Een studie om de ziekteactiviteit en bijwerkingen van intraveneuze (IV) Telisotuzumab Vedotin te beoordelen in vergelijking met IV docetaxel bij volwassen deelnemers met eerder behandelde niet-plaveiselcel niet-kleincellige longkanker (NSCLC)
27 oktober 2026 bijgewerkt door: AbbVie
Een open-label, gerandomiseerde, gecontroleerde, wereldwijde fase 3-studie van Telisotuzumab Vedotin (ABBV-399) versus docetaxel bij proefpersonen met eerder behandelde c-Met-overexpressie, EGFR-wildtype, lokaal gevorderde/gemetastaseerde niet-plaveiselcel niet-kleincellige longkanker
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin or docetaxel at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 768 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 330 sites worldwide.
Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. At the conclusion of the study, participants who continue to demonstrate clinical benefit may be eligible to receive study treatment via an extension of the study, a rollover study, or through another mechanism.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
768
Fase
- Fase 3
Uitgebreide toegang
Tijdelijk niet beschikbaar buiten de klinische proef.
Zie uitgebreid toegangsrecord.
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: ABBVIE CALL CENTER
- Telefoonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studie Locaties
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Buenos Aires, Argentinië, 1125
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- LC Investigacion /ID# 239880
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Buenos Aires, Argentinië, 1417
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- Instituto de Oncologia Angel H Roffo /ID# 231499
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Contact:
- Site Coordinator
- Telefoonnummer: 5491141689984
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Buenos Aires
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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentinië, 1431
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- Cemic /Id# 231486
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentinië, 1280
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- Hospital Britanico de Buenos Aires /ID# 231495
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Buenos Aires F.D.
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Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentinië, 1019
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- Centro Médico Austral /ID# 239860
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Río Negro Province
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Viedma, Río Negro Province, Argentinië, 8500
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- Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339
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New South Wales
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Port Macquarie, New South Wales, Australië, 2444
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- Port Macquarie Base Hospital /ID# 273654
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Westmead, New South Wales, Australië, 2145
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- Westmead Hospital /ID# 274447
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Victoria
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Geelong, Victoria, Australië, 3220
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- Barwon Health /ID# 241920
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Heidelberg, Victoria, Australië, 3084
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- Austin Health /ID# 247507
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Anderlecht, België, 1070
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- Institut Jules Bordet /ID# 246770
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Ghent, België, 9000
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- AZ Maria Middelares /ID# 246768
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Liège, België, 4000
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- CHU de Liege /ID# 246772
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Namur, België, 5000
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- UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769
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Antwerpen
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Brasschaat, Antwerpen, België, 2930
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- Algemeen Ziekenhuis klina /ID# 239853
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Edegem, Antwerpen, België, 2650
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- Universitair Ziekenhuis Antwerpen /ID# 239971
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Hainaut
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Charleroi, Hainaut, België, 6280
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- Grand Hopital de Charleroi - Les Viviers /ID# 234178
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La Louvière, Hainaut, België, 7100
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- Hospital La Louviere Site Jolimont - Helora /ID# 246771
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Limburg
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Hasselt, Limburg, België, 3500
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- Jessa Ziekenhuis /ID# 246766
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, België, 9000
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- UZ Gent /ID# 273244
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Sint-Niklaas, Oost-Vlaanderen, België, 9100
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- Vitaz /Id# 246773
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Rio de Janeiro, Brazilië, 20231-050
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- Instituto Nacional de Cancer (INCA) /ID# 231509
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Rio de Janeiro, Brazilië, 22281-100
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- Instituto Dor de Pesquisa e Ensino /ID# 233245
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São Paulo, Brazilië, 01236-030
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- Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417
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São Paulo, Brazilië, 08270-070
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- Casa de Saúde Santa Marcelina /ID# 231605
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São Paulo, Brazilië, 01308-050
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- Hospital Sirio Libanes - Sao Paulo /ID# 261827
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Estado de Bahia
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Salvador, Estado de Bahia, Brazilië, 41950-640
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- Clinica Amo - Rio Vermelho /ID# 231604
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazilië, 90020-090
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- Hospital Da Crianca Santo Antonio /ID# 233249
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São Paulo
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Barretos, São Paulo, Brazilië, 14784-400
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- Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247
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São Paulo, São Paulo, Brazilië, 05874-230
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- OC Oncoclínicas SP /ID# 261828
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Burgas, Bulgarije, 8000
- Voltooid
- Complex Oncology Center - Burgas /ID# 240532
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Plovdiv, Bulgarije, 4004
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- Complex Cancer Center Plovdiv /ID# 234106
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Varna, Bulgarije, 9009
- Werving
- UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 234112
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Pazardzhik
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Panagyurishte, Pazardzhik, Bulgarije, 4500
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- Uni Hospital /ID# 273707
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Sofia
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Sofiya, Sofia, Bulgarije, 1797
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- University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
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- Cross Cancer Institute. /ID# 252065
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Ontario
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Brampton, Ontario, Canada, L6R 3J7
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- William Osler Health System - Brampton Civic Hospital /ID# 254420
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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- CISSS de la Monteregie /ID# 239081
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Lévis, Quebec, Canada, G6V 3Z1
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- CSSS Alphonse-Desjardins, CHAU de Levis /ID# 261158
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Montreal, Quebec, Canada, H4J 1C5
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- Hopital Du Sacre-Coeur De Montreal /ID# 274584
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Santiago, Chili, 7501504
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- Hospital Clinico Universidad De Los Andes /ID# 260974
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Maule Region
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Talca, Maule Region, Chili, 3461341
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- Clinica Universidad Catolica del Maule /ID# 231294
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Santiago Metropolitan
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La Florida, Santiago Metropolitan, Chili, 8241479
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- Icegclinic /Id# 231212
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Providencia, Santiago Metropolitan, Chili, 7500713
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- Sociedad Prosalud Montes y Orlandi /ID# 231154
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Providencia, Santiago Metropolitan, Chili, 7500921
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- Fundacion Arturo Lopez Perez /ID# 231151
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Providencia, Santiago Metropolitan, Chili, 7510032
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- Sociedad Oncovida /ID# 231152
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Anhui
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Hefei, Anhui, China, 230032
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- Anhui Medical University - Anhui Chest Hospital /ID# 231899
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Werving
- Beijing Cancer Hospital /ID# 231923
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Beijing, Beijing Municipality, China, 101149
- Werving
- Beijing Chest Hospital, Capital Medical University /ID# 232202
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Beijing, Beijing Municipality, China, 100730
- Werving
- Peking Union Medical College Hospital East - Dongdan Campus /ID# 233175
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400016
- Werving
- The First Affiliated Hospital of Chongqing Medical University /ID# 251592
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Fujian
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Fuzhou, Fujian, China, 350014
- Werving
- Fujian Provincial Cancer Hospital /ID# 243134
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Xiamen, Fujian, China, 361003
- Werving
- The First Affiliated Hospital of Xiamen University /ID# 242381
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Werving
- The First Affiliated Hospital Of Guangzhou Medical University - Yanjiang W Road /ID# 238591
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Shantou, Guangdong, China, 515041
- Werving
- Cancer Hospital of Shantou University Medical College /ID# 242182
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Zhanjiang, Guangdong, China, 524004
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- Affiliated Hospital of Guangdong Medical College /ID# 233317
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Guangxi
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Nanning, Guangxi, China, 530021
- Werving
- Affiliated Cancer Hospital of Guangxi Medical University /ID# 231855
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Guizhou
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Guiyang, Guizhou, China, 550002
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- People's Hospital of Guizhou Province /ID# 243614
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Hebei
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Baoding, Hebei, China, 071000
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- Affiliated Hospital of Hebei University /ID# 239586
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Heilongjiang
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Harbin, Heilongjiang, China, 150081
- Werving
- Harbin Medical University Cancer Hospital /Id# 231941
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Henan
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Nanyang, Henan, China, 473007
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- The First affiliated Hospital of Nanyang Medical College /ID# 244652
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Zhengzhou, Henan, China, 450008
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- Henan Cancer Hospital /ID# 239577
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Zhengzhou, Henan, China, 450003
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- People's Hospital of Henan Province /ID# 242187
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Hubei
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Wuhan, Hubei, China, 430030
- Werving
- Tongji Hospital Tongji Medical College of HUST /ID# 239575
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Wuhan, Hubei, China, 430079
- Werving
- Hubei Cancer Hospital /ID# 240045
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Wuhan, Hubei, China, 430048
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- Union Hospital Tongji Medical College /ID# 231904
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Hunan
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Changsha, Hunan, China, 410006
- Werving
- Hunan Cancer Hospital /ID# 231943
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Inner Mongolia
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Hohhot, Inner Mongolia, China, 010050
- Voltooid
- The Affiliated Hospital of Inner Mongolia Medical University /ID# 242179
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- Werving
- Nanjing Drum Tower Hospital /ID# 231791
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Nantong, Jiangsu, China, 226300
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- Nantong Tumor Hospital /ID# 232424
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Jiangxi
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Nanchang, Jiangxi, China, 330008
- Werving
- The Second Affiliated Hospital of Nanchang University /ID# 231935
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Nanchang, Jiangxi, China, 330209
- Werving
- The First Affiliated Hospital of Nanchang University - Xianghu Campus /ID# 231934
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Jilin
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Changchun, Jilin, China, 130012
- Werving
- Jilin Cancer Hospital /ID# 244702
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Liaoning
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Dalian, Liaoning, China, 116023
- Werving
- The Second Affiliated Hospital of Dalian Medical University /ID# 239755
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Shenyang, Liaoning, China, 110001
- Werving
- First Affiliated Hospital of China Medical University /ID# 231924
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Shaanxi
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Xi'an, Shaanxi, China, 710061
- Werving
- The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023
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Shandong
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Jinan, Shandong, China, 250013
- Werving
- Jinan Central Hospital /ID# 231895
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Jinan, Shandong, China, 251601
- Werving
- Shandong Cancer Hospital /ID# 251506
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Linyi, Shandong, China, 276001
- Werving
- LinYi Cancer Hospital /ID# 239713
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200030
- Werving
- Shanghai Chest Hospital /ID# 231897
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Shanxi
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Taiyuan, Shanxi, China, 030009
- Werving
- Shanxi Cancer Hospital /ID# 258674
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Sichuan
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Chengdu, Sichuan, China, 610041
- Werving
- Sichuan Cancer Hospital /ID# 239707
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Chengdu, Sichuan, China, 610041
- Werving
- West China Hospital, Sichuan University /ID# 233703
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300000
- Werving
- Tianjin Cancer Hospital /ID# 233176
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Tianjin, Tianjin Municipality, China, 300052
- Werving
- Tianjin Medical University General Hospital /ID# 231839
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Xinjiang
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Ürümqi, Xinjiang, China, 830000
- Werving
- The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 240094
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Yunnan
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Kunming, Yunnan, China, 650118
- Werving
- Yunnan Cancer Hospital /ID# 251388
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Zhejiang
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Hangzhou, Zhejiang, China, 310022
- Werving
- Zhejiang Cancer hospital /ID# 242476
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Hangzhou, Zhejiang, China, 310003
- Werving
- The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032
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Linhai, Zhejiang, China, 317000
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- Taizhou Hospital of Zhejiang Province /ID# 232021
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Ningbo, Zhejiang, China, 315010
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- Ningbo No. 2 Hospital /ID# 242478
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Antioquia
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Medellín, Antioquia, Colombia, 050034
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- Hospital Pablo Tobon Uribe /ID# 258128
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110131
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- Fundacion Ctic - Centro De Tratamiento E Investigacion Sobre Cancer Luis Carlos /ID# 258131
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Cesar Department
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Valledupar, Cesar Department, Colombia, 200001
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- Sociedad de Oncologia y Hematologia del Cesar SAS /ID# 258130
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Departamento de Córdoba
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Montería, Departamento de Córdoba, Colombia, 230018
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- Imat Oncomedica /ID# 258129
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Region Sjælland
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Køge, Region Sjælland, Denemarken, 4600
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- Zealand University Hospital /ID# 241842
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Region Syddanmark
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Odense, Region Syddanmark, Denemarken, 5000
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- Odense University Hospital /ID# 241663
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Berlin, Duitsland, 13353
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- Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 234247
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Hamburg, Duitsland, 20251
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- Haemato-Onkologie Hamburg /ID# 241047
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Hamburg, Duitsland, 20246
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- Universitaetsklinikum Hamburg-Eppendorf /ID# 239658
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Duitsland, 69126
- Werving
- Thoraxklinik Heidelberg gGmbH /ID# 239656
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Mannheim, Baden-Wurttemberg, Duitsland, 68167
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- Universitatsklinikum Mannheim /ID# 238331
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Bavaria
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Gauting, Bavaria, Duitsland, 82131
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- Asklepios Fachkliniken Muenchen-Gauting /ID# 272768
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Hesse
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Giessen, Hesse, Duitsland, 35392
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- Universitaetsklinikum Giessen /ID# 252973
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Kassel, Hesse, Duitsland, 34125
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- Klinikum Kassel /ID# 240142
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Saxony
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Dresden, Saxony, Duitsland, 01307
- Werving
- Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274719
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Thuringia
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Bad Berka, Thuringia, Duitsland, 99437
- Werving
- Zentralklinik Bad Berka /ID# 239661
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Paris, Frankrijk, 75020
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- AP-HP - Hopital Tenon /ID# 239179
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Bouches-du-Rhone
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Marseille, Bouches-du-Rhone, Frankrijk, 13015
- Werving
- APHM - Hopital Nord /ID# 251935
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Hauts-de-France
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Lille, Hauts-de-France, Frankrijk, 59037
- Werving
- Centre Hospitalier Regional Universitaire de Lille - Hopital Albert Calmette /ID# 251934
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Herault
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Montpellier, Herault, Frankrijk, 34295
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- Hopital Arnaud de Villeneuve /ID# 239404
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New Aquitaine
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Pessac, New Aquitaine, Frankrijk, 33604
- Werving
- Centre Hospitalier Universitaire de Bordeaux /ID# 244953
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Paris
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Paris, Paris, Frankrijk, 75248
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- Institut Curie /ID# 240141
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Paris, Paris, Frankrijk, 75679
- Werving
- Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 239409
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Provence-Alpes-Côte d'Azur Region
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Avignon, Provence-Alpes-Côte d'Azur Region, Frankrijk, 84000
- Werving
- Centre Hospitalier d'Avignon /ID# 275229
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Rhone
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Bron, Rhone, Frankrijk, 69500
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- Hospices Civils de Lyon - Hopital Louis Pradel /ID# 251933
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Lyon, Rhone, Frankrijk, 69373
- Werving
- Centre Leon Berard /ID# 267397
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Val-de-Marne
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Créteil, Val-de-Marne, Frankrijk, 94000
- Werving
- Centre Hosp Intercommunal de Creteil /ID# 251936
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Île-de-France Region
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Villejuif, Île-de-France Region, Frankrijk, 94800
- Werving
- Institut Gustave Roussy /ID# 267415
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Thessaloniki, Griekenland, 57001
- Voltooid
- Interbalkan Medical Center Of Thessaloniki /ID# 254407
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Attica
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Athens, Attica, Griekenland, 11526
- Werving
- Henry Dunnant Hospital Center /ID# 267021
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Athens, Attica, Griekenland, 11527
- Werving
- Thoracic General Hospital of Athens I Sotiria /ID# 230824
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Piraeus, Attica, Griekenland, 18547
- Werving
- Metropolitan Hospital /ID# 232158
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Piraeus, Attica, Griekenland, 18547
- Werving
- Metropolitan Hospital /ID# 239170
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Northern District
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Safed, Northern District, Israël, 13100
- Werving
- ZIV Medical Center /ID# 238606
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Southern District
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Beersheba, Southern District, Israël, 8410101
- Werving
- Soroka University Medical Center /ID# 252711
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Holon, Southern District, Israël, 5822000
- Voltooid
- The Edith Wolfson Medical Center /ID# 233781
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Tel Aviv
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Tel Aviv, Tel Aviv, Israël, 6423906
- Werving
- Tel Aviv Sourasky Medical Center /ID# 260519
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Bari, Italië, 70124
- Werving
- I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696
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Cremona, Italië, 26100
- Werving
- Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698
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Messina, Italië, 98158
- Voltooid
- Azienda Ospedaliera Papardo /ID# 258038
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Perugia, Italië, 06156
- Werving
- Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 238473
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Varese, Italië, 21100
- Werving
- ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 238536
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Catania
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Misterbianco, Catania, Italië, 95045
- Werving
- Humanitas Istituto Clinico Catanese /ID# 273050
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Milano
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Milan, Milano, Italië, 20132
- Werving
- IRCCS Ospedale San Raffaele /ID# 254376
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Napoli
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Naples, Napoli, Italië, 80138
- Werving
- Azienda Ospedaliera Universitaria Luigi Vanvitelli - Miraglia /ID# 252942
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Roma
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Rome, Roma, Italië, 00184
- Werving
- Azienda Ospedaliera Complesso Ospedaliero San Giovanni-Addolorata /ID# 238618
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Fukushima, Japan, 960-1295
- Werving
- Fukushima Medical University Hospital /ID# 249691
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 460-0001
- Werving
- NHO Nagoya Medical Center /ID# 246306
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Nagoya, Aichi-ken, Japan, 466-8560
- Werving
- Nagoya University Hospital /ID# 239990
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Aomori
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Hirosaki-shi, Aomori, Japan, 036-8203
- Werving
- Hirosaki University Hospital /ID# 242377
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Chiba
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Kashiwa-shi, Chiba, Japan, 277-8577
- Werving
- National Cancer Center Hospital East /ID# 233775
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Fukuoka
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Fukuoka, Fukuoka, Japan, 810-8563
- Werving
- National Hospital Organization Kyushu Medical Center /ID# 238533
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Kitakyushu-shi, Fukuoka, Japan, 807-8556
- Werving
- Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 241191
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Kurume-shi, Fukuoka, Japan, 830-0011
- Werving
- Kurume University Hospital /ID# 254900
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Gunma
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Ota-shi, Gunma, Japan, 373-8550
- Werving
- Gunma Prefectural Cancer Center /ID# 233723
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Hiroshima
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Fukuyama, Hiroshima, Japan, 720-0001
- Werving
- Chugoku Central Hospital /ID# 242970
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Hiroshima, Hiroshima, Japan, 734-8551
- Werving
- Hiroshima University Hospital /ID# 241882
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Werving
- Hokkaido University Hospital /ID# 241289
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0046
- Werving
- Kobe Minimally Invasive Cancer Center /ID# 254131
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Takarazuka-shi, Hyōgo, Japan, 665-0827
- Werving
- Takarazuka City Hospital /ID# 240786
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Ibaraki
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Higashiibaraki-gun, Ibaraki, Japan, 311-3193
- Werving
- NHO Mito Medical Center /ID# 241709
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Kasama-shi, Ibaraki, Japan, 309-1793
- Werving
- Ibaraki Prefectural Central Hospital /ID# 246145
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Iwate
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Shiwa-gun, Iwate, Japan, 028-3695
- Werving
- Iwate Medical University Hospital /ID# 239027
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Kanagawa
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Sagamihara-shi, Kanagawa, Japan, 252-0375
- Werving
- Kitasato University Hospital /ID# 239958
-
Yokohama, Kanagawa, Japan, 232-0024
- Werving
- Yokohama City University Medical Center /ID# 246554
-
Yokohama, Kanagawa, Japan, 236-0051
- Werving
- Kanagawa Cardiovascular and Respiratory Center /ID# 239052
-
-
Kumamoto
-
Kumamoto, Kumamoto, Japan, 8608556
- Werving
- Kumamoto University Hospital /ID# 241039
-
-
Mie-ken
-
Tsu, Mie-ken, Japan, 514-1101
- Werving
- National Hospital Organization Mie Chuo Medical Center /ID# 246659
-
-
Miyagi
-
Natori-shi, Miyagi, Japan, 981-1293
- Werving
- Miyagi Cancer Center /ID# 234198
-
Sendai, Miyagi, Japan, 980-0873
- Werving
- Sendai Kousei Hospital /ID# 253350
-
-
Miyazaki
-
Miyazaki, Miyazaki, Japan, 889-1692
- Werving
- University of Miyazaki Hospital /ID# 242161
-
-
Niigata
-
Nagaoka-shi, Niigata, Japan, 940-2085
- Werving
- Nagaoka Red Cross Hospital /ID# 240714
-
-
Okayama-ken
-
Kurashiki-shi, Okayama-ken, Japan, 710-8602
- Werving
- Kurashiki Central Hospital /ID# 239344
-
-
Osaka
-
Habikino-shi, Osaka, Japan, 583-8588
- Werving
- Osaka Habikino Medical Center /ID# 239989
-
Hirakata-shi, Osaka, Japan, 573-1191
- Werving
- Kansai Medical University Hospital /ID# 233476
-
Osaka, Osaka, Japan, 545-8586
- Werving
- Osaka Metropolitan University Hospital /ID# 238895
-
Sakai-shi, Osaka, Japan, 590-0197
- Werving
- Kindai University Hospital /ID# 239085
-
-
Shizuoka
-
Fujieda-shi, Shizuoka, Japan, 426-8677
- Werving
- Fujieda Municipal General Hospital /ID# 255155
-
-
Tochigi
-
Utsunomiya, Tochigi, Japan, 320-0834
- Werving
- Tochigi Cancer Center /ID# 240020
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8431
- Werving
- Juntendo University Hospital /ID# 239932
-
Chuo-ku, Tokyo, Japan, 104-0045
- Werving
- National Cancer Center Hospital /ID# 251134
-
Meguro-ku, Tokyo, Japan, 152-8902
- Werving
- National Hospital Organization Tokyo Medical Center /ID# 246581
-
Contact:
- Site Coordinator
- Telefoonnummer: +81-3-3411-0111
-
Shinagawa-ku, Tokyo, Japan, 141-8625
- Werving
- NTT Medical Center Tokyo /ID# 241067
-
Shinjuku-ku, Tokyo, Japan, 160-8582
- Werving
- Keio University Hospital /ID# 239506
-
-
Toyama
-
Toyama, Toyama, Japan, 930-0194
- Werving
- Toyama University Hospital /ID# 241660
-
-
Wakayama
-
Wakayama, Wakayama, Japan, 641-8510
- Werving
- Wakayama Medical University Hospital /ID# 234004
-
-
Yamagata
-
Yamagata, Yamagata, Japan, 990-9585
- Voltooid
- Yamagata University Hospital /ID# 240815
-
-
Yamaguchi
-
Ube-shi, Yamaguchi, Japan, 755-0241
- Werving
- Yamaguchi - Ube Medical Center /ID# 258779
-
-
-
-
-
Oaxaca City, Mexico, 68020
- Werving
- Clinical Research & Oncology Oaxaca /ID# 231883
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44280
- Werving
- O.P.D. Hospital Civil de Guadalajara /ID# 238488
-
-
Michoacán
-
Morelia, Michoacán, Mexico, 58260
- Voltooid
- Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928
-
-
-
-
-
's-Hertogenbosch, Nederland, 5223 GZ
- Werving
- Jeroen Bosch Ziekenhuis /ID# 234087
-
-
Gelderland
-
Harderwijk, Gelderland, Nederland, 3844 DG
- Werving
- Ziekenhuis St. Jansdal /ID# 251932
-
-
Limburg
-
Maastricht, Limburg, Nederland, 6229 HX
- Werving
- Maastricht Universitair Medisch Centrum /ID# 233932
-
-
Overijssel
-
Zwolle, Overijssel, Nederland, 8025 AB
- Werving
- Isala /ID# 238846
-
-
South Holland
-
The Hague, South Holland, Nederland, 2545 AA
- Werving
- HagaZiekenhuis /ID# 243693
-
-
-
-
-
Salzburg, Oostenrijk, 5020
- Werving
- Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467
-
-
State of Vienna
-
Vienna, State of Vienna, Oostenrijk, 1090
- Werving
- Medizinische Universitaet Wien /ID# 230615
-
Vienna, State of Vienna, Oostenrijk, 1140
- Werving
- Klinik Penzing /ID# 230700
-
Vienna, State of Vienna, Oostenrijk, 1210
- Werving
- Klinik Floridsdorf /ID# 230608
-
-
Tyrol
-
Innsbruck, Tyrol, Oostenrijk, 6020
- Werving
- Medizinische Universitaet Innsbruck /ID# 240981
-
Contact:
- Site Coordinator
- Telefoonnummer: 004351290030
-
-
Upper Austria
-
Linz, Upper Austria, Oostenrijk, 4010
- Werving
- Ordensklinikum Linz Elisabethinen /ID# 240967
-
Wels, Upper Austria, Oostenrijk, 4600
- Werving
- Klinikum Wels-Grieskirchen Gmbh /ID# 249000
-
-
Vorarlberg
-
Feldkirch, Vorarlberg, Oostenrijk, 6800
- Werving
- Landeskrankenhaus Feldkirch /ID# 250333
-
-
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polen, 60-569
- Werving
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 262489
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 02-781
- Werving
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 262095
-
-
Podkarpackie Voivodeship
-
Rzeszów, Podkarpackie Voivodeship, Polen, 35-021
- Werving
- MRUK-MED I Sp. z o.o. /ID# 239363
-
-
Warmian-Masurian Voivodeship
-
Olsztyn, Warmian-Masurian Voivodeship, Polen, 10-357
- Werving
- Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, Polen, 93-338
- Werving
- Instytut Centrum Zdrowia Matki Polki /ID# 239024
-
-
-
-
-
Porto, Portugal, 4100-180
- Werving
- Hospital CUF Porto /ID# 241570
-
Porto, Portugal, 4099-001
- Werving
- Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 241572
-
Porto, Portugal, 4200-072
- Werving
- IPO Porto FG, EPE /ID# 241569
-
Porto, Portugal, 4200-319
- Werving
- Unidade Local de Saude Sao Joao /ID# 241930
-
-
Lisbon District
-
Lisbon, Lisbon District, Portugal, 1400-038
- Werving
- Fundacao Champalimaud /ID# 241925
-
-
-
-
-
Brasov, Roemenië, 500283
- Werving
- Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826
-
Iași, Roemenië, 700483
- Werving
- Institutul Regional de Oncologie /ID# 254065
-
Suceava, Roemenië, 720214
- Werving
- S.C. Sigmedical Services SRL /ID# 239108
-
-
Bihor County
-
Oradea, Bihor County, Roemenië, 410469
- Werving
- Spitalul Pelican /ID# 254066
-
-
Cluj
-
Cluj-Napoca, Cluj, Roemenië, 400015
- Werving
- Cardiomed Srl /Id# 255320
-
-
Dolj
-
Craiova, Dolj, Roemenië, 200385
- Werving
- Sc Oncolab Srl /Id# 239105
-
-
Ilfov
-
Otopeni, Ilfov, Roemenië, 075100
- Werving
- SC RTC Radiology Therapeutic Center SRL /ID# 240744
-
-
Timiș County
-
Timișoara, Timiș County, Roemenië, 300166
- Werving
- Oncocenter - Oncologie Clinica Srl /Id# 239103
-
-
-
-
Banská Bystrica Region
-
Banská Bystrica, Banská Bystrica Region, Slowakije, 975 17
- Voltooid
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084
-
-
-
-
-
Barcelona, Spanje, 08017
- Werving
- UOMi Cancer Center - Clinica Tres Torres /ID# 240584
-
Barcelona, Spanje, 08028
- Werving
- Hospital Universitario Dexeus - Grupo Quironsalud /ID# 255105
-
Jaén, Spanje, 23007
- Werving
- Hospital Universitario de Jaen /ID# 240588
-
Madrid, Spanje, 28041
- Werving
- Hospital Universitario 12 de Octubre /ID# 240176
-
Valencia, Spanje, 46010
- Werving
- Hospital Clinico Universitario de Valencia /ID# 240378
-
Ávila, Spanje, 05004
- Werving
- Hospital Nuestra Senora de Sonsoles /ID# 255102
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spanje, 35016
- Werving
- CHU Insular-Materno Infantil /ID# 255094
-
-
Madrid
-
Alcorcón, Madrid, Spanje, 28922
- Werving
- Hospital Universitario Fundacion Alcorcon /ID# 255100
-
Fuenlabrada, Madrid, Spanje, 28942
- Werving
- Hospital Universitario de Fuenlabrada /ID# 255093
-
-
-
-
-
Changhua City, Changhua County, Taiwan, 50006
- Werving
- Changhua Christian Hospital /ID# 238394
-
Hsinchu, Taiwan, 30059
- Werving
- National Taiwan University Hospital - Hsinchu branch /ID# 238393
-
Hualien City, Taiwan, 97002
- Werving
- Hualien Tzu Chi Hospital /ID# 238398
-
Taichung, Taiwan, 402
- Werving
- Chung Shan Medical University Hospital /ID# 238444
-
Taipei, Taiwan, 104
- Werving
- Mackay Memorial Hospital /ID# 238392
-
Taipei, Taiwan, 11031
- Werving
- Taipei Medical University Hospital /ID# 238380
-
Taipei, Taiwan, 100
- Werving
- National Taiwan University Hospital /ID# 238378
-
-
Kaohsiung
-
Kaohsiung City, Kaohsiung, Taiwan, 82445
- Werving
- E-DA Cancer Hospital /ID# 239718
-
-
-
-
-
Brno, Tsjechië, 656 53
- Werving
- Masarykuv onkologicky ustav /ID# 232426
-
Nový Jičín, Tsjechië, 741 01
- Voltooid
- Nemocnice AGEL Novy Jicin, a.s. /ID# 232427
-
-
-
-
-
Adana, Turkije (Türkiye), 01060
- Werving
- Adana Sehir Egitim ve Arastirma Hastanesi /ID# 255638
-
Adana, Turkije (Türkiye), 01130
- Voltooid
- Adana Acıbadem Hospital /ID# 234208
-
Adana, Turkije (Türkiye), 01140
- Werving
- Medical Park Seyhan Hastanesi /ID# 255637
-
Ankara, Turkije (Türkiye), 06560
- Werving
- Gazi Universitesi /ID# 265425
-
Ankara, Turkije (Türkiye), 06800
- Werving
- Ankara City hospital /ID# 234210
-
Battalgazi/malatya, Turkije (Türkiye), 44280
- Werving
- Inonu Universitesi Turgut Ozal /ID# 234038
-
Bursa, Turkije (Türkiye), 16059
- Werving
- Uludag University Medical Faculty /ID# 234205
-
Diyarbakır, Turkije (Türkiye), 21200
- Werving
- Dicle Universitesi Tip /ID# 234036
-
Istanbul, Turkije (Türkiye), 34214
- Werving
- Bagcilar Medipol Mega Universite Hastanesi /ID# 234211
-
Izmir, Turkije (Türkiye), 35040
- Werving
- Ege University Medical Faculty /ID# 234039
-
Izmir, Turkije (Türkiye), 35110
- Werving
- Dr. Suat Seren Gogus Has /ID# 262291
-
-
Ankara
-
Çankaya, Ankara, Turkije (Türkiye), 06520
- Werving
- Memorial Ankara Hastanesi /ID# 234212
-
-
İzmir
-
Cordaleo, İzmir, Turkije (Türkiye), 35575
- Werving
- Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209
-
-
-
-
-
London, Verenigd Koninkrijk, SW3 6JJ
- Werving
- The Royal Marsden NHS Foundation Trust /ID# 246974
-
Manchester, Verenigd Koninkrijk, M20 4BX
- Werving
- The Christie Hospital /ID# 243422
-
-
Greater London
-
London, Greater London, Verenigd Koninkrijk, NW1 2BU
- Werving
- UCLH NHS FT - University College Hospital /ID# 249407
-
London, Greater London, Verenigd Koninkrijk, EC1A 7BE
- Werving
- St Bartholomews Hospital - Barts Health /ID# 254342
-
-
Nottinghamshire
-
Nottingham, Nottinghamshire, Verenigd Koninkrijk, NG5 1PB
- Werving
- Nottingham City Hospital /ID# 254707
-
-
West Midlands
-
Birmingham, West Midlands, Verenigd Koninkrijk, B9 5SS
- Werving
- Heartlands Hospital - University Hospitals Birmingham /ID# 258141
-
-
-
-
Alabama
-
Birmingham, Alabama, Verenigde Staten, 35233
- Voltooid
- University of Alabama at Birmingham - Main /ID# 247074
-
-
Arizona
-
Chandler, Arizona, Verenigde Staten, 85224-5665
- Actief, niet wervend
- Ironwood Cancer & Res Ctr /ID# 262446
-
Phoenix, Arizona, Verenigde Staten, 85054-4504
- Actief, niet wervend
- Mayo Clinic Arizona /ID# 255858
-
Yuma, Arizona, Verenigde Staten, 85364
- Voltooid
- Onvida Health Yuma Medical Center /ID# 253625
-
-
California
-
Duarte, California, Verenigde Staten, 91010
- Werving
- City of Hope /ID# 243157
-
Huntington Beach, California, Verenigde Staten, 92648
- Werving
- City Of Hope - Seacliff /ID# 263143
-
Irvine, California, Verenigde Staten, 92618
- Werving
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144
-
Lancaster, California, Verenigde Staten, 93534
- Werving
- City Of Hope - Antelope Valley /ID# 263138
-
Los Angeles, California, Verenigde Staten, 90033
- Voltooid
- The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774
-
Rancho Mirage, California, Verenigde Staten, 92270-3221
- Voltooid
- Eisenhower Medical Center /ID# 233189
-
Santa Monica, California, Verenigde Staten, 90404
- Voltooid
- Premiere Oncology Foundation /ID# 253954
-
-
Florida
-
Jacksonville, Florida, Verenigde Staten, 32224
- Voltooid
- Mayo Clinic Hospital Jacksonville /ID# 254688
-
Ocala, Florida, Verenigde Staten, 34474-4445
- Voltooid
- Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228
-
Tamarac, Florida, Verenigde Staten, 33321-2919
- Voltooid
- BRCR Medical Center Inc /ID# 262344
-
-
Georgia
-
Savannah, Georgia, Verenigde Staten, 31404
- Voltooid
- Memorial University Medical Center /ID# 264081
-
-
Hawaii
-
Honolulu, Hawaii, Verenigde Staten, 96819-1469
- Werving
- Kaiser Permanente Moanalua Medical Center /ID# 238363
-
-
Illinois
-
Elmhurst, Illinois, Verenigde Staten, 60126
- Actief, niet wervend
- Edward-Elmhurst Cancer Center /ID# 238552
-
Springfield, Illinois, Verenigde Staten, 62702
- Actief, niet wervend
- Springfield Clinic - First /ID# 262290
-
-
Indiana
-
Goshen, Indiana, Verenigde Staten, 46526
- Voltooid
- Goshen Center for Cancer Care /ID# 257734
-
Indianapolis, Indiana, Verenigde Staten, 46260
- Voltooid
- Investigative Clinical Research of Indiana - Indianapolis /ID# 260468
-
-
Kentucky
-
Lexington, Kentucky, Verenigde Staten, 40503
- Voltooid
- Baptist Health Lexington /ID# 252769
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02215
- Voltooid
- Dana-Farber Cancer Institute /ID# 247132
-
-
Michigan
-
Ypsilanti, Michigan, Verenigde Staten, 48197-1051
- Voltooid
- Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190
-
-
Minnesota
-
Rochester, Minnesota, Verenigde Staten, 55905
- Actief, niet wervend
- Mayo Clinic Hospital Rochester /ID# 252052
-
-
Mississippi
-
Hattiesburg, Mississippi, Verenigde Staten, 39401
- Werving
- Hattiesburg Clinic /ID# 248033
-
-
Missouri
-
Chesterfield, Missouri, Verenigde Staten, 63017
- Voltooid
- St. Luke's Hospital - Chesterfield /ID# 251688
-
Kansas City, Missouri, Verenigde Staten, 64114-4859
- Voltooid
- Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567
-
Kansas City, Missouri, Verenigde Staten, 64111
- Werving
- St. Lukes Hosp. of Kansas City /ID# 259940
-
Springfield, Missouri, Verenigde Staten, 65807-5287
- Werving
- Hulston Cancer Center /ID# 232226
-
St Louis, Missouri, Verenigde Staten, 63110-2539
- Voltooid
- Saint Louis University Cancer Center /ID# 260722
-
-
Montana
-
Billings, Montana, Verenigde Staten, 59102
- Actief, niet wervend
- Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147
-
-
Nebraska
-
Lincoln, Nebraska, Verenigde Staten, 68506
- Voltooid
- Nebraska Hematology Oncology /ID# 257710
-
-
Nevada
-
Reno, Nevada, Verenigde Staten, 89502-1464
- Voltooid
- Renown Medical Group - Oncology/Hematology /ID# 247942
-
-
New Jersey
-
East Brunswick, New Jersey, Verenigde Staten, 08816-4096
- Voltooid
- Astera Cancer Care /ID# 257753
-
-
New Mexico
-
Farmington, New Mexico, Verenigde Staten, 87401
- Voltooid
- San Juan Oncology Associates /ID# 244387
-
-
New York
-
Brooklyn, New York, Verenigde Staten, 11219
- Actief, niet wervend
- Maimonides Medical Center /ID# 240783
-
Lake Success, New York, Verenigde Staten, 11042
- Voltooid
- Northwell Health - Monter Cancer Center /ID# 247081
-
-
North Carolina
-
Hendersonville, North Carolina, Verenigde Staten, 28792
- Voltooid
- AdventHealth Hendersonville /ID# 265349
-
Pinehurst, North Carolina, Verenigde Staten, 28374
- Voltooid
- FirstHealth of the Carolinas- Speciality Center /ID# 241279
-
-
Ohio
-
Zanesville, Ohio, Verenigde Staten, 43701-1406
- Actief, niet wervend
- Genesis Cancer Care Center /ID# 239190
-
-
Pennsylvania
-
York, Pennsylvania, Verenigde Staten, 17403
- Voltooid
- Cancer Care Associates Of York /ID# 266143
-
-
South Carolina
-
Charleston, South Carolina, Verenigde Staten, 29425
- Voltooid
- Medical University of South Carolina /ID# 251383
-
Greenville, South Carolina, Verenigde Staten, 29607-5253
- Voltooid
- St Francis Cancer Center /ID# 243596
-
-
South Dakota
-
Aberdeen, South Dakota, Verenigde Staten, 57401
- Voltooid
- Avera Cancer Institute - Aberdeen /ID# 257759
-
Sioux Falls, South Dakota, Verenigde Staten, 57105
- Voltooid
- Avera Cancer Institute /ID# 239635
-
-
Tennessee
-
Memphis, Tennessee, Verenigde Staten, 38104
- Voltooid
- Duplicate_Memphis VA Medical Center /ID# 263250
-
-
Texas
-
Austin, Texas, Verenigde Staten, 78701
- Actief, niet wervend
- Dell Seton Medical Center /ID# 247016
-
-
Utah
-
Ogden, Utah, Verenigde Staten, 84405-7194
- Voltooid
- Community Cancer Trials of Utah - South Ogden /ID# 262829
-
-
Washington
-
Renton, Washington, Verenigde Staten, 98055-5738
- Werving
- Valley Medical Center /ID# 253950
-
Spokane, Washington, Verenigde Staten, 99208
- Voltooid
- Medical Oncology Associates /ID# 247003
-
-
-
-
Gyeonggido
-
Goyang-si, Gyeonggido, Zuid -Korea, 10408
- Werving
- National Cancer Center /ID# 260663
-
Seongnam, Gyeonggido, Zuid -Korea, 13496
- Werving
- CHA Bundang Medical Center /ID# 233318
-
Suwon, Gyeonggido, Zuid -Korea, 16247
- Werving
- The Catholic University Of Korea St. Vincent's Hospital /ID# 256942
-
Suwon, Gyeonggido, Zuid -Korea, 16499
- Werving
- Ajou University Hospital - Suwon-si /ID# 233319
-
-
Gyeongsangnam-do
-
Jinju, Gyeongsangnam-do, Zuid -Korea, 52727
- Werving
- Gyeongsang National University Hospital /ID# 234244
-
Yangsan, Gyeongsangnam-do, Zuid -Korea, 50612
- Werving
- Pusan National University Yangsan Hospital /ID# 257836
-
-
North Chungcheong
-
Cheongju-si, North Chungcheong, Zuid -Korea, 28644
- Werving
- Chungbuk National University Hospital /ID# 257891
-
Contact:
- Site Coordinator
- Telefoonnummer: 043-261-3703
-
-
Seoul Teugbyeolsi
-
Seoul, Seoul Teugbyeolsi, Zuid -Korea, 03181
- Werving
- Kangbuk Samsung Hospital /ID# 233711
-
Seoul, Seoul Teugbyeolsi, Zuid -Korea, 06351
- Werving
- Samsung Medical Center /ID# 256941
-
Seoul, Seoul Teugbyeolsi, Zuid -Korea, 07061
- Werving
- SMG-SNU Boramae Medical Center /ID# 233710
-
-
-
-
Gauteng
-
Johannesburg, Gauteng, Zuid-Afrika, 2196
- Voltooid
- Sandton Oncology Medical Group PTY Ltd /ID# 230843
-
Johannesburg, Gauteng, Zuid-Afrika, 1864
- Voltooid
- Wits Clinical Research /ID# 230841
-
Pretoria, Gauteng, Zuid-Afrika, 0001
- Werving
- Steve Biko Academic Hospital /ID# 230883
-
-
-
-
Stockholm County
-
Solna, Stockholm County, Zweden, 171 64
- Werving
- Karolinska University Hospital Solna /ID# 229853
-
-
Västra Götaland County
-
Gothenburg, Västra Götaland County, Zweden, 413 46
- Werving
- Sahlgrenska Universitetssjukhuset /ID# 229943
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
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Projected life expectancy of at least 12 weeks.
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Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
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Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
- If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
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A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
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A known epidermal growth factor receptor (EGFR) activating mutation status.
-- Participants with EGFR activating mutations are not eligible
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Actionable alterations in genes other than EGFR are eligible.
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Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
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Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
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Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC
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Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
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Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.
- Participants with gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
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Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
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Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:
- They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day [QD] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
Exclusion Criteria:
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Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
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Evidence of leptomeningeal disease.
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Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
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Epidermal growth factor receptor (EGFR) activating mutations.
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Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
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Participants who have received prior docetaxel therapy.
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A history of other malignancies except:
- Malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization..
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without current evidence of disease.
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A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or prior pneumonectomy. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
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Unresolved nor adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
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Major surgery within 21 days prior to randomization.
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Clinically significant condition(s) as listed in the protocol.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Telisotuzumab Vedotin
Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. |
Intravenous (IV) Infusion
Andere namen:
|
|
Actieve vergelijker: Docetaxel
Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria. |
IV Infusion |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
Tijdsspanne: Up to approximately 39 months
|
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause. |
Up to approximately 39 months
|
|
Overall Survival (OS)
Tijdsspanne: Up to approximately 39 months
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OS is defined as the time from randomization to the event of death from any cause. |
Up to approximately 39 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Objective Response Rate (ORR), per BICR.
Tijdsspanne: Up to approximately 58.25 months
|
ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1 |
Up to approximately 58.25 months
|
|
Duration of Response (DoR), per BICR
Tijdsspanne: Up to approximately 58.25 months
|
DoR is defined for responders as the time from response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause. |
Up to approximately 58.25 months
|
|
PFS per Investigator Assessment
Tijdsspanne: Up to approximately 58.25 months
|
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 per investigator or death from any cause. Participants with no PFS event will be censored at the last evaluable radiographic assessment per investigator. Participants with no event and no evaluable post-baseline assessment will be censored at randomization. |
Up to approximately 58.25 months
|
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Change from Baseline of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).
Tijdsspanne: Up to approximately 12 Weeks
|
The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden. |
Up to approximately 12 Weeks
|
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Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.
Tijdsspanne: Up to approximately 12 Weeks
|
The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden. |
Up to approximately 12 Weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: ABBVIE INC., AbbVie
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
25 maart 2022
Primaire voltooiing (Geschat)
1 december 2028
Studie voltooiing (Geschat)
1 februari 2029
Studieregistratiedata
Eerst ingediend
14 juni 2021
Eerst ingediend dat voldeed aan de QC-criteria
14 juni 2021
Eerst geplaatst (Werkelijk)
16 juni 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 oktober 2026
Laatste update ingediend die voldeed aan QC-criteria
27 oktober 2026
Laatst geverifieerd
1 oktober 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Ziekten van de luchtwegen
- Longziekten
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Longneoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Neoplasmata
- Carcinoom, niet-kleincellige long
- Organische chemicaliën
- Koolwaterstoffen
- Cycloparaffins
- Koolwaterstoffen, alicyclisch
- Koolwaterstoffen, cyclisch
- Terpenen
- Taxoids
- Cyclodecanes
- Diterpenen
- Docetaxel
- telisotuzumab vedotine
Andere studie-ID-nummers
- M18-868
- 2023-505749-14-00 (Andere identificatie: EU CT)
- 2023 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD-tijdsbestek voor delen
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD-toegangscriteria voor delen
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .