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)
3 other identifiers
interventional
540
23 countries
223
Brief Summary
This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2024
Longer than P75 for phase_3
223 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
January 12, 2024
CompletedStudy Start
First participant enrolled
May 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 22, 2029
March 2, 2026
February 1, 2026
2.9 years
January 2, 2024
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review
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
From the date of randomization to the date of death due to any cause, up to approximately 5 years
Secondary Outcomes (12)
Number of Participants With Objective Response Rate Assessed by Investigator
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
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
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
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
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
- +7 more secondary outcomes
Study Arms (2)
Ifinatamab deruxtecan (I-DXd)
EXPERIMENTALParticipants 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.
Treatment of Physician's Choice (TPC)
ACTIVE COMPARATORParticipants 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.
Interventions
Lurbinectedin will be administered per local SoC
12 mg/kg intravenous dose on Day 1 of each 21-day cycle
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLCcollaborator
- Daiichi Sankyolead
Study Sites (230)
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Clinical Research Providence Medical Foundation
Fullerton, California, 92835, United States
UCLA Hematology-Oncology
Los Angeles, California, 90095, United States
UCSF Mission Bay Mission Hall
San Francisco, California, 94115, United States
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
AdventHealth Orlando, Cancer Institute
Orlando, Florida, 32804, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, 33612, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
John Hopkins School of Medicine
Baltimore, Maryland, 21287, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02216, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mercy Clinic Oncology and Hematology Sindelar Cancer Center
St Louis, Missouri, 63128, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6811, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
Meridian Health Systems
Neptune City, New Jersey, 07753, United States
Clinical Research Alliance, Inc
Lake Success, New York, 11042, United States
New York University Cancer Center - Laura and Isaac
New York, New York, 10016, United States
Montefiore Medical Center Prime
The Bronx, New York, 10461, United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708, United States
Oncology/Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, 45236, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
THE WEST CLINIC, PLLC dba West Cancer Center
Germantown, Tennessee, 38138, United States
Houston Methodist Cancer Center
Houston, Texas, 77030, United States
University of Texas Md Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Ballarat Base Hospital
Ballarat, 3350, Australia
Flinders Medical Centre (Fmc)
Bedford Park, 5042, Australia
Chris O Brien Lifehouse
Camperdown, 2050, Australia
Sunshine Hospital
St Albans, 3021, Australia
St John of God Subiaco Hospital
Subiaco, 6008, Australia
Townsville Cancer Centre
Townsville, 4814, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Landeskrankenhaus Feldkirch
Feldkirch, 6800, Austria
Landesklinikum Krems
Krems, 3500, Austria
Kepler University Hospital
Linz, 4020, Austria
Wiener Gesundheitsverband Klinik Penzing
Vienna, 1140, Austria
Klinik Floridsdorf
Vienna, 1210, Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Jessa Ziekenhuis Hospital
Hasselt, 3500, Belgium
Centre Hospitalier Universitaire de Liege
Liège, 4000, Belgium
AZ DELTA
Roeselare, 8800, Belgium
Chu Ucl Namur
Yvoir, 5530, Belgium
Departmento de Pesquisa Clinica- Hospital de Amor de Barretos
Barretos, 14784-400, Brazil
Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
Florianópolis, 88034-000, Brazil
Clínica de Neoplasias Litoral
Itajaí, 88301-220, Brazil
Hospital São Lucas Da Pucrs
Porto Alegre, 90610-000, Brazil
Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo André, 09060-650, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, 15090-000, Brazil
ICESP Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, 01246-000, Brazil
Hospital Sirio-Libanes
São Paulo, 01308-050, Brazil
Hospital Benefică Ncia Portuguesa de Să O Paulo
São Paulo, 01321-001, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, 01327-001, Brazil
A. C. Camargo Cancer Center
São Paulo, 01509-900, Brazil
William Osler Health System - Brampton Civic Hospital
Brampton, L6R 3J7, Canada
Cross Cancer Institute
Edmonton, T6G 1Z2, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, G1V 4G5, Canada
Princess Margaret Cancer Center
Toronto, M5G 2M9, Canada
Cancercare Manitoba
Winnipeg, R3E0V9, Canada
China-Japan Friendship Hospital
Beijing, 100029, China
Beijing Cancer Hospital
Beijing, 100142, China
Beijing Chest Hospital,Capital Medical University
Beijing, 101149, China
Jilin Province Tumor Hospital
Changchun, 130012, China
Hunan Cancer Hospital
Changsha, 410013, China
Sichuan Cancer Hospital
Chengdu, 610041, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Harbin Medical University Cancer Hospital
Haerbin, 150081, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, 310003, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
The Second Affiliated Hospital of Nanchang University
Jiangxi, 330030, China
Shandong Cancer Hospital
Jinan, 250117, China
Linyi Cancer Hospital
Linyi, 276001, China
The Second Peoples Hospital of Neijiang
Neijiang, 641000, China
Yantai Yuhuangding Hospital
Shandong, 264099, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Liaoning Cancer Hospital & Institute
Shenyang, 110042, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, 830000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022, China
Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital Tjh
Wuhan, 430030, China
Hubei Cancer Hospital
Wuhan, 430079, China
The First Affiliated Hospital of Xiân Jiaotong University
Xi'an, 710061, China
Xiangyang Central Hospital
Xiangyang, 441021, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Krajska Nemocnice Liberec A.S.
Liberec, 460 63, Czechia
Fakultni Nemocnice Olomouc
Olomouc, 77900, Czechia
Fakultni Thomayerova Nemocnice
Prague, 140 59, Czechia
Institut Sainte Catherine
Avignon, 84000, France
Chu Bordeaux
Bordeaux, 33075, France
Centre Hospitalier Intercommunal de Cră Teil
Créteil, 94010, France
Institut Cœur Poumon CHU de Lille
Lille, 69037, France
Chu Limoges - Hopital Du Cluzeau
Limoges, 87042, France
Centre Léon Bérard
Lyon, 69008, France
Assistance Publique-Hă"Pitaux de Marseille
Marseille, 13005, France
Hopital Arnaud de Villeneuve
Montpellier, 34295, France
Institut Régional Du Cancer de Montpellier
Montpellier, 34298, France
Ch de Mulhouse - Hă"Pital Emile Muller
Mulhouse, 68100, France
Institut Curie - Site de Paris
Paris, 75005, France
Hopital Tenon
Paris, 75020, France
Chu Rennes - Hopital Pontchaillou
Rennes, 35033, France
Chu Nantes - Hă"Pital Guillaume Et Renă Laă<Nnec
Saint-Herblain, 44805, France
Institut de Cancerologie de La Loire
Saint-Priest-en-Jarez, 42270, France
Hă"Pital Foch
Suresnes, 92151, France
Institut Gustave Roussy
Villejuif, 94805, France
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Helios Klinikum Erfurt
Erfurt, 99089, Germany
Universtitaetsklinikum Essen
Essen, 45122, Germany
Krankenhaus Nordwest Gmbh
Frankfurt, 60488, Germany
Universitaetsklinikum Frankfurt Goethe-Universitaet
Frankfurt am Main, 60590, Germany
Asklepios Fachkliniken Muenchen-Gauting
Gauting, 82131, Germany
Srh Wald-Klinikum Gera Gmbh
Gera, 7548, Germany
UNIVERSITATSKLINIKUM GIeBEN UND MARBURG GMBH
Giessen, 35392, Germany
Asklepios Klinik Harburg
Hamburg, 21075, Germany
Lki Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Staedtisches Krankenhaus Kiel
Kiel, 24116, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Pius-Hospital Oldenburg
Oldenburg, 26121, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
'Henry Dynant' Hospital Center
Athens, 11526, Greece
General Hospital of Athens of Chest Diseases 'Sotiria'
Athens, 11527, Greece
General Hospital of Athens Alexandra
Athens, 11528, Greece
University General Hospital "Attikon"
Chaïdári, 124 62, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
General Hospital of Patra Agios Andreas
Pátrai, 26335, Greece
Metropolitan Hospital
Piraeus, 185 47, Greece
St Luke'S Hospital
Thessaloniki, 55236, Greece
Semmelweis Egyetem
Budapest, 1088, Hungary
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121, Hungary
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024, Hungary
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, 6000, Hungary
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari, 70124, Italy
Humanitas Gavazzeni
Bergamo, 24125, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
Brescia, 25124, Italy
Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)
Catania, 95123, Italy
Azienda Ospedaliero Universitaria Renato Dulbecco
Catanzaro, 88100, Italy
Istituto Nazionale Per La Ricerca Sul Cancro Di Genova
Genova, 16132, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
IEO Istituto Europeo di Oncologia
Milan, 20141, Italy
Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
Monza, 20900, Italy
Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania  Luigi Vanvitelliâ
Naples, 80131, Italy
Azienda Ospedaliero Universitaria Di Parma
Parma, 43100, Italy
Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia
Perugia, 06132, Italy
Istituto Nazionale Tumori Regina Elena Irccs
Roma, 00144, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Centro Ricerche Cliniche Di Verona S.R.L.
Verona, 37134, Italy
National Cancer Center Hospital
Chūōku, 104-0045, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Kansai Medical University Hospital
Hirakata-shi, 573-1191, Japan
National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Shizuoka Cancer Center
Nakatogari, 411-8777, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Kindai University Hospital
Osaka-Sakai, 590-0197, Japan
Kitasato University Hospital
Sagamihara, 252-0375, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, 003-0804, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686, Japan
Wakayama Medical University Hospital
Wakayama, 641-8509, Japan
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ, Netherlands
Netherlands Cancer Institute
Amsterdam, 1066 CX, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
Etz Elisabeth
Tilburg, 5022 GC, Netherlands
Centrum Onkologii Im. Prof. F. Lukaszczyka W Bydgoszczy
Bydgoszcz, 85-796, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Otwock, 05-400, Poland
Szpital Specjalistyczny W Prabutach
Prabuty, 82-550, Poland
Provita Prolife
Tomaszów Mazowiecki, 97-200, Poland
Centro Hospitalar E Universită Rio de Coimbra E.P.E.
Coimbra, 3040, Portugal
Hospital Da Senhora Da Oliveira Guimară Es
Guimarães, 4835-044, Portugal
Hospital Da Luz
Lisbon, 1500-650, Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente
Lisbon, 1769-001, Portugal
Centro Hospitalar Do Porto, E.P.E. - Hospital de Santo António
Porto, 4099-001, Portugal
S.C Radiotherapy Center Cluj S.R.L
Bucharest, 407280, Romania
Institutul Oncologic 'Prof. Dr. Ion Chiricuta' Cluj Napoca
Cluj-Napoca, 400015, Romania
S.C Centrul de Oncologie Sfantul Nectarie Craiova
Craiova, 200745, Romania
S.C. Sigmedical Services Srl
Suceava, 720214, Romania
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Asan Medical Center
Seoul, 5505, South Korea
The Catholic University of Korea, St. Vincent'S Hospital
Suwon, 16247, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 8025, Spain
Hospital Universitari Vall D'Hebron
Barcelona, 8035, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Ciudad de Jaen
Jaén, 23007, Spain
Hospital de Especialidades de Jerez de La Frontera
Jerez de la Frontera, 11408, Spain
Ico L'Hospitalet - Hospital Duran I Reynals
L'Hospitalet de Llobregat, 08908, Spain
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, 35016, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitario Nuestra Señora de Valme
Seville, 41014, Spain
Inselspital - Universitaetsspital Bern
Bern, 3010, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 9007, Switzerland
Hfr Fribourg/Kantonsspital Fribourg
Villars-sur-Glâne, 1752, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
China Medical University Hospital
Taichung, 404327, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospitalx
Tainan, 70403, Taiwan
National Taiwan University Cancer Centre
Taipei, 10048, Taiwan
Taipei Medical University Hospital
Taipei, 110301, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 06105, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 6800, Turkey (Türkiye)
Dicle University, Medical Faculty
Diyarbakır, 21080, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul, 34093, Turkey (Türkiye)
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, 34214, Turkey (Türkiye)
Izmir Medicalpark Hospital
Izmir, 35530, Turkey (Türkiye)
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
St James'S University Hospital
Leeds, LS9 7TF, United Kingdom
Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
Related Publications (1)
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.
PMID: 41055143DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director
Daiichi Sankyo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2024
First Posted
January 12, 2024
Study Start
May 21, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
February 22, 2029
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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
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/