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RECRUITING
NCT06203210
PHASE3

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

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

Interventions

DRUG

Ifinatamab deruxtecan

12 mg/kg intravenous dose on Day 1 of each 21-day cycle

DRUG

Topotecan

Topotecan will be administered per local standard-of-care (SoC)

DRUG

Amrubicin

Amrubicin will be administered per local SoC

DRUG

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

And 129 more locations on ClinicalTrials.gov