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Spots Global Cancer Trial Database for A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Global Clinical Director

Affiliation: Daiichi Sankyo

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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