En undersøgelse af Ifinatamab Deruxtecan versus behandling af lægens valg hos forsøgspersoner med recidiverende småcellet lungekræft (IDeate-Lung02)
4. august 2026 opdateret af: Daiichi Sankyo
En fase 3, multicenter, randomiseret, åben-label undersøgelse af Ifinatamab Deruxtecan (I-DXd), et B7-H3-antistofkonjugat (ADC), versus behandling af lægens valg (TPC) hos forsøgspersoner med recidiverende småcellet lungekræft (SCLC) ) (IDeate-2)
Denne undersøgelse blev designet til at sammenligne effektiviteten og sikkerheden af I-DXd med behandling efter lægens valg hos deltagere med recidiverende småcellet lungekræft (SCLC).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Det primære formål med denne undersøgelse er at vurdere, om behandling med I-DXd forbedrer objektiv responsrate (ORR) og forlænger den samlede overlevelse (OS) sammenlignet med behandling efter lægens valg blandt deltagere med recidiverende SCLC.
De sekundære mål med undersøgelsen er yderligere at evaluere effektiviteten/sikkerheden af I-DXd, sundhedsøkonomi og resultatforskningsmålinger (herunder patientrapporterede resultater), immunogenicitet af I-DXd og B7-H3-proteinekspression.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
540
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Daiichi Sankyo Contact for Clinical Trial Information
- Telefonnummer: 9089926400
- E-mail: CTRinfo@dsi.com
Studiesteder
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Ballarat, Australien, 3350
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- Ballarat Base Hospital
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Kontakt:
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Bedford Park, Australien, 5042
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- Flinders Medical Centre (Fmc)
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Kontakt:
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Camperdown, Australien, 2050
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- Chris O Brien Lifehouse
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Kontakt:
- Principal Investigator
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St Albans, Australien, 3021
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- Sunshine Hospital
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Kontakt:
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Subiaco, Australien, 6008
- Rekruttering
- St John of God Subiaco Hospital
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Townsville, Australien, 4814
- Rekruttering
- Townsville Cancer Centre
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Kontakt:
- Principal Investigator
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Woolloongabba, Australien, 4102
- Rekruttering
- Princess Alexandra Hospital
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Kontakt:
- Principal Investigator
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Brussels, Belgien, 1200
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- Cliniques universitaires Saint-Luc
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Edegem, Belgien, 2650
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- Universitair Ziekenhuis Antwerpen
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Hasselt, Belgien, 3500
- Rekruttering
- Jessa Ziekenhuis Hospital
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Kontakt:
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Liège, Belgien, 4000
- Rekruttering
- Centre Hospitalier Universitaire de Liege
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Kontakt:
- Principal Investigator
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Roeselare, Belgien, 8800
- Ikke rekrutterer endnu
- AZ Delta
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Kontakt:
- Principal Investigator
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Yvoir, Belgien, 5530
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- CHU UCL Namur
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Kontakt:
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Barretos, Brasilien, 14784-400
- Rekruttering
- Departmento de Pesquisa Clinica- Hospital de Amor de Barretos
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Kontakt:
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Florianópolis, Brasilien, 88034-000
- Rekruttering
- Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
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Kontakt:
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Itajaí, Brasilien, 88301-220
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- Clinica de Neoplasias Litoral
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Kontakt:
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Porto Alegre, Brasilien, 90610-000
- Rekruttering
- Hospital Sao Lucas da PUCRS
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Kontakt:
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Santo André, Brasilien, 09060-650
- Rekruttering
- Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
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Kontakt:
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São José do Rio Preto, Brasilien, 15090-000
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- Fundação Faculdade Regional de Medicina de São José do Rio Preto
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Kontakt:
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São Paulo, Brasilien, 01327-001
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- Hospital Alemao Oswaldo Cruz
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Kontakt:
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São Paulo, Brasilien, 01308-050
- Ikke rekrutterer endnu
- Hospital Sírio-Libanês
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Kontakt:
- Principal Investigator
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São Paulo, Brasilien, 01509-900
- Ikke rekrutterer endnu
- A. C. Camargo Cancer Center
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Kontakt:
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São Paulo, Brasilien, 01246-000
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- Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
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Kontakt:
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São Paulo, Brasilien, 01321-001
- Rekruttering
- Hospital Beneficăncia Portuguesa de Săo Paulo
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Kontakt:
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Brampton, Canada, L6R 3J7
- Rekruttering
- William Osler Health System - Brampton Civic Hospital
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Edmonton, Canada, T6G 1Z2
- Rekruttering
- Cross Cancer Institute
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Kontakt:
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Québec, Canada, G1V 4G5
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- Institut Universitaire de cardiologie et de pneumologie de Quebec
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Kontakt:
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Toronto, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Center
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Kontakt:
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Winnipeg, Canada, R3E0V9
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- CancerCare Manitoba
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Kontakt:
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Arkansas
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Springdale, Arkansas, Forenede Stater, 72762
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- Highlands Oncology Group
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Kontakt:
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California
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Fullerton, California, Forenede Stater, 92835
- Rekruttering
- Clinical Research Providence Medical Foundation
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Kontakt:
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Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- UCLA Hematology-Oncology
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- Principal Investigator
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San Francisco, California, Forenede Stater, 94115
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- UCSF Mission Bay Mission Hall
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Florida
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Miami, Florida, Forenede Stater, 33136
- Rekruttering
- University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
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Kontakt:
- Principal Investigator
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Orlando, Florida, Forenede Stater, 32804
- Rekruttering
- AdventHealth Orlando, Cancer Institute
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Kontakt:
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Tampa, Florida, Forenede Stater, 33612
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- H. Lee Moffitt Cancer Center and Research Institute, Inc
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Kontakt:
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- Rush MD Anderson Cancer Center
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Kontakt:
- Principal Investigator
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
- Rekruttering
- Baptist Health Lexington
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Kontakt:
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Rekruttering
- University of Maryland Greenebaum Comprehensive Cancer Center
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Kontakt:
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Baltimore, Maryland, Forenede Stater, 21287
- Rekruttering
- John Hopkins School of Medicine
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Kontakt:
- Principal Investigator
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02216
- Rekruttering
- Dana-Farber Cancer Institute
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Kontakt:
- Principal Investigator
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Ikke rekrutterer endnu
- Henry Ford Health System
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Kontakt:
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Missouri
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St Louis, Missouri, Forenede Stater, 63128
- Rekruttering
- Mercy Clinic Oncology and Hematology Sindelar Cancer Center
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Kontakt:
- Principal Investigator
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198-6811
- Rekruttering
- University of Nebraska Medical Center
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Kontakt:
- Principal Investigator
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03766
- Rekruttering
- Dartmouth-Hitchcock Medical Center
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Kontakt:
- Principal Investigator
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New Jersey
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East Brunswick, New Jersey, Forenede Stater, 08816
- Rekruttering
- Astera Cancer Care
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Kontakt:
- Principal Investigator
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Neptune City, New Jersey, Forenede Stater, 07753
- Rekruttering
- Hackensack Meridian Health Jsumc
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Kontakt:
- Principal Investigator
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New York
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Lake Success, New York, Forenede Stater, 11042
- Rekruttering
- Clinical Research Alliance, Inc
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Kontakt:
- Principal Investigator
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New York, New York, Forenede Stater, 10016
- Rekruttering
- New York University Cancer Center - Laura and Isaac
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New York, New York, Forenede Stater, 10016
- Rekruttering
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long Island
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Kontakt:
- Principal Investigator
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The Bronx, New York, Forenede Stater, 10461
- Ikke rekrutterer endnu
- Montefiore Medical Center PRIME
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Kontakt:
- Principal Investigator
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Ohio
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Canton, Ohio, Forenede Stater, 44708
- Rekruttering
- Cleveland Clinic Mercy Hospital
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Kontakt:
- Principal Investigator
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Cincinnati, Ohio, Forenede Stater, 45236
- Rekruttering
- Oncology/Hematology Care Clinical Trials, Llc
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Kontakt:
- Principal Investigator
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- Ikke rekrutterer endnu
- Providence Portland Medical Center
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Kontakt:
- Principal Investigator
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- Rekruttering
- The West Clinic, PLLC dba West Cancer Center
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Kontakt:
- Principal Investigator
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Texas
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- University of Texas MD Anderson Cancer Center
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Kontakt:
- Principal Investigator
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Houston Methodist Cancer Center
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Kontakt:
- Principal Investigator
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Tyler, Texas, Forenede Stater, 75702
- Rekruttering
- Texas Oncology, P.A. - Tyler
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Kontakt:
- Principal Investigator
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
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- Medical College of Wisconsin
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Kontakt:
- Principal Investigator
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Avignon, Frankrig, 84000
- Rekruttering
- Institut Sainte Catherine
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Kontakt:
- Principal Investigator
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Bordeaux, Frankrig, 33075
- Ikke rekrutterer endnu
- CHU Bordeaux
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Kontakt:
- Principal Investigator
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Créteil, Frankrig, 94010
- Rekruttering
- Centre Hospitalier Intercommunal de Crăteil
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Kontakt:
- Principal Investigator
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Lille, Frankrig, 69037
- Rekruttering
- Institut Cœur Poumon CHU de Lille
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Limoges, Frankrig, 87042
- Rekruttering
- Chu Limoges - Hopital Du Cluzeau
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Kontakt:
- Principal Investigator
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Lyon, Frankrig, 69008
- Ikke rekrutterer endnu
- Centre Léon Bérard
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Kontakt:
- Principal Investigator
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Marseille, Frankrig, 13005
- Rekruttering
- Assistance Publique-Hăpitaux de Marseille
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Kontakt:
- Principal Investigator
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Montpellier, Frankrig, 34295
- Rekruttering
- Hopital Arnaud de Villeneuve
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Kontakt:
- Principal Investigator
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Montpellier, Frankrig, 34298
- Rekruttering
- Institut régional du Cancer de Montpellier
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Kontakt:
- Principal Investigator
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Mulhouse, Frankrig, 68100
- Rekruttering
- Ch de Mulhouse - Hăpital Emile Muller
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Kontakt:
- Principal Investigator
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Paris, Frankrig, 75020
- Rekruttering
- Hôpital Tenon
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Kontakt:
- Principal Investigator
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Paris, Frankrig, 75005
- Rekruttering
- Institut Curie - Site de Paris
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Kontakt:
- Principal Investigator
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Rennes, Frankrig, 35033
- Rekruttering
- CHU Rennes - Hôpital Pontchaillou
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Saint-Etienne, Frankrig, 42055
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- CHU de Saint Etienne
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Kontakt:
- Principal Investigator
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Saint-Herblain, Frankrig, 44805
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- Chu Nantes - Hăpital Guillaume Et Renă Laănnec
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Kontakt:
- Principal Investigator
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Saint-Priest-en-Jarez, Frankrig, 42270
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- Institut de Cancérologie de la Loire
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Kontakt:
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Suresnes, Frankrig, 92151
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- Hăpital Foch
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Kontakt:
- Principal Investigator
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Villejuif, Frankrig, 94805
- Ikke rekrutterer endnu
- Institut Gustave Roussy
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Kontakt:
- Principal Investigator
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Athens, Grækenland, 11528
- Ikke rekrutterer endnu
- General Hospital of Athens Alexandra
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Kontakt:
- Principal Investigator
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Athens, Grækenland, 11526
- Ikke rekrutterer endnu
- 'Henry Dynant' Hospital Center
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Kontakt:
- Principal Investigator
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Athens, Grækenland, 11527
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- General Hospital of Athens of Chest Diseases 'Sotiria'
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Kontakt:
- Principal Investigator
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Chaïdári, Grækenland, 124 62
- Ikke rekrutterer endnu
- University General Hospital "Attikon"
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Kontakt:
- Principal Investigator
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Larissa, Grækenland, 41110
- Rekruttering
- University General Hospital of Larissa
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Kontakt:
- Principal Investigator
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Piraeus, Grækenland, 185 47
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- Metropolitan Hospital
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Kontakt:
- Principal Investigator
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Pátrai, Grækenland, 26335
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- General Hospital of Patra Agios Andreas
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Kontakt:
- Principal Investigator
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Thessaloniki, Grækenland, 55236
- Rekruttering
- St Luke's Hospital
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Kontakt:
- Principal Investigator
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's-Hertogenbosch, Holland, 5223 GZ
- Rekruttering
- Jeroen Bosch Ziekenhuis
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Kontakt:
- Principal Investigator
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Amsterdam, Holland, 1066 CX
- Ikke rekrutterer endnu
- Netherlands Cancer Institute
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Kontakt:
- Principal Investigator
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Maastricht, Holland, 6229 HX
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- Maastricht University Medical Center
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Kontakt:
- Principal Investigator
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Tilburg, Holland, 5022 GC
- Rekruttering
- ETZ Elisabeth
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Bari, Italien, 70124
- Rekruttering
- Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
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Kontakt:
- Principal Investigator
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Bergamo, Italien, 24125
- Rekruttering
- Humanitas Gavazzeni
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Kontakt:
- Principal Investigator
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Brescia, Italien, 25124
- Ikke rekrutterer endnu
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
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Kontakt:
- Principal Investigator
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Catania, Italien, 95123
- Ikke rekrutterer endnu
- Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)
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Kontakt:
- Principal Investigator
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Catanzaro, Italien, 88100
- Rekruttering
- Azienda Ospedaliero Universitaria Renato Dulbecco
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Kontakt:
- Principal Investigator
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Genova, Italien, 16132
- Rekruttering
- Istituto Nazionale per la Ricerca sul Cancro di Genova
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Kontakt:
- Principal Investigator
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Milan, Italien, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Kontakt:
- Principal Investigator
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Milan, Italien, 20132
- Ikke rekrutterer endnu
- Ospedale San Raffaele
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Kontakt:
- Principal Investigator
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Milan, Italien, 20141
- Rekruttering
- IEO Istituto Europeo di Oncologia
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Kontakt:
- Principal Investigator
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Monza, Italien, 20900
- Ikke rekrutterer endnu
- Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
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Kontakt:
- Principal Investigator
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Naples, Italien, 80131
- Rekruttering
- Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania Âluigi Vanvitelliâ
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Kontakt:
- Principal Investigator
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Parma, Italien, 43100
- Rekruttering
- Azienda Ospedaliero Universitaria di Parma
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Kontakt:
- Principal Investigator
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Perugia, Italien, 06132
- Rekruttering
- Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
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Kontakt:
- Principal Investigator
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Roma, Italien, 00144
- Rekruttering
- Istituto Nazionale Tumori Regina Elena IRCCS
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Kontakt:
- Principal Investigator
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Rozzano, Italien, 20089
- Rekruttering
- Istituto Clinico Humanitas
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Kontakt:
- Principal Investigator
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Verona, Italien, 37134
- Rekruttering
- Centro Ricerche Cliniche di Verona s.r.l.
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Kontakt:
- Principal Investigator
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Chūōku, Japan, 104-0045
- Rekruttering
- National Cancer Center Hospital
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Kontakt:
- Principal Investigator
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Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital
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Kontakt:
- Principal Investigator
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Hirakata-shi, Japan, 573-1191
- Rekruttering
- Kansai Medical University Hospital
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Kontakt:
- Principal Investigator
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Kashiwa, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
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Kontakt:
- Principal Investigator
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Kōtoku, Japan, 135-8550
- Rekruttering
- The Cancer Institute Hospital of JFCR
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Kontakt:
- Principal Investigator
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Matsuyama, Japan, 791-0280
- Rekruttering
- National Hospital Organization Shikoku Cancer Center
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Kontakt:
- Principal Investigator
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Nakatogari, Japan, 411-8777
- Rekruttering
- Shizuoka Cancer Center
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Kontakt:
- Principal Investigator
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Okayama, Japan, 700-8558
- Rekruttering
- Okayama University Hospital
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Kontakt:
- Principal Investigator
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Osaka-Sakai, Japan, 590-0197
- Rekruttering
- Kindai University Hospital
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Kontakt:
- Principal Investigator
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Sagamihara, Japan, 252-0375
- Rekruttering
- Kitasato University Hospital
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Kontakt:
- Principal Investigator
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Sapporo, Japan, 003-0804
- Rekruttering
- National Hospital Organization Hokkaido Cancer Center
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Kontakt:
- Principal Investigator
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Takatsuki, Japan, 569-8686
- Rekruttering
- Osaka Medical and Pharmaceutical University Hospital
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Kontakt:
- Principal Investigator
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Wakayama, Japan, 641-8509
- Rekruttering
- Wakayama Medical University Hospital
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Kontakt:
- Principal Investigator
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Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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Kontakt:
- Principal Investigator
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Beijing, Kina, 100029
- Rekruttering
- China-Japan Friendship Hospital
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Beijing, Kina, 101149
- Rekruttering
- Beijing Chest Hospital,Capital Medical University
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Kontakt:
- Principal Investigator
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Changchun, Kina, 130012
- Rekruttering
- Jilin Province Tumor Hospital
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Kontakt:
- Principal Investigator
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Changsha, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital
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Kontakt:
- Principal Investigator
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Chengdu, Kina, 610041
- Rekruttering
- West China Hospital, Sichuan University
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Kontakt:
- Principal Investigator
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Chengdu, Kina, 610041
- Rekruttering
- Sichuan Cancer Hospital
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Kontakt:
- Principal Investigator
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Chongqing, Kina, 400030
- Rekruttering
- Chongqing University Cancer Hospital
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Kontakt:
- Principal Investigator
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Haerbin, Kina, 150081
- Ikke rekrutterer endnu
- Harbin Medical University Cancer Hospital
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Kontakt:
- Principal Investigator
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Hangzhou, Kina, 310022
- Ikke rekrutterer endnu
- Zhejiang Cancer Hospital
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Kontakt:
- Principal Investigator
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Hangzhou, Kina, 310003
- Rekruttering
- The First Affiliated Hospital, College of Medicine, Zhejiang University
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Kontakt:
- Principal Investigator
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Jiangxi, Kina, 330030
- Rekruttering
- The Second Affiliated Hospital of Nanchang University
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Kontakt:
- Principal Investigator
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Jinan, Kina, 250117
- Rekruttering
- Shandong Cancer Hospital
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Kontakt:
- Principal Investigator
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Linyi, Kina, 276001
- Rekruttering
- Linyi Cancer Hospital
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Kontakt:
- Principal Investigator
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Neijiang, Kina, 641000
- Rekruttering
- The Second Peoples Hospital of Neijiang
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Kontakt:
- Principal Investigator
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Shandong, Kina, 264099
- Rekruttering
- Yantai YuHuangDing Hospital
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Shanghai, Kina, 200032
- Ikke rekrutterer endnu
- Fudan University Shanghai Cancer Center
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Kontakt:
- Principal Investigator
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Shenyang, Kina, 110042
- Rekruttering
- Liaoning Cancer Hospital & Institute
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Tianjin, Kina, 300060
- Rekruttering
- Tianjin Medical University Cancer Institute & Hospital
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Kontakt:
- Principal Investigator
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Wuhan, Kina, 430079
- Ikke rekrutterer endnu
- Hubei Cancer Hospital
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Kontakt:
- Principal Investigator
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Wuhan, Kina, 430022
- Rekruttering
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Kontakt:
- Principal Investigator
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Wuhan, Kina, 430030
- Rekruttering
- Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH
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Kontakt:
- Principal Investigator
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Xi'an, Kina, 710061
- Rekruttering
- The First Affiliated Hospital of Xian Jiaotong University
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Xiangyang, Kina, 441021
- Ikke rekrutterer endnu
- Xiangyang Central Hospital
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Kontakt:
- Principal Investigator
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Zhengzhou, Kina, 450008
- Rekruttering
- Henan Cancer Hospital
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Kontakt:
- Principal Investigator
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Ürümqi, Kina, 830000
- Rekruttering
- The Affiliated Cancer Hospital of Xinjiang Medical university
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Kontakt:
- Principal Investigator
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Bydgoszcz, Polen, 85-796
- Rekruttering
- Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
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Kontakt:
- Principal Investigator
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Lodz, Polen, 93-338
- Ikke rekrutterer endnu
- Instytut Centrum Zdrowia Matki Polki
-
Kontakt:
- Principal Investigator
-
Otwock, Polen, 05-400
- Rekruttering
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
-
Kontakt:
- Principal Investigator
-
Prabuty, Polen, 82-550
- Ikke rekrutterer endnu
- Szpital Specjalistyczny w Prabutach
-
Kontakt:
- Principal Investigator
-
Tomaszów Mazowiecki, Polen, 97-200
- Rekruttering
- Provita Prolife
-
Kontakt:
- Principal Investigator
-
-
-
-
-
Coimbra, Portugal, 3040
- Rekruttering
- Centro Hospitalar E Universitărio de Coimbra E.P.E.
-
Kontakt:
- Principal Investigator
-
Guimarães, Portugal, 4835-044
- Rekruttering
- Hospital da Senhora da Oliveira Guimarães
-
Kontakt:
- Principal Investigator
-
Lisbon, Portugal, 1500-650
- Rekruttering
- Hospital da Luz
-
Kontakt:
- Principal Investigator
-
Lisbon, Portugal, 1769-001
- Rekruttering
- Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente
-
Kontakt:
- Principal Investigator
-
Porto, Portugal, 4099-001
- Rekruttering
- Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António
-
Kontakt:
- Principal Investigator
-
-
-
-
-
Bucharest, Rumænien, 407280
- Rekruttering
- S.C Radiotherapy Center Cluj S.R.L
-
Kontakt:
- Principal Investigator
-
Cluj-Napoca, Rumænien, 400015
- Ikke rekrutterer endnu
- Institutul Oncologic 'Prof. Dr. Ion Chiricuta' Cluj Napoca
-
Kontakt:
- Principal Investigator
-
Craiova, Rumænien, 200745
- Rekruttering
- S.C Centrul de Oncologie Sfantul Nectarie Craiova
-
Kontakt:
- Principal Investigator
-
Suceava, Rumænien, 720214
- Ikke rekrutterer endnu
- S.C. Sigmedical Services Srl
-
Kontakt:
- Principal Investigator
-
-
-
-
-
Bern, Schweiz, 3010
- Rekruttering
- Inselspital - Universitaetsspital Bern
-
Kontakt:
- Principal Investigator
-
Sankt Gallen, Schweiz, 9007
- Rekruttering
- Kantonsspital St. Gallen
-
Kontakt:
- Principal Investigator
-
Villars-sur-Glâne, Schweiz, 1752
- Rekruttering
- HFR Fribourg/Kantonsspital Fribourg
-
Kontakt:
- Principal Investigator
-
-
-
-
-
Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Kontakt:
- Principal Investigator
-
Barcelona, Spanien, 8035
- Rekruttering
- Hospital Universitari Vall d'Hebron
-
Kontakt:
- Principal Investigator
-
Barcelona, Spanien, 8025
- Rekruttering
- Hospital de La Santa Creu i Sant Pau
-
Kontakt:
- Principal Investigator
-
Córdoba, Spanien, 14004
- Rekruttering
- Hospital Universitario Reina Sofia
-
Kontakt:
- Principal Investigator
-
Jaén, Spanien, 23007
- Ikke rekrutterer endnu
- Hospital Universitario Ciudad de Jaen
-
Kontakt:
- Principal Investigator
-
Jerez de la Frontera, Spanien, 11408
- Rekruttering
- Hospital de Especialidades de Jerez de La Frontera
-
Kontakt:
- Principal Investigator
-
L'Hospitalet de Llobregat, Spanien, 08908
- Rekruttering
- ICO L'Hospitalet - Hospital Duran i Reynals
-
Kontakt:
- Principal Investigator
-
Las Palmas de Gran Canaria, Spanien, 35016
- Rekruttering
- Complejo Hospitalario Universitario Insular Materno-Infantil
-
Kontakt:
- Principal Investigator
-
Madrid, Spanien, 28034
- Rekruttering
- Hospital Universitario Ramon y Cajal
-
Kontakt:
- Principal Investigator
-
Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Kontakt:
- Principal Investigator
-
Madrid, Spanien, 28046
- Rekruttering
- Hospital Universitario La Paz
-
Kontakt:
- Principal Investigator
-
Madrid, Spanien, 28007
- Rekruttering
- Hospital General Universitario Gregorio Marañón
-
Kontakt:
- Principal Investigator
-
Madrid, Spanien, 28040
- Rekruttering
- Hospital Universitario Fundación Jiménez Díaz
-
Kontakt:
- Principal Investigator
-
Málaga, Spanien, 29010
- Rekruttering
- Hospital Regional Universitario de Málaga
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Seville, Spanien, 41013
- Rekruttering
- Hospital Universitario Virgen del Rocío
-
Kontakt:
- Principal Investigator
-
Seville, Spanien, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
-
Kontakt:
- Principal Investigator
-
Seville, Spanien, 41014
- Rekruttering
- Hospital Universitario Nuestra Señora de Valme
-
Kontakt:
- Principal Investigator
-
-
-
-
-
Cheongju-si, Sydkorea, 28644
- Rekruttering
- Chungbuk National University Hospital
-
Kontakt:
- Principal Investigator
-
Daegu, Sydkorea, 41404
- Rekruttering
- Kyungpook National University Chilgok Hospital
-
Kontakt:
- Principal Investigator
-
Seongnam-si, Sydkorea, 13620
- Rekruttering
- Seoul National University Bundang Hospital
-
Kontakt:
- Principal Investigator
-
Seoul, Sydkorea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System
-
Kontakt:
- Principal Investigator
-
Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Kontakt:
- Principal Investigator
-
Seoul, Sydkorea, 5505
- Rekruttering
- Asan Medical Center
-
Kontakt:
- Principal Investigator
-
Seoul, Sydkorea, 3080
- Rekruttering
- Seoul National University Hospital
-
Kontakt:
- Principal Investigator
-
Suwon, Sydkorea, 16499
- Rekruttering
- Ajou University Hospital
-
Kontakt:
- Principal Investigator
-
Suwon, Sydkorea, 16247
- Rekruttering
- The Catholic University of Korea, St. Vincent's Hospital
-
-
-
-
-
Kaohsiung City, Taiwan, 80756
- Rekruttering
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Kontakt:
- Principal Investigator
-
Taichung, Taiwan, 40705
- Rekruttering
- Taichung Veterans General Hospital
-
Kontakt:
- Principal Investigator
-
Taichung, Taiwan, 404327
- Rekruttering
- China Medical University Hospital
-
Kontakt:
- Principal Investigator
-
Tainan, Taiwan, 70403
- Rekruttering
- National Cheng Kung University Hospitalx
-
Kontakt:
- Principal Investigator
-
Taipei, Taiwan, 110301
- Rekruttering
- Taipei Medical University Hospital
-
Kontakt:
- Principal Investigator
-
Taipei, Taiwan, 11217
- Rekruttering
- Taipei Veterans General Hospital
-
Kontakt:
- Principal Investigator
-
Taipei, Taiwan, 10048
- Rekruttering
- National Taiwan University Cancer Centre
-
Kontakt:
- Principal Investigator
-
Taoyuan City, Taiwan, 333
- Rekruttering
- Chang Gung Memorial Hospital
-
Kontakt:
- Principal Investigator
-
-
-
-
-
Liberec, Tjekkiet, 460 63
- Rekruttering
- Krajska nemocnice Liberec a.s.
-
Kontakt:
- Principal Investigator
-
Olomouc, Tjekkiet, 77900
- Rekruttering
- Fakultni Nemocnice Olomouc
-
Kontakt:
- Principal Investigator
-
Prague, Tjekkiet, 140 59
- Rekruttering
- Fakultni Thomayerova nemocnice
-
Kontakt:
- Principal Investigator
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 6800
- Rekruttering
- Ankara Bilkent City Hospital
-
Kontakt:
- Principal Investigator
-
Ankara, Tyrkiet (Türkiye), 06105
- Rekruttering
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
-
Kontakt:
- Principal Investigator
-
Diyarbakır, Tyrkiet (Türkiye), 21080
- Rekruttering
- Dicle University, Medical faculty
-
Kontakt:
- Principal Investigator
-
Istanbul, Tyrkiet (Türkiye), 34093
- Rekruttering
- Goztepe Prof Dr Suleyman Yalcin City Hospital
-
Kontakt:
- Principal Investigator
-
Istanbul, Tyrkiet (Türkiye), 34098
- Rekruttering
- Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
-
Kontakt:
- Principal Investigator
-
Istanbul, Tyrkiet (Türkiye), 34214
- Rekruttering
- Medipol University Medical Faculty
-
Kontakt:
- Principal Investigator
-
Izmir, Tyrkiet (Türkiye), 35530
- Ikke rekrutterer endnu
- Izmir Medicalpark Hospital
-
Kontakt:
- Principal Investigator
-
-
-
-
-
Berlin, Tyskland, 13125
- Rekruttering
- Evangelische Lungenklinik Berlin
-
Kontakt:
- Principal Investigator
-
Erfurt, Tyskland, 99089
- Rekruttering
- Helios Klinikum Erfurt
-
Kontakt:
- Principal Investigator
-
Essen, Tyskland, 45122
- Rekruttering
- Universtitaetsklinikum Essen
-
Kontakt:
- Principal Investigator
-
Frankfurt, Tyskland, 60488
- Rekruttering
- Krankenhaus Nordwest GmbH
-
Kontakt:
- Principal Investigator
-
Frankfurt am Main, Tyskland, 60590
- Rekruttering
- Universitaetsklinikum Frankfurt Goethe-Universitaet
-
Kontakt:
- Principal Investigator
-
Gauting, Tyskland, 82131
- Rekruttering
- Asklepios Fachkliniken Muenchen-Gauting
-
Kontakt:
- Principal Investigator
-
Gera, Tyskland, 7548
- Rekruttering
- SRH Wald-Klinikum Gera GmbH
-
Kontakt:
- Principal Investigator
-
Giessen, Tyskland, 35392
- Rekruttering
- UNIVERSITATSKLINIKUM GIeBEN UND MARBURG GMBH
-
Kontakt:
- Principal Investigator
-
Hamburg, Tyskland, 21075
- Ikke rekrutterer endnu
- Asklepios Klinik Harburg
-
Kontakt:
- Principal Investigator
-
Immenhausen, Tyskland, 34376
- Rekruttering
- LKI Lungenfachklinik Immenhausen
-
Kontakt:
- Principal Investigator
-
Kiel, Tyskland, 24116
- Rekruttering
- Staedtisches Krankenhaus Kiel
-
Kontakt:
- Principal Investigator
-
Minden, Tyskland, 32429
- Ikke rekrutterer endnu
- Johannes Wesling Klinikum Minden
-
Kontakt:
- Principal Investigator
-
Oldenburg, Tyskland, 26121
- Ikke rekrutterer endnu
- Pius-Hospital Oldenburg
-
Kontakt:
- Principal Investigator
-
Ulm, Tyskland, 89081
- Ikke rekrutterer endnu
- Universitaetsklinikum Ulm
-
Kontakt:
- Principal Investigator
-
-
-
-
-
Budapest, Ungarn, 1088
- Ikke rekrutterer endnu
- Semmelweis Egyetem
-
Kontakt:
- Principal Investigator
-
Budapest, Ungarn, 1122
- Ikke rekrutterer endnu
- Országos Onkológiai Intézet
-
Kontakt:
- Principal Investigator
-
Budapest, Ungarn, 1121
- Rekruttering
- Orszagos Koranyi Pulmonologiai Intezet
-
Kontakt:
- Principal Investigator
-
Győr, Ungarn, 9024
- Rekruttering
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
-
Kontakt:
- Principal Investigator
-
Kecskemét, Ungarn, 6000
- Rekruttering
- Bacs-Kiskun Varmegyei Oktatokorhaz
-
Kontakt:
- Principal Investigator
-
-
-
-
-
Feldkirch, Østrig, 6800
- Rekruttering
- Landeskrankenhaus Feldkirch
-
Kontakt:
- Principal Investigator
-
Krems, Østrig, 3500
- Rekruttering
- Landesklinikum Krems
-
Kontakt:
- Principal Investigator
-
Linz, Østrig, 4020
- Rekruttering
- Kepler University Hospital
-
Kontakt:
- Principal Investigator
-
Vienna, Østrig, 1210
- Ikke rekrutterer endnu
- Klinik Floridsdorf
-
Kontakt:
- Principal Investigator
-
Vienna, Østrig, 1140
- Rekruttering
- Wiener Gesundheitsverband Klinik Penzing
-
Kontakt:
- Principal Investigator
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier
Deltagerne skal opfylde alle følgende kriterier for at være berettiget til randomisering i undersøgelsen:
- Underskriv og dater formularen til informeret samtykke før starten af eventuelle studiespecifikke kvalifikationsprocedurer.
- Voksne ≥18 år eller den lovlige minimumsalder (alt efter hvad der er højest) på det tidspunkt, hvor formularen til informeret samtykke underskrives.
- Har histologisk eller cytologisk dokumenteret SCLC.
- Deltageren skal levere tilstrækkelige baseline tumorprøver med tilstrækkelig mængde og kvalitet af tumorvævsindhold.
- Har modtaget tidligere behandling med mindst én tidligere platinbaseret linje som systemisk terapi for SCLC med mindst 2 behandlingscyklusser.
- Har mindst én målbar læsion i henhold til RECIST v1.1 som vurderet af investigator.
- Har dokumentation for radiologisk sygdomsprogression på eller efter den seneste systemiske behandling.
- Har ECOG PS på ≤1.
- Deltagere med ubehandlede og asymptomatiske hjernemetastaser eller forsøgspersoner med behandlede hjernemetastaser, som ikke længere er symptomatiske, og som ikke kræver behandling med steroider, kan indgå i undersøgelsen, hvis de er kommet sig over den akutte toksiske effekt af strålebehandling.
Eksklusionskriterier
Deltagere, der opfylder et af følgende kriterier, vil blive diskvalificeret fra at deltage i undersøgelsen:
- Har modtaget tidligere behandling med orlotamab, enoblituzumab eller andre humaniserede anti-B7 homolog 3 (B7-H3) målrettede midler, inklusive I-DXd.
- Har modtaget tidligere behandling med en ADC, der består af et exatecanderivat (f.eks. trastuzumab deruxtecan).
- Har modtaget nogen af komparatorerne anvendt i denne undersøgelse eller en hvilken som helst topoisomerase I-hæmmer.
- Har utilstrækkelig udvaskningsperiode før randomisering som specificeret i protokollen.
- Har nogen af følgende tilstande inden for de seneste 6 måneder: cerebrovaskulær ulykke, forbigående iskæmisk anfald eller en anden arteriel tromboembolisk hændelse.
- Har ukontrolleret eller betydelig hjerte-kar-sygdom.
- Har klinisk signifikant hornhindesygdom.
- Har en historie med (ikke-infektiøs) interstitiel lungesygdom (ILD)/pneumonitis, der krævede kortikosteroider, nuværende ILD/pneumonitis eller mistanke om ILD/pneumonitis, som ikke kan udelukkes ved billeddiagnostik ved screening.
- Har klinisk alvorlig lungekompromittering som følge af interkurrente lungesygdomme, inklusive, men ikke begrænset til, enhver underliggende lungesygdom og potentiel lungepåvirkning forårsaget af autoimmune, bindevævs- eller inflammatoriske lidelser, forudgående fuldstændig pneumonektomi eller behov for supplerende ilt.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 dosis på dag 1 i hver 21-dages cyklus
Andre navne:
|
|
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 blive administreret pr. lokal SoC
Topotecan will be administered per local standard-of-care (SoC)
Amrubicin will be administered per local SoC
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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)
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Tmax will be assessed using non-compartmental methods in participants randomized to the I-DXd group.
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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)
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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)
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AUClast will be assessed using non-compartmental methods in participants randomized to the I-DXd group.
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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)
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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)
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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)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Global Clinical Director, Daiichi Sankyo
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. maj 2024
Primær færdiggørelse (Anslået)
30. januar 2028
Studieafslutning (Anslået)
1. december 2029
Datoer for studieregistrering
Først indsendt
2. januar 2024
Først indsendt, der opfyldte QC-kriterier
2. januar 2024
Først opslået (Faktiske)
12. januar 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DS7300-188
- 2023-509628-16-00 (Ctis: EU CT)
- 2031230631 (Anden identifikator: jRCT)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identificerede individuelle deltagerdata (IPD) om afsluttede undersøgelser og relevante understøttende kliniske forsøgsdokumenter kan være tilgængelige efter anmodning på https://vivli.org/.
I tilfælde, hvor data fra kliniske forsøg og understøttende dokumenter leveres i overensstemmelse med vores virksomheds politikker og procedurer, vil Daiichi Sankyo fortsætte med at beskytte privatlivets fred for vores deltagere i kliniske forsøg.
Detaljer om datadelingskriterier og proceduren for at anmode om adgang kan findes på denne webadresse: https://vivli.org/ourmember/daiichi-sankyo/
IPD-delingstidsramme
Fuldførte undersøgelser, der har nået en global afslutning eller afslutning med alle datasæt indsamlet og analyseret, og for hvilke medicinen og indikationen har modtaget markedsføringsgodkendelse fra EU (EU) og USA (USA) og/eller Japan (JP) på eller efter den 1. januar 2014 eller af sundhedsmyndighederne i USA eller EU eller JP, når regulatoriske indsendelser i alle regioner ikke er planlagt, og efter at de primære undersøgelsesresultater er blevet accepteret til offentliggørelse.
IPD-delingsadgangskriterier
Formel anmodning fra kvalificerede videnskabelige og medicinske forskere om IPD og kliniske undersøgelsesdokumenter om afsluttede kliniske forsøg, der understøtter produkter indsendt og licenseret i USA, EU og/eller Japan fra 1. januar 2014 og videre med det formål at udføre lovlig forskning.
Dette skal være i overensstemmelse med princippet om at beskytte undersøgelsesdeltageres privatliv og i overensstemmelse med afgivelse af informeret samtykke
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .