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A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Sponsor: Daiichi Sankyo
Summary
This study is 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).
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
540
Start Date
2024-05-21
Completion Date
2029-12-01
Last Updated
2026-08-06
Healthy Volunteers
No
Conditions
Interventions
Ifinatamab deruxtecan
12 mg/kg intravenous dose on Day 1 of each 21-day cycle
Topotecan
Topotecan will be administered per local standard-of-care (SoC)
Amrubicin
Amrubicin will be administered per local SoC
Lurbinectedin
Lurbinectedin will be administered per local SoC
Locations (229)
Highlands Oncology Group
Springdale, Arkansas, United States
Clinical Research Providence Medical Foundation
Fullerton, California, United States
UCLA Hematology-Oncology
Los Angeles, California, United States
UCSF Mission Bay Mission Hall
San Francisco, California, United States
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami, Florida, United States
AdventHealth Orlando, Cancer Institute
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Maryland Greenebaum Comprehensive Cancer Center
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
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Hackensack Meridian Health Jsumc
Neptune City, New Jersey, United States
Clinical Research Alliance, Inc
Lake Success, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long Island
New York, New York, United States
New York University Cancer Center - Laura and Isaac
New York, New York, United States
Montefiore Medical Center Prime
The Bronx, New York, United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, United States
Oncology/Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
THE WEST CLINIC, PLLC dba West Cancer Center
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
Flinders Medical Centre (Fmc)
Bedford Park, Australia
Chris O 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
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Landesklinikum Krems
Krems, Austria
Kepler University Hospital
Linz, Austria
Wiener Gesundheitsverband Klinik Penzing
Vienna, Austria
Klinik Floridsdorf
Vienna, Austria
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Jessa Ziekenhuis Hospital
Hasselt, Belgium
Centre Hospitalier Universitaire de Liege
Liège, Belgium
AZ DELTA
Roeselare, Belgium
Chu Ucl Namur
Yvoir, Belgium
Departmento de Pesquisa Clinica- Hospital de Amor de Barretos
Barretos, Brazil
Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
Florianópolis, Brazil
Clínica de Neoplasias Litoral
Itajaí, Brazil
Hospital São Lucas Da Pucrs
Porto Alegre, Brazil
Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, Brazil
ICESP Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, Brazil
Hospital Sirio-Libanes
São Paulo, Brazil
Hospital Beneficăncia Portuguesa de Săo Paulo
São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil
A. C. Camargo Cancer Center
São Paulo, Brazil
William Osler Health System - Brampton Civic Hospital
Brampton, Canada
Cross Cancer Institute
Edmonton, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Canada
Princess Margaret Cancer Center
Toronto, Canada
Cancercare Manitoba
Winnipeg, Canada
China-Japan Friendship Hospital
Beijing, China
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
Harbin Medical University Cancer Hospital
Haerbin, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
The Second Affiliated Hospital of Nanchang University
Jiangxi, China
Shandong Cancer Hospital
Jinan, China
Linyi Cancer Hospital
Linyi, China
The Second Peoples Hospital of Neijiang
Neijiang, China
Yantai Yuhuangding Hospital
Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, China
Liaoning Cancer Hospital & Institute
Shenyang, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital Tjh
Wuhan, China
Hubei Cancer Hospital
Wuhan, China
The First Affiliated Hospital of Xiân Jiaotong University
Xi'an, China
Xiangyang Central Hospital
Xiangyang, China
Henan Cancer Hospital
Zhengzhou, China
Krajska Nemocnice Liberec A.S.
Liberec, Czechia
Fakultni Nemocnice Olomouc
Olomouc, Czechia
Fakultni Thomayerova Nemocnice
Prague, Czechia
Institut Sainte Catherine
Avignon, France
Chu Bordeaux
Bordeaux, France
Centre Hospitalier Intercommunal de Crăteil
Créteil, France
Institut Cœur Poumon CHU de Lille
Lille, France
Chu Limoges - Hopital Du Cluzeau
Limoges, France
Centre Léon Bérard
Lyon, France
Assistance Publique-Hăpitaux de Marseille
Marseille, France