General Hospital "Attikon"
-
Ta kontakt med:
- Principal Investigator
-
Larissa, Hellas, 41110
- Rekruttering
- University General Hospital of Larissa
-
Ta kontakt med:
- Principal Investigator
-
Piraeus, Hellas, 185 47
- Rekruttering
- Metropolitan Hospital
-
Ta kontakt med:
- Principal Investigator
-
Pátrai, Hellas, 26335
- Rekruttering
- General Hospital of Patra Agios Andreas
-
Ta kontakt med:
- Principal Investigator
-
Thessaloniki, Hellas, 55236
- Rekruttering
- St Luke's Hospital
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Bari, Italia, 70124
- Rekruttering
- Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
-
Ta kontakt med:
- Principal Investigator
-
Bergamo, Italia, 24125
- Rekruttering
- Humanitas Gavazzeni
-
Ta kontakt med:
- Principal Investigator
-
Brescia, Italia, 25124
- Har ikke rekruttert ennå
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
-
Ta kontakt med:
- Principal Investigator
-
Catania, Italia, 95123
- Har ikke rekruttert ennå
- Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)
-
Ta kontakt med:
- Principal Investigator
-
Catanzaro, Italia, 88100
- Rekruttering
- Azienda Ospedaliero Universitaria Renato Dulbecco
-
Ta kontakt med:
- Principal Investigator
-
Genova, Italia, 16132
- Rekruttering
- Istituto Nazionale per la Ricerca sul Cancro di Genova
-
Ta kontakt med:
- Principal Investigator
-
Milan, Italia, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
Ta kontakt med:
- Principal Investigator
-
Milan, Italia, 20132
- Har ikke rekruttert ennå
- Ospedale San Raffaele
-
Ta kontakt med:
- Principal Investigator
-
Milan, Italia, 20141
- Rekruttering
- IEO Istituto Europeo di Oncologia
-
Ta kontakt med:
- Principal Investigator
-
Monza, Italia, 20900
- Har ikke rekruttert ennå
- Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
-
Ta kontakt med:
- Principal Investigator
-
Naples, Italia, 80131
- Rekruttering
- Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania Âluigi Vanvitelliâ
-
Ta kontakt med:
- Principal Investigator
-
Parma, Italia, 43100
- Rekruttering
- Azienda Ospedaliero Universitaria di Parma
-
Ta kontakt med:
- Principal Investigator
-
Perugia, Italia, 06132
- Rekruttering
- Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
-
Ta kontakt med:
- Principal Investigator
-
Roma, Italia, 00144
- Rekruttering
- Istituto Nazionale Tumori Regina Elena IRCCS
-
Ta kontakt med:
- Principal Investigator
-
Rozzano, Italia, 20089
- Rekruttering
- Istituto Clinico Humanitas
-
Ta kontakt med:
- Principal Investigator
-
Verona, Italia, 37134
- Rekruttering
- Centro Ricerche Cliniche di Verona s.r.l.
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Chūōku, Japan, 104-0045
- Rekruttering
- National Cancer Center Hospital
-
Ta kontakt med:
- Principal Investigator
-
Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Hirakata-shi, Japan, 573-1191
- Rekruttering
- Kansai Medical University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Kashiwa, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
-
Ta kontakt med:
- Principal Investigator
-
Kōtoku, Japan, 135-8550
- Rekruttering
- The Cancer Institute Hospital of JFCR
-
Ta kontakt med:
- Principal Investigator
-
Matsuyama, Japan, 791-0280
- Rekruttering
- National Hospital Organization Shikoku Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
Nakatogari, Japan, 411-8777
- Rekruttering
- Shizuoka Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
Okayama, Japan, 700-8558
- Rekruttering
- Okayama University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Osaka-Sakai, Japan, 590-0197
- Rekruttering
- Kindai University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Sagamihara, Japan, 252-0375
- Rekruttering
- Kitasato University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Sapporo, Japan, 003-0804
- Rekruttering
- National Hospital Organization Hokkaido Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
Takatsuki, Japan, 569-8686
- Rekruttering
- Osaka Medical and Pharmaceutical University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Wakayama, Japan, 641-8509
- Rekruttering
- Wakayama Medical University Hospital
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
-
Ta kontakt med:
- Principal Investigator
-
Beijing, Kina, 100029
- Rekruttering
- China-Japan Friendship Hospital
-
Beijing, Kina, 101149
- Rekruttering
- Beijing Chest Hospital,Capital Medical University
-
Ta kontakt med:
- Principal Investigator
-
Changchun, Kina, 130012
- Rekruttering
- Jilin Province Tumor Hospital
-
Ta kontakt med:
- Principal Investigator
-
Changsha, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital
-
Ta kontakt med:
- Principal Investigator
-
Chengdu, Kina, 610041
- Rekruttering
- West China Hospital, Sichuan University
-
Ta kontakt med:
- Principal Investigator
-
Chengdu, Kina, 610041
- Rekruttering
- Sichuan Cancer Hospital
-
Ta kontakt med:
- Principal Investigator
-
Chongqing, Kina, 400030
- Rekruttering
- Chongqing University Cancer Hospital
-
Ta kontakt med:
- Principal Investigator
-
Haerbin, Kina, 150081
- Har ikke rekruttert ennå
- Harbin Medical University Cancer Hospital
-
Ta kontakt med:
- Principal Investigator
-
Hangzhou, Kina, 310022
- Har ikke rekruttert ennå
- Zhejiang Cancer Hospital
-
Ta kontakt med:
- Principal Investigator
-
Hangzhou, Kina, 310003
- Rekruttering
- The First Affiliated Hospital, College of Medicine, Zhejiang University
-
Ta kontakt med:
- Principal Investigator
-
Jiangxi, Kina, 330030
- Rekruttering
- The Second Affiliated Hospital of Nanchang University
-
Ta kontakt med:
- Principal Investigator
-
Jinan, Kina, 250117
- Rekruttering
- Shandong Cancer Hospital
-
Ta kontakt med:
- Principal Investigator
-
Linyi, Kina, 276001
- Rekruttering
- Linyi Cancer Hospital
-
Ta kontakt med:
- Principal Investigator
-
Neijiang, Kina, 641000
- Rekruttering
- The Second Peoples Hospital of Neijiang
-
Ta kontakt med:
- Principal Investigator
-
Shandong, Kina, 264099
- Rekruttering
- Yantai YuHuangDing Hospital
-
Shanghai, Kina, 200032
- Har ikke rekruttert ennå
- Fudan University Shanghai Cancer Center
-
Ta kontakt med:
- Principal Investigator
-
Shenyang, Kina, 110042
- Rekruttering
- Liaoning Cancer Hospital & Institute
-
Tianjin, Kina, 300060
- Rekruttering
- Tianjin Medical University Cancer Institute & Hospital
-
Ta kontakt med:
- Principal Investigator
-
Wuhan, Kina, 430079
- Har ikke rekruttert ennå
- Hubei Cancer Hospital
-
Ta kontakt med:
- Principal Investigator
-
Wuhan, Kina, 430022
- Rekruttering
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
-
Ta kontakt med:
- Principal Investigator
-
Wuhan, Kina, 430030
- Rekruttering
- Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH
-
Ta kontakt med:
- Principal Investigator
-
Xi'an, Kina, 710061
- Rekruttering
- The First Affiliated Hospital of Xian Jiaotong University
-
Xiangyang, Kina, 441021
- Har ikke rekruttert ennå
- Xiangyang Central Hospital
-
Ta kontakt med:
- Principal Investigator
-
Zhengzhou, Kina, 450008
- Rekruttering
- Henan Cancer Hospital
-
Ta kontakt med:
- Principal Investigator
-
Ürümqi, Kina, 830000
- Rekruttering
- The Affiliated Cancer Hospital of Xinjiang Medical university
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
's-Hertogenbosch, Nederland, 5223 GZ
- Rekruttering
- Jeroen Bosch Ziekenhuis
-
Ta kontakt med:
- Principal Investigator
-
Amsterdam, Nederland, 1066 CX
- Har ikke rekruttert ennå
- Netherlands Cancer Institute
-
Ta kontakt med:
- Principal Investigator
-
Maastricht, Nederland, 6229 HX
- Rekruttering
- Maastricht University Medical Center
-
Ta kontakt med:
- Principal Investigator
-
Tilburg, Nederland, 5022 GC
- Rekruttering
- ETZ Elisabeth
-
-
-
-
-
Bydgoszcz, Polen, 85-796
- Rekruttering
- Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
-
Ta kontakt med:
- Principal Investigator
-
Lodz, Polen, 93-338
- Har ikke rekruttert ennå
- Instytut Centrum Zdrowia Matki Polki
-
Ta kontakt med:
- Principal Investigator
-
Otwock, Polen, 05-400
- Rekruttering
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
-
Ta kontakt med:
- Principal Investigator
-
Prabuty, Polen, 82-550
- Har ikke rekruttert ennå
- Szpital Specjalistyczny w Prabutach
-
Ta kontakt med:
- Principal Investigator
-
Tomaszów Mazowiecki, Polen, 97-200
- Rekruttering
- Provita Prolife
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Coimbra, Portugal, 3040
- Rekruttering
- Centro Hospitalar E Universitărio de Coimbra E.P.E.
-
Ta kontakt med:
- Principal Investigator
-
Guimarães, Portugal, 4835-044
- Rekruttering
- Hospital da Senhora da Oliveira Guimarães
-
Ta kontakt med:
- Principal Investigator
-
Lisbon, Portugal, 1500-650
- Rekruttering
- Hospital da Luz
-
Ta kontakt med:
- Principal Investigator
-
Lisbon, Portugal, 1769-001
- Rekruttering
- Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente
-
Ta kontakt med:
- Principal Investigator
-
Porto, Portugal, 4099-001
- Rekruttering
- Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Bucharest, Romania, 407280
- Rekruttering
- S.C Radiotherapy Center Cluj S.R.L
-
Ta kontakt med:
- Principal Investigator
-
Cluj-Napoca, Romania, 400015
- Har ikke rekruttert ennå
- Institutul Oncologic 'Prof. Dr. Ion Chiricuta' Cluj Napoca
-
Ta kontakt med:
- Principal Investigator
-
Craiova, Romania, 200745
- Rekruttering
- S.C Centrul de Oncologie Sfantul Nectarie Craiova
-
Ta kontakt med:
- Principal Investigator
-
Suceava, Romania, 720214
- Har ikke rekruttert ennå
- S.C. Sigmedical Services Srl
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Barcelona, Spania, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Ta kontakt med:
- Principal Investigator
-
Barcelona, Spania, 8035
- Rekruttering
- Hospital Universitari Vall d'Hebron
-
Ta kontakt med:
- Principal Investigator
-
Barcelona, Spania, 8025
- Rekruttering
- Hospital de La Santa Creu i Sant Pau
-
Ta kontakt med:
- Principal Investigator
-
Córdoba, Spania, 14004
- Rekruttering
- Hospital Universitario Reina Sofia
-
Ta kontakt med:
- Principal Investigator
-
Jaén, Spania, 23007
- Har ikke rekruttert ennå
- Hospital Universitario Ciudad de Jaen
-
Ta kontakt med:
- Principal Investigator
-
Jerez de la Frontera, Spania, 11408
- Rekruttering
- Hospital de Especialidades de Jerez de La Frontera
-
Ta kontakt med:
- Principal Investigator
-
L'Hospitalet de Llobregat, Spania, 08908
- Rekruttering
- ICO L'Hospitalet - Hospital Duran i Reynals
-
Ta kontakt med:
- Principal Investigator
-
Las Palmas de Gran Canaria, Spania, 35016
- Rekruttering
- Complejo Hospitalario Universitario Insular Materno-Infantil
-
Ta kontakt med:
- Principal Investigator
-
Madrid, Spania, 28034
- Rekruttering
- Hospital Universitario Ramon y Cajal
-
Ta kontakt med:
- Principal Investigator
-
Madrid, Spania, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Ta kontakt med:
- Principal Investigator
-
Madrid, Spania, 28046
- Rekruttering
- Hospital Universitario La Paz
-
Ta kontakt med:
- Principal Investigator
-
Madrid, Spania, 28007
- Rekruttering
- Hospital General Universitario Gregorio Marañón
-
Ta kontakt med:
- Principal Investigator
-
Madrid, Spania, 28040
- Rekruttering
- Hospital Universitario Fundación Jiménez Díaz
-
Ta kontakt med:
- Principal Investigator
-
Málaga, Spania, 29010
- Rekruttering
- Hospital Regional Universitario de Málaga
-
Seville, Spania, 41013
- Rekruttering
- Hospital Universitario Virgen del Rocío
-
Ta kontakt med:
- Principal Investigator
-
Seville, Spania, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
-
Ta kontakt med:
- Principal Investigator
-
Seville, Spania, 41014
- Rekruttering
- Hospital Universitario Nuestra Señora de Valme
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Bern, Sveits, 3010
- Rekruttering
- Inselspital - Universitaetsspital Bern
-
Ta kontakt med:
- Principal Investigator
-
Sankt Gallen, Sveits, 9007
- Rekruttering
- Kantonsspital St. Gallen
-
Ta kontakt med:
- Principal Investigator
-
Villars-sur-Glâne, Sveits, 1752
- Rekruttering
- HFR Fribourg/Kantonsspital Fribourg
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Cheongju-si, Sør -Korea, 28644
- Rekruttering
- Chungbuk National University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Daegu, Sør -Korea, 41404
- Rekruttering
- Kyungpook National University Chilgok Hospital
-
Ta kontakt med:
- Principal Investigator
-
Seongnam-si, Sør -Korea, 13620
- Rekruttering
- Seoul National University Bundang Hospital
-
Ta kontakt med:
- Principal Investigator
-
Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System
-
Ta kontakt med:
- Principal Investigator
-
Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center
-
Ta kontakt med:
- Principal Investigator
-
Seoul, Sør -Korea, 5505
- Rekruttering
- Asan Medical Center
-
Ta kontakt med:
- Principal Investigator
-
Seoul, Sør -Korea, 3080
- Rekruttering
- Seoul National University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Suwon, Sør -Korea, 16499
- Rekruttering
- Ajou University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Suwon, Sør -Korea, 16247
- Rekruttering
- The Catholic University of Korea, St. Vincent's Hospital
-
-
-
-
-
Kaohsiung City, Taiwan, 80756
- Rekruttering
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Ta kontakt med:
- Principal Investigator
-
Taichung, Taiwan, 40705
- Rekruttering
- Taichung Veterans General Hospital
-
Ta kontakt med:
- Principal Investigator
-
Taichung, Taiwan, 404327
- Rekruttering
- China Medical University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Tainan, Taiwan, 70403
- Rekruttering
- National Cheng Kung University Hospitalx
-
Ta kontakt med:
- Principal Investigator
-
Taipei, Taiwan, 110301
- Rekruttering
- Taipei Medical University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Taipei, Taiwan, 11217
- Rekruttering
- Taipei Veterans General Hospital
-
Ta kontakt med:
- Principal Investigator
-
Taipei, Taiwan, 10048
- Rekruttering
- National Taiwan University Cancer Centre
-
Ta kontakt med:
- Principal Investigator
-
Taoyuan City, Taiwan, 333
- Rekruttering
- Chang Gung Memorial Hospital
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Liberec, Tsjekkia, 460 63
- Rekruttering
- Krajska nemocnice Liberec a.s.
-
Ta kontakt med:
- Principal Investigator
-
Olomouc, Tsjekkia, 77900
- Rekruttering
- Fakultni Nemocnice Olomouc
-
Ta kontakt med:
- Principal Investigator
-
Prague, Tsjekkia, 140 59
- Rekruttering
- Fakultni Thomayerova nemocnice
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Ankara, Tyrkia (Türkiye), 6800
- Rekruttering
- Ankara Bilkent City Hospital
-
Ta kontakt med:
- Principal Investigator
-
Ankara, Tyrkia (Türkiye), 06105
- Rekruttering
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
Ta kontakt med:
- Principal Investigator
-
Diyarbakır, Tyrkia (Türkiye), 21080
- Rekruttering
- Dicle University, Medical faculty
-
Ta kontakt med:
- Principal Investigator
-
Istanbul, Tyrkia (Türkiye), 34093
- Rekruttering
- Goztepe Prof Dr Suleyman Yalcin City Hospital
-
Ta kontakt med:
- Principal Investigator
-
Istanbul, Tyrkia (Türkiye), 34098
- Rekruttering
- Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
-
Ta kontakt med:
- Principal Investigator
-
Istanbul, Tyrkia (Türkiye), 34214
- Rekruttering
- Medipol University Medical Faculty
-
Ta kontakt med:
- Principal Investigator
-
Izmir, Tyrkia (Türkiye), 35530
- Har ikke rekruttert ennå
- Izmir Medicalpark Hospital
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Berlin, Tyskland, 13125
- Rekruttering
- Evangelische Lungenklinik Berlin
-
Ta kontakt med:
- Principal Investigator
-
Erfurt, Tyskland, 99089
- Rekruttering
- Helios Klinikum Erfurt
-
Ta kontakt med:
- Principal Investigator
-
Essen, Tyskland, 45122
- Rekruttering
- Universtitaetsklinikum Essen
-
Ta kontakt med:
- Principal Investigator
-
Frankfurt, Tyskland, 60488
- Rekruttering
- Krankenhaus Nordwest GmbH
-
Ta kontakt med:
- Principal Investigator
-
Frankfurt am Main, Tyskland, 60590
- Rekruttering
- Universitaetsklinikum Frankfurt Goethe-Universitaet
-
Ta kontakt med:
- Principal Investigator
-
Gauting, Tyskland, 82131
- Rekruttering
- Asklepios Fachkliniken Muenchen-Gauting
-
Ta kontakt med:
- Principal Investigator
-
Gera, Tyskland, 7548
- Rekruttering
- SRH Wald-Klinikum Gera GmbH
-
Ta kontakt med:
- Principal Investigator
-
Giessen, Tyskland, 35392
- Rekruttering
- UNIVERSITATSKLINIKUM GIeBEN UND MARBURG GMBH
-
Ta kontakt med:
- Principal Investigator
-
Hamburg, Tyskland, 21075
- Har ikke rekruttert ennå
- Asklepios Klinik Harburg
-
Ta kontakt med:
- Principal Investigator
-
Immenhausen, Tyskland, 34376
- Rekruttering
- LKI Lungenfachklinik Immenhausen
-
Ta kontakt med:
- Principal Investigator
-
Kiel, Tyskland, 24116
- Rekruttering
- Staedtisches Krankenhaus Kiel
-
Ta kontakt med:
- Principal Investigator
-
Minden, Tyskland, 32429
- Har ikke rekruttert ennå
- Johannes Wesling Klinikum Minden
-
Ta kontakt med:
- Principal Investigator
-
Oldenburg, Tyskland, 26121
- Har ikke rekruttert ennå
- Pius-Hospital Oldenburg
-
Ta kontakt med:
- Principal Investigator
-
Ulm, Tyskland, 89081
- Har ikke rekruttert ennå
- Universitaetsklinikum Ulm
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Budapest, Ungarn, 1088
- Har ikke rekruttert ennå
- Semmelweis Egyetem
-
Ta kontakt med:
- Principal Investigator
-
Budapest, Ungarn, 1122
- Har ikke rekruttert ennå
- Országos Onkológiai Intézet
-
Ta kontakt med:
- Principal Investigator
-
Budapest, Ungarn, 1121
- Rekruttering
- Orszagos Koranyi Pulmonologiai Intezet
-
Ta kontakt med:
- Principal Investigator
-
Győr, Ungarn, 9024
- Rekruttering
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
-
Ta kontakt med:
- Principal Investigator
-
Kecskemét, Ungarn, 6000
- Rekruttering
- Bacs-Kiskun Varmegyei Oktatokorhaz
-
Ta kontakt med:
- Principal Investigator
-
-
-
-
-
Feldkirch, Østerrike, 6800
- Rekruttering
- Landeskrankenhaus Feldkirch
-
Ta kontakt med:
- Principal Investigator
-
Krems, Østerrike, 3500
- Rekruttering
- Landesklinikum Krems
-
Ta kontakt med:
- Principal Investigator
-
Linz, Østerrike, 4020
- Rekruttering
- Kepler University Hospital
-
Ta kontakt med:
- Principal Investigator
-
Vienna, Østerrike, 1210
- Har ikke rekruttert ennå
- Klinik Floridsdorf
-
Ta kontakt med:
- Principal Investigator
-
Vienna, Østerrike, 1140
- Rekruttering
- Wiener Gesundheitsverband Klinik Penzing
-
Ta kontakt med:
- Principal Investigator
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier
Deltakere må oppfylle alle følgende kriterier for å være kvalifisert for randomisering i studien:
- Signer og dater skjemaet for informert samtykke før starten av eventuelle studiespesifikke kvalifiseringsprosedyrer.
- Voksne ≥18 år eller minimum lovlig voksen alder (den som er høyest) på det tidspunktet skjemaet for informert samtykke signeres.
- Har histologisk eller cytologisk dokumentert SCLC.
- Deltakeren må gi tilstrekkelige baseline tumorprøver med tilstrekkelig mengde og kvalitet på tumorvevsinnhold.
- Har mottatt tidligere behandling med minst én tidligere platinabasert linje som systemisk terapi for SCLC med minst 2 behandlingssykluser.
- Har minst én målbar lesjon i henhold til RECIST v1.1 vurdert av utrederen.
- Har dokumentasjon på radiologisk sykdomsprogresjon på eller etter siste systembehandling.
- Har ECOG PS på ≤1.
- Deltakere med ubehandlede og asymptomatiske hjernemetastaser eller forsøkspersoner med behandlede hjernemetastaser som ikke lenger er symptomatiske og som ikke krever behandling med steroider, kan inkluderes i studien dersom de er kommet seg etter den akutte toksiske effekten av strålebehandling.
Eksklusjonskriterier
Deltakere som oppfyller noen av følgende kriterier vil bli diskvalifisert fra å delta i studien:
- Har mottatt tidligere behandling med orlotamab, enoblituzumab eller andre humaniserte anti-B7 homolog 3 (B7-H3) målrettede midler, inkludert I-DXd.
- Har mottatt tidligere behandling med en ADC som består av et exatekanderivat (f.eks. trastuzumab deruxtecan).
- Har mottatt noen av komparatorene brukt i denne studien eller en hvilken som helst topoisomerase I-hemmer.
- Har utilstrekkelig utvaskingsperiode før randomisering som spesifisert i protokollen.
- Har noen av følgende tilstander i løpet av de siste 6 månedene: cerebrovaskulær ulykke, forbigående iskemisk anfall eller en annen arteriell tromboembolisk hendelse.
- Har ukontrollert eller betydelig kardiovaskulær sykdom.
- Har klinisk signifikant hornhinnesykdom.
- Har en historie med (ikke-infeksiøs) interstitiell lungesykdom (ILD)/pneumonitt som krevde kortikosteroider, nåværende ILD/pneumonitt, eller mistenkt ILD/pneumonitt som ikke kan utelukkes ved bildediagnostikk ved screening.
- Har klinisk alvorlig lungekompromittering som følge av interkurrente lungesykdommer, inkludert, men ikke begrenset til, enhver underliggende lungesykdom og potensiell lungepåvirkning forårsaket av autoimmune, bindevevs- eller inflammatoriske lidelser, tidligere fullstendig pneumonektomi eller behov for ekstra oksygen.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Ifinatamab deruxtecan (I-DXd)
Participants will be randomized to receive 12 milligrams per kilogram (mg/kg) I-DXd, intravenously (IV), as monotherapy on Day 1 of each 21-day cycle, once every 3 weeks (Q3W), until clinical or radiologic evidence of progression of disease determined by the investigator, unacceptable toxicity, withdrawal of informed consent, death, loss to follow-up, or other treatment discontinuation criteria are met as specified in the protocol.
|
12 mg/kg intravenøs dose på dag 1 i hver 21-dagers syklus
Andre navn:
|
|
Aktiv komparator: Treatment of Physician's Choice (TPC)
Participants will be randomized to receive topotecan or lurbinectedin, or amrubicin, as per investigator's choice and per locally approved label (indicated dose and frequency), until a treatment discontinuation criteria are met as specified in the protocol.
|
Lurbinectedin vil bli administrert per lokal SoC
Topotecan will be administered per local standard-of-care (SoC)
Amrubicin will be administered per local SoC
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: From the date of randomization to the date of death due to any cause, up to approximately 3.7 years
|
OS is defined as the time interval from the date of randomization to the date of death due to any cause.
|
From the date of randomization to the date of death due to any cause, up to approximately 3.7 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response (OR) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)
Tidsramme: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years
|
Objective response as assessed by BICR is defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per BICR according to RECIST v1.1.
CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level.
PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
|
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years
|
|
Number of Participants With OR Assessed by Investigator Per RECIST v1.1
Tidsramme: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years
|
Objective response as assessed by the investigator is defined as a BOR of confirmed CR or confirmed PR by the investigator according to RECIST v1.1.
CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level.
PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
|
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years
|
|
Progression-free Survival (PFS) as Assessed by BICR and Investigator
Tidsramme: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years
|
PFS is defined as the time interval from randomization to the earlier date of the first documented radiographic disease progression or death due to any cause.
|
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years
|
|
Duration of Response (DoR) as Assessed by BICR and Investigator
Tidsramme: From the date of first documentation of BOR (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 3.7 years
|
DoR is defined as the time from the date of the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the date of the first documentation of objective tumor progressive or death to any cause, whichever occurs first.
The DoR will be calculated for responding participants (PR or CR) only.
|
From the date of first documentation of BOR (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 3.7 years
|
|
Disease Control as Assessed by BICR and Investigator
Tidsramme: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years
|
Disease control is defined as a BOR of confirmed CR, confirmed PR, or stable disease (SD).
CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level.
PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study for target lesions and unequivocal progression of existing non-target lesions for non-target lesions.
|
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years
|
|
Time to Response (TTR) as Assessed by BICR and Investigator
Tidsramme: From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 3.7 years
|
TTR is defined as the time from the date of randomization to the first documentation of objective tumor response (CR or PR) that is subsequently confirmed by BICR and investigator assessment.
Time to response (TTR) will be calculated for confirmed responders only.
|
From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 3.7 years
|
|
Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30
Tidsramme: Baseline up to 3.7 years
|
EORTC QLQ-C30 is a 30-item questionnaire that assesses global health status (GHS)/quality of life (QoL), subject functioning, and general cancer symptoms.
All scores for the EORTC QLQ-C30 instrument are linearly transformed to a 0 to 100 metric, where a higher score on GHS/QoL and functioning scales indicates a better outcome and a higher score for the symptom scales indicates worse outcomes.
|
Baseline up to 3.7 years
|
|
Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 (EORTC QLQ-LC29)
Tidsramme: Baseline up to 3.7 years
|
The LC29 is a self-reported 29-item questionnaire that measures SCLC-related symptoms and the side effects of treatments and has a recall period of one week.
All scores range from 0 to 100, with a higher score indicating a worse outcome.
|
Baseline up to 3.7 years
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsramme: Up to 3.7 years
|
TEAEs are assessed based on NCI CTCAE v5.0.
|
Up to 3.7 years
|
|
Percentage of Participants Who are Anti-Drug Antibody (ADA)-Positive at Any Time (Baseline and Post-baseline) and Who Have a Treatment-emergent Anti-Drug Antibody
Tidsramme: Baseline up to 3.7 years
|
The ADA prevalence, which is the percentage of participants who are ADA positive at any time point (baseline or post-baseline), as well as the ADA incidence, which is the proportion of participants having treatment-emergent ADA during the study period, will only be reported in participants receiving I-DXd.
|
Baseline up to 3.7 years
|
|
Pharmacokinetic Parameter Maximum Concentration (Cmax) for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
Tidsramme: Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336 and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI and 6 hrs post dose; Cycles 4, 5, and every 2 cycles thereafter up to 3.7 years BI (each cycle is 21 days)
|
Cmax will be assessed using non-compartmental methods in participants randomized to the I-DXd group.
|
Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336 and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI and 6 hrs post dose; Cycles 4, 5, and every 2 cycles thereafter up to 3.7 years BI (each cycle is 21 days)
|
|
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
Tidsramme: Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336 and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI and 6 hrs post dose; Cycles 4, 5 and every 2 cycles thereafter up to 3.7 years BI (each cycle is 21 days)
|
Tmax will be assessed using non-compartmental methods in participants randomized to the I-DXd group.
|
Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336 and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI and 6 hrs post dose; Cycles 4, 5 and every 2 cycles thereafter up to 3.7 years BI (each cycle is 21 days)
|
|
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve Up to the Last Quantifiable Time Point (AUClast) for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
Tidsramme: Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336 and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI and 6 hrs post dose; Cycles 4, 5, and every 2 cycles thereafter up to 3.7 years BI (each cycle is 21 days)
|
AUClast will be assessed using non-compartmental methods in participants randomized to the I-DXd group.
|
Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336 and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI and 6 hrs post dose; Cycles 4, 5, and every 2 cycles thereafter up to 3.7 years BI (each cycle is 21 days)
|
|
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve dosing interval (AUCtau) for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
Tidsramme: Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336 and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI and 6 hrs post dose; Cycles 4, 5, and every 2 cycles thereafter up to 3.7 years BI (each cycle is 21 days)
|
AUCtau will be assessed using non-compartmental methods in participants randomized to the I-DXd group.
|
Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336 and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI and 6 hrs post dose; Cycles 4, 5, and every 2 cycles thereafter up to 3.7 years BI (each cycle is 21 days)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Global Clinical Director, Daiichi Sankyo
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. mai 2024
Primær fullføring (Antatt)
30. januar 2028
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
2. januar 2024
Først innsendt som oppfylte QC-kriteriene
2. januar 2024
Først lagt ut (Faktiske)
12. januar 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DS7300-188
- 2023-509628-16-00 (Ctis: EU CT)
- 2031230631 (Annen identifikator: jRCT)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Avidentifiserte individuelle deltakerdata (IPD) om fullførte studier og relevante kliniske utprøvingsdokumenter kan være tilgjengelig på forespørsel på https://vivli.org/.
I tilfeller der kliniske forsøksdata og støttedokumenter er gitt i henhold til selskapets retningslinjer og prosedyrer, vil Daiichi Sankyo fortsette å beskytte personvernet til deltakerne i kliniske forsøk.
Detaljer om datadelingskriterier og prosedyren for å be om tilgang finnes på denne nettadressen: https://vivli.org/ourmember/daiichi-sankyo/
IPD-delingstidsramme
Fullførte studier som har nådd en global slutt eller fullføring med alle datasett som er samlet inn og analysert, og som legemidlet og indikasjonen har mottatt markedsføringsgodkjenning fra EU (EU) og USA (USA), og/eller Japan (JP) for på eller etter 1. januar 2014 eller av helsemyndighetene i USA eller EU eller JP når regulatoriske innsendinger i alle regioner ikke er planlagt og etter at de primære studieresultatene er akseptert for publisering.
Tilgangskriterier for IPD-deling
Formell forespørsel fra kvalifiserte vitenskapelige og medisinske forskere om IPD og kliniske studiedokumenter om fullførte kliniske studier som støtter produkter sendt inn og lisensiert i USA, EU og/eller Japan fra 1. januar 2014 og utover med det formål å utføre legitim forskning.
Dette må være i samsvar med prinsippet om å ivareta studiedeltakernes personvern og i samsvar med å gi informert samtykke
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .