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Brief Title: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Official Title: A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)
Study ID: NCT06203210
Brief Summary: This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
Detailed Description: The primary objective of this study is to assess whether treatment with I-DXd improves objective response rate (ORR) and prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC. The secondary objectives of the study are to further evaluate the efficacy/safety of I-DXd, health economics and outcome research measures (including patient reported outcomes), immunogenicity of I-DXd, B7-H3 protein expression, and characterize the pharmacokinetics of I-DXd.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Highlands Oncology Group, Springdale, Arkansas, United States
Providence Medical Foundation, Fullerton, California, United States
David Geffen School of Medicine, Los Angeles, California, United States
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Adventhealth Cancer Insitute, Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc, Tampa, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Baptist Health Lexington, Lexington, Kentucky, United States
University of Maryland Medical Group, Baltimore, Maryland, United States
John Hopkins School of Medicine, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Mercy Clinic Oncology and Hematology Sindelar Cancer Center, Saint Louis, Missouri, United States
Nebraska Educational Biomedical Research Association, Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Astera Cancer Care, East Brunswick, New Jersey, United States
Meridian Health Systems, Neptune, New Jersey, United States
Montefiore Medical Center Prime, Bronx, New York, United States
Clinical Research Alliance, Inc, Lake Success, New York, United States
New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone, Mineola, New York, United States
Duke University Health System, Durham, North Carolina, United States
Mercy Medical Center, Canton, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
The West Clinic, Germantown, Tennessee, United States
Houston Methodist Cancer Center, Houston, Texas, United States
University of Texas Md Anderson Cancer Center, Houston, Texas, United States
Texas Oncology, P.A. - Tyler, Tyler, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Ballarat Base Hospital, Ballarat, , Australia
Chris Oâ Brien Lifehouse, Camperdown, , Australia
Sunshine Hospital, St Albans, , Australia
St John of God Subiaco Hospital, Subiaco, , Australia
Townsville Cancer Centre, Townsville, , Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
UZA, Edegem, , Belgium
Jessa Ziekenhuis Hospital, Hasselt, , Belgium
Chu de Liă Ge, Liege, , Belgium
AZ DELTA, Roeselare, , Belgium
Chu Ucl Namur, Yvoir, , Belgium
Hospital de Că'Ncer de Barretos - Fundaă Ă O Pio Xii, Barretos, , Brazil
Cepon - Centro de Pesquisas Oncolă"Gicas de Santa Catarina, FlorianĂłpolis, , Brazil
Clínica de Neoplasias Litoral Ltda., ItajaĂ-, , Brazil
Hospital São Lucas Da Pucrs, Porto Alegre, , Brazil
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia, Santo Andre, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto, Sao Jose Rio Preto, , Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira, SĂŁo Paulo, , Brazil
Hospital Sirio-Libanes, SĂŁo Paulo, , Brazil
Hospital Benefică Ncia Portuguesa de Să O Paulo, SĂŁo Paulo, , Brazil
A. C. Camargo Cancer Center, SĂŁo Paulo, , Brazil
Queen Elizabeth Ii Health Sciences Centre, Halifax, , Canada
Princess Margaret Cancer Center, Toronto, , Canada
Beijing Cancer Hospital, Beijing, , China
Beijing Chest Hospital,Capital Medical University, Beijing, , China
Jilin Province Tumor Hospital, Changchun, , China
Hunan Cancer Hospital, Changsha, , China
Sichuan Cancer Hospital, Chengdu, , China
West China Hospital, Sichuan University, Chengdu, , China
Chongqing University Cancer Hospital, Chongqing, , China
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Shandong Cancer Hospital, Jinan, , China
Linyi Cancer Hospital, Linyi, , China
The Second Peoples Hospital of Neijiang, Neijiang, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
The Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, , China
Hubei Cancer Hospital, Wuhan, , China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, , China
The First Affiliated Hospital of Xiâ An Jiaotong University, Xi'an, , China
Xiangyang Central Hospital, Xiangyang, , China
Yantai Yuhuangding Hospital, Yantai, , China
Henan Cancer Hospital, Zhengzhou, , China
Institut Sainte Catherine, Avignon Cedex 9, , France
Chu Bordeaux, Bordeaux cedex, , France
Centre Hospitalier Intercommunal de Cră Teil, Creteil Cedex, , France
Hopital Albert Calmette - Chu Lille, Lille Cedex, , France
Chu Limoges - Hopital Du Cluzeau, Limoges cedex, , France
Centre Léon Bérard, Lyon, , France
Assistance Publique-Hă"Pitaux de Marseille, Marseille, , France
Hopital Arnaud de Villeneuve, Montpellier cedex 05, , France
Institut Régional Du Cancer de Montpellier, Montpellier, , France
Ch de Mulhouse - Hă"Pital Emile Muller, Mulhouse Cedex, , France
Institut Curie - Site de Paris, Paris Cedex 05, , France
Hopital Tenon, Paris, , France
Chu Rennes - Hopital Pontchaillou, Rennes cedex 09, , France
Chu Nantes - Hă"Pital Guillaume Et Renă Laă<Nnec, Saint Herblain, , France
Institut de Cancerologie de La Loire, Saint-Priest-En-Jarez, , France
Hă"Pital Foch, Suresnes Cedex, , France
Institut Gustave Roussy, Villejuif cedex, , France
Evangelische Lungenklinik Berlin, Berlin, , Germany
Helios Klinikum Erfurt, Erfurt, , Germany
Universtitaetsklinikum Essen, Essen, , Germany
Universitaetsklinikum Frankfurt Goethe-Universitaet, Frankfurt am Main, , Germany
Krankenhaus Nordwest Gmbh, Frankfurt, , Germany
Asklepios Fachkliniken Muenchen-Gauting, Gauting, , Germany
Srh Wald-Klinikum Gera Gmbh, Gera, , Germany
Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen, Giessen, , Germany
Asklepios Klinik Harburg, Hamburg, , Germany
Lki Lungenfachklinik Immenhausen, Immenhausen/Krs. Kassel, , Germany
Staedtisches Krankenhaus Kiel, Kiel, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Pius-Hospital Oldenburg, Oldenburg, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Semmelweis Egyetem, Budapest, , Hungary
Orszagos Koranyi Pulmonologiai Intezet, Budapest, , Hungary
Orszagos Onkologiai Intezet, Budapest, , Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz, Gyor, , Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz, Kecskemet, , Hungary
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari, Bari, , Italy
Humanitas Gavazzeni, Bergamo, , Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili), Brescia, , Italy
Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico), Catania, , Italy
Azienda Ospedaliero Universitaria Mater Domini, Catanzaro, , Italy
Istituto Nazionale Per La Ricerca Sul Cancro Di Genova, Genova, , Italy
Ospedale San Raffaele, Milano, , Italy
Fondazione Irccs Istituto Nazionale Dei Tumori, Milano, , Italy
Ieo Istituto Europeo Di Oncologia, Milano, , Italy
Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo), Monza, , Italy
Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania  Luigi Vanvitelliâ, Napoli, , Italy
Azienda Ospedaliero Universitaria Di Parma, Parma, , Italy
Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia, Perugia, , Italy
Istituto Nazionale Tumori Regina Elena Irccs, Roma, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Centro Ricerche Cliniche Di Verona S.R.L., Verona, , Italy
National Cancer Center Hospital, Chuo-ku, , Japan
Kyushu University Hospital, Fukuoka, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
The Cancer Institute Hospital of Jfcr, Koto-ku, , Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, , Japan
Okayama University Hospital, Okayama, , Japan
Kindai University Hospital, Osaka-Sayama, , Japan
Kitasato University Hospital, Sagamihara, , Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, , Japan
Shizuoka Cancer Center, Sunto-gun, , Japan
Osaka Medical and Pharmaceutical University Hospital, Takatsuki, , Japan
Wakayama Medical University Hospital, Wakayama, , Japan
Chungbuk National University Hospital, Cheongju, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyan-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, St. Vincent'S Hospital, Suwon-si, , Korea, Republic of
Jeroen Bosch Ziekenhuis, 's Hertogenbosch, , Netherlands
Netherlands Cancer Institute, Amsterdam, , Netherlands
Maastricht University Medical Center, Maastricht, , Netherlands
Etz Elisabeth, Tilburg, , Netherlands
Krakowski Szpital Specjalistyczny Im. Jana Pawla Ii, Krakow, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy, Otwock, , Poland
Szpital Specjalistyczny W Prabutach, Prabuty, , Poland
Provita Prolife, Tomaszow Mazowiecki, , Poland
Centro Hospitalar E Universită Rio de Coimbra E.P.E., Coimbra, , Portugal
Hospital Da Senhora Da Oliveira Guimară Es, Guimarães, , Portugal
Hospital Da Luz, Lisboa, , Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente, Lisboa, , Portugal
Institutul Oncologic 'Prof. Dr. Ion Chiricuta' Cluj Napoca, Cluj Napoca, , Romania
S.C Radiotherapy Center Cluj S.R.L, Comuna Floresti, , Romania
S.C Centrul de Oncologie Sfantul Nectarie Craiova, Craiova, , Romania
S.C. Sigmedical Services Srl, Suceava, , Romania
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau, Barcelona, , Spain
Hospital Universitari Vall D'Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Hospital Universitario Ciudad de Jaen, Jaen, , Spain
Hospital de Especialidades de Jerez de La Frontera, Jerez De Frontera, , Spain
Ico L'Hospitalet - Hospital Duran I Reynals, L'Hospitalet de Llobregat, , Spain
Complejo Hospitalario Universitario Insular Materno-Infantil, Las Palmas de Gran Canaria, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Regional Universitario de Malaga, MĂĄlaga, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Inselspital - Universitaetsspital Bern, Bern, , Switzerland
Hfr Fribourg/Kantonsspital Fribourg, Fribourg, , Switzerland
Kantonsspital St. Gallen, St. Gallen, , Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospitalx, Tainan, , Taiwan
National Taiwan University Cancer Centre, Taipei, , Taiwan
Taipei Medical University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Taoyuan County, , Taiwan
Taipei Veterans General Hospital, Tapei, , Taiwan
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital, Ankara, , Turkey
Ankara City Hospital, Ankara, , Turkey
Dicle University, Medical Faculty, Diyarbakir, , Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul, , Turkey
Medipol University Medical Faculty, Istanbul, , Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, , Turkey
Izmir Medicalpark Hospital, Izmir, , Turkey
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
St James'S University Hospital, Leeds, , United Kingdom
The Christie, Manchester, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Name: Global Clinical Director
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR