A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

May 28, 2026 updated by: AbbVie

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

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 Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 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.

Study Overview

Status

Recruiting

Conditions

Non Small Cell Lung Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

698

Phase

Phase 3

Expanded Access

Temporarily not available outside the clinical trial. See expanded access record.

Contacts and Locations

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

Study Contact

Name: ABBVIE CALL CENTER
Phone Number: 844-663-3742
Email: abbvieclinicaltrials@abbvie.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1417
    - Recruiting
    - Instituto de Oncología Angel H. Roffo /ID# 231499
    - Contact:
      
      Site Coordinator
      
      Phone Number: 5491141689984
  - Buenos Aires, Argentina, 1125
    - Recruiting
    - LC Investigacion /ID# 239880
- Buenos Aires
  - Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1431
    - Recruiting
    - Cemic /Id# 231486
  - Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1280
    - Recruiting
    - Hospital Britanico de Buenos Aires /ID# 231495
- Buenos Aires F.D.
  - Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina, 1019
    - Recruiting
    - Centro Médico Austral /ID# 239860
- Río Negro Province
  - Viedma, Río Negro Province, Argentina, 8500
    - Recruiting
    - Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339
Australia
- New South Wales
  - Port Macquarie, New South Wales, Australia, 2444
    - Recruiting
    - Port Macquarie Base Hospital /ID# 273654
  - Westmead, New South Wales, Australia, 2145
    - Recruiting
    - Westmead Hospital /ID# 274447
- Victoria
  - Geelong, Victoria, Australia, 3220
    - Recruiting
    - Barwon Health /ID# 241920
  - Heidelberg, Victoria, Australia, 3084
    - Recruiting
    - Austin Health /ID# 247507
Austria
- - Salzburg, Austria, 5020
    - Recruiting
    - Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467
- State of Vienna
  - Vienna, State of Vienna, Austria, 1090
    - Recruiting
    - Medizinische Universitaet Wien /ID# 230615
  - Vienna, State of Vienna, Austria, 1140
    - Recruiting
    - Klinik Penzing /ID# 230700
  - Vienna, State of Vienna, Austria, 1210
    - Recruiting
    - Klinik Floridsdorf /ID# 230608
- Tyrol
  - Innsbruck, Tyrol, Austria, 6020
    - Recruiting
    - Medizinische Universitaet Innsbruck /ID# 240981
    - Contact:
      
      Site Coordinator
      
      Phone Number: 004351290030
- Upper Austria
  - Linz, Upper Austria, Austria, 4010
    - Recruiting
    - Ordensklinikum Linz Elisabethinen /ID# 240967
  - Wels, Upper Austria, Austria, 4600
    - Recruiting
    - Klinikum Wels-Grieskirchen GmbH /ID# 249000
- Vorarlberg
  - Feldkirch, Vorarlberg, Austria, 6800
    - Recruiting
    - Landeskrankenhaus Feldkirch /ID# 250333
Belgium
- - Anderlecht, Belgium, 1070
    - Recruiting
    - Institut Jules Bordet /ID# 246770
  - Ghent, Belgium, 9000
    - Recruiting
    - AZ Maria Middelares /ID# 246768
  - Liège, Belgium, 4000
    - Recruiting
    - CHU de Liege /ID# 246772
  - Namur, Belgium, 5000
    - Recruiting
    - UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769
- Antwerpen
  - Brasschaat, Antwerpen, Belgium, 2930
    - Recruiting
    - Algemeen Ziekenhuis klina /ID# 239853
  - Edegem, Antwerpen, Belgium, 2650
    - Recruiting
    - Universitair Ziekenhuis Antwerpen /ID# 239971
- Hainaut
  - Charleroi, Hainaut, Belgium, 6280
    - Recruiting
    - Grand Hopital de Charleroi - Les Viviers /ID# 234178
  - La Louvière, Hainaut, Belgium, 7100
    - Recruiting
    - Hospital La Louviere Site Jolimont - Helora /ID# 246771
- Limburg
  - Hasselt, Limburg, Belgium, 3500
    - Recruiting
    - Jessa Ziekenhuis /ID# 246766
- Oost-Vlaanderen
  - Ghent, Oost-Vlaanderen, Belgium, 9000
    - Recruiting
    - UZ Gent /ID# 273244
  - Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
    - Recruiting
    - Vitaz /Id# 246773
Brazil
- - Rio de Janeiro, Brazil, 20231-050
    - Recruiting
    - Instituto Nacional de Cancer (INCA) /ID# 231509
  - Rio de Janeiro, Brazil, 22281-100
    - Recruiting
    - Instituto Dor de Pesquisa e Ensino /ID# 233245
  - São Paulo, Brazil, 01236-030
    - Recruiting
    - Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417
  - São Paulo, Brazil, 08270-070
    - Recruiting
    - Casa de Saúde Santa Marcelina /ID# 231605
  - São Paulo, Brazil, 01308-050
    - Recruiting
    - Hospital Sirio Libanes - Sao Paulo /ID# 261827
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 41950-640
    - Recruiting
    - Clinica Amo - Rio Vermelho /ID# 231604
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
    - Recruiting
    - Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 233249
- São Paulo
  - Barretos, São Paulo, Brazil, 14784-400
    - Recruiting
    - Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247
  - São Paulo, São Paulo, Brazil, 05874-230
    - Recruiting
    - OC Oncoclínicas SP /ID# 261828
Bulgaria
- - Burgas, Bulgaria, 8000
    - Completed
    - Complex Oncology Center - Burgas /ID# 240532
  - Plovdiv, Bulgaria, 4004
    - Recruiting
    - Complex Cancer Center Plovdiv /ID# 234106
  - Varna, Bulgaria, 9009
    - Recruiting
    - UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 234112
- Pazardzhik
  - Panagyurishte, Pazardzhik, Bulgaria, 4500
    - Recruiting
    - Mbal Uni Hospital /ID# 273707
- Sofia
  - Sofiya, Sofia, Bulgaria, 1797
    - Recruiting
    - University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Recruiting
    - Cross Cancer Institute. /ID# 252065
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - Recruiting
    - William Osler Health System - Brampton Civic Hospital /ID# 254420
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Recruiting
    - CISSS de la Monteregie /ID# 239081
  - Lévis, Quebec, Canada, G6V 3Z1
    - Recruiting
    - CSSS Alphonse-Desjardins, CHAU de Levis /ID# 261158
  - Montreal, Quebec, Canada, H4J 1C5
    - Recruiting
    - Hopital Du Sacre-Coeur De Montreal /ID# 274584
Chile
- - Santiago, Chile, 7501504
    - Recruiting
    - Hospital Clinico Universidad De Los Andes /ID# 260974
- Maule Region
  - Talca, Maule Region, Chile, 3461341
    - Recruiting
    - Clinica Universidad Catolica del Maule /ID# 231294
- Santiago Metropolitan
  - La Florida, Santiago Metropolitan, Chile, 8241479
    - Recruiting
    - Icegclinic /Id# 231212
  - Providencia, Santiago Metropolitan, Chile, 7500713
    - Recruiting
    - Sociedad Prosalud Montes y Orlandi /ID# 231154
  - Providencia, Santiago Metropolitan, Chile, 7500921
    - Recruiting
    - Fundacion Arturo Lopez Perez /ID# 231151
  - Providencia, Santiago Metropolitan, Chile, 7510032
    - Completed
    - Sociedad Oncovida /ID# 231152
China
- Anhui
  - Hefei, Anhui, China, 230032
    - Recruiting
    - Anhui Medical University - Anhui Chest Hospital /ID# 231899
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100142
    - Recruiting
    - Beijing Cancer Hospital /ID# 231923
  - Beijing, Beijing Municipality, China, 101149
    - Recruiting
    - Beijing Chest Hospital, Capital Medical University /ID# 232202
  - Beijing, Beijing Municipality, China, 100730
    - Recruiting
    - Peking Union Medical College Hospital East - Dongdan Campus /ID# 233175
- Chongqing Municipality
  - Chongqing, Chongqing Municipality, China, 400016
    - Recruiting
    - The First Affiliated Hospital of Chongqing Medical University /ID# 251592
- Fujian
  - Fuzhou, Fujian, China, 350014
    - Recruiting
    - Fujian Provincial Cancer Hospital /ID# 243134
  - Xiamen, Fujian, China, 361003
    - Recruiting
    - The First Affiliated Hospital of Xiamen University /ID# 242381
- Guangdong
  - Guangzhou, Guangdong, China, 510163
    - Recruiting
    - The First Affiliated Hospital Of Guangzhou Medical University /ID# 238591
  - Shantou, Guangdong, China, 515041
    - Recruiting
    - Cancer Hospital of Shantou University Medical College /ID# 242182
  - Zhanjiang, Guangdong, China, 524004
    - Recruiting
    - Affiliated Hospital of Guangdong Medical College /ID# 233317
- Guangxi
  - Nanning, Guangxi, China, 530021
    - Recruiting
    - Affiliated Cancer Hospital of Guangxi Medical University /ID# 231855
- Guizhou
  - Guiyang, Guizhou, China, 550002
    - Recruiting
    - People's Hospital of Guizhou Province /ID# 243614
- Hebei
  - Baoding, Hebei, China, 071000
    - Recruiting
    - Affiliated Hospital of Hebei University /ID# 239586
- Heilongjiang
  - Harbin, Heilongjiang, China, 150081
    - Recruiting
    - Harbin Medical University Cancer Hospital /Id# 231941
- Henan
  - Nanyang, Henan, China, 473007
    - Recruiting
    - The First affiliated Hospital of Nanyang Medical College /ID# 244652
  - Zhengzhou, Henan, China, 450008
    - Recruiting
    - Henan Cancer Hospital /ID# 239577
  - Zhengzhou, Henan, China, 450003
    - Recruiting
    - People's Hospital of Henan Province /ID# 242187
- Hubei
  - Wuhan, Hubei, China, 430030
    - Recruiting
    - Tongji Hospital Tongji Medical College of HUST /ID# 239575
  - Wuhan, Hubei, China, 430022
    - Recruiting
    - Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904
  - Wuhan, Hubei, China, 430079
    - Recruiting
    - Hubei Cancer Hospital /ID# 240045
- Hunan
  - Changsha, Hunan, China, 410006
    - Recruiting
    - Hunan Cancer Hospital /ID# 231943
- Inner Mongolia
  - Hohhot, Inner Mongolia, China, 010050
    - Completed
    - The Affiliated Hospital of Inner Mongolia Medical University /ID# 242179
- Jiangsu
  - Nanjing, Jiangsu, China, 210008
    - Recruiting
    - Nanjing Drum Tower Hospital /ID# 231791
  - Nantong, Jiangsu, China, 226300
    - Recruiting
    - Nantong Tumor Hospital /ID# 232424
- Jiangxi
  - Nanchang, Jiangxi, China, 330008
    - Recruiting
    - The Second Affiliated Hospital of Nanchang University /ID# 231935
  - Nanchang, Jiangxi, China, 330006
    - Recruiting
    - The First Affiliated Hospital of Nanchang University /ID# 231934
- Jilin
  - Changchun, Jilin, China, 130012
    - Recruiting
    - Jilin Cancer Hospital /ID# 244702
- Liaoning
  - Dalian, Liaoning, China, 116023
    - Recruiting
    - The Second Affiliated Hospital of Dalian Medical University /ID# 239755
  - Shenyang, Liaoning, China, 110001
    - Recruiting
    - First Affiliated Hospital of China Medical University /ID# 231924
- Shaanxi
  - Xi'an, Shaanxi, China, 710061
    - Recruiting
    - The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023
- Shandong
  - Jinan, Shandong, China, 251601
    - Recruiting
    - Shandong Cancer Hospital /ID# 251506
  - Jinan, Shandong, China, 250013
    - Recruiting
    - Shandong University - Jinan Central Hospital /ID# 231895
  - Linyi, Shandong, China, 276001
    - Recruiting
    - LinYi Cancer Hospital /ID# 239713
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200030
    - Recruiting
    - Shanghai Chest Hospital /ID# 231897
- Shanxi
  - Taiyuan, Shanxi, China, 030009
    - Recruiting
    - Shanxi Cancer Hospital /ID# 258674
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Recruiting
    - Sichuan Cancer Hospital /ID# 239707
  - Chengdu, Sichuan, China, 610041
    - Recruiting
    - West China Hospital, Sichuan University /ID# 233703
- Tianjin Municipality
  - Tianjin, Tianjin Municipality, China, 300000
    - Recruiting
    - Tianjin Cancer Hospital /ID# 233176
  - Tianjin, Tianjin Municipality, China, 300052
    - Recruiting
    - Tianjin Medical University General Hospital /ID# 231839
- Xinjiang
  - Ürümqi, Xinjiang, China, 830000
    - Recruiting
    - The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 240094
- Yunnan
  - Kunming, Yunnan, China, 650118
    - Recruiting
    - Yunnan Cancer Hospital /ID# 251388
- Zhejiang
  - Hangzhou, Zhejiang, China, 310022
    - Recruiting
    - Zhejiang Cancer hospital /ID# 242476
  - Hangzhou, Zhejiang, China, 310003
    - Recruiting
    - The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032
  - Linhai, Zhejiang, China, 317000
    - Recruiting
    - Taizhou Hospital of Zhejiang Province /ID# 232021
  - Ningbo, Zhejiang, China, 315010
    - Recruiting
    - Ningbo No. 2 Hospital /ID# 242478
Colombia
- Antioquia
  - Medellín, Antioquia, Colombia, 050034
    - Recruiting
    - Hospital Pablo Tobon Uribe /ID# 258128
- Bogota D.C.
  - Bogotá, Bogota D.C., Colombia, 110131
    - Recruiting
    - Fundación Ctic - Centro De Tratamiento E Investigación Sobre Cáncer Luis Carlos /ID# 258131
- Cesar Department
  - Valledupar, Cesar Department, Colombia, 200001
    - Recruiting
    - Sociedad de Oncologia y Hematologia del Cesar SAS /ID# 258130
- Departamento de Córdoba
  - Montería, Departamento de Córdoba, Colombia, 230018
    - Recruiting
    - Imat Oncomedica /ID# 258129
Czechia
- - Brno, Czechia, 656 53
    - Recruiting
    - Masarykuv onkologicky ustav /ID# 232426
  - Nový Jičín, Czechia, 741 01
    - Completed
    - Nemocnice AGEL Novy Jicin, a.s. /ID# 232427
Denmark
- Region Sjælland
  - Roskilde, Region Sjælland, Denmark, 4000
    - Recruiting
    - Roskilde Sygehus /ID# 241842
- Region Syddanmark
  - Odense, Region Syddanmark, Denmark, 5000
    - Recruiting
    - Odense University Hospital /ID# 241663
France
- - Paris, France, 75020
    - Recruiting
    - AP-HP - Hopital Tenon /ID# 239179
- Bouches-du-Rhone
  - Marseille, Bouches-du-Rhone, France, 13015
    - Recruiting
    - APHM - Hopital Nord /ID# 251935
- Hauts-de-France
  - Lille, Hauts-de-France, France, 59037
    - Recruiting
    - CHU Lille - Hôpital Albert Calmette /ID# 251934
- Herault
  - Montpellier, Herault, France, 34295
    - Recruiting
    - Hopital Arnaud de Villeneuve /ID# 239404
- New Aquitaine
  - Pessac, New Aquitaine, France, 33604
    - Recruiting
    - Centre Hospitalier Universitaire de Bordeaux /ID# 244953
- Paris
  - Paris, Paris, France, 75248
    - Recruiting
    - Institut Curie /ID# 240141
  - Paris, Paris, France, 75679
    - Recruiting
    - Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 239409
- Provence-Alpes-Côte d'Azur Region
  - Avignon, Provence-Alpes-Côte d'Azur Region, France, 84000
    - Recruiting
    - Centre Hospitalier d'Avignon /ID# 275229
- Rhone
  - Bron, Rhone, France, 69500
    - Recruiting
    - Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 251933
  - Lyon, Rhone, France, 69373
    - Recruiting
    - Centre Leon Berard /ID# 267397
- Val-de-Marne
  - Créteil, Val-de-Marne, France, 94000
    - Recruiting
    - Centre Hosp Intercommunal de Creteil /ID# 251936
- Île-de-France Region
  - Villejuif, Île-de-France Region, France, 94800
    - Recruiting
    - Institut Gustave Roussy /ID# 267415
Germany
- - Berlin, Germany, 13353
    - Recruiting
    - Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 234247
  - Hamburg, Germany, 20251
    - Recruiting
    - Haemato-Onkologie Hamburg /ID# 241047
  - Hamburg, Germany, 20246
    - Recruiting
    - Universitaetsklinikum Hamburg-Eppendorf /ID# 239658
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, Germany, 69126
    - Recruiting
    - Thoraxklinik Heidelberg gGmbH /ID# 239656
  - Mannheim, Baden-Wurttemberg, Germany, 68167
    - Recruiting
    - Universitatsklinikum Mannheim /ID# 238331
- Bavaria
  - Gauting, Bavaria, Germany, 82131
    - Recruiting
    - Asklepios Fachkliniken Muenchen-Gauting /ID# 272768
- Hesse
  - Giessen, Hesse, Germany, 35392
    - Recruiting
    - Universitaetsklinikum Giessen /ID# 252973
  - Kassel, Hesse, Germany, 34125
    - Recruiting
    - Klinikum Kassel /ID# 240142
- Saxony
  - Dresden, Saxony, Germany, 01307
    - Recruiting
    - Universitaetsklinikum Carl Gustav Carus Dresden /ID# 274719
- Thuringia
  - Jena, Thuringia, Germany, 07747
    - Recruiting
    - Universitaetsklinikum Jena /ID# 239661
Greece
- - Thessaloniki, Greece, 57001
    - Completed
    - Interbalkan Medical Center Of Thessaloniki /ID# 254407
- Attica
  - Athens, Attica, Greece, 11526
    - Recruiting
    - Henry Dunnant Hospital Center /ID# 267021
  - Athens, Attica, Greece, 11527
    - Recruiting
    - General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824
  - Piraeus, Attica, Greece, 18547
    - Recruiting
    - Metropolitan Hospital /ID# 232158
  - Piraeus, Attica, Greece, 18547
    - Recruiting
    - Metropolitan Hospital /ID# 239170
Israel
- Northern District
  - Safed, Northern District, Israel, 13100
    - Recruiting
    - ZIV Medical Center /ID# 238606
- Southern District
  - Ashkelon, Southern District, Israel, 5822000
    - Completed
    - The Edith Wolfson Medical Center /ID# 233781
  - Beersheba, Southern District, Israel, 8410101
    - Recruiting
    - Soroka University Medical Center /ID# 252711
- Tel Aviv
  - Tel Aviv, Tel Aviv, Israel, 6423906
    - Recruiting
    - Tel Aviv Sourasky Medical Center /ID# 260519
Italy
- - Bari, Italy, 70124
    - Recruiting
    - I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696
  - Cremona, Italy, 26100
    - Recruiting
    - Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698
  - Messina, Italy, 98158
    - Completed
    - Azienda Ospedaliera Papardo /ID# 258038
  - Perugia, Italy, 06156
    - Recruiting
    - Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 238473
  - Varese, Italy, 21100
    - Recruiting
    - ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 238536
- Catania
  - Misterbianco, Catania, Italy, 95045
    - Recruiting
    - Humanitas Istituto Clinico Catanese /ID# 273050
- Milano
  - Milan, Milano, Italy, 20132
    - Recruiting
    - IRCCS Ospedale San Raffaele /ID# 254376
- Napoli
  - Naples, Napoli, Italy, 80138
    - Recruiting
    - Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 252942
- Roma
  - Rome, Roma, Italy, 00184
    - Recruiting
    - Azienda Ospedaliera Complesso Ospedaliero San Giovanni-Addolorata /ID# 238618
Japan
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 460-0001
    - Recruiting
    - NHO Nagoya Medical Center /ID# 246306
  - Nagoya, Aichi-ken, Japan, 466-8560
    - Recruiting
    - Nagoya University Hospital /ID# 239990
- Aomori
  - Hirosaki-shi, Aomori, Japan, 036-8203
    - Recruiting
    - Hirosaki University Hospital /ID# 242377
- Chiba
  - Kashiwa-shi, Chiba, Japan, 277-8577
    - Recruiting
    - National Cancer Center Hospital East /ID# 233775
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 810-8563
    - Recruiting
    - National Hospital Organization Kyushu Medical Center /ID# 238533
  - Kitakyushu-shi, Fukuoka, Japan, 807-8556
    - Recruiting
    - Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 241191
  - Kurume-shi, Fukuoka, Japan, 830-0011
    - Recruiting
    - Kurume University Hospital /ID# 254900
- Fukushima
  - Fukushima, Fukushima, Japan, 960-1295
    - Recruiting
    - Fukushima Medical University Hospital /ID# 249691
- Gunma
  - Ota-shi, Gunma, Japan, 373-8550
    - Recruiting
    - Gunma Prefectural Cancer Center /ID# 233723
- Hiroshima
  - Fukuyama, Hiroshima, Japan, 720-0001
    - Recruiting
    - Chugoku Central Hospital /ID# 242970
  - Hiroshima, Hiroshima, Japan, 734-8551
    - Recruiting
    - Hiroshima University Hospital /ID# 241882
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Recruiting
    - Hokkaido University Hospital /ID# 241289
- Hyōgo
  - Kobe, Hyōgo, Japan, 650-0046
    - Recruiting
    - Kobe Minimally Invasive Cancer Center /ID# 254131
  - Takarazuka-shi, Hyōgo, Japan, 665-0827
    - Recruiting
    - Takarazuka City Hospital /ID# 240786
- Ibaraki
  - Higashiibaraki-gun, Ibaraki, Japan, 311-3193
    - Recruiting
    - NHO Mito Medical Center /ID# 241709
  - Kasama-shi, Ibaraki, Japan, 309-1793
    - Recruiting
    - Ibaraki Prefectural Central Hospital /ID# 246145
- Iwate
  - Shiwa-gun, Iwate, Japan, 028-3695
    - Recruiting
    - Iwate Medical University Hospital /ID# 239027
- Kanagawa
  - Sagamihara-shi, Kanagawa, Japan, 252-0375
    - Recruiting
    - Kitasato University Hospital /ID# 239958
  - Yokohama, Kanagawa, Japan, 232-0024
    - Recruiting
    - Yokohama City University Medical Center /ID# 246554
  - Yokohama, Kanagawa, Japan, 236-0051
    - Recruiting
    - Kanagawa Cardiovascular and Respiratory Center /ID# 239052
- Kumamoto
  - Kumamoto, Kumamoto, Japan, 8608556
    - Recruiting
    - Kumamoto University Hospital /ID# 241039
- Mie-ken
  - Tsu, Mie-ken, Japan, 514-1101
    - Recruiting
    - National Hospital Organization Mie Chuo Medical Center /ID# 246659
- Miyagi
  - Natori-shi, Miyagi, Japan, 981-1293
    - Recruiting
    - Miyagi Cancer Center /ID# 234198
  - Sendai, Miyagi, Japan, 980-0873
    - Recruiting
    - Sendai Kousei Hospital /ID# 253350
- Miyazaki
  - Miyazaki, Miyazaki, Japan, 889-1692
    - Recruiting
    - University of Miyazaki Hospital /ID# 242161
- Niigata
  - Nagaoka-shi, Niigata, Japan, 940-2085
    - Recruiting
    - Nagaoka Red Cross Hospital /ID# 240714
- Okayama-ken
  - Kurashiki-shi, Okayama-ken, Japan, 710-8602
    - Recruiting
    - Kurashiki Central Hospital /ID# 239344
- Osaka
  - Habikino-shi, Osaka, Japan, 583-8588
    - Recruiting
    - Osaka Habikino Medical Center /ID# 239989
  - Hirakata-shi, Osaka, Japan, 573-1191
    - Recruiting
    - Kansai Medical University Hospital /ID# 233476
  - Osaka, Osaka, Japan, 545-8586
    - Recruiting
    - Osaka Metropolitan University Hospital /ID# 238895
  - Sakai-shi, Osaka, Japan, 590-0197
    - Recruiting
    - Kindai University Hospital /ID# 239085
- Shizuoka
  - Fujieda-shi, Shizuoka, Japan, 426-8677
    - Recruiting
    - Fujieda Municipal General Hospital /ID# 255155
- Tochigi
  - Utsunomiya, Tochigi, Japan, 320-0834
    - Recruiting
    - Tochigi Cancer Center /ID# 240020
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-8431
    - Recruiting
    - Juntendo University Hospital /ID# 239932
  - Chuo-ku, Tokyo, Japan, 104-0045
    - Recruiting
    - National Cancer Center Hospital /ID# 251134
  - Meguro-ku, Tokyo, Japan, 152-8902
    - Recruiting
    - National Hospital Organization Tokyo Medical Center /ID# 246581
    - Contact:
      
      Site Coordinator
      
      Phone Number: +81-3-3411-0111
  - Shinagawa-ku, Tokyo, Japan, 141-8625
    - Recruiting
    - NTT Medical Center Tokyo /ID# 241067
  - Shinjuku-ku, Tokyo, Japan, 160-8582
    - Recruiting
    - Keio University Hospital /ID# 239506
- Toyama
  - Toyama, Toyama, Japan, 930-0194
    - Recruiting
    - Toyama University Hospital /ID# 241660
- Wakayama
  - Wakayama, Wakayama, Japan, 641-8510
    - Recruiting
    - Wakayama Medical University Hospital /ID# 234004
- Yamagata
  - Yamagata, Yamagata, Japan, 990-9585
    - Completed
    - Yamagata University Hospital /ID# 240815
- Yamaguchi
  - Ube-shi, Yamaguchi, Japan, 755-0241
    - Recruiting
    - Yamaguchi - Ube Medical Center /ID# 258779
Mexico
- - Oaxaca City, Mexico, 68020
    - Recruiting
    - Clinical Research & Oncology Oaxaca /ID# 231883
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44280
    - Recruiting
    - O.P.D. Hospital Civil de Guadalajara /ID# 238488
- Michoacán
  - Morelia, Michoacán, Mexico, 58260
    - Completed
    - Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928
Netherlands
- - 's-Hertogenbosch, Netherlands, 5223 GZ
    - Recruiting
    - Jeroen Bosch Ziekenhuis /ID# 234087
- Gelderland
  - Harderwijk, Gelderland, Netherlands, 3844 DG
    - Recruiting
    - Ziekenhuis St. Jansdal /ID# 251932
- Limburg
  - Maastricht, Limburg, Netherlands, 6229 HX
    - Recruiting
    - Maastricht Universitair Medisch Centrum /ID# 233932
- Overijssel
  - Zwolle, Overijssel, Netherlands, 8025 AB
    - Recruiting
    - Isala /ID# 238846
- South Holland
  - The Hague, South Holland, Netherlands, 2545 AA
    - Recruiting
    - HagaZiekenhuis /ID# 243693
Poland
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Poland, 60-569
    - Recruiting
    - Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 262489
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-781
    - Recruiting
    - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 262095
- Podkarpackie Voivodeship
  - Rzeszów, Podkarpackie Voivodeship, Poland, 35-021
    - Recruiting
    - MRUK-MED I Sp. z o.o. /ID# 239363
- Warmian-Masurian Voivodeship
  - Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-357
    - Recruiting
    - Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Poland, 93-338
    - Recruiting
    - Instytut Centrum Zdrowia Matki Polki /ID# 239024
Portugal
- - Porto, Portugal, 4100-180
    - Recruiting
    - Hospital CUF Porto /ID# 241570
  - Porto, Portugal, 4099-001
    - Recruiting
    - Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 241572
  - Porto, Portugal, 4200-072
    - Recruiting
    - IPO Porto FG, EPE /ID# 241569
  - Porto, Portugal, 4200-319
    - Recruiting
    - Unidade Local de Saude Sao Joao /ID# 241930
- Lisbon District
  - Lisbon, Lisbon District, Portugal, 1400-038
    - Recruiting
    - Fundacao Champalimaud /ID# 241925
Romania
- - Brasov, Romania, 500283
    - Recruiting
    - Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826
  - Suceava, Romania, 720214
    - Recruiting
    - S.C. Sigmedical Services SRL /ID# 239108
- Bihor County
  - Oradea, Bihor County, Romania, 410469
    - Recruiting
    - Spitalul Pelican /ID# 254066
- Cluj
  - Cluj-Napoca, Cluj, Romania, 400015
    - Recruiting
    - Cardiomed Srl /Id# 255320
- Dolj
  - Craiova, Dolj, Romania, 200385
    - Recruiting
    - Sc Oncolab Srl /Id# 239105
- Iaşi
  - Iași, Iaşi, Romania, 700483
    - Recruiting
    - Institutul Regional de Oncologie /ID# 254065
- Ilfov
  - Otopeni, Ilfov, Romania, 075100
    - Recruiting
    - SC RTC Radiology Therapeutic Center SRL /ID# 240744
- Timiș County
  - Timișoara, Timiș County, Romania, 300166
    - Recruiting
    - Oncocenter - Oncologie Clinica Srl /Id# 239103
Slovakia
- Banská Bystrica Region
  - Banská Bystrica, Banská Bystrica Region, Slovakia, 975 17
    - Completed
    - Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084
South Africa
- Gauteng
  - Johannesburg, Gauteng, South Africa, 2196
    - Completed
    - Sandton Oncology Medical Group PTY Ltd /ID# 230843
  - Johannesburg, Gauteng, South Africa, 1864
    - Recruiting
    - Wits Clinical Research /ID# 230841
  - Pretoria, Gauteng, South Africa, 0001
    - Recruiting
    - Steve Biko Academic Hospital /ID# 230883
South Korea
- Gyeonggido
  - Goyang-si, Gyeonggido, South Korea, 10408
    - Recruiting
    - National Cancer Center /ID# 260663
  - Seongnam, Gyeonggido, South Korea, 13496
    - Recruiting
    - CHA Bundang Medical Center /ID# 233318
  - Suwon, Gyeonggido, South Korea, 16247
    - Recruiting
    - The Catholic University Of Korea St. Vincent's Hospital /ID# 256942
  - Suwon, Gyeonggido, South Korea, 16499
    - Recruiting
    - Ajou University Hospital - Suwon-si /ID# 233319
- Gyeongsangnam-do
  - Jinju, Gyeongsangnam-do, South Korea, 52727
    - Recruiting
    - Gyeongsang National University Hospital /ID# 234244
  - Yangsan, Gyeongsangnam-do, South Korea, 50612
    - Recruiting
    - Pusan National University Yangsan Hospital /ID# 257836
- North Chungcheong
  - Cheongju-si, North Chungcheong, South Korea, 28644
    - Recruiting
    - Chungbuk National University Hospital /ID# 257891
    - Contact:
      
      Site Coordinator
      
      Phone Number: 043-261-3703
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 03181
    - Recruiting
    - Kangbuk Samsung Hospital /ID# 233711
  - Seoul, Seoul Teugbyeolsi, South Korea, 06351
    - Recruiting
    - Samsung Medical Center /ID# 256941
  - Seoul, Seoul Teugbyeolsi, South Korea, 07061
    - Recruiting
    - SMG-SNU Boramae Medical Center /ID# 233710
Spain
- - Barcelona, Spain, 08017
    - Recruiting
    - UOMi Cancer Center - Clinica Tres Torres /ID# 240584
  - Barcelona, Spain, 08028
    - Recruiting
    - Hospital Universitario Dexeus - Grupo Quironsalud /ID# 255105
  - Jaén, Spain, 23007
    - Recruiting
    - Hospital Universitario de Jaen /ID# 240588
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre /ID# 240176
  - Valencia, Spain, 46010
    - Recruiting
    - Hospital Clinico Universitario de Valencia /ID# 240378
  - Ávila, Spain, 05004
    - Recruiting
    - Hospital Nuestra Senora de Sonsoles /ID# 255102
- Las Palmas
  - Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
    - Recruiting
    - CHU Insular-Materno Infantil /ID# 255094
- Madrid
  - Alcorcón, Madrid, Spain, 28922
    - Recruiting
    - Hospital Universitario Fundacion Alcorcon /ID# 255100
  - Fuenlabrada, Madrid, Spain, 28942
    - Recruiting
    - Hospital Universitario de Fuenlabrada /ID# 255093
Sweden
- Stockholm County
  - Solna, Stockholm County, Sweden, 171 64
    - Recruiting
    - Karolinska University Hospital Solna /ID# 229853
- Västra Götaland County
  - Gothenburg, Västra Götaland County, Sweden, 413 46
    - Recruiting
    - Sahlgrenska Universitetssjukhuset /ID# 229943
Taiwan
- - Changhua City, Changhua County, Taiwan, 50006
    - Recruiting
    - Changhua Christian Hospital /ID# 238394
  - Hsinchu, Taiwan, 30059
    - Recruiting
    - National Taiwan University Hospital - Hsinchu branch /ID# 238393
  - Hualien City, Taiwan, 97002
    - Recruiting
    - Hualien Tzu Chi Hospital /ID# 238398
  - Taichung, Taiwan, 402
    - Recruiting
    - Chung Shan Medical University Hospital /ID# 238444
  - Taipei, Taiwan, 104
    - Recruiting
    - Mackay Memorial Hospital /ID# 238392
  - Taipei, Taiwan, 11031
    - Recruiting
    - Taipei Medical University Hospital /ID# 238380
  - Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital /ID# 238378
- Kaohsiung
  - Kaohsiung City, Kaohsiung, Taiwan, 82445
    - Recruiting
    - E-DA Cancer Hospital /ID# 239718
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01060
    - Recruiting
    - Adana Sehir Egitim ve Arastirma Hastanesi /ID# 255638
  - Adana, Turkey (Türkiye), 01130
    - Completed
    - Adana Acıbadem Hospital /ID# 234208
  - Adana, Turkey (Türkiye), 01140
    - Recruiting
    - Medical Park Seyhan Hastanesi /ID# 255637
  - Ankara, Turkey (Türkiye), 06800
    - Recruiting
    - Ankara City Hospital /ID# 234210
  - Ankara, Turkey (Türkiye), 06560
    - Recruiting
    - Gazi Universitesi /ID# 265425
  - Battalgazi/malatya, Turkey (Türkiye), 44280
    - Recruiting
    - Inonu Universitesi Turgut Ozal /ID# 234038
  - Bursa, Turkey (Türkiye), 16059
    - Recruiting
    - Uludag University Medical Faculty /ID# 234205
  - Diyarbakır, Turkey (Türkiye), 21200
    - Recruiting
    - Dicle Universitesi Tip /ID# 234036
  - Istanbul, Turkey (Türkiye), 34214
    - Recruiting
    - Bagcilar Medipol Mega Universite Hastanesi /ID# 234211
  - Izmir, Turkey (Türkiye), 35040
    - Recruiting
    - Ege University Medical Faculty /ID# 234039
  - Izmir, Turkey (Türkiye), 35110
    - Recruiting
    - Dr. Suat Seren Gogus Has /ID# 262291
- Ankara
  - Çankaya, Ankara, Turkey (Türkiye), 06520
    - Recruiting
    - Memorial Ankara Hastanesi /ID# 234212
- İzmir
  - Cordaleo, İzmir, Turkey (Türkiye), 35575
    - Recruiting
    - Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209
United Kingdom
- - Birmingham, United Kingdom, B15 2TH
    - Recruiting
    - University Hospitals Birmingham NHS Foundation Trust /ID# 258141
  - London, United Kingdom, SW3 6JJ
    - Recruiting
    - The Royal Marsden NHS Foundation Trust /ID# 246974
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - The Christie Hospital /ID# 243422
- Greater London
  - London, Greater London, United Kingdom, NW1 2BU
    - Recruiting
    - University College London Hospital /ID# 249407
  - London, Greater London, United Kingdom, E1 2ES
    - Recruiting
    - Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 254342
- Nottinghamshire
  - Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    - Recruiting
    - Nottingham City Hospital /ID# 254707
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Active, not recruiting
    - University of Alabama at Birmingham - Main /ID# 247074
- Arizona
  - Chandler, Arizona, United States, 85224-5665
    - Active, not recruiting
    - Ironwood Cancer & Res Ctr /ID# 262446
  - Phoenix, Arizona, United States, 85054-4504
    - Active, not recruiting
    - Mayo Clinic Arizona /ID# 255858
  - Yuma, Arizona, United States, 85364
    - Completed
    - Onvida Health Yuma Medical Center /ID# 253625
- California
  - Duarte, California, United States, 91010
    - Recruiting
    - City of Hope /ID# 243157
  - Huntington Beach, California, United States, 92648
    - Recruiting
    - City Of Hope - Seacliff /ID# 263143
  - Irvine, California, United States, 92618
    - Recruiting
    - City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144
  - Lancaster, California, United States, 93534
    - Recruiting
    - City Of Hope - Antelope Valley /ID# 263138
  - Los Angeles, California, United States, 90095
    - Recruiting
    - University of California, Los Angeles /ID# 253954
  - Los Angeles, California, United States, 90033
    - Completed
    - The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774
  - Rancho Mirage, California, United States, 92270-3221
    - Recruiting
    - Eisenhower Medical Center /ID# 233189
- Florida
  - Jacksonville, Florida, United States, 32224
    - Active, not recruiting
    - Mayo Clinic Hospital Jacksonville /ID# 254688
  - Ocala, Florida, United States, 34474-4445
    - Completed
    - Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228
  - Tamarac, Florida, United States, 33321-2919
    - Completed
    - BRCR Medical Center Inc /ID# 262344
- Georgia
  - Savannah, Georgia, United States, 31404
    - Completed
    - Memorial University Medical Center /ID# 264081
- Hawaii
  - Honolulu, Hawaii, United States, 96819-1469
    - Recruiting
    - Kaiser Permanente Moanalua Medical Center /ID# 238363
- Illinois
  - Elmhurst, Illinois, United States, 60126
    - Active, not recruiting
    - Edward-Elmhurst Cancer Center /ID# 238552
  - Springfield, Illinois, United States, 62702
    - Active, not recruiting
    - Springfield Clinic - First /ID# 262290
- Indiana
  - Goshen, Indiana, United States, 46526
    - Completed
    - Goshen Center for Cancer Care /ID# 257734
  - Indianapolis, Indiana, United States, 46260
    - Completed
    - Investigative Clinical Research of Indiana - Indianapolis /ID# 260468
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Completed
    - Baptist Health Lexington /ID# 252769
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Active, not recruiting
    - Dana-Farber Cancer Institute /ID# 247132
- Michigan
  - Ypsilanti, Michigan, United States, 48197-1051
    - Completed
    - Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190
- Minnesota
  - Rochester, Minnesota, United States, 55905-0001
    - Active, not recruiting
    - Mayo Clinic - Rochester /ID# 252052
- Mississippi
  - Hattiesburg, Mississippi, United States, 39401
    - Recruiting
    - Hattiesburg Clinic /ID# 248033
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Completed
    - St. Luke's Hospital - Chesterfield /ID# 251688
  - Kansas City, Missouri, United States, 64114-4859
    - Completed
    - Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567
  - Kansas City, Missouri, United States, 64111
    - Recruiting
    - St. Lukes Hosp. of Kansas City /ID# 259940
  - Springfield, Missouri, United States, 65807-5287
    - Recruiting
    - Hulston Cancer Center /ID# 232226
  - St Louis, Missouri, United States, 63110-2539
    - Completed
    - Saint Louis University Cancer Center /ID# 260722
- Montana
  - Billings, Montana, United States, 59102
    - Active, not recruiting
    - Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147
- Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Completed
    - Nebraska Hematology Oncology /ID# 257710
- Nevada
  - Reno, Nevada, United States, 89502-1464
    - Recruiting
    - Renown Medical Group - Oncology/Hematology /ID# 247942
- New Jersey
  - East Brunswick, New Jersey, United States, 08816-4096
    - Active, not recruiting
    - Astera Cancer Care /ID# 257753
- New Mexico
  - Farmington, New Mexico, United States, 87401
    - Completed
    - San Juan Oncology Associates /ID# 244387
- New York
  - Brooklyn, New York, United States, 11219
    - Active, not recruiting
    - Maimonides Medical Center /ID# 240783
  - Lake Success, New York, United States, 11042
    - Completed
    - Northwell Health - Monter Cancer Center /ID# 247081
- North Carolina
  - Hendersonville, North Carolina, United States, 28792
    - Recruiting
    - AdventHealth Hendersonville /ID# 265349
  - Pinehurst, North Carolina, United States, 28374
    - Completed
    - FirstHealth of the Carolinas- Speciality Center /ID# 241279
- Ohio
  - Zanesville, Ohio, United States, 43701-1406
    - Active, not recruiting
    - Genesis Cancer Care Center /ID# 239190
- Pennsylvania
  - York, Pennsylvania, United States, 17403
    - Completed
    - Cancer Care Associates Of York /ID# 266143
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina /ID# 251383
  - Greenville, South Carolina, United States, 29607-5253
    - Completed
    - St Francis Cancer Center /ID# 243596
- South Dakota
  - Aberdeen, South Dakota, United States, 57401
    - Active, not recruiting
    - Avera Cancer Institute - Aberdeen /ID# 257759
  - Sioux Falls, South Dakota, United States, 57105
    - Active, not recruiting
    - Avera Cancer Institute /ID# 239635
- Tennessee
  - Memphis, Tennessee, United States, 38104
    - Completed
    - Duplicate_Memphis VA Medical Center /ID# 263250
- Texas
  - Austin, Texas, United States, 78701
    - Active, not recruiting
    - Dell Seton Medical Center /ID# 247016
- Utah
  - Ogden, Utah, United States, 84405-7194
    - Completed
    - Community Cancer Trials of Utah - South Ogden /ID# 262829
- Washington
  - Renton, Washington, United States, 98055-5738
    - Recruiting
    - Valley Medical Center /ID# 253950
  - Spokane, Washington, United States, 99208
    - Completed
    - Medical Oncology Associates /ID# 247003

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Projected life expectancy of at least 12 weeks.
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.
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).
A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
A known epidermal growth factor receptor (EGFR) activating mutation status.
-- Participants with actionable EGFR activating mutations are not eligible
Actionable alterations in genes other than EGFR are eligible.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
- Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:
- 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).
- 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 actionable 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).
Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
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:

Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
Evidence of leptomeningeal disease.
Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
Epidermal growth factor receptor (EGFR) activating mutations.
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..
Participants who have received prior docetaxel therapy.
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.
A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
Unresolved or neuroendocrine histology, nor sarcomatoid features 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.
Major surgery within 21 days prior to randomization.
Clinically significant condition(s) as listed in the protocol.

Study Plan

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

How is the study designed?

Design Details

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telisotuzumab Vedotin Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.	Biological: Telisotuzumab Vedotin Intravenous (IV) Infusion Other Names: ABBV-399
Active Comparator: Docetaxel Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.	Drug: Docetaxel IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: Up to approximately 39 months	OS is defined as the time from randomization to the event of death from any cause.	Up to approximately 39 months
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) Time Frame: 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS per Investigator Assessment Time Frame: 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
Objective Response Rate (ORR), per BICR. Time Frame: 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 Time Frame: 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
Change from Baseline of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30). Time Frame: 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
Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30. Time Frame: 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

Collaborators and Investigators

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

Sponsor

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study record dates

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

Study Major Dates

Study Start (Actual)

March 25, 2022

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M18-868
2023-505749-14-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

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

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Expanded Access

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Clinical Trials on Telisotuzumab Vedotin

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