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AzTrials

Small Cell Lung CancerPhase 3IDeate-Lung02NCT06203210

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

A Phase 3 study testing Ifinatamab deruxtecan, Topotecan and Amrubicin in people with Small Cell Lung Cancer, run by Daiichi Sankyo at 229 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Ifinatamab deruxtecan, Topotecan and Amrubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
229 sitesin 23 countries
Study dates
21 May 2024to 1 Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all the following criteria to be eligible for randomization into the study:
  • Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.
  • Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
  • Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
  • The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
  • Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy free-interval [CTFI] (duration from stop date of the platinum agent in 1L therapy to radiological PD) of ≥30 days.
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  • Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
  • Has documentation of radiological disease progression on or after the most recent systemic therapy.
  • Has ECOG PS of less than or equal to (≤)1 within 7 days prior to Cycle 1 Day 1 (C1D1).
  • Participants with brain metastasis/leptomeningeal disease are eligible if protocol specified criteria are met.

Who cannot join

  • Participants who meet any of the following criteria will be disqualified from entering the study:
  • Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
  • Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
  • Has received any of the comparators used in this study or any topoisomerase I inhibitor.
  • Has inadequate washout period before randomization as specified in the protocol.
  • Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
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  • Has uncontrolled or significant cardiovascular (CV) disease.
  • Has clinically significant corneal disease.
  • All of the following indicators of interstitial lung disease (ILD)/pneumonitis are excluded:
  • Any history of ILD/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids.
  • Current diagnosis of ILD.
  • Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out. Radiographic findings may include presence of lung parenchymal fibrosis, combined fibrosis and emphysema (CPFE), and/or interstitial lung abnormalities such as reticular opacities, traction bronchiectasis, honeycombing, or extensive ground glass opacities. Screening computed tomography (CT) scans must be submitted for independent central radiology review and results before randomization.
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.

Trial locations and contacts

229 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

Daiichi Sankyo Contact for Clinical Trial Information contact

9089926400

CTRinfo@dsi.com

229 sites in 23 countries

United States30 sites, 30 recruiting

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Principal Investigator

    Recruiting

  • John Hopkins School of Medicine

    Baltimore, Maryland, 21287

    Principal Investigator

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02216

    Principal Investigator

    Recruiting

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

    Principal Investigator

    Recruiting

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Principal Investigator

    Recruiting

  • Oncology/Hematology Care Clinical Trials, Llc

    Cincinnati, Ohio, 45236

    Principal Investigator

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Principal Investigator

    Not yet recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Principal Investigator

    Recruiting

  • Clinical Research Providence Medical Foundation

    Fullerton, California, 92835

    Principal Investigator

    Recruiting

  • THE WEST CLINIC, PLLC dba West Cancer Center

    Germantown, Tennessee, 38138

    Principal Investigator

    Recruiting

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

    Principal Investigator

    Recruiting

  • University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030

    Principal Investigator

    Recruiting

  • Clinical Research Alliance, Inc

    Lake Success, New York, 11042

    Principal Investigator

    Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Principal Investigator

    Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

    Principal Investigator

    Recruiting

  • UCLA Hematology-Oncology

    Los Angeles, California, 90095

    Principal Investigator

    Recruiting

  • University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Principal Investigator

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Principal Investigator

    Not yet recruiting

  • Hackensack Meridian Health Jsumc

    Neptune City, New Jersey, 07753

    Principal Investigator

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long Island

    New York, New York, 10016

    Principal Investigator

    Recruiting

  • New York University Cancer Center - Laura and Isaac

    New York, New York, 10016

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6811

    Principal Investigator

    Recruiting

  • AdventHealth Orlando, Cancer Institute

    Orlando, Florida, 32804

    Principal Investigator

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Principal Investigator

    Not yet recruiting

  • UCSF Mission Bay Mission Hall

    San Francisco, California, 94115

    Principal Investigator

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Principal Investigator

    Recruiting

  • Mercy Clinic Oncology and Hematology Sindelar Cancer Center

    St Louis, Missouri, 63128

    Principal Investigator

    Recruiting

  • H. Lee Moffitt Cancer Center and Research Institute, Inc

    Tampa, Florida, 33612

    Principal Investigator

    Not yet recruiting

  • Montefiore Medical Center Prime

    The Bronx, New York, 10461

    Principal Investigator

    Not yet recruiting

  • Texas Oncology, P.A. - Tyler

    Tyler, Texas, 75702

    Principal Investigator

    Recruiting

Other trials in United States

China26 sites, 26 recruiting

  • China-Japan Friendship Hospital

    Beijing, 100029

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Principal Investigator

    Recruiting

  • Beijing Chest Hospital,Capital Medical University

    Beijing, 101149

    Principal Investigator

    Recruiting

  • Jilin Province Tumor Hospital

    Changchun, 130012

    Principal Investigator

    Recruiting

  • Hunan Cancer Hospital

    Changsha, 410013

    Principal Investigator

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, 610041

    Principal Investigator

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, 610041

    Principal Investigator

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400030

    Principal Investigator

    Recruiting

  • Harbin Medical University Cancer Hospital

    Haerbin, 150081

    Principal Investigator

    Not yet recruiting

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, 310003

    Principal Investigator

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Principal Investigator

    Not yet recruiting

  • The Second Affiliated Hospital of Nanchang University

    Jiangxi, 330030

    Principal Investigator

    Recruiting

  • Shandong Cancer Hospital

    Jinan, 250117

    Principal Investigator

    Recruiting

  • Linyi Cancer Hospital

    Linyi, 276001

    Principal Investigator

    Recruiting

  • The Second Peoples Hospital of Neijiang

    Neijiang, 641000

    Principal Investigator

    Recruiting

  • Yantai Yuhuangding Hospital

    Shandong, 264099

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Principal Investigator

    Not yet recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, 110042

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

    Principal Investigator

    Recruiting

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, 830000

    Principal Investigator

    Recruiting

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022

    Principal Investigator

    Recruiting

  • Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital Tjh

    Wuhan, 430030

    Principal Investigator

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, 430079

    Principal Investigator

    Not yet recruiting

  • The First Affiliated Hospital of Xiân Jiaotong University

    Xi'an, 710061

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, 441021

    Principal Investigator

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, 450008

    Principal Investigator

    Recruiting

Other trials in China

France18 sites, 18 recruiting

  • Institut Sainte Catherine

    Avignon, 84000

    Principal Investigator

    Recruiting

  • Chu Bordeaux

    Bordeaux, 33075

    Principal Investigator

    Not yet recruiting

  • Centre Hospitalier Intercommunal de Crăteil

    Créteil, 94010

    Principal Investigator

    Recruiting

  • Institut Cœur Poumon CHU de Lille

    Lille, 69037

    Recruiting

  • Chu Limoges - Hopital Du Cluzeau

    Limoges, 87042

    Principal Investigator

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Principal Investigator

    Not yet recruiting

  • Assistance Publique-Hăpitaux de Marseille

    Marseille, 13005

    Principal Investigator

    Recruiting

  • Hopital Arnaud de Villeneuve

    Montpellier, 34295

    Principal Investigator

    Recruiting

  • Institut Régional Du Cancer de Montpellier

    Montpellier, 34298

    Principal Investigator

    Recruiting

  • Ch de Mulhouse - Hăpital Emile Muller

    Mulhouse, 68100

    Principal Investigator

    Recruiting

  • Institut Curie - Site de Paris

    Paris, 75005

    Principal Investigator

    Recruiting

  • Hopital Tenon

    Paris, 75020

    Principal Investigator

    Recruiting

  • Chu Rennes - Hopital Pontchaillou

    Rennes, 35033

    Recruiting

  • CHU de Saint Etienne

    Saint-Etienne, 42055

    Principal Investigator

    Recruiting

  • Chu Nantes - Hăpital Guillaume Et Renă Laănnec

    Saint-Herblain, 44805

    Principal Investigator

    Not yet recruiting

  • Institut de Cancerologie de La Loire

    Saint-Priest-en-Jarez, 42270

    Principal Investigator

    Recruiting

  • Hăpital Foch

    Suresnes, 92151

    Principal Investigator

    Not yet recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Principal Investigator

    Not yet recruiting

Other trials in France

Spain17 sites, 17 recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Principal Investigator

    Recruiting

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 8025

    Principal Investigator

    Recruiting

  • Hospital Universitari Vall D'Hebron

    Barcelona, 8035

    Principal Investigator

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

    Principal Investigator

    Recruiting

  • Hospital Universitario Ciudad de Jaen

    Jaén, 23007

    Principal Investigator

    Not yet recruiting

  • Hospital de Especialidades de Jerez de La Frontera

    Jerez de la Frontera, 11408

    Principal Investigator

    Recruiting

  • Ico L'Hospitalet - Hospital Duran I Reynals

    L'Hospitalet de Llobregat, 08908

    Principal Investigator

    Recruiting

  • Complejo Hospitalario Universitario Insular Materno-Infantil

    Las Palmas de Gran Canaria, 35016

    Principal Investigator

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Principal Investigator

    Recruiting

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

    Principal Investigator

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Principal Investigator

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Principal Investigator

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Principal Investigator

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Principal Investigator

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    Principal Investigator

    Recruiting

  • Hospital Universitario Nuestra Señora de Valme

    Seville, 41014

    Principal Investigator

    Recruiting

Other trials in Spain

Italy16 sites, 16 recruiting

  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

    Bari, 70124

    Principal Investigator

    Recruiting

  • Humanitas Gavazzeni

    Bergamo, 24125

    Principal Investigator

    Recruiting

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)

    Brescia, 25124

    Principal Investigator

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)

    Catania, 95123

    Principal Investigator

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Renato Dulbecco

    Catanzaro, 88100

    Principal Investigator

    Recruiting

  • Istituto Nazionale Per La Ricerca Sul Cancro Di Genova

    Genova, 16132

    Principal Investigator

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Principal Investigator

    Not yet recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Principal Investigator

    Recruiting

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

    Principal Investigator

    Recruiting

  • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)

    Monza, 20900

    Principal Investigator

    Not yet recruiting

  • Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania Âluigi Vanvitelliâ

    Naples, 80131

    Principal Investigator

    Recruiting

  • Azienda Ospedaliero Universitaria Di Parma

    Parma, 43100

    Principal Investigator

    Recruiting

  • Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia

    Perugia, 06132

    Principal Investigator

    Recruiting

  • Istituto Nazionale Tumori Regina Elena Irccs

    Roma, 00144

    Principal Investigator

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Principal Investigator

    Recruiting

  • Centro Ricerche Cliniche Di Verona S.R.L.

    Verona, 37134

    Principal Investigator

    Recruiting

Other trials in Italy

Germany14 sites, 14 recruiting

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

    Principal Investigator

    Recruiting

  • Helios Klinikum Erfurt

    Erfurt, 99089

    Principal Investigator

    Recruiting

  • Universtitaetsklinikum Essen

    Essen, 45122

    Principal Investigator

    Recruiting

  • Krankenhaus Nordwest Gmbh

    Frankfurt, 60488

    Principal Investigator

    Recruiting

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt am Main, 60590

    Principal Investigator

    Recruiting

  • Asklepios Fachkliniken Muenchen-Gauting

    Gauting, 82131

    Principal Investigator

    Recruiting

  • Srh Wald-Klinikum Gera Gmbh

    Gera, 7548

    Principal Investigator

    Recruiting

  • UNIVERSITATSKLINIKUM GIeBEN UND MARBURG GMBH

    Giessen, 35392

    Principal Investigator

    Recruiting

  • Asklepios Klinik Harburg

    Hamburg, 21075

    Principal Investigator

    Not yet recruiting

  • Lki Lungenfachklinik Immenhausen

    Immenhausen, 34376

    Principal Investigator

    Recruiting

  • Staedtisches Krankenhaus Kiel

    Kiel, 24116

    Principal Investigator

    Recruiting

  • Johannes Wesling Klinikum Minden

    Minden, 32429

    Principal Investigator

    Not yet recruiting

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

    Principal Investigator

    Not yet recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    Principal Investigator

    Not yet recruiting

Other trials in Germany

Japan13 sites, 13 recruiting

  • National Cancer Center Hospital

    Chūōku, 104-0045

    Principal Investigator

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    Principal Investigator

    Recruiting

  • Kansai Medical University Hospital

    Hirakata-shi, 573-1191

    Principal Investigator

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

    Principal Investigator

    Recruiting

  • The Cancer Institute Hospital of Jfcr

    Kōtoku, 135-8550

    Principal Investigator

    Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280

    Principal Investigator

    Recruiting

  • Shizuoka Cancer Center

    Nakatogari, 411-8777

    Principal Investigator

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Principal Investigator

    Recruiting

  • Kindai University Hospital

    Osaka-Sakai, 590-0197

    Principal Investigator

    Recruiting

  • Kitasato University Hospital

    Sagamihara, 252-0375

    Principal Investigator

    Recruiting

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804

    Principal Investigator

    Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686

    Principal Investigator

    Recruiting

  • Wakayama Medical University Hospital

    Wakayama, 641-8509

    Principal Investigator

    Recruiting

Other trials in Japan

Brazil11 sites, 11 recruiting

  • Departmento de Pesquisa Clinica- Hospital de Amor de Barretos

    Barretos, 14784-400

    Principal Investigator

    Recruiting

  • Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina

    Florianópolis, 88034-000

    Principal Investigator

    Recruiting

  • Clínica de Neoplasias Litoral

    Itajaí, 88301-220

    Principal Investigator

    Recruiting

  • Hospital São Lucas Da Pucrs

    Porto Alegre, 90610-000

    Principal Investigator

    Recruiting

  • Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia

    Santo André, 09060-650

    Principal Investigator

    Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto, 15090-000

    Principal Investigator

    Recruiting

  • ICESP Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

    São Paulo, 01246-000

    Principal Investigator

    Recruiting

  • Hospital Sirio-Libanes

    São Paulo, 01308-050

    Principal Investigator

    Not yet recruiting

  • Hospital Beneficăncia Portuguesa de Săo Paulo

    São Paulo, 01321-001

    Principal Investigator

    Recruiting

  • Hospital Alemão Oswaldo Cruz

    São Paulo, 01327-001

    Principal Investigator

    Recruiting

  • A. C. Camargo Cancer Center

    São Paulo, 01509-900

    Principal Investigator

    Not yet recruiting

Other trials in Brazil

South Korea9 sites, 9 recruiting

  • Chungbuk National University Hospital

    Cheongju-si, 28644

    Principal Investigator

    Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

    Principal Investigator

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Principal Investigator

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Principal Investigator

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Principal Investigator

    Recruiting

  • Seoul National University Hospital

    Seoul, 3080

    Principal Investigator

    Recruiting

  • Asan Medical Center

    Seoul, 5505

    Principal Investigator

    Recruiting

  • The Catholic University of Korea, St. Vincent'S Hospital

    Suwon, 16247

    Recruiting

  • Ajou University Hospital

    Suwon, 16499

    Principal Investigator

    Recruiting

Other trials in South Korea

Greece8 sites, 8 recruiting

  • 'Henry Dynant' Hospital Center

    Athens, 11526

    Principal Investigator

    Not yet recruiting

  • General Hospital of Athens of Chest Diseases 'Sotiria'

    Athens, 11527

    Principal Investigator

    Recruiting

  • General Hospital of Athens Alexandra

    Athens, 11528

    Principal Investigator

    Not yet recruiting

  • University General Hospital "Attikon"

    Chaïdári, 124 62

    Principal Investigator

    Not yet recruiting

  • University General Hospital of Larissa

    Larissa, 41110

    Principal Investigator

    Recruiting

  • General Hospital of Patra Agios Andreas

    Pátrai, 26335

    Principal Investigator

    Recruiting

  • Metropolitan Hospital

    Piraeus, 185 47

    Principal Investigator

    Recruiting

  • St Luke'S Hospital

    Thessaloniki, 55236

    Principal Investigator

    Recruiting

Other trials in Greece

Taiwan8 sites, 8 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

    Principal Investigator

    Recruiting

  • China Medical University Hospital

    Taichung, 404327

    Principal Investigator

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Principal Investigator

    Recruiting

  • National Cheng Kung University Hospitalx

    Tainan, 70403

    Principal Investigator

    Recruiting

  • National Taiwan University Cancer Centre

    Taipei, 10048

    Principal Investigator

    Recruiting

  • Taipei Medical University Hospital

    Taipei, 110301

    Principal Investigator

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Principal Investigator

    Recruiting

  • Chang Gung Memorial Hospital

    Taoyuan City, 333

    Principal Investigator

    Recruiting

Other trials in Taiwan

Australia7 sites, 7 recruiting

  • Ballarat Base Hospital

    Ballarat, 3350

    Principal Investigator

    Recruiting

  • Flinders Medical Centre (Fmc)

    Bedford Park, 5042

    Principal Investigator

    Recruiting

  • Chris O Brien Lifehouse

    Camperdown, 2050

    Principal Investigator

    Recruiting

  • Sunshine Hospital

    St Albans, 3021

    Principal Investigator

    Recruiting

  • St John of God Subiaco Hospital

    Subiaco, 6008

    Recruiting

  • Townsville Cancer Centre

    Townsville, 4814

    Principal Investigator

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102

    Principal Investigator

    Recruiting

Other trials in Australia

Turkey (Türkiye)7 sites, 7 recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06105

    Principal Investigator

    Recruiting

  • Ankara Bilkent City Hospital

    Ankara, 6800

    Principal Investigator

    Recruiting

  • Dicle University, Medical Faculty

    Diyarbakır, 21080

    Principal Investigator

    Recruiting

  • Goztepe Prof Dr Suleyman Yalcin City Hospital

    Istanbul, 34093

    Principal Investigator

    Recruiting

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul, 34098

    Principal Investigator

    Recruiting

  • Medipol University Medical Faculty

    Istanbul, 34214

    Principal Investigator

    Recruiting

  • Izmir Medicalpark Hospital

    Izmir, 35530

    Principal Investigator

    Not yet recruiting

Other trials in Turkey (Türkiye)

Belgium6 sites, 6 recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Principal Investigator

    Not yet recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

    Principal Investigator

    Recruiting

  • Jessa Ziekenhuis Hospital

    Hasselt, 3500

    Principal Investigator

    Recruiting

  • Centre Hospitalier Universitaire de Liege

    Liège, 4000

    Principal Investigator

    Recruiting

  • AZ DELTA

    Roeselare, 8800

    Principal Investigator

    Not yet recruiting

  • Chu Ucl Namur

    Yvoir, 5530

    Principal Investigator

    Recruiting

Other trials in Belgium

Austria5 sites, 5 recruiting

  • Landeskrankenhaus Feldkirch

    Feldkirch, 6800

    Principal Investigator

    Recruiting

  • Landesklinikum Krems

    Krems, 3500

    Principal Investigator

    Recruiting

  • Kepler University Hospital

    Linz, 4020

    Principal Investigator

    Recruiting

  • Wiener Gesundheitsverband Klinik Penzing

    Vienna, 1140

    Principal Investigator

    Recruiting

  • Klinik Floridsdorf

    Vienna, 1210

    Principal Investigator

    Not yet recruiting

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About this study

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)

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).

Read the detailed description

The primary objective of this study is to assess whether treatment with I-DXd 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.

Being tested
Ifinatamab deruxtecan, Topotecan, Amrubicin, Lurbinectedin
Keywords
Small cell lung cancer, Ifinatamab deruxtecan, I-DXd
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ifinatamab deruxtecanDrug

    Also called I-DXd

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

  • TopotecanDrug

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

  • AmrubicinDrug

    Amrubicin will be administered per local SoC

  • LurbinectedinDrug

    Lurbinectedin will be administered per local SoC

Study groups in NCT06203210
Study groupRoleWhat they receive
Ifinatamab deruxtecan (I-DXd)ExperimentalParticipants 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.
Receives: Drug: Ifinatamab deruxtecan
Treatment of Physician's Choice (TPC)Active comparatorParticipants 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.
Receives: Drug: Topotecan; Drug: Amrubicin; Drug: Lurbinectedin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS is defined as the time interval from the date of randomization to the date of death due to any cause.

    Measured: From the date of randomization to the date of death due to any cause, up to approximately 3.7 years

Secondary outcomes (14)

  1. Objective Response (OR) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

    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.

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years

  2. Number of Participants With OR Assessed by Investigator Per RECIST v1.1

    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.

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years

  3. Progression-free Survival (PFS) as Assessed by BICR and Investigator

    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.

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years

  4. Duration of Response (DoR) as Assessed by BICR and Investigator

    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.

    Measured: 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

  5. Disease Control as Assessed by BICR and Investigator

    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.

    Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 3.7 years

  6. Time to Response (TTR) as Assessed by BICR and Investigator

    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.

    Measured: 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

  7. Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30

    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.

    Measured: Baseline up to 3.7 years

  8. Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 (EORTC QLQ-LC29)

    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.

    Measured: Baseline up to 3.7 years

  9. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    TEAEs are assessed based on NCI CTCAE v5.0.

    Measured: Up to 3.7 years

  10. 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

    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.

    Measured: Baseline up to 3.7 years

  11. Pharmacokinetic Parameter Maximum Concentration (Cmax) for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a

    Cmax will be assessed using non-compartmental methods in participants randomized to the I-DXd group.

    Measured: 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)

  12. Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a

    Tmax will be assessed using non-compartmental methods in participants randomized to the I-DXd group.

    Measured: 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)

  13. 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

    AUClast will be assessed using non-compartmental methods in participants randomized to the I-DXd group.

    Measured: 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)

  14. Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve dosing interval (AUCtau) for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a

    AUCtau will be assessed using non-compartmental methods in participants randomized to the I-DXd group.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2024
  2. Study start21 May 2024
  3. Primary completion30 Jan 2028 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06203210
Sponsor's protocol ID
DS7300-188
Other IDs
2023-509628-16-00, 2031230631, 2023
Acronym
IDeate-Lung02
Status last verified
Aug 2026
First submitted
2 Jan 2024
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Owonikoko TK, Byers L, Cheng Y, Hayashi H, Paz-Ares L, Perol M, Hu H, Qian M, Garcia CR, Godard J, Tang M, Rudin CM. IDeate-Lung02: a Phase 3 study of second-line ifinatamab deruxtecan in patients with relapsed small cell lung cancer. Future Oncol. 2025 Oct;21(25):3275-3282. doi: 10.1080/14796694.2025.2565995. Epub 2025 Oct 7.

    PubMed 41055143

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ifinatamab deruxtecan, Topotecan and Amrubicin in people with Small Cell Lung Cancer, run by Daiichi Sankyo at 229 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States, China, France, Spain, Italy and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daiichi Sankyo Contact for Clinical Trial Information (9089926400, CTRinfo@dsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From the date of randomization to the date of death due to any cause, up to approximately 3.7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06203210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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