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JOURNAL ONKOLOGIE – STUDIE

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)

Rekrutierend

NCT-Nummer:
NCT04928846

Studienbeginn:
März 2022

Letztes Update:
26.04.2024

Wirkstoff:
Telisotuzumab vedotin, Docetaxel

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AbbVie

Collaborator:
-

Studienleiter

ABBVIE INC.
Study Director
AbbVie

Kontakt

Studienlocations
(3 von 262)

Universitatsklinikum Mannheim /ID# 238331
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Giessen /ID# 252973
35392 Gießen
(Hessen)
GermanyRekrutierend» Google-Maps
Klinikum Kassel /ID# 240142
34125 Kassel
(Hessen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Jena /ID# 239661
07747 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 234247
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Hamburg-Eppendorf /ID# 239658
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Haemato-Onkologie Hamburg /ID# 241047
20251 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Thoraxklinik Heidelberg gGmbH /ID# 239656
69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
City of Hope /ID# 243157
91010 Duarte
United StatesRekrutierend» Google-Maps
City of Hope - Huntington Beach /ID# 263143
92648 Huntington Beach
United StatesRekrutierend» Google-Maps
City of Hope Orange County Lennar Foundation Cancer Center /ID# 263144
92618 Irvine
United StatesRekrutierend» Google-Maps
City of Hope - Antelope Valley /ID# 263138
93534 Lancaster
United StatesRekrutierend» Google-Maps
The Oncology Institute of Hope and Innovation - DTLA /ID# 239774
90015-3070 Los Angeles
United StatesAbgeschlossen» Google-Maps
Eisenhower Medical Center /ID# 233189
92270-3221 Rancho Mirage
United StatesRekrutierend» Google-Maps
Mayo Clinic /ID# 254688
32224 Jacksonville
United StatesRekrutierend» Google-Maps
Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228
34474-4445 Ocala
United StatesRekrutierend» Google-Maps
Kaiser Permanente Moanalua Medical Center /ID# 238363
96819-1469 Honolulu
United StatesRekrutierend» Google-Maps
Edward-Elmhurst Cancer Center /ID# 238552
60126 Elmhurst
United StatesRekrutierend» Google-Maps
Springfield Clinic /ID# 262290
62702-3749 Springfield
United StatesRekrutierend» Google-Maps
Goshen Center for Cancer Care /ID# 257734
46526 Goshen
United StatesRekrutierend» Google-Maps
Investigative Clinical Research of Indiana - Indianapolis /ID# 260468
46260 Indianapolis
United StatesRekrutierend» Google-Maps
Baptist Health /ID# 252769
40503-1463 Lexington
United StatesRekrutierend» Google-Maps
Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190
48197-1051 Ypsilanti
United StatesRekrutierend» Google-Maps
Hattiesburg Clinic /ID# 248033
39401 Hattiesburg
United StatesRekrutierend» Google-Maps
St. Luke's Hospital - Chesterfield /ID# 251688
63017 Chesterfield
United StatesRekrutierend» Google-Maps
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567
64114-4859 Kansas City
United StatesRekrutierend» Google-Maps
Hulston Cancer Center /ID# 232226
65807-5287 Springfield
United StatesRekrutierend» Google-Maps
Intermountain Health - St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147
59102 Billings
United StatesRekrutierend» Google-Maps
Renown Medical Group - Oncology/Hematology /ID# 247942
89502-1464 Reno
United StatesRekrutierend» Google-Maps
Astera Cancer Care /ID# 257753
08816-4096 East Brunswick
United StatesRekrutierend» Google-Maps
San Juan Oncology Associates /ID# 244387
87401 Farmington
United StatesRekrutierend» Google-Maps
Maimonides Medical Center /ID# 240783
11219 Brooklyn
United StatesRekrutierend» Google-Maps
First Health of the Carolinas /ID# 241279
28374 Pinehurst
United StatesRekrutierend» Google-Maps
Genesis Cancer Care Center /ID# 239190
43701-1406 Zanesville
United StatesRekrutierend» Google-Maps
Medical University of South Carolina - Charleston - Jonathan Lucas Street /ID# 251383
29425 Charleston
United StatesRekrutierend» Google-Maps
Avera Cancer Institute - Aberdeen /ID# 257759
57401 Aberdeen
United StatesRekrutierend» Google-Maps
Avera Cancer Institute /ID# 239635
57105 Sioux Falls
United StatesRekrutierend» Google-Maps
Valley Medical Center /ID# 253950
98055-5738 Renton
United StatesRekrutierend» Google-Maps
Centro Médico Austral /ID# 239860
1019 Ciudad Autonoma Buenos Aires
ArgentinaRekrutierend» Google-Maps
Cenit /Id# 239880
1125 Ciudad Autonoma de Buenos Aire
ArgentinaRekrutierend» Google-Maps
Hospital Britanico de Buenos Aires /ID# 231495
1280 Ciudad Autonoma de Buenos Aire
ArgentinaRekrutierend» Google-Maps
Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339
8500 Viedma
ArgentinaRekrutierend» Google-Maps
Austin Health /ID# 247507
3084 Heidelberg
AustraliaRekrutierend» Google-Maps
Ordensklinikum Linz GmbH Elisabethinen /ID# 240967
4010 Linz
AustriaRekrutierend» Google-Maps
Klinikum Wels-Grieskirchen GmbH /ID# 249000
4600 Wels
AustriaRekrutierend» Google-Maps
Landeskrankenhaus Feldkirch /ID# 250333
6800 Feldkirch
AustriaRekrutierend» Google-Maps
Medizinische Universitaet Wien /ID# 230615
1090 Vienna
AustriaRekrutierend» Google-Maps
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467
5020 Salzburg
AustriaRekrutierend» Google-Maps
Universitair Ziekenhuis Antwerpen /ID# 239971
2650 Edegem
BelgiumRekrutierend» Google-Maps
Grand Hopital de Charleroi /ID# 234178
6000 Charleroi
BelgiumRekrutierend» Google-Maps
Hospital La Louviere Site Jolimont - Helora /ID# 246771
7100 La Louvière
BelgiumRekrutierend» Google-Maps
Institut Jules Bordet /ID# 246770
1070 Anderlecht
BelgiumRekrutierend» Google-Maps
Algemeen Ziekenhuis klina /ID# 239853
2930 Brasschaat
BelgiumRekrutierend» Google-Maps
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769
5000 Namur
BelgiumRekrutierend» Google-Maps
Ensino e Terapia de Inovacao - Clinica AMO /ID# 231604
41950-610 Salvador
BrazilRekrutierend» Google-Maps
Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 233249
90020-090 Porto Alegre
BrazilRekrutierend» Google-Maps
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247
14784-400 Barretos
BrazilRekrutierend» Google-Maps
Instituto Nacional de Cancer (INCA) /ID# 231509
20231-050 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Instituto D'or de Pesquisa e Ensino /ID# 233245
22281-100 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417
01236-030 Sao Paulo
BrazilRekrutierend» Google-Maps
Casa de Saúde Santa Marcelina /ID# 231605
08270-070 Sao Paulo
BrazilRekrutierend» Google-Maps
Complex Oncology Center - Burgas /ID# 240532
8000 Burgas
BulgariaRekrutierend» Google-Maps
Complex Cancer Center Plovdiv /ID# 234106
4004 Plovdiv
BulgariaRekrutierend» Google-Maps
UMHAT Sveta Marina /ID# 234112
9010 Varna
BulgariaRekrutierend» Google-Maps
CISSS de la Monteregie /ID# 239081
J4V 2H1 Greenfield Park
CanadaRekrutierend» Google-Maps
Clinica Universidad Catolica del Maule /ID# 231294
3461341 Talca
ChileRekrutierend» Google-Maps
Sociedad Prosalud Montes y Orlandi /ID# 231154
7500713 Providencia
ChileRekrutierend» Google-Maps
Fundacion Arturo Lopez Perez /ID# 231151
7500921 Providencia
ChileRekrutierend» Google-Maps
Sociedad Oncovida /ID# 231152
7510032 Providencia
ChileRekrutierend» Google-Maps
Anhui Chest Hospital /ID# 231899
230022 Hefei
ChinaRekrutierend» Google-Maps
Beijing Cancer Hospital /ID# 231923
100142 Beijing
ChinaRekrutierend» Google-Maps
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 233175
100730 Beijing
ChinaRekrutierend» Google-Maps
Beijing Chest Hospital, Capital Medical University /ID# 232202
101149 Beijing
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Chongqing Medical University /ID# 251592
400016 Chongqing
ChinaRekrutierend» Google-Maps
Fujian Provincial Cancer Hospital /ID# 243134
350014 Fuzhou
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Xiamen University /ID# 242381
361003 Xiamen
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Guangzhou Medical University /ID# 238591
510163 Guangzhou
ChinaRekrutierend» Google-Maps
Cancer Hospital of Shantou University Medical College /ID# 242182
515041 Shantou
ChinaRekrutierend» Google-Maps
Affiliated Hospital Of Guangdong Medical University /ID# 233317
524001 Zhanjiang
ChinaRekrutierend» Google-Maps
Guangxi Medical University Cancer Center /ID# 231855
530027 Nanning
ChinaRekrutierend» Google-Maps
Guizhou Provincial People's Hospital /ID# 243614
550002 Guiyang
ChinaRekrutierend» Google-Maps
Affiliated Hospital of Hebei University /ID# 239586
071000 Baoding
ChinaRekrutierend» Google-Maps
Harbin Medical University Cancer Hospital /Id# 231941
150081 Harbin
ChinaRekrutierend» Google-Maps
The First affiliated Hospital of Nanyang Medical College /ID# 244652
473007 Nanyang
ChinaRekrutierend» Google-Maps
People's Hospital of Henan Province /ID# 242187
450003 Zhengzhou
ChinaRekrutierend» Google-Maps
Henan Cancer Hospital /ID# 239577
450008 Zhengzhou
ChinaRekrutierend» Google-Maps
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904
430022 Wuhan
ChinaRekrutierend» Google-Maps
Tongji Hospital Tongji Medical College of HUST /ID# 239575
430030 Wuhan
ChinaRekrutierend» Google-Maps
Hubei Cancer Hospital /ID# 240045
430079 Wuhan
ChinaRekrutierend» Google-Maps
Hunan Cancer Hospital /ID# 231943
410006 Changsha
ChinaRekrutierend» Google-Maps
The Affiliated Hospital of Inner Mongolia Medical University /ID# 242179
010050 Huhehaote
ChinaRekrutierend» Google-Maps
Nanjing Drum Tower Hospital /ID# 231791
210008 Nanjing
ChinaRekrutierend» Google-Maps
Nantong Tumor Hospital /ID# 232424
226300 Nantong
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Nanchang University /ID# 231934
330006 Nanchang
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of Nanchang University /ID# 231935
330008 Nanchang
ChinaRekrutierend» Google-Maps
Jilin Cancer Hospital /ID# 244702
130012 Changchun
ChinaRekrutierend» Google-Maps
The Second Affiliated Hospital of Dalian Medical University /ID# 239755
116023 Dalian
ChinaRekrutierend» Google-Maps
The First Hospital of China Medical University /ID# 231924
110001 Shenyang
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023
710061 Xi'an
ChinaRekrutierend» Google-Maps
Jinan Central Hospital /ID# 231895
250013 Jinan
ChinaRekrutierend» Google-Maps
Shandong Cancer Hospital /ID# 251506
251601 Jinan
ChinaRekrutierend» Google-Maps
Shanghai Chest Hospital /ID# 231897
200030 Shanghai
ChinaRekrutierend» Google-Maps
Sichuan Cancer Hospital /ID# 239707
610041 Chengdu
ChinaRekrutierend» Google-Maps
West China Hospital, Sichuan University /ID# 233703
610041 Chengdu
ChinaRekrutierend» Google-Maps
Tianjin Cancer Hospital /ID# 233176
300000 Tianjin
ChinaRekrutierend» Google-Maps
The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 240094
830000 Urumqi
ChinaRekrutierend» Google-Maps
Yunnan Cancer Hospital /ID# 251388
650118 Kunming
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032
310003 Hangzhou
ChinaRekrutierend» Google-Maps
Zhejiang Cancer hospital /ID# 242476
310022 Hangzhou
ChinaRekrutierend» Google-Maps
Taizhou Hospital, Zhejiang Province /ID# 232021
317013 Taizhou
ChinaRekrutierend» Google-Maps
Linyi Cancer Hospital /ID# 239713
276000 Linyi
ChinaRekrutierend» Google-Maps
Ningbo No. 2 Hospital /ID# 242478
315010 Ningbo
ChinaRekrutierend» Google-Maps
Tianjin Medical University General Hospital /ID# 231839
300052 Tianjin
ChinaRekrutierend» Google-Maps
Masarykuv onkologicky ustav /ID# 232426
656 53 Brno
CzechiaRekrutierend» Google-Maps
Nemocnice AGEL Novy Jicin, a.s. /ID# 232427
741 01 Novy Jicin
CzechiaAbgeschlossen» Google-Maps
Roskilde Sygehus /ID# 241842
4000 Roskilde
DenmarkRekrutierend» Google-Maps
Odense University Hospital /ID# 241663
5000 Odense C
DenmarkRekrutierend» Google-Maps
APHM - Hopital Nord /ID# 251935
13015 Marseille
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Bordeaux /ID# 244953
33604 Pessac CEDEX
FranceRekrutierend» Google-Maps
CHU Lille - Hôpital Albert Calmette /ID# 251934
59037 Lille
FranceRekrutierend» Google-Maps
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 239409
75679 Paris CEDEX 14
FranceRekrutierend» Google-Maps
Centre Hosp Intercommunal de Creteil /ID# 251936
94000 Creteil
FranceRekrutierend» Google-Maps
Hopital Arnaud de Villeneuve /ID# 239404
34295 Montpellier Cedex 5
FranceRekrutierend» Google-Maps
AP-HP - Hopital Tenon /ID# 239179
75020 Paris
FranceRekrutierend» Google-Maps
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824
11527 Athens
GreeceRekrutierend» Google-Maps
Metropolitan Hospital /ID# 232158
18547 Piraeus
GreeceRekrutierend» Google-Maps
Metropolitan Hospital /ID# 239170
18547 Piraeus
GreeceRekrutierend» Google-Maps
Euromedica General Clinic /ID# 254407
54645 Thessaloniki
GreeceRekrutierend» Google-Maps
The Edith Wolfson Medical Center /ID# 233781
5822000 Ashkelon
IsraelAbgeschlossen» Google-Maps
Soroka University Medical Center /ID# 252711
8410101 Be'er Sheva
IsraelRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center /ID# 260519
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Azienda Ospedaliera San Giovanni Addolorata /ID# 238618
00184 Rome
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera di Perugia /ID# 238473
06129 Perugia
ItalyRekrutierend» Google-Maps
I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696
70124 Bari
ItalyRekrutierend» Google-Maps
Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698
26100 Cremona
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Papardo /ID# 258038
98158 Messina
ItalyRekrutierend» Google-Maps
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 252942
80138 Napoli
ItalyRekrutierend» Google-Maps
NHO Nagoya Medical Center /ID# 246306
460-0001 Nagoya-shi
JapanRekrutierend» Google-Maps
Nagoya University Hospital /ID# 239990
4668560 Nagoya-shi
JapanRekrutierend» Google-Maps
Hirosaki University Hospital /ID# 242377
036-8203 Hirosaki-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East /ID# 233775
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Medical Center /ID# 238533
810-8563 Fukuoka shi
JapanRekrutierend» Google-Maps
Hospital of the University of Occupational and Environmental Health, Japan /ID# 241191
807-8556 Kitakyushu-shi
JapanRekrutierend» Google-Maps
Kurume University Hospital /ID# 254900
830-0011 Kurume-shi
JapanRekrutierend» Google-Maps
Fukushima Medical University Hospital /ID# 249691
960-1295 Fukushima-shi
JapanRekrutierend» Google-Maps
Gunma Prefectural Cancer Center /ID# 233723
373-8550 Ota-shi
JapanRekrutierend» Google-Maps
Chugoku Central Hospital /ID# 242970
720-0001 Fukuyama
JapanRekrutierend» Google-Maps
Hiroshima University Hospital /ID# 241882
734-8551 Hiroshima-shi
JapanRekrutierend» Google-Maps
Hokkaido University Hospital /ID# 241289
060-8648 Sapporo-shi
JapanRekrutierend» Google-Maps
Kobe Minimally Invasive Cancer Center /ID# 254131
650-0046 Kobe-shi
JapanRekrutierend» Google-Maps
Takarazuka City Hospital /ID# 240786
665-0827 Takarazuka-shi
JapanRekrutierend» Google-Maps
National Hospital Organization Mito Medical Center /ID# 241709
311-3193 Higashi Ibaraki-gun
JapanRekrutierend» Google-Maps
Ibaraki Prefectural Central Hospital /ID# 246145
309-1793 Kasama-shi
JapanRekrutierend» Google-Maps
Iwate Medical University Hospital /ID# 239027
028-3695 Shiwa-gun
JapanRekrutierend» Google-Maps
Kitasato University Hospital /ID# 239958
252-0375 Sagamihara-shi
JapanRekrutierend» Google-Maps
Yokohama City University Medical Center /ID# 246554
232-0024 Yokohama shi
JapanRekrutierend» Google-Maps
Kanagawa Cardiovascular and Respiratory Center /ID# 239052
236-0051 Yokohama-shi
JapanRekrutierend» Google-Maps
Kumamoto University Hospital /ID# 241039
8608556 Kumamoto shi
JapanRekrutierend» Google-Maps
National Hospital Organization Mie Chuo Medical Center /ID# 246659
514-1101 Tsu-shi
JapanRekrutierend» Google-Maps
Miyagi Cancer Center /ID# 234198
981-1293 Natori-shi
JapanRekrutierend» Google-Maps
Sendai Kousei Hospital /ID# 253350
980-0873 Sendai-shi
JapanRekrutierend» Google-Maps
University of Miyazaki Hospital /ID# 242161
889-1692 Miyazaki-shi
JapanRekrutierend» Google-Maps
Nagaoka Red Cross Hospital /ID# 240714
940-2085 Nagaoka-shi
JapanRekrutierend» Google-Maps
Kurashiki Central Hospital /ID# 239344
710-8602 Kurashiki-shi
JapanRekrutierend» Google-Maps
Osaka Habikino Medical Center /ID# 239989
583-8588 Habikino-shi
JapanRekrutierend» Google-Maps
Kansai Medical University Hospital /ID# 233476
573-1191 Hirakata-shi
JapanRekrutierend» Google-Maps
Osaka Metropolitan University Hospital /ID# 238895
545-8586 Osaka-shi
JapanRekrutierend» Google-Maps
Kindai University Hospital /ID# 239085
589-8511 Osakasayama-shi
JapanRekrutierend» Google-Maps
Tochigi Cancer Center /ID# 240020
320-0834 Utsunomiya-shi
JapanRekrutierend» Google-Maps
Juntendo University Hospital /ID# 239932
113-8431 Bunkyo-ku
JapanRekrutierend» Google-Maps
National Cancer Center Hospital /ID# 251134
104-0045 Chuo-ku
JapanRekrutierend» Google-Maps
NTT Medical Center Tokyo /ID# 241067
141-8625 Shinagawa-ku
JapanRekrutierend» Google-Maps
Keio University Hospital /ID# 239506
160-8582 Shinjuku-ku
JapanRekrutierend» Google-Maps
Toyama University Hospital /ID# 241660
930-0194 Toyama-shi
JapanRekrutierend» Google-Maps
Wakayama Medical University Hospital /ID# 234004
641-8510 Wakayama-shi
JapanRekrutierend» Google-Maps
Yamagata University Hospital /ID# 240815
990-9585 Yamagata-shi
JapanAbgeschlossen» Google-Maps
Yamaguchi - Ube Medical Center /ID# 258779
755-0241 Ube-shi
JapanRekrutierend» Google-Maps
Fujieda Municipal General Hospital /ID# 255155
426-8677 Fujieda-shi
JapanRekrutierend» Google-Maps
National Cancer Center /ID# 260663
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
CHA Bundang Medical Center /ID# 233318
13496 Seongnam
Korea, Republic ofRekrutierend» Google-Maps
Ajou University Hospital /ID# 233319
16499 Suwon-si
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University Of Korea St. Vincent's Hospital /ID# 256942
16247 Suwon
Korea, Republic ofRekrutierend» Google-Maps
Gyeongsang National University Hospital /ID# 234244
52727 Jinju
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Yangsan Hospital /ID# 257836
50612 Yangsan-si
Korea, Republic ofRekrutierend» Google-Maps
Kangbuk Samsung Hospital /ID# 233711
03181 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center /ID# 256941
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
SMG-SNU Boramae Medical Center /ID# 233710
07061 동작구
Korea, Republic ofRekrutierend» Google-Maps
O.P.D. Hospital Civil de Guadalajara /ID# 238488
44280 Guadalajara
MexicoRekrutierend» Google-Maps
Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928
58260 Morelia
MexicoRekrutierend» Google-Maps
Clinical Research & Oncology Oaxaca /ID# 231883
68020 Oaxaca
MexicoRekrutierend» Google-Maps
HagaZiekenhuis /ID# 243693
2545 AA Den Haag
NetherlandsRekrutierend» Google-Maps
Ziekenhuis St. Jansdal /ID# 251932
3844 DG Harderwijk
NetherlandsRekrutierend» Google-Maps
Maastricht Universitair Medisch Centrum /ID# 233932
6229 HX Maastricht
NetherlandsRekrutierend» Google-Maps
Instytut Centrum Zdrowia Matki Polki /ID# 239024
93-338 Lodz
PolandRekrutierend» Google-Maps
MRUK-MED I Sp. z o.o. /ID# 239363
35-021 Rzeszow
PolandRekrutierend» Google-Maps
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025
10-357 Olsztyn
PolandRekrutierend» Google-Maps
Fundacao Champalimaud /ID# 241925
1400-038 Lisbon
PortugalRekrutierend» Google-Maps
Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 241572
4099-001 Porto
PortugalRekrutierend» Google-Maps
Hospital CUF Porto /ID# 241570
4100-180 Porto
PortugalRekrutierend» Google-Maps
IPO Porto FG, EPE /ID# 241569
4200-072 Porto
PortugalRekrutierend» Google-Maps
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 241930
4200-319 Porto
PortugalRekrutierend» Google-Maps
Spitalul Pelican /ID# 254066
410469 Oradea
RomaniaRekrutierend» Google-Maps
Cardiomed Srl /Id# 255320
400015 Cluj-Napoca
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Alle anzeigen

Studien-Informationen

Brief Summary:

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 250 sites worldwide.

Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks

until meeting study drug discontinuation criteria.

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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 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 documented non-squamous cell NSCLC that is locally advanced or

metastatic.

- A known epidermal growth factor receptor (EGFR) activating mutation status.

- Actionable alterations in genes other than EGFR .

- 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 definitive therapy (such as surgery or radiotherapy) is provided and:

- There is no evidence of progression of CNS metastases at least 2 weeks after

definitive therapy.

- They are asymptomatic and off or on a stable or reducing dose of systemic

steroids and/or anticonvulsants for at least 2 weeks prior to first dose of

telisotuzumab vedotin.

Exclusion Criteria:

- Participants with adenosquamous histology.

- Actionable 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.

- 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 permitted.

- Unresolved adverse event (AE) >= Grade 2 from prior anticancer therapy, except for

alopecia or anemia.

- Major surgery within 21 days prior to the first dose of telisotuzumab vedotin.

- Clinically significant condition(s) as listed in the protocol.

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) per Independent Central Review (ICR) (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 ICR or death from any cause.

2. 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.

Secondary outcome:

1. Objective Response Rate (ORR), per ICR. (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

2. Duration of Response (DoR), per ICR (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.

3. 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.

4. Time to Deterioration in Cough, Pain or Dyspnea as measured by the Cough, Pain and Dyspnea items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) (Time Frame - Up to approximately 58.25 months):
The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30. The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.

5. Time to Deterioration of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30). (Time Frame - Up to approximately 58.25 months):
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.

6. 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 58.25 months):
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.

Studien-Arme

  • Experimental: Telisotuzumab Vedotin
    Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
  • Active Comparator: Docetaxel
    Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.

Geprüfte Regime

  • Telisotuzumab Vedotin (ABBV-399):
    Intravenous (IV) Infusion
  • Docetaxel:
    IV Infusion

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"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)"

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