A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (IDeate-Lung02)

May 29, 2026 updated by: Daiichi Sankyo

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 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).

Study Overview

Status

Recruiting

Conditions

Small Cell Lung Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

540

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Daiichi Sankyo Contact for Clinical Trial Information
Phone Number: 9089926400
Email: CTRinfo@dsi.com

Study Locations

Australia
- - Ballarat, Australia, 3350
    - Recruiting
    - Ballarat Base Hospital
    - Contact:
      
      Principal Investigator
  - Bedford Park, Australia, 5042
    - Recruiting
    - Flinders Medical Centre (Fmc)
    - Contact:
      
      Principal Investigator
  - Camperdown, Australia, 2050
    - Recruiting
    - Chris O Brien Lifehouse
    - Contact:
      
      Principal Investigator
  - St Albans, Australia, 3021
    - Recruiting
    - Sunshine Hospital
    - Contact:
      
      Principal Investigator
  - Subiaco, Australia, 6008
    - Recruiting
    - St John of God Subiaco Hospital
  - Townsville, Australia, 4814
    - Recruiting
    - Townsville Cancer Centre
    - Contact:
      
      Principal Investigator
  - Woolloongabba, Australia, 4102
    - Recruiting
    - Princess Alexandra Hospital
    - Contact:
      
      Principal Investigator
Austria
- - Feldkirch, Austria, 6800
    - Not yet recruiting
    - Landeskrankenhaus Feldkirch
    - Contact:
      
      Principal Investigator
  - Krems, Austria, 3500
    - Not yet recruiting
    - Landesklinikum Krems
    - Contact:
      
      Principal Investigator
  - Linz, Austria, 4020
    - Not yet recruiting
    - Kepler University Hospital
    - Contact:
      
      Principal Investigator
  - Vienna, Austria, 1210
    - Not yet recruiting
    - Klinik Floridsdorf
    - Contact:
      
      Principal Investigator
  - Vienna, Austria, 1140
    - Not yet recruiting
    - Wiener Gesundheitsverband Klinik Penzing
    - Contact:
      
      Principal Investigator
Belgium
- - Brussels, Belgium, 1200
    - Not yet recruiting
    - Cliniques Universitaires Saint-Luc
    - Contact:
      
      Principal Investigator
  - Edegem, Belgium, 2650
    - Recruiting
    - Universitair Ziekenhuis Antwerpen
    - Contact:
      
      Principal Investigator
  - Hasselt, Belgium, 3500
    - Recruiting
    - Jessa Ziekenhuis Hospital
    - Contact:
      
      Principal Investigator
  - Liège, Belgium, 4000
    - Recruiting
    - Centre Hospitalier Universitaire de Liege
    - Contact:
      
      Principal Investigator
  - Roeselare, Belgium, 8800
    - Not yet recruiting
    - AZ Delta
    - Contact:
      
      Principal Investigator
  - Yvoir, Belgium, 5530
    - Recruiting
    - CHU UCL Namur
    - Contact:
      
      Principal Investigator
Brazil
- - Barretos, Brazil, 14784-400
    - Recruiting
    - Departmento de Pesquisa Clinica- Hospital de Amor de Barretos
    - Contact:
      
      Principal Investigator
  - Florianópolis, Brazil, 88034-000
    - Recruiting
    - Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
    - Contact:
      
      Principal Investigator
  - Itajaí, Brazil, 88301-220
    - Recruiting
    - Clínica de Neoplasias Litoral
    - Contact:
      
      Principal Investigator
  - Porto Alegre, Brazil, 90610-000
    - Recruiting
    - Hospital Sao Lucas da PUCRS
    - Contact:
      
      Principal Investigator
  - Santo André, Brazil, 09060-650
    - Recruiting
    - Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
    - Contact:
      
      Principal Investigator
  - São José do Rio Preto, Brazil, 15090-000
    - Recruiting
    - Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
    - Contact:
      
      Principal Investigator
  - São Paulo, Brazil, 01327-001
    - Recruiting
    - Hospital Alemao Oswaldo Cruz
    - Contact:
      
      Principal Investigator
  - São Paulo, Brazil, 01308-050
    - Not yet recruiting
    - Hospital Sirio-Libanes
    - Contact:
      
      Principal Investigator
  - São Paulo, Brazil, 01509-900
    - Not yet recruiting
    - A. C. Camargo Cancer Center
    - Contact:
      
      Principal Investigator
  - São Paulo, Brazil, 01246-000
    - Recruiting
    - Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
    - Contact:
      
      Principal Investigator
  - São Paulo, Brazil, 01321-001
    - Recruiting
    - Hospital Beneficăncia Portuguesa de Săo Paulo
    - Contact:
      
      Principal Investigator
Canada
- - Brampton, Canada, L6R 3J7
    - Recruiting
    - William Osler Health System - Brampton Civic Hospital
  - Edmonton, Canada, T6G 1Z2
    - Recruiting
    - Cross Cancer Institute
    - Contact:
      
      Principal Investigator
  - Québec, Canada, G1V 4G5
    - Recruiting
    - Institut universitaire de Cardiologie et de Pneumologie de Quebec
    - Contact:
      
      Principal Investigator
  - Toronto, Canada, M5G 2M9
    - Recruiting
    - Princess Margaret Cancer Center
    - Contact:
      
      Principal Investigator
  - Winnipeg, Canada, R3E0V9
    - Recruiting
    - CancerCare Manitoba
    - Contact:
      
      Principal Investigator
China
- - Beijing, China, 100142
    - Recruiting
    - Beijing Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Beijing, China, 100029
    - Recruiting
    - China-Japan Friendship Hospital
  - Beijing, China, 101149
    - Recruiting
    - Beijing Chest Hospital,Capital Medical University
    - Contact:
      
      Principal Investigator
  - Changchun, China, 130012
    - Recruiting
    - Jilin Province Tumor Hospital
    - Contact:
      
      Principal Investigator
  - Changsha, China, 410013
    - Recruiting
    - Hunan Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Chengdu, China, 610041
    - Recruiting
    - West China Hospital, Sichuan University
    - Contact:
      
      Principal Investigator
  - Chengdu, China, 610041
    - Recruiting
    - Sichuan Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Chongqing, China, 400030
    - Recruiting
    - Chongqing University Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Haerbin, China, 150081
    - Not yet recruiting
    - Harbin Medical University Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Hangzhou, China, 310022
    - Not yet recruiting
    - Zhejiang Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Hangzhou, China, 310003
    - Recruiting
    - The First Affiliated Hospital, College of Medicine, Zhejiang University
    - Contact:
      
      Principal Investigator
  - Jiangxi, China, 330030
    - Recruiting
    - The Second Affiliated Hospital of Nanchang University
    - Contact:
      
      Principal Investigator
  - Jinan, China, 250117
    - Recruiting
    - Shandong Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Linyi, China, 276001
    - Recruiting
    - Linyi Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Neijiang, China, 641000
    - Recruiting
    - The Second Peoples Hospital of Neijiang
    - Contact:
      
      Principal Investigator
  - Shandong, China, 264099
    - Recruiting
    - Yantai Yuhuangding Hospital
  - Shanghai, China, 200032
    - Not yet recruiting
    - Fudan University Shanghai Cancer Center
    - Contact:
      
      Principal Investigator
  - Shenyang, China, 110042
    - Recruiting
    - Liaoning cancer Hospital & Institute
  - Tianjin, China, 300060
    - Recruiting
    - Tianjin Medical University Cancer Institute & Hospital
    - Contact:
      
      Principal Investigator
  - Wuhan, China, 430079
    - Not yet recruiting
    - Hubei Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Wuhan, China, 430022
    - Recruiting
    - Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    - Contact:
      
      Principal Investigator
  - Wuhan, China, 430030
    - Recruiting
    - Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital Tjh
    - Contact:
      
      Principal Investigator
  - Xi'an, China, 710061
    - Recruiting
    - The First Affiliated Hospital of Xian Jiaotong University
  - Xiangyang, China, 441021
    - Not yet recruiting
    - Xiangyang Central Hospital
    - Contact:
      
      Principal Investigator
  - Zhengzhou, China, 450008
    - Recruiting
    - Henan Cancer Hospital
    - Contact:
      
      Principal Investigator
  - Ürümqi, China, 830000
    - Recruiting
    - The Affiliated Cancer Hospital of Xinjiang Medical University
    - Contact:
      
      Principal Investigator
Czechia
- - Liberec, Czechia, 460 63
    - Recruiting
    - Krajska nemocnice Liberec a.s.
    - Contact:
      
      Principal Investigator
  - Olomouc, Czechia, 77900
    - Recruiting
    - Fakultni nemocnice Olomouc
    - Contact:
      
      Principal Investigator
  - Prague, Czechia, 140 59
    - Recruiting
    - Fakultni Thomayerova nemocnice
    - Contact:
      
      Principal Investigator
France
- - Avignon, France, 84000
    - Recruiting
    - Institut Sainte Catherine
    - Contact:
      
      Principal Investigator
  - Bordeaux, France, 33075
    - Not yet recruiting
    - CHU Bordeaux
    - Contact:
      
      Principal Investigator
  - Créteil, France, 94010
    - Recruiting
    - Centre Hospitalier Intercommunal de Crăteil
    - Contact:
      
      Principal Investigator
  - Lille, France, 69037
    - Recruiting
    - Institut Cœur Poumon CHU de Lille
  - Limoges, France, 87042
    - Recruiting
    - Chu Limoges - Hopital Du Cluzeau
    - Contact:
      
      Principal Investigator
  - Lyon, France, 69008
    - Not yet recruiting
    - Centre Leon Berard
    - Contact:
      
      Principal Investigator
  - Marseille, France, 13005
    - Recruiting
    - Assistance Publique-Hăpitaux de Marseille
    - Contact:
      
      Principal Investigator
  - Montpellier, France, 34295
    - Recruiting
    - Hopital Arnaud de Villeneuve
    - Contact:
      
      Principal Investigator
  - Montpellier, France, 34298
    - Recruiting
    - Institut Régional du Cancer de Montpellier
    - Contact:
      
      Principal Investigator
  - Mulhouse, France, 68100
    - Recruiting
    - Ch de Mulhouse - Hăpital Emile Muller
    - Contact:
      
      Principal Investigator
  - Paris, France, 75020
    - Recruiting
    - Hopital Tenon
    - Contact:
      
      Principal Investigator
  - Paris, France, 75005
    - Recruiting
    - Institut Curie - Site de Paris
    - Contact:
      
      Principal Investigator
  - Rennes, France, 35033
    - Recruiting
    - CHU Rennes - Hôpital Pontchaillou
  - Saint-Etienne, France, 42055
    - Recruiting
    - Chu de Saint Etienne
    - Contact:
      
      Principal Investigator
  - Saint-Herblain, France, 44805
    - Not yet recruiting
    - Chu Nantes - Hăpital Guillaume Et Renă Laănnec
    - Contact:
      
      Principal Investigator
  - Saint-Priest-en-Jarez, France, 42270
    - Recruiting
    - Institut de Cancerologie de La Loire
    - Contact:
      
      Principal Investigator
  - Suresnes, France, 92151
    - Not yet recruiting
    - Hăpital Foch
    - Contact:
      
      Principal Investigator
  - Villejuif, France, 94805
    - Not yet recruiting
    - Institut Gustave Roussy
    - Contact:
      
      Principal Investigator
Germany
- - Berlin, Germany, 13125
    - Recruiting
    - Evangelische Lungenklinik Berlin
    - Contact:
      
      Principal Investigator
  - Erfurt, Germany, 99089
    - Recruiting
    - Helios Klinikum Erfurt
    - Contact:
      
      Principal Investigator
  - Essen, Germany, 45122
    - Recruiting
    - Universtitaetsklinikum Essen
    - Contact:
      
      Principal Investigator
  - Frankfurt, Germany, 60488
    - Recruiting
    - Krankenhaus Nordwest GmbH
    - Contact:
      
      Principal Investigator
  - Frankfurt am Main, Germany, 60590
    - Recruiting
    - Universitaetsklinikum Frankfurt Goethe-Universitaet
    - Contact:
      
      Principal Investigator
  - Gauting, Germany, 82131
    - Recruiting
    - Asklepios Fachkliniken Muenchen-Gauting
    - Contact:
      
      Principal Investigator
  - Gera, Germany, 7548
    - Recruiting
    - SRH Wald-Klinikum Gera GmbH
    - Contact:
      
      Principal Investigator
  - Giessen, Germany, 35392
    - Recruiting
    - UNIVERSITATSKLINIKUM GIeBEN UND MARBURG GMBH
    - Contact:
      
      Principal Investigator
  - Hamburg, Germany, 21075
    - Not yet recruiting
    - Asklepios Klinik Harburg
    - Contact:
      
      Principal Investigator
  - Immenhausen, Germany, 34376
    - Recruiting
    - Lki Lungenfachklinik Immenhausen
    - Contact:
      
      Principal Investigator
  - Kiel, Germany, 24116
    - Recruiting
    - Staedtisches Krankenhaus Kiel
    - Contact:
      
      Principal Investigator
  - Minden, Germany, 32429
    - Not yet recruiting
    - Johannes Wesling Klinikum Minden
    - Contact:
      
      Principal Investigator
  - Oldenburg, Germany, 26121
    - Not yet recruiting
    - Pius-Hospital Oldenburg
    - Contact:
      
      Principal Investigator
  - Ulm, Germany, 89081
    - Not yet recruiting
    - Universitaetsklinikum Ulm
    - Contact:
      
      Principal Investigator
Greece
- - Athens, Greece, 11528
    - Not yet recruiting
    - General Hospital of Athens Alexandra
    - Contact:
      
      Principal Investigator
  - Athens, Greece, 11526
    - Not yet recruiting
    - 'Henry Dynant' Hospital Center
    - Contact:
      
      Principal Investigator
  - Athens, Greece, 11527
    - Not yet recruiting
    - General Hospital of Athens of Chest Diseases 'Sotiria'
    - Contact:
      
      Principal Investigator
  - Chaïdári, Greece, 124 62
    - Not yet recruiting
    - University General Hospital "Attikon"
    - Contact:
      
      Principal Investigator
  - Larissa, Greece, 41110
    - Not yet recruiting
    - University General Hospital of Larissa
    - Contact:
      
      Principal Investigator
  - Piraeus, Greece, 185 47
    - Not yet recruiting
    - Metropolitan Hospital
    - Contact:
      
      Principal Investigator
  - Pátrai, Greece, 26335
    - Not yet recruiting
    - General Hospital of Patra Agios Andreas
    - Contact:
      
      Principal Investigator
  - Thessaloniki, Greece, 55236
    - Not yet recruiting
    - St Luke's Hospital
    - Contact:
      
      Principal Investigator
Hungary
- - Budapest, Hungary, 1088
    - Not yet recruiting
    - Semmelweis Egyetem
    - Contact:
      
      Principal Investigator
  - Budapest, Hungary, 1122
    - Not yet recruiting
    - Orszagos Onkologiai Intezet
    - Contact:
      
      Principal Investigator
  - Budapest, Hungary, 1121
    - Recruiting
    - Orszagos Koranyi Pulmonologiai Intezet
    - Contact:
      
      Principal Investigator
  - Győr, Hungary, 9024
    - Recruiting
    - Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
    - Contact:
      
      Principal Investigator
  - Kecskemét, Hungary, 6000
    - Recruiting
    - Bács-Kiskun Vármegyei Oktatókórház
    - Contact:
      
      Principal Investigator
Italy
- - Bari, Italy, 70124
    - Recruiting
    - Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
    - Contact:
      
      Principal Investigator
  - Bergamo, Italy, 24125
    - Recruiting
    - Humanitas Gavazzeni
    - Contact:
      
      Principal Investigator
  - Brescia, Italy, 25124
    - Not yet recruiting
    - Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
    - Contact:
      
      Principal Investigator
  - Catania, Italy, 95123
    - Not yet recruiting
    - Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)
    - Contact:
      
      Principal Investigator
  - Catanzaro, Italy, 88100
    - Recruiting
    - Azienda Ospedaliero Universitaria Renato Dulbecco
    - Contact:
      
      Principal Investigator
  - Genova, Italy, 16132
    - Recruiting
    - Istituto Nazionale per la Ricerca sul Cancro di Genova
    - Contact:
      
      Principal Investigator
  - Milan, Italy, 20133
    - Recruiting
    - Fondazione IRCCS Istituto Nazionale dei Tumori
    - Contact:
      
      Principal Investigator
  - Milan, Italy, 20132
    - Not yet recruiting
    - Ospedale San Raffaele
    - Contact:
      
      Principal Investigator
  - Milan, Italy, 20141
    - Recruiting
    - IEO Istituto Europeo di Oncologia
    - Contact:
      
      Principal Investigator
  - Monza, Italy, 20900
    - Not yet recruiting
    - Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
    - Contact:
      
      Principal Investigator
  - Naples, Italy, 80131
    - Recruiting
    - Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania Âluigi Vanvitelliâ
    - Contact:
      
      Principal Investigator
  - Parma, Italy, 43100
    - Recruiting
    - Azienda Ospedaliero Universitaria di Parma
    - Contact:
      
      Principal Investigator
  - Perugia, Italy, 06132
    - Recruiting
    - Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
    - Contact:
      
      Principal Investigator
  - Roma, Italy, 00144
    - Recruiting
    - Istituto Nazionale Tumori Regina Elena Irccs
    - Contact:
      
      Principal Investigator
  - Rozzano, Italy, 20089
    - Recruiting
    - Istituto Clinico Humanitas
    - Contact:
      
      Principal Investigator
  - Verona, Italy, 37134
    - Recruiting
    - Centro Ricerche Cliniche di Verona S.r.l.
    - Contact:
      
      Principal Investigator
Japan
- - Chūōku, Japan, 104-0045
    - Recruiting
    - National Cancer Center Hospital
    - Contact:
      
      Principal Investigator
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Kyushu University Hospital
    - Contact:
      
      Principal Investigator
  - Hirakata-shi, Japan, 573-1191
    - Recruiting
    - Kansai Medical University Hospital
    - Contact:
      
      Principal Investigator
  - Kashiwa, Japan, 277-8577
    - Recruiting
    - National Cancer Center Hospital East
    - Contact:
      
      Principal Investigator
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - The Cancer Institute Hospital of JFCR
    - Contact:
      
      Principal Investigator
  - Matsuyama, Japan, 791-0280
    - Recruiting
    - National Hospital Organization Shikoku Cancer Center
    - Contact:
      
      Principal Investigator
  - Nakatogari, Japan, 411-8777
    - Recruiting
    - Shizuoka Cancer Center
    - Contact:
      
      Principal Investigator
  - Okayama, Japan, 700-8558
    - Recruiting
    - Okayama University Hospital
    - Contact:
      
      Principal Investigator
  - Osaka-Sakai, Japan, 590-0197
    - Recruiting
    - Kindai University Hospital
    - Contact:
      
      Principal Investigator
  - Sagamihara, Japan, 252-0375
    - Recruiting
    - Kitasato University Hospital
    - Contact:
      
      Principal Investigator
  - Sapporo, Japan, 003-0804
    - Recruiting
    - National Hospital Organization Hokkaido Cancer Center
    - Contact:
      
      Principal Investigator
  - Takatsuki, Japan, 569-8686
    - Recruiting
    - Osaka Medical and Pharmaceutical University Hospital
    - Contact:
      
      Principal Investigator
  - Wakayama, Japan, 641-8509
    - Recruiting
    - Wakayama Medical University Hospital
    - Contact:
      
      Principal Investigator
Netherlands
- - 's-Hertogenbosch, Netherlands, 5223 GZ
    - Recruiting
    - Jeroen Bosch Ziekenhuis
    - Contact:
      
      Principal Investigator
  - Amsterdam, Netherlands, 1066 CX
    - Not yet recruiting
    - Netherlands Cancer Institute
    - Contact:
      
      Principal Investigator
  - Maastricht, Netherlands, 6229 HX
    - Recruiting
    - Maastricht University Medical Center
    - Contact:
      
      Principal Investigator
  - Tilburg, Netherlands, 5022 GC
    - Recruiting
    - ETZ Elisabeth
Poland
- - Bydgoszcz, Poland, 85-796
    - Recruiting
    - Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
    - Contact:
      
      Principal Investigator
  - Lodz, Poland, 93-338
    - Not yet recruiting
    - Instytut Centrum Zdrowia Matki Polki
    - Contact:
      
      Principal Investigator
  - Otwock, Poland, 05-400
    - Recruiting
    - Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
    - Contact:
      
      Principal Investigator
  - Prabuty, Poland, 82-550
    - Not yet recruiting
    - Szpital Specjalistyczny W Prabutach
    - Contact:
      
      Principal Investigator
  - Tomaszów Mazowiecki, Poland, 97-200
    - Recruiting
    - Provita Prolife
    - Contact:
      
      Principal Investigator
Portugal
- - Coimbra, Portugal, 3040
    - Not yet recruiting
    - Centro Hospitalar E Universitărio de Coimbra E.P.E.
    - Contact:
      
      Principal Investigator
  - Guimarães, Portugal, 4835-044
    - Recruiting
    - Hospital Da Senhora Da Oliveira Guimarăes
    - Contact:
      
      Principal Investigator
  - Lisbon, Portugal, 1500-650
    - Recruiting
    - Hospital da Luz
    - Contact:
      
      Principal Investigator
  - Lisbon, Portugal, 1769-001
    - Recruiting
    - Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente
    - Contact:
      
      Principal Investigator
  - Porto, Portugal, 4099-001
    - Recruiting
    - Centro Hospitalar Do Porto, E.P.E. - Hospital de Santo António
    - Contact:
      
      Principal Investigator
Romania
- - Bucharest, Romania, 407280
    - Recruiting
    - S.C Radiotherapy Center Cluj S.R.L
    - Contact:
      
      Principal Investigator
  - Cluj-Napoca, Romania, 400015
    - Not yet recruiting
    - Institutul Oncologic 'Prof. Dr. Ion Chiricuta' Cluj Napoca
    - Contact:
      
      Principal Investigator
  - Craiova, Romania, 200745
    - Recruiting
    - S.C Centrul de Oncologie Sfantul Nectarie Craiova
    - Contact:
      
      Principal Investigator
  - Suceava, Romania, 720214
    - Not yet recruiting
    - S.C. Sigmedical Services Srl
    - Contact:
      
      Principal Investigator
South Korea
- - Cheongju-si, South Korea, 28644
    - Recruiting
    - Chungbuk National University Hospital
    - Contact:
      
      Principal Investigator
  - Daegu, South Korea, 41404
    - Recruiting
    - Kyungpook National University Chilgok Hospital
    - Contact:
      
      Principal Investigator
  - Seongnam-si, South Korea, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
    - Contact:
      
      Principal Investigator
  - Seoul, South Korea, 03722
    - Recruiting
    - Severance Hospital, Yonsei University Health System
    - Contact:
      
      Principal Investigator
  - Seoul, South Korea, 06351
    - Recruiting
    - Samsung Medical Center
    - Contact:
      
      Principal Investigator
  - Seoul, South Korea, 5505
    - Recruiting
    - Asan Medical Center
    - Contact:
      
      Principal Investigator
  - Seoul, South Korea, 3080
    - Recruiting
    - Seoul National University Hospital
    - Contact:
      
      Principal Investigator
  - Suwon, South Korea, 16499
    - Recruiting
    - Ajou University Hospital
    - Contact:
      
      Principal Investigator
  - Suwon, South Korea, 16247
    - Recruiting
    - The Catholic university of Korea, St. Vincent's Hospital
Spain
- - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic de Barcelona
    - Contact:
      
      Principal Investigator
  - Barcelona, Spain, 8035
    - Recruiting
    - Hospital Universitari Vall d'Hebron
    - Contact:
      
      Principal Investigator
  - Barcelona, Spain, 8025
    - Recruiting
    - Hospital de la Santa Creu i Sant Pau
    - Contact:
      
      Principal Investigator
  - Córdoba, Spain, 14004
    - Recruiting
    - Hospital Universitario Reina Sofia
    - Contact:
      
      Principal Investigator
  - Jaén, Spain, 23007
    - Not yet recruiting
    - Hospital Universitario Ciudad de Jaen
    - Contact:
      
      Principal Investigator
  - Jerez de la Frontera, Spain, 11408
    - Recruiting
    - Hospital de Especialidades de Jerez de La Frontera
    - Contact:
      
      Principal Investigator
  - L'Hospitalet de Llobregat, Spain, 08908
    - Recruiting
    - ICO l'Hospitalet - Hospital Duran i Reynals
    - Contact:
      
      Principal Investigator
  - Las Palmas de Gran Canaria, Spain, 35016
    - Recruiting
    - Complejo Hospitalario Universitario Insular Materno-Infantil
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28034
    - Recruiting
    - Hospital Universitario Ramón y Cajal
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28007
    - Recruiting
    - Hospital General Universitario Gregorio Marañón
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Universitario Fundacion Jimenez Diaz
    - Contact:
      
      Principal Investigator
  - Málaga, Spain, 29010
    - Recruiting
    - Hospital Regional Universitario de Málaga
  - Seville, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen del Rocio
    - Contact:
      
      Principal Investigator
  - Seville, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena
    - Contact:
      
      Principal Investigator
  - Seville, Spain, 41014
    - Recruiting
    - Hospital Universitario Nuestra Señora de Valme
    - Contact:
      
      Principal Investigator
Switzerland
- - Bern, Switzerland, 3010
    - Recruiting
    - Inselspital - Universitaetsspital Bern
    - Contact:
      
      Principal Investigator
  - Sankt Gallen, Switzerland, 9007
    - Recruiting
    - Kantonsspital St. Gallen
    - Contact:
      
      Principal Investigator
  - Villars-sur-Glâne, Switzerland, 1752
    - Recruiting
    - Hfr Fribourg/Kantonsspital Fribourg
    - Contact:
      
      Principal Investigator
Taiwan
- - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
    - Contact:
      
      Principal Investigator
  - Taichung, Taiwan, 40705
    - Recruiting
    - Taichung Veterans General Hospital
    - Contact:
      
      Principal Investigator
  - Taichung, Taiwan, 404327
    - Recruiting
    - China Medical University Hospital
    - Contact:
      
      Principal Investigator
  - Tainan, Taiwan, 70403
    - Recruiting
    - National Cheng Kung University Hospitalx
    - Contact:
      
      Principal Investigator
  - Taipei, Taiwan, 110301
    - Recruiting
    - Taipei Medical University Hospital
    - Contact:
      
      Principal Investigator
  - Taipei, Taiwan, 11217
    - Recruiting
    - Taipei Veterans General Hospital
    - Contact:
      
      Principal Investigator
  - Taipei, Taiwan, 10048
    - Recruiting
    - National Taiwan University Cancer Centre
    - Contact:
      
      Principal Investigator
  - Taoyuan City, Taiwan, 333
    - Recruiting
    - Chang Gung Memorial Hospital
    - Contact:
      
      Principal Investigator
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 6800
    - Recruiting
    - Ankara Bilkent City Hospital
    - Contact:
      
      Principal Investigator
  - Ankara, Turkey (Türkiye), 06105
    - Recruiting
    - Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
    - Contact:
      
      Principal Investigator
  - Diyarbakır, Turkey (Türkiye), 21080
    - Recruiting
    - Dicle University, Medical Faculty
    - Contact:
      
      Principal Investigator
  - Istanbul, Turkey (Türkiye), 34093
    - Recruiting
    - Goztepe Prof Dr Suleyman Yalcin City Hospital
    - Contact:
      
      Principal Investigator
  - Istanbul, Turkey (Türkiye), 34098
    - Recruiting
    - Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
    - Contact:
      
      Principal Investigator
  - Istanbul, Turkey (Türkiye), 34214
    - Recruiting
    - Medipol University Medical Faculty
    - Contact:
      
      Principal Investigator
  - Izmir, Turkey (Türkiye), 35530
    - Not yet recruiting
    - Izmir Medicalpark Hospital
    - Contact:
      
      Principal Investigator
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - Recruiting
    - Birmingham Heartlands Hospital
    - Contact:
      
      Principal Investigator
  - Leeds, United Kingdom, LS9 7TF
    - Recruiting
    - St James's University Hospital
    - Contact:
      
      Principal Investigator
  - Oxford, United Kingdom, OX3 7LJ
    - Recruiting
    - Churchill Hospital
    - Contact:
      
      Principal Investigator
United States
- Arkansas
  - Springdale, Arkansas, United States, 72762
    - Recruiting
    - Highlands Oncology Group
    - Contact:
      
      Principal Investigator
- California
  - Fullerton, California, United States, 92835
    - Recruiting
    - Clinical Research Providence Medical Foundation
    - Contact:
      
      Principal Investigator
  - Los Angeles, California, United States, 90095
    - Recruiting
    - UCLA Hematology-Oncology
    - Contact:
      
      Principal Investigator
  - San Francisco, California, United States, 94115
    - Recruiting
    - UCSF Mission Bay Mission Hall
    - Contact:
      
      Principal Investigator
- Florida
  - Miami, Florida, United States, 33136
    - Recruiting
    - University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
    - Contact:
      
      Principal Investigator
  - Orlando, Florida, United States, 32804
    - Recruiting
    - AdventHealth Orlando, Cancer Institute
    - Contact:
      
      Principal Investigator
  - Tampa, Florida, United States, 33612
    - Not yet recruiting
    - H. Lee Moffitt Cancer Center and Research Institute, Inc
    - Contact:
      
      Principal Investigator
- Illinois
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - Rush MD Anderson Cancer Center
    - Contact:
      
      Principal Investigator
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Recruiting
    - Baptist Health Lexington
    - Contact:
      
      Principal Investigator
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - University of Maryland Greenebaum Comprehensive Cancer Center
    - Contact:
      
      Principal Investigator
  - Baltimore, Maryland, United States, 21287
    - Recruiting
    - John Hopkins School of Medicine
    - Contact:
      
      Principal Investigator
- Massachusetts
  - Boston, Massachusetts, United States, 02216
    - Recruiting
    - Dana-Farber Cancer Institute
    - Contact:
      
      Principal Investigator
- Michigan
  - Detroit, Michigan, United States, 48202
    - Not yet recruiting
    - Henry Ford Health System
    - Contact:
      
      Principal Investigator
- Missouri
  - St Louis, Missouri, United States, 63128
    - Recruiting
    - Mercy Clinic Oncology and Hematology Sindelar Cancer Center
    - Contact:
      
      Principal Investigator
- Nebraska
  - Omaha, Nebraska, United States, 68198-6811
    - Recruiting
    - University of Nebraska Medical Center
    - Contact:
      
      Principal Investigator
- New Hampshire
  - Lebanon, New Hampshire, United States, 03766
    - Recruiting
    - Dartmouth-Hitchcock Medical Center
    - Contact:
      
      Principal Investigator
- New Jersey
  - East Brunswick, New Jersey, United States, 08816
    - Recruiting
    - Astera Cancer Care
    - Contact:
      
      Principal Investigator
  - Neptune City, New Jersey, United States, 07753
    - Recruiting
    - Hackensack Meridian Health Jsumc
    - Contact:
      
      Principal Investigator
- New York
  - Lake Success, New York, United States, 11042
    - Recruiting
    - Clinical Research Alliance, Inc
    - Contact:
      
      Principal Investigator
  - New York, New York, United States, 10016
    - Recruiting
    - New York University Cancer Center - Laura and Isaac
  - New York, New York, United States, 10016
    - Recruiting
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Long Island
    - Contact:
      
      Principal Investigator
  - The Bronx, New York, United States, 10461
    - Not yet recruiting
    - Montefiore Medical Center Prime
    - Contact:
      
      Principal Investigator
- Ohio
  - Canton, Ohio, United States, 44708
    - Recruiting
    - Cleveland Clinic Mercy Hospital
    - Contact:
      
      Principal Investigator
  - Cincinnati, Ohio, United States, 45236
    - Recruiting
    - Oncology/Hematology Care Clinical Trials, Llc
    - Contact:
      
      Principal Investigator
- Oregon
  - Portland, Oregon, United States, 97213
    - Not yet recruiting
    - Providence Portland Medical Center
    - Contact:
      
      Principal Investigator
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Recruiting
    - The West Clinic, PLLC dba West Cancer Center
    - Contact:
      
      Principal Investigator
- Texas
  - Houston, Texas, United States, 77030
    - Recruiting
    - University of Texas MD Anderson Cancer Center
    - Contact:
      
      Principal Investigator
  - Houston, Texas, United States, 77030
    - Recruiting
    - Houston Methodist Cancer Center
    - Contact:
      
      Principal Investigator
  - Tyler, Texas, United States, 75702
    - Recruiting
    - Texas Oncology, P.A. - Tyler
    - Contact:
      
      Principal Investigator
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Not yet recruiting
    - Medical College of Wisconsin
    - Contact:
      
      Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria

Participants must meet all the following criteria to be eligible for randomization into the study:

Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form 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 of ≥30 days.
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 ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1).
Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system [CNS] metastases) based on history and physical examination. Subjects must require no treatment with steroids or anticonvulsants and have a stable neurologic status for at least 2 weeks prior to the first dose of study drug.

Exclusion Criteria

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.
Has uncontrolled or significant cardiovascular disease.
Has clinically significant corneal disease.
Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids.
Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE) and any radiographic features consistent with ILA, including but not limited to, extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing.
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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ifinatamab deruxtecan (I-DXd) Participants randomized to receive 12 mg/kg I-DXd monotherapy on Day 1 of each 21-day cycle until unacceptable toxicity, progressive disease (PD), or withdrawal of consent as specified in the protocol.	Drug: Ifinatamab deruxtecan 12 mg/kg intravenous dose on Day 1 of each 21-day cycle Other Names: I-DXd
Active Comparator: Treatment of Physician's Choice (TPC) Participants randomized to receive topotecan, lurbinectedin, or amrubicin, as per investigator's choice and per locally approved label (indicated dose and frequency), until a treatment discontinuation criterion is met as specified in the protocol.	Drug: Topotecan Topotecan will be administered per local SoC. Drug: Amrubicin Amrubicin will be administered per local SoC. Drug: Lurbinectedin Lurbinectedin will be administered per local SoC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review Time Frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years	Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on BICR by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Overall Survival Time Frame: From the date of randomization to the date of death due to any cause, up to approximately 5 years		From the date of randomization to the date of death due to any cause, up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Objective Response Rate Assessed by Investigator Time Frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years	Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator Time Frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years	PFS is defined as the time interval from the date of randomization to the date of disease progression as per BICR and investigator assessment or death due to any cause.	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Duration of Response As Assessed by Blinded Independent Central Review and Investigator Time Frame: From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 5 years	Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first documentation of progressive disease (PD) or death. The DoR will be calculated for responding participants (PR or CR) only.	From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 5 years
Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator Time Frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years	Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) by BICR and investigator assessment per RECIST v1.1.	Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Time to Response As Assessed by Blinded Independent Central Review and Investigator Time Frame: 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 5 years	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.	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 5 years
Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Time Frame: Baseline up to 5 years	This 30-item questionnaire assesses global health status (GHS)/quality of life (QoL), subject functioning, and general cancer symptoms and has a recall period of one week. 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.	Baseline up to 5 years
Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 (EORTC QLQ-LC29) Time Frame: Baseline up to 5 years	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.	Baseline up to 5 years
Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd Monotherapy Time Frame: Baseline up to 5 years	TEAEs are assessed based on NCI CTCAE v5.0.	Baseline up to 5 years
The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody Time Frame: Baseline up to 5 years	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.	Baseline up to 5 years
Pharmacokinetic Parameter Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a Time Frame: 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 postdose; Cycles 4, 5, and every 2 cycles thereafter up to 5 years BI (each cycle is 21 days)	Maximum concentration (Cmax) will be assessed using non-compartmental methods in participants randomized to the I-DXd group.	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 postdose; Cycles 4, 5, and every 2 cycles thereafter up to 5 years BI (each cycle is 21 days)
Pharmacokinetic Parameter Time to Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a Time Frame: 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 postdose; Cycles 4, 5, and every 2 cycles thereafter up to 5 years BI (each cycle is 21 days)	Time to maximum concentration (Tmax) will be assessed using non-compartmental methods in participants randomized to the I-DXd group.	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 postdose; Cycles 4, 5, and every 2 cycles thereafter up to 5 years BI (each cycle is 21 days)
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a Time Frame: 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 postdose; Cycles 4, 5, and every 2 cycles thereafter up to 5 years BI (each cycle is 21 days)	Area under the plasma concentration-time curve up to the last quantifiable time point (AUClast) and area under the plasma concentration-time curve dosing interval (AUCtau) will be assessed using non-compartmental methods in participants randomized to the I-DXd group.	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 postdose; Cycles 4, 5, and every 2 cycles thereafter up to 5 years BI (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Collaborators

Merck Sharp & Dohme LLC

Investigators

Study Director: Global Clinical Director, Daiichi Sankyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

February 22, 2029

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

DS7300-188
2023-509628-16-00 (Other Identifier: EU CT)
2031230631 (Other Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Recruiting

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

Non Small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage IV | Non-small Cell Lung Cancer Stage IIIC | Non-small Cell Lung Cancer Unresectable

United States
Shanghai Chest Hospital

Recruiting

Molecular Analysis and Treatment Options of SCLC

Small Cell Lung Carcinoma | Small-cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive Stage | Small Cell Lung Cancer, Combined Type

China
National Cancer Institute (NCI)

Completed

FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer

Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer

United States

Clinical Trials on Ifinatamab deruxtecan

Daiichi Sankyo
Merck Sharp & Dohme LLC

Available

Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer

Extensive-stage Small Cell Lung Cancer | SCLC

United States
Daiichi Sankyo
Merck Sharp & Dohme LLC

Recruiting

A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

Recurrent or Metastatic Solid Tumors

United States, Belgium, Netherlands, Taiwan, Spain, France, Germany, Italy, Poland, Ireland, Australia, Japan, Argentina, Portugal, Mexico, Brazil, Chile, Turkey (Türkiye)
Daiichi Sankyo
Merck Sharp & Dohme LLC

Active, not recruiting

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)

Extensive-stage Small-cell Lung Cancer

United States, Germany, Spain, China, Taiwan, France, Japan, South Korea
Merck Sharp & Dohme LLC
Daiichi Sankyo

Not yet recruiting

A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)

Malignant Neoplasm
Merck Sharp & Dohme LLC
Daiichi Sankyo

Recruiting

A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)

Oesophageal Squamous Cell Carcinoma

Japan, South Korea, Taiwan, Switzerland, Czechia, Norway, China
Daiichi Sankyo
Merck Sharp & Dohme LLC

Recruiting

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

Advanced Solid Tumor | Malignant Solid Tumor

United States, Japan
Daiichi Sankyo
Merck Sharp & Dohme LLC

Recruiting

A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)

Extensive Stage-small Cell Lung Cancer

United States, France, Spain, Japan
Merck Sharp & Dohme LLC
Daiichi Sankyo

Recruiting

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)

Small Cell Lung Cancer

United States, Israel, Spain, Japan, Chile, South Korea, Turkey (Türkiye), China, Taiwan, Argentina, United Kingdom, Australia
Merck Sharp & Dohme LLC
Daiichi Sankyo

Recruiting

Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

Lung Neoplasm

United States, Israel, Spain, Greece, Italy, Chile, Poland, Hungary, China, Germany, Turkey (Türkiye)
Harpoon Therapeutics, Inc., a subsidiary of Merck...
Daiichi Sankyo

Active, not recruiting

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

Neuroendocrine Carcinoma | Small-Cell Lung Cancer

United States

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (IDeate-Lung02)

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)

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