Clinical trial NCT06203210: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Keywords: Small cell lung cancer
Ifinatamab deruxtecan
I-DXd
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-01-12
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria

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

1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
2. Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
3. Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
5. 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.
6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
7. Has documentation of radiological disease progression on or after the most recent systemic therapy.
8. Has ECOG PS of ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1).
9. 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:

1. Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
3. Has received any of the comparators used in this study or any topoisomerase I inhibitor.
4. Has inadequate washout period before randomization as specified in the protocol.
5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
6. Has uncontrolled or significant cardiovascular disease.
7. Has clinically significant corneal disease.
8. Has history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
9. 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.

Primary outcomes:
measure: Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review
timeFrame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
measure: Overall Survival
timeFrame: From the date of randomization to the date of death due to any cause, up to approximately 5 years
Secondary outcomes:
measure: Number of Participants With Objective Response Rate Assessed by Investigator
timeFrame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
measure: Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator
timeFrame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
measure: Duration of Response As Assessed by Blinded Independent Central Review and Investigator
timeFrame: 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
measure: Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator
timeFrame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
measure: Time to Response As Assessed by Blinded Independent Central Review and Investigator
timeFrame: 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
measure: Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30
timeFrame: Baseline up to 5 years
measure: Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 (EORTC QLQ-LC29)
timeFrame: Baseline up to 5 years
measure: Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd Monotherapy
timeFrame: Baseline up to 5 years
measure: The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody
timeFrame: Baseline up to 5 years
measure: Pharmacokinetic Parameter Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
timeFrame: 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)
measure: Pharmacokinetic Parameter Time to Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
timeFrame: 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)
measure: Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a
timeFrame: 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)
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Fullerton
country: United States
facility: Clinical Research Providence Medical Foundation
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology-Oncology
state: California
city: San Francisco
country: United States
facility: Ucsf Mount Zion Medical Ctr
state: California
city: Miami
country: United States
facility: University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando, Cancer Institute
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute, Inc
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Comprehensive Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: John Hopkins School of Medicine
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Clinic Oncology and Hematology Sindelar Cancer Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: Neptune
country: United States
facility: Meridian Health Systems
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center Prime
state: New York
city: Lake Success
country: United States
facility: Clinical Research Alliance, Inc
state: New York
city: New York
country: United States
facility: New York University Cancer Center - Laura and Isaac
state: New York
city: Canton
country: United States
facility: Mercy Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Oncology/Hematology Care Clinical Trials, Llc
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Germantown
country: United States
facility: THE WEST CLINIC, PLLC dba West Cancer Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas Md Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology, P.A. - Tyler
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
city: Bedford Park
country: Australia
facility: Flinders Medical Centre (Fmc)
city: Camperdown
country: Australia
facility: Chris O Brien Lifehouse
city: St Albans
country: Australia
facility: Sunshine Hospital
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
city: Townsville
country: Australia
facility: Townsville Cancer Centre
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Krems
country: Austria
facility: Landesklinikum Krems
city: Linz
country: Austria
facility: Kepler University Hospital
city: Wien
country: Austria
facility: Wiener Gesundheitsverband Klinik Penzing
city: Wien
country: Austria
facility: Klinik Floridsdorf
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: UZA
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis Hospital
city: Liege
country: Belgium
facility: Chu de Liă Ge
city: Roeselare
country: Belgium
facility: AZ DELTA
city: Yvoir
country: Belgium
facility: Chu Ucl Namur
city: Barretos
country: Brazil
facility: Departmento de Pesquisa Clinica- Hospital de Amor de Barretos
city: FlorianĂłpolis
country: Brazil
facility: Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
city: ItajaĂ-
country: Brazil
facility: Clínica de Neoplasias Litoral
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas Da Pucrs
city: Santo Andre
country: Brazil
facility: Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
city: Sao Jose Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
city: São Paulo
country: Brazil
facility: ICESP Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
city: São Paulo
country: Brazil
facility: Hospital Benefică Ncia Portuguesa de Să O Paulo
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
city: SĂŁo Paulo
country: Brazil
facility: Hospital Sirio-Libanes
city: SĂŁo Paulo
country: Brazil
facility: A. C. Camargo Cancer Center
city: Brampton
country: Canada
facility: William Osler Health System - Brampton Civic Hospital
city: Edmonton
country: Canada
facility: Cross Cancer Institute
city: Quebec City
country: Canada
facility: Institut Universitaire de Cardiologie Et de Pneumologie de Quebec
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
city: Winnipeg
country: Canada
facility: Cancercare Manitoba
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing Chest Hospital,Capital Medical University
city: Changchun
country: China
facility: Jilin Province Tumor Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu Shi
country: China
facility: West China Hospital, Sichuan University
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Haerbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Jiangxi
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Neijiang
country: China
facility: The Second Peoples Hospital of Neijiang
city: Shandong
country: China
facility: Yantai Yuhuangding Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital Tjh
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xiân Jiaotong University
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Liberec
country: Czechia
facility: Krajska Nemocnice Liberec A.S.
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova Nemocnice
city: Avignon Cedex 9
country: France
facility: Institut Sainte Catherine
city: Bordeaux cedex
country: France
facility: Chu Bordeaux
city: Creteil Cedex
country: France
facility: Centre Hospitalier Intercommunal de Cră Teil
city: Lille
country: France
facility: Institut Cœur Poumon CHU de Lille
city: Limoges cedex
country: France
facility: Chu Limoges - Hopital Du Cluzeau
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Assistance Publique-Hă"Pitaux de Marseille
city: Montpellier cedex 05
country: France
facility: Hopital Arnaud de Villeneuve
city: Montpellier
country: France
facility: Institut Régional Du Cancer de Montpellier
city: Mulhouse Cedex
country: France
facility: Ch de Mulhouse - Hă"Pital Emile Muller
city: Paris Cedex 05
country: France
facility: Institut Curie - Site de Paris
city: Paris
country: France
facility: Hopital Tenon
city: Rennes cedex 09
country: France
facility: Chu Rennes - Hopital Pontchaillou
city: Saint Herblain
country: France
facility: Chu Nantes - Hă"Pital Guillaume Et Renă Laă<Nnec
city: Saint-Priest-En-Jarez
country: France
facility: Institut de Cancerologie de La Loire
city: Suresnes Cedex
country: France
facility: Hă"Pital Foch
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Essen
country: Germany
facility: Universtitaetsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt Goethe-Universitaet
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest Gmbh
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen-Gauting
city: Gera
country: Germany
facility: Srh Wald-Klinikum Gera Gmbh
city: Giessen
country: Germany
facility: UNIVERSITATSKLINIKUM GIeBEN UND MARBURG GMBH
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Immenhausen/Krs. Kassel
country: Germany
facility: Lki Lungenfachklinik Immenhausen
city: Kiel
country: Germany
facility: Staedtisches Krankenhaus Kiel
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Athens
country: Greece
facility: 'Henry Dynant' Hospital Center
city: Athens
country: Greece
facility: General Hospital of Athens of Chest Diseases 'Sotiria'
city: Athens
country: Greece
facility: General Hospital of Athens Alexandra
city: Chaidari
country: Greece
facility: University General Hospital "Attikon"
city: Larisa
country: Greece
facility: University General Hospital of Larissa
city: Patra
country: Greece
facility: General Hospital of Patra Agios Andreas
city: Piraeus
country: Greece
facility: Metropolitan Hospital
city: Thessaloniki
country: Greece
facility: St Luke'S Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
city: Kecskemet
country: Hungary
facility: Bács-Kiskun Vármegyei Oktatókórház
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
city: Catania
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero Universitaria Renato Dulbecco
city: Genova
country: Italy
facility: Istituto Nazionale Per La Ricerca Sul Cancro Di Genova
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
city: Milano
country: Italy
facility: Ieo Istituto Europeo Di Oncologia
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania Â Luigi Vanvitelliâ
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria Di Parma
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena Irccs
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Di Verona S.R.L.
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Jfcr
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka-Sayama
country: Japan
facility: Kindai University Hospital
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent'S Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: s Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Tilburg
country: Netherlands
facility: Etz Elisabeth
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii Im. Prof. F. Lukaszczyka W Bydgoszczy
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
city: Prabuty
country: Poland
facility: Szpital Specjalistyczny W Prabutach
city: Tomaszow Mazowiecki
country: Poland
facility: Provita Prolife
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universită Rio de Coimbra E.P.E.
city: Guimarães
country: Portugal
facility: Hospital Da Senhora Da Oliveira Guimară Es
city: Lisboa
country: Portugal
facility: Hospital Da Luz
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente
city: Porto
country: Portugal
facility: Centro Hospitalar Do Porto, E.P.E. - Hospital de Santo António
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic 'Prof. Dr. Ion Chiricuta' Cluj Napoca
city: Comuna Floresti
country: Romania
facility: S.C Radiotherapy Center Cluj S.R.L
city: Craiova
country: Romania
facility: S.C Centrul de Oncologie Sfantul Nectarie Craiova
city: Suceava
country: Romania
facility: S.C. Sigmedical Services Srl
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Jaen
country: Spain
facility: Hospital Universitario Ciudad de Jaen
city: Jerez De Frontera
country: Spain
facility: Hospital de Especialidades de Jerez de La Frontera
city: L'Hospitalet de Llobregat
country: Spain
facility: Ico L'Hospitalet - Hospital Duran I Reynals
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno-Infantil
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
city: Bern
country: Switzerland
facility: Inselspital - Universitaetsspital Bern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Villars-sur-Glâne
country: Switzerland
facility: Hfr Fribourg/Kantonsspital Fribourg
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospitalx
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Centre
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Diyarbakir
country: Turkey
facility: Dicle University, Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Istanbul
country: Turkey
facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital
city: Izmir
country: Turkey
facility: Izmir Medicalpark Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Leeds
country: United Kingdom
facility: St James'S University Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Director
role: STUDY_DIRECTOR
References: