JOURNAL ONKOLOGIE – STUDIE
VISION Tepotinib Phase II in Non-small Cell Lung Cancer (NSCLC) Harboring MET Alterations
Rekrutierend
NCT-Nummer:
NCT02864992
Studienbeginn:
September 2016
Letztes Update:
23.02.2021
Wirkstoff:
Tepotinib
Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 2
Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborator:
Merck KGaA, Darmstadt, Germany
Studienleiter
Study Director
EMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany
Kontakt
Kontakt:
Phone: 888-275-7376
E-Mail: eMediUSA@emdserono.com» Kontaktdaten anzeigen
Kontakt:
Phone: +49 6151 72 5200
E-Mail: service@emdgroup.com» Kontaktdaten anzeigen
Studienlocations (3 von 151)
Asklepios Fachkliniken Muenchen-Gauting
82131 Gauting
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-MapsPius-Hospital Oldenburg
26121 Oldenburg
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsUniversitaetsklinikum des Saarlandes
66421 Homburg / Saar
(Saarland)
GermanyAktiv, nicht rekrutierend» Google-Maps
82131 Gauting
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-MapsPius-Hospital Oldenburg
26121 Oldenburg
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsUniversitaetsklinikum des Saarlandes
66421 Homburg / Saar
(Saarland)
GermanyAktiv, nicht rekrutierend» Google-Maps
Klinikum Chemnitz gGmbH
09113 Chemnitz
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsStaedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
01067 Dresden
(Sachsen)
GermanyRekrutierend» Google-MapsUniversitaetsklinikum Carl Gustav Carus TU Dresden
01307 Dresden
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsPOIS Leipzig GbR
04357 Leipzig
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsLungenkrebszentrum Helios Klinikum Erfurt
Nordhäuser Straße 74
99089 Erfurt
(Thüringen)
DeutschlandAktiv, nicht rekrutierend» Google-MapsSRH Wald-Klinikum Gera gGmbH
07548 Gera
(Thüringen)
GermanyAktiv, nicht rekrutierend» Google-MapsCharite Universitaetsmedizin Berlin - Campus Charite Mitte
10117 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-MapsUniversitaetsmedizin Goettingen
Goettingen
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsEvangelisches Krankenhaus Hamm GmbH
Hamm
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-MapsUniversitaetsklinikum Heidelberg
69126 Heidelberg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-MapsUniversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz
(Rheinland-Pfalz)
GermanyAktiv, nicht rekrutierend» Google-MapsCity of Hope Cancer Center
91010 Duarte
United StatesAktiv, nicht rekrutierend» Google-MapsUCI Medical Center
92868 Orange
United StatesZurückgezogen» Google-MapsTorrance Health Association
90277 Redondo Beach
United StatesAktiv, nicht rekrutierend» Google-MapsSt Joseph Heritage Healthcare
95403 Santa Rosa
United StatesAktiv, nicht rekrutierend» Google-MapsRocky Mountain Cancer Centers, LLP
80218 Denver
United StatesAktiv, nicht rekrutierend» Google-MapsHoly Cross Hospital Inc.
33308 Fort Lauderdale
United StatesAktiv, nicht rekrutierend» Google-MapsUniversity Cancer & Blood Center, LLC
30607 Athens
United StatesZurückgezogen» Google-MapsWinship Cancer Institute
30322 Atlanta
United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of Chicago Medical Center
60637 Chicago
United StatesAktiv, nicht rekrutierend» Google-MapsIngalls Hospital
60426-3558 Harvey
United StatesAktiv, nicht rekrutierend» Google-MapsCommunity Regional Cancer Care
46250 Indianapolis
United StatesAktiv, nicht rekrutierend» Google-MapsSt. Louis Cancer Care, LLP
63044 Bridgeton
United StatesAktiv, nicht rekrutierend» Google-MapsSaint Louis University Cancer Center
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: richartj@slu.edu» Ansprechpartner anzeigenSaint Louis University
63110 Saint Louis
United StatesAktiv, nicht rekrutierend» Google-MapsRegional Cancer Care Associates East Brunswick
08816 East Brunswick
United StatesAktiv, nicht rekrutierend» Google-MapsHackensack University Medical Center PARTNER
07601 Hackensack
United StatesAktiv, nicht rekrutierend» Google-MapsThe Valley Hospital
07450 Ridgewood
United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center - Commack
11725 Commack
United StatesRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: paikp@mskcc.org» Ansprechpartner anzeigenMemorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion
10604 Harrison
United StatesRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: paikp@mskcc.org» Ansprechpartner anzeigenMemorial Sloan Kettering Cancer Center
10022 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Paul Paik
Phone: 646-888-4202
E-Mail: paikp@mskcc.org» Ansprechpartner anzeigenUC Health Clinical Trials Office
45229 Cincinnati
United StatesAktiv, nicht rekrutierend» Google-MapsTennessee Oncology
37203 Nashville
United StatesAktiv, nicht rekrutierend» Google-MapsVanderbilt University Medical Center
37232 Nashville
United StatesAktiv, nicht rekrutierend» Google-MapsTexas Oncology, P.A. - Austin
78731 Austin
United StatesAktiv, nicht rekrutierend» Google-MapsTexas Oncology, PA
77702-1449 Beaumont
United StatesAktiv, nicht rekrutierend» Google-MapsTexas Oncology, P.A.
75231 Dallas
United StatesZurückgezogen» Google-MapsUniversity of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-MapsVirginia Cancer Specialists, PC
22031 Fairfax
United StatesAktiv, nicht rekrutierend» Google-MapsSwedish Medical Center
98104 Seattle
United StatesAktiv, nicht rekrutierend» Google-MapsWenatchee Valley Hospital & Clinics - ATTN: Jay Johnson
98801 Wenatchee
United StatesAktiv, nicht rekrutierend» Google-MapsLKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg
AustriaAktiv, nicht rekrutierend» Google-MapsUZ Antwerpen
2650 Edegem
BelgiumAktiv, nicht rekrutierend» Google-MapsCHU Ambroise Paré
7000 Mons
BelgiumAktiv, nicht rekrutierend» Google-MapsAZ Delta
8800 Roeselare
BelgiumAktiv, nicht rekrutierend» Google-MapsPeking University Cancer Hospital
Beijing
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: fangjian5555@yeah.net» Ansprechpartner anzeigenPeking University Cancer Hospital
Beijing
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: ohjerry@163.com» Ansprechpartner anzeigenJilin Cancer Hospital - Oncology
Changchun
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: jl.cheng@163.com» Ansprechpartner anzeigenHunan Cancer Hospital
Changsha
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: yangnongpi@163.com» Ansprechpartner anzeigenSichuan Cancer Hospital
Chengdu
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: dr.lijuan@hotmail.com» Ansprechpartner anzeigenWest China Hospital, Sichuan University
Chengdu
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: zhouqh135@163.com» Ansprechpartner anzeigenGuangdong General Hospital
Guangzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: yangjinji2003@163.com» Ansprechpartner anzeigenAffiliated Tumor Hospital of Harbin Medical University
Harbin
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: chengongyan@163.com» Ansprechpartner anzeigenAnhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital
Hefei City
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: zhangzhihope@126.com» Ansprechpartner anzeigenJinan Central Hospital
Jinan
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: sunypclinicaltrial@163.com» Ansprechpartner anzeigenLinyi Tumor Hospital
Linyi
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: shijianhualy@126.com» Ansprechpartner anzeigenJiangsu Province Hospital
Nanjing
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: shuyongqian@csco.org.cn» Ansprechpartner anzeigenShanghai Cancer Hospital, Fudan University
Shanghai
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: luwangjialei@hotmail.com» Ansprechpartner anzeigenLiaoning Cancer Hospital & Institute
Shenyang
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: ruima1215@163.com» Ansprechpartner anzeigenThe Affiliated Cancer Hospital of Xinjiang Medical university
Urumqi
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: zhigang.han@gmail.com» Ansprechpartner anzeigenGroupe Hospitalier Sud - Hôpital Haut-Lévêque
33604 Pessac
FranceAktiv, nicht rekrutierend» Google-MapsCHU de Toulouse - Hôpital Larrey
31059 Toulouse
FranceRekrutierend» Google-MapsICO - Site René Gauducheau
44805 Saint Herblain
FranceAktiv, nicht rekrutierend» Google-MapsClinique Mutualiste de l'Estuaire
44606 Saint Nazaire Cedex
FranceAktiv, nicht rekrutierend» Google-MapsICO - Site Paul Papin
49055 Angers Cedex 2
FranceAktiv, nicht rekrutierend» Google-MapsCentre Hospitalier de Cholet
49300 Cholet
FranceAktiv, nicht rekrutierend» Google-MapsCentre Hospitalier de Bretagne Sud
56322 Lorient cedex
FranceAktiv, nicht rekrutierend» Google-MapsHopital Albert Calmette - CHU Lille
59037 Lille Cedex
FranceAktiv, nicht rekrutierend» Google-MapsHôpital Saint-Louis
75475 Paris Cedex 10
FranceRekrutierend» Google-MapsCentre Hospitalier de la côte Basque
64100 Bayonne
FranceRekrutierend» Google-Maps
Ansprechpartner:
Sophia Schneider
Phone: +33559443158
E-Mail: sschneider@ch-cotebasque.fr» Ansprechpartner anzeigenCentre Hospitalier Intercommunal de Créteil
94010 Creteil cedex
FranceAktiv, nicht rekrutierend» Google-MapsCentre Hospitalier Départemental Les Oudairies
85925 La Roche sur Yon
FranceAktiv, nicht rekrutierend» Google-MapsSoroka University Medical Center
Beer-Sheva
IsraelAktiv, nicht rekrutierend» Google-MapsHadassah University Hospital - Ein Kerem
Jerusalem
IsraelAktiv, nicht rekrutierend» Google-MapsMeir Medical Center
Kfar- Saba
IsraelAktiv, nicht rekrutierend» Google-MapsRabin Medical Center-Beilinson Campus
Petach Tikva
IsraelAktiv, nicht rekrutierend» Google-MapsTel Aviv Sourasky Medical Center
Tel Aviv
IsraelAktiv, nicht rekrutierend» Google-MapsIstituto Clinico Humanitas
20089 Rozzano
ItalyAktiv, nicht rekrutierend» Google-MapsOspedale Valduce
22100 Como
ItalyZurückgezogen» Google-MapsIstituto Nazionale per la Ricerca sul Cancro di Genova
16132 Genova
ItalyAktiv, nicht rekrutierend» Google-MapsFondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Marina Garassino
Phone: +390223903066
E-Mail: garassino.studiclinici@istitutotumori.mi.it» Ansprechpartner anzeigenIEO Istituto Europeo di Oncologia
20141 Milano
ItalyAktiv, nicht rekrutierend» Google-MapsSeconda Università degli Studi di Napoli
80131 Napoli
ItalyAktiv, nicht rekrutierend» Google-MapsAzienda Ospedaliera di Padova
35128 Padova
ItalyAktiv, nicht rekrutierend» Google-MapsIOV - Istituto Oncologico Veneto IRCCS
35128 Padova
ItalyAktiv, nicht rekrutierend» Google-MapsOspedale Santa Maria di Cà Foncello
35128 Padova
ItalyRekrutierend» Google-MapsUniversità Campus Bio-Medico di Roma
00128 Roma
ItalyAktiv, nicht rekrutierend» Google-MapsAzienda Ospedaliera San Camillo Forlanini
00149 Roma
ItalyAktiv, nicht rekrutierend» Google-MapsNagoya University Hospital
466-8560 Nagoya-shi
JapanAktiv, nicht rekrutierend» Google-MapsNational Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanAktiv, nicht rekrutierend» Google-MapsNHO Shikoku Cancer Center
791-0280 Matsuyama-shi
JapanAktiv, nicht rekrutierend» Google-MapsNHO Kyushu Medical Center
810-8563 Fukuoka-shi
JapanAktiv, nicht rekrutierend» Google-MapsKurume University Hospital
830-0011 Kurume-shi
JapanAktiv, nicht rekrutierend» Google-MapsHokkaido University Hospital
060-8648 Sapporo-shi
JapanAktiv, nicht rekrutierend» Google-MapsKanagawa Cancer Center
241-8515 Yokohama-shi
JapanAktiv, nicht rekrutierend» Google-MapsNiigata Cancer Center Hospital
951-8566 Niigata-shi
JapanAktiv, nicht rekrutierend» Google-MapsOsaka International Cancer Institute
541-8567 Osaka-shi
JapanAktiv, nicht rekrutierend» Google-MapsNHO Kinki-Chuo Chest Medical Center
591-8555 Sakai-shi
JapanAktiv, nicht rekrutierend» Google-MapsSaitama Cancer Center
362-0806 Kitaadachi-gun
JapanRekrutierend» Google-MapsTottori University Hospital
683-8504 Yonago-shi
JapanAktiv, nicht rekrutierend» Google-MapsNHO Yamaguchi - Ube Medical Center
755-0241 Ube-shi
JapanAktiv, nicht rekrutierend» Google-MapsDong-A University Hospital
Busan
Korea, Republic ofAbgebrochen» Google-MapsKosin University Gospel Hospital
Busan
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsKyungpook National University Medical Center
Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsNational Cancer Center
Goyang-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsKorea University Guro Hospital
Guro-Gu
Korea, Republic ofZurückgezogen» Google-MapsChonnam National University Hwasun Hospital
Hwasun-gun
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsGachon University Gil Medical Center
Incheon
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSeoul National University Bundang Hospital
Seongnam-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsAsan Medical Center
Seoul
Korea, Republic ofZurückgezogen» Google-MapsKorea University Anam Hospital
Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSamsung Medical Center
Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: kpark@skku.edu» Ansprechpartner anzeigenSeverance Hospital, Yonsei University
Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsThe Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsThe Catholic University of Korea, St. Vincent's Hospital
Suwon-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsAjou University Hospital
Suwon
Korea, Republic ofZurückgezogen» Google-MapsUlsan University Hospital
Ulsan
Korea, Republic ofZurückgezogen» Google-MapsAntoni van Leeuwenhoek Ziekenhuis
Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-MapsVU Medisch Centrum
Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-MapsUniversitair Medisch Centrum Groningen (UMCG) - Parent
Groningen
NetherlandsAktiv, nicht rekrutierend» Google-MapsCentrum Pulmonologii i Torakochirurgii w Bystrej
43-360 Bystra
PolandAktiv, nicht rekrutierend» Google-MapsDr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska
20-093 Lublin
PolandAktiv, nicht rekrutierend» Google-MapsNZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
10-513 Olsztyn
PolandAktiv, nicht rekrutierend» Google-MapsPrzychodnia Med-Polonia Sp. z o.o.
60-693 Poznan
PolandAktiv, nicht rekrutierend» Google-MapsCentrum Onkologii-Instytut im. M. Sklodowskiej Curie
02-781 Warszawa
PolandAktiv, nicht rekrutierend» Google-MapsHospital General de Catalunya
08190 Sant Cugat del Valles
SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario HM Puerta del Sur
28938 Mostoles
SpainZurückgezogen» Google-MapsHospital Universitario Infanta Sofia
28702 San Sebastian de los Reyes
SpainAbgebrochen» Google-MapsHospital General Universitario Santa Lucia
30202 Cartagena
SpainAktiv, nicht rekrutierend» Google-MapsHospital Clinico Universitario Virgen de la Victoria
29010 Malaga
SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitari Quiron Dexeus
08028 Barcelona
SpainRekrutierend» Google-MapsHospital Universitari Sagrat Cor
08029 Barcelona
SpainAbgebrochen» Google-MapsHospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Ansprechpartner:
Enriqueta Felip Font
Phone: +34932746085
E-Mail: efelip@vhebron.net» Ansprechpartner anzeigenHospital General Universitario Gregorio Marañon
28007 Madrid
SpainAktiv, nicht rekrutierend» Google-MapsMD Anderson Cancer Centre
28033 Madrid
SpainZurückgezogen» Google-MapsHospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-MapsHospital Universitario La Paz
28046 Madrid
SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario HM Madrid Sanchinarro
28050 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Javier de Castro Carpeño
Phone: +34917277516
E-Mail: javier.decastro@salud.madrid.org» Ansprechpartner anzeigenHospital Universitario Virgen Macarena
41009 Sevilla
SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario Nuestra Señora de Valme
41014 Sevilla
SpainAktiv, nicht rekrutierend» Google-MapsInselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie
Bern
SwitzerlandAktiv, nicht rekrutierend» Google-MapsUniversitaetsspital Zuerich - Klinik fuer Onkologie
Zuerich
SwitzerlandAktiv, nicht rekrutierend» Google-MapsKaohsiung Chang Gung Memorial Hospital
Kaohsiung
TaiwanAktiv, nicht rekrutierend» Google-MapsChina Medical University Hospital
Taichung
TaiwanAktiv, nicht rekrutierend» Google-MapsTaichung Veterans General Hospital
Taichung
TaiwanAktiv, nicht rekrutierend» Google-MapsNational Taiwan University Hospital
Taipei
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: chihyang@ntu.edu.tw» Ansprechpartner anzeigenTaipei Veterans General Hospital
Taipei
TaiwanAktiv, nicht rekrutierend» Google-MapsTri-Service General Hospital
Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen 09113 Chemnitz
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsStaedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
01067 Dresden
(Sachsen)
GermanyRekrutierend» Google-MapsUniversitaetsklinikum Carl Gustav Carus TU Dresden
01307 Dresden
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsPOIS Leipzig GbR
04357 Leipzig
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsLungenkrebszentrum Helios Klinikum Erfurt
Nordhäuser Straße 74
99089 Erfurt
(Thüringen)
DeutschlandAktiv, nicht rekrutierend» Google-MapsSRH Wald-Klinikum Gera gGmbH
07548 Gera
(Thüringen)
GermanyAktiv, nicht rekrutierend» Google-MapsCharite Universitaetsmedizin Berlin - Campus Charite Mitte
10117 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-MapsUniversitaetsmedizin Goettingen
Goettingen
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-MapsEvangelisches Krankenhaus Hamm GmbH
Hamm
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-MapsUniversitaetsklinikum Heidelberg
69126 Heidelberg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-MapsUniversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz
(Rheinland-Pfalz)
GermanyAktiv, nicht rekrutierend» Google-MapsCity of Hope Cancer Center
91010 Duarte
United StatesAktiv, nicht rekrutierend» Google-MapsUCI Medical Center
92868 Orange
United StatesZurückgezogen» Google-MapsTorrance Health Association
90277 Redondo Beach
United StatesAktiv, nicht rekrutierend» Google-MapsSt Joseph Heritage Healthcare
95403 Santa Rosa
United StatesAktiv, nicht rekrutierend» Google-MapsRocky Mountain Cancer Centers, LLP
80218 Denver
United StatesAktiv, nicht rekrutierend» Google-MapsHoly Cross Hospital Inc.
33308 Fort Lauderdale
United StatesAktiv, nicht rekrutierend» Google-MapsUniversity Cancer & Blood Center, LLC
30607 Athens
United StatesZurückgezogen» Google-MapsWinship Cancer Institute
30322 Atlanta
United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of Chicago Medical Center
60637 Chicago
United StatesAktiv, nicht rekrutierend» Google-MapsIngalls Hospital
60426-3558 Harvey
United StatesAktiv, nicht rekrutierend» Google-MapsCommunity Regional Cancer Care
46250 Indianapolis
United StatesAktiv, nicht rekrutierend» Google-MapsSt. Louis Cancer Care, LLP
63044 Bridgeton
United StatesAktiv, nicht rekrutierend» Google-MapsSaint Louis University Cancer Center
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: richartj@slu.edu» Ansprechpartner anzeigenSaint Louis University
63110 Saint Louis
United StatesAktiv, nicht rekrutierend» Google-MapsRegional Cancer Care Associates East Brunswick
08816 East Brunswick
United StatesAktiv, nicht rekrutierend» Google-MapsHackensack University Medical Center PARTNER
07601 Hackensack
United StatesAktiv, nicht rekrutierend» Google-MapsThe Valley Hospital
07450 Ridgewood
United StatesAktiv, nicht rekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center - Commack
11725 Commack
United StatesRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: paikp@mskcc.org» Ansprechpartner anzeigenMemorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion
10604 Harrison
United StatesRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: paikp@mskcc.org» Ansprechpartner anzeigenMemorial Sloan Kettering Cancer Center
10022 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Paul Paik
Phone: 646-888-4202
E-Mail: paikp@mskcc.org» Ansprechpartner anzeigenUC Health Clinical Trials Office
45229 Cincinnati
United StatesAktiv, nicht rekrutierend» Google-MapsTennessee Oncology
37203 Nashville
United StatesAktiv, nicht rekrutierend» Google-MapsVanderbilt University Medical Center
37232 Nashville
United StatesAktiv, nicht rekrutierend» Google-MapsTexas Oncology, P.A. - Austin
78731 Austin
United StatesAktiv, nicht rekrutierend» Google-MapsTexas Oncology, PA
77702-1449 Beaumont
United StatesAktiv, nicht rekrutierend» Google-MapsTexas Oncology, P.A.
75231 Dallas
United StatesZurückgezogen» Google-MapsUniversity of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-MapsVirginia Cancer Specialists, PC
22031 Fairfax
United StatesAktiv, nicht rekrutierend» Google-MapsSwedish Medical Center
98104 Seattle
United StatesAktiv, nicht rekrutierend» Google-MapsWenatchee Valley Hospital & Clinics - ATTN: Jay Johnson
98801 Wenatchee
United StatesAktiv, nicht rekrutierend» Google-MapsLKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg
AustriaAktiv, nicht rekrutierend» Google-MapsUZ Antwerpen
2650 Edegem
BelgiumAktiv, nicht rekrutierend» Google-MapsCHU Ambroise Paré
7000 Mons
BelgiumAktiv, nicht rekrutierend» Google-MapsAZ Delta
8800 Roeselare
BelgiumAktiv, nicht rekrutierend» Google-MapsPeking University Cancer Hospital
Beijing
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: fangjian5555@yeah.net» Ansprechpartner anzeigenPeking University Cancer Hospital
Beijing
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: ohjerry@163.com» Ansprechpartner anzeigenJilin Cancer Hospital - Oncology
Changchun
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: jl.cheng@163.com» Ansprechpartner anzeigenHunan Cancer Hospital
Changsha
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: yangnongpi@163.com» Ansprechpartner anzeigenSichuan Cancer Hospital
Chengdu
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: dr.lijuan@hotmail.com» Ansprechpartner anzeigenWest China Hospital, Sichuan University
Chengdu
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: zhouqh135@163.com» Ansprechpartner anzeigenGuangdong General Hospital
Guangzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: yangjinji2003@163.com» Ansprechpartner anzeigenAffiliated Tumor Hospital of Harbin Medical University
Harbin
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: chengongyan@163.com» Ansprechpartner anzeigenAnhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital
Hefei City
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: zhangzhihope@126.com» Ansprechpartner anzeigenJinan Central Hospital
Jinan
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: sunypclinicaltrial@163.com» Ansprechpartner anzeigenLinyi Tumor Hospital
Linyi
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: shijianhualy@126.com» Ansprechpartner anzeigenJiangsu Province Hospital
Nanjing
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: shuyongqian@csco.org.cn» Ansprechpartner anzeigenShanghai Cancer Hospital, Fudan University
Shanghai
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: luwangjialei@hotmail.com» Ansprechpartner anzeigenLiaoning Cancer Hospital & Institute
Shenyang
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: ruima1215@163.com» Ansprechpartner anzeigenThe Affiliated Cancer Hospital of Xinjiang Medical university
Urumqi
ChinaRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: zhigang.han@gmail.com» Ansprechpartner anzeigenGroupe Hospitalier Sud - Hôpital Haut-Lévêque
33604 Pessac
FranceAktiv, nicht rekrutierend» Google-MapsCHU de Toulouse - Hôpital Larrey
31059 Toulouse
FranceRekrutierend» Google-MapsICO - Site René Gauducheau
44805 Saint Herblain
FranceAktiv, nicht rekrutierend» Google-MapsClinique Mutualiste de l'Estuaire
44606 Saint Nazaire Cedex
FranceAktiv, nicht rekrutierend» Google-MapsICO - Site Paul Papin
49055 Angers Cedex 2
FranceAktiv, nicht rekrutierend» Google-MapsCentre Hospitalier de Cholet
49300 Cholet
FranceAktiv, nicht rekrutierend» Google-MapsCentre Hospitalier de Bretagne Sud
56322 Lorient cedex
FranceAktiv, nicht rekrutierend» Google-MapsHopital Albert Calmette - CHU Lille
59037 Lille Cedex
FranceAktiv, nicht rekrutierend» Google-MapsHôpital Saint-Louis
75475 Paris Cedex 10
FranceRekrutierend» Google-MapsCentre Hospitalier de la côte Basque
64100 Bayonne
FranceRekrutierend» Google-Maps
Ansprechpartner:
Sophia Schneider
Phone: +33559443158
E-Mail: sschneider@ch-cotebasque.fr» Ansprechpartner anzeigenCentre Hospitalier Intercommunal de Créteil
94010 Creteil cedex
FranceAktiv, nicht rekrutierend» Google-MapsCentre Hospitalier Départemental Les Oudairies
85925 La Roche sur Yon
FranceAktiv, nicht rekrutierend» Google-MapsSoroka University Medical Center
Beer-Sheva
IsraelAktiv, nicht rekrutierend» Google-MapsHadassah University Hospital - Ein Kerem
Jerusalem
IsraelAktiv, nicht rekrutierend» Google-MapsMeir Medical Center
Kfar- Saba
IsraelAktiv, nicht rekrutierend» Google-MapsRabin Medical Center-Beilinson Campus
Petach Tikva
IsraelAktiv, nicht rekrutierend» Google-MapsTel Aviv Sourasky Medical Center
Tel Aviv
IsraelAktiv, nicht rekrutierend» Google-MapsIstituto Clinico Humanitas
20089 Rozzano
ItalyAktiv, nicht rekrutierend» Google-MapsOspedale Valduce
22100 Como
ItalyZurückgezogen» Google-MapsIstituto Nazionale per la Ricerca sul Cancro di Genova
16132 Genova
ItalyAktiv, nicht rekrutierend» Google-MapsFondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Marina Garassino
Phone: +390223903066
E-Mail: garassino.studiclinici@istitutotumori.mi.it» Ansprechpartner anzeigenIEO Istituto Europeo di Oncologia
20141 Milano
ItalyAktiv, nicht rekrutierend» Google-MapsSeconda Università degli Studi di Napoli
80131 Napoli
ItalyAktiv, nicht rekrutierend» Google-MapsAzienda Ospedaliera di Padova
35128 Padova
ItalyAktiv, nicht rekrutierend» Google-MapsIOV - Istituto Oncologico Veneto IRCCS
35128 Padova
ItalyAktiv, nicht rekrutierend» Google-MapsOspedale Santa Maria di Cà Foncello
35128 Padova
ItalyRekrutierend» Google-MapsUniversità Campus Bio-Medico di Roma
00128 Roma
ItalyAktiv, nicht rekrutierend» Google-MapsAzienda Ospedaliera San Camillo Forlanini
00149 Roma
ItalyAktiv, nicht rekrutierend» Google-MapsNagoya University Hospital
466-8560 Nagoya-shi
JapanAktiv, nicht rekrutierend» Google-MapsNational Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanAktiv, nicht rekrutierend» Google-MapsNHO Shikoku Cancer Center
791-0280 Matsuyama-shi
JapanAktiv, nicht rekrutierend» Google-MapsNHO Kyushu Medical Center
810-8563 Fukuoka-shi
JapanAktiv, nicht rekrutierend» Google-MapsKurume University Hospital
830-0011 Kurume-shi
JapanAktiv, nicht rekrutierend» Google-MapsHokkaido University Hospital
060-8648 Sapporo-shi
JapanAktiv, nicht rekrutierend» Google-MapsKanagawa Cancer Center
241-8515 Yokohama-shi
JapanAktiv, nicht rekrutierend» Google-MapsNiigata Cancer Center Hospital
951-8566 Niigata-shi
JapanAktiv, nicht rekrutierend» Google-MapsOsaka International Cancer Institute
541-8567 Osaka-shi
JapanAktiv, nicht rekrutierend» Google-MapsNHO Kinki-Chuo Chest Medical Center
591-8555 Sakai-shi
JapanAktiv, nicht rekrutierend» Google-MapsSaitama Cancer Center
362-0806 Kitaadachi-gun
JapanRekrutierend» Google-MapsTottori University Hospital
683-8504 Yonago-shi
JapanAktiv, nicht rekrutierend» Google-MapsNHO Yamaguchi - Ube Medical Center
755-0241 Ube-shi
JapanAktiv, nicht rekrutierend» Google-MapsDong-A University Hospital
Busan
Korea, Republic ofAbgebrochen» Google-MapsKosin University Gospel Hospital
Busan
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsKyungpook National University Medical Center
Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsNational Cancer Center
Goyang-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsKorea University Guro Hospital
Guro-Gu
Korea, Republic ofZurückgezogen» Google-MapsChonnam National University Hwasun Hospital
Hwasun-gun
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsGachon University Gil Medical Center
Incheon
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSeoul National University Bundang Hospital
Seongnam-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsAsan Medical Center
Seoul
Korea, Republic ofZurückgezogen» Google-MapsKorea University Anam Hospital
Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsSamsung Medical Center
Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: kpark@skku.edu» Ansprechpartner anzeigenSeverance Hospital, Yonsei University
Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsThe Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsThe Catholic University of Korea, St. Vincent's Hospital
Suwon-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsAjou University Hospital
Suwon
Korea, Republic ofZurückgezogen» Google-MapsUlsan University Hospital
Ulsan
Korea, Republic ofZurückgezogen» Google-MapsAntoni van Leeuwenhoek Ziekenhuis
Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-MapsVU Medisch Centrum
Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-MapsUniversitair Medisch Centrum Groningen (UMCG) - Parent
Groningen
NetherlandsAktiv, nicht rekrutierend» Google-MapsCentrum Pulmonologii i Torakochirurgii w Bystrej
43-360 Bystra
PolandAktiv, nicht rekrutierend» Google-MapsDr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska
20-093 Lublin
PolandAktiv, nicht rekrutierend» Google-MapsNZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
10-513 Olsztyn
PolandAktiv, nicht rekrutierend» Google-MapsPrzychodnia Med-Polonia Sp. z o.o.
60-693 Poznan
PolandAktiv, nicht rekrutierend» Google-MapsCentrum Onkologii-Instytut im. M. Sklodowskiej Curie
02-781 Warszawa
PolandAktiv, nicht rekrutierend» Google-MapsHospital General de Catalunya
08190 Sant Cugat del Valles
SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario HM Puerta del Sur
28938 Mostoles
SpainZurückgezogen» Google-MapsHospital Universitario Infanta Sofia
28702 San Sebastian de los Reyes
SpainAbgebrochen» Google-MapsHospital General Universitario Santa Lucia
30202 Cartagena
SpainAktiv, nicht rekrutierend» Google-MapsHospital Clinico Universitario Virgen de la Victoria
29010 Malaga
SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitari Quiron Dexeus
08028 Barcelona
SpainRekrutierend» Google-MapsHospital Universitari Sagrat Cor
08029 Barcelona
SpainAbgebrochen» Google-MapsHospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Ansprechpartner:
Enriqueta Felip Font
Phone: +34932746085
E-Mail: efelip@vhebron.net» Ansprechpartner anzeigenHospital General Universitario Gregorio Marañon
28007 Madrid
SpainAktiv, nicht rekrutierend» Google-MapsMD Anderson Cancer Centre
28033 Madrid
SpainZurückgezogen» Google-MapsHospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-MapsHospital Universitario La Paz
28046 Madrid
SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario HM Madrid Sanchinarro
28050 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Javier de Castro Carpeño
Phone: +34917277516
E-Mail: javier.decastro@salud.madrid.org» Ansprechpartner anzeigenHospital Universitario Virgen Macarena
41009 Sevilla
SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario Nuestra Señora de Valme
41014 Sevilla
SpainAktiv, nicht rekrutierend» Google-MapsInselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie
Bern
SwitzerlandAktiv, nicht rekrutierend» Google-MapsUniversitaetsspital Zuerich - Klinik fuer Onkologie
Zuerich
SwitzerlandAktiv, nicht rekrutierend» Google-MapsKaohsiung Chang Gung Memorial Hospital
Kaohsiung
TaiwanAktiv, nicht rekrutierend» Google-MapsChina Medical University Hospital
Taichung
TaiwanAktiv, nicht rekrutierend» Google-MapsTaichung Veterans General Hospital
Taichung
TaiwanAktiv, nicht rekrutierend» Google-MapsNational Taiwan University Hospital
Taipei
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
E-Mail: chihyang@ntu.edu.tw» Ansprechpartner anzeigenTaipei Veterans General Hospital
Taipei
TaiwanAktiv, nicht rekrutierend» Google-MapsTri-Service General Hospital
Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
Studien-Informationen
Detailed Description:The study includes 3 cohorts with one primary endpoint (Objective Response Rate). Enrollment
number and completion data is changed by new cohorts.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Signed, written informed consent by subject or legal representative prior to any
trial-specific screening procedure
- Male or female, greater than or equal to (>=) 18 years of age (or having reached the
age of majority according to local laws and regulations
- Measurable disease confirmed by an independent review committee (IRC) in accordance
with RECIST version 1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- A female subject is eligible to participate if she is not pregnant, not breastfeeding,
and at least one of the following conditions applies:
- Not a woman of childbearing potential OR
- A woman of childbearing potential who agrees to use a highly effective contraception
- A male subject must agree to use and to have their female partners of childbearing
potential to use a highly effective contraception
- Histologically or cytologically confirmed advanced (locally advanced or metastatic)
NSCLC (all types including squamous and sarcomatoid)
- Treatment naïve patients in first-line or pretreated patients with no more than 2
lines of prior therapy
- Subjects with MET alterations, namely METex14 skipping alterations in plasma and/or
tissue as determined by the central laboratory or by an assay with appropriate
regulatory status
Exclusion Criteria:
- Subjects with characterized Epidermal Growth Factor Receptor (EGFR) activating
mutations that predict sensitivity to anti-EGFR-therapy
- Subjects with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that
predict sensitivity to anti-ALK therapy
- Subjects with symptomatic brain metastases who are neurologically unstable
- Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy
- Need for transfusion within 14 days prior to the first dose of trial treatment
- Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for
anti-cancer purposes, targeted therapy, or other investigational anticancer therapy
(not including palliative radiotherapy at focal sites) within 21 days prior to the
first dose of trial treatment;
- Subjects who have brain metastasis as the only measurable lesion
- Inadequate hematological, liver, renal, cardiac function
- Prior treatment with other agents targeting the Hepatocyte Growth Factor c(HGF/c) -Met
pathway
- Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 mmHg)
- Past or current history of neoplasm other than Non-small Cell Lung Cancer (NSCLC),
except for curatively treated non-melanoma skin cancer, in situ carcinoma of the
cervix, or other cancer curatively treated and with no evidence of disease for at
least 5 years
- Medical history of difficulty swallowing, malabsorption, or other chronic
gastrointestinal disease, or conditions that may hamper compliance and/or absorption
of the test product
- Major surgery within 28 days prior to Day 1 of trial treatment
- Known infection with human immunodeficiency virus, or an active infection with
hepatitis B or hepatitis C virus
- Substance abuse, active infection, or other acute or chronic medical or psychiatric
condition or laboratory abnormalities that might increase the risk associated with
trial participation at the discretion of Investigators
- Known hypersensitivity to any of the trial treatment ingredients
- Legal incapacity or limited legal capacity
- Any other reason that, in the opinion of the Principal Investigator, precludes the
subject from participating in the trial
- Participation in another clinical trial within the past 30 days
Studien-Rationale
Primary outcome:1. Objective response as assessed by independent review committee (Time Frame - Baseline up to 20 months):
Objective response will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and as adjudicated by an Independent review committee. Objective response is defined as either a confirmed complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Secondary outcome:
1. Objective response assessed as per Investigator (Time Frame - Baseline up to 20 months):
Objective response will be determined according to RECIST 1.1 and as per investigator's discretion. Objective response is defined as either a confirmed complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
2. Duration of response as assessed by independent review committee (Time Frame - Baseline until PD/ death within 84 days of last tumor assessment; assessed up to 20 months):
Duration of response according to RECIST 1.1 and as adjudicated by an Independent review committee is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
3. Duration of response as assessed by investigator (Time Frame - Baseline until PD/ death within 84 days of last tumor assessment; assessed up to 20 months):
Duration of response according to RECIST 1.1 and as per investigator's discretion is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
4. Objective disease control as assessed by independent review committee (Time Frame - Baseline up to 20 months):
Objective disease control will be determined according to RECIST 1.1 and as adjudicated by an Independent review committee. Objective disease control is defined as either a confirmed CR or PR, or stable disease (SD) lasting at least 12 weeks (84 days) as assessed by independent review committee. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
5. Objective disease control as assessed by investigator (Time Frame - Baseline up to 20 months):
Objective disease control will be determined according to RECIST 1.1 and as per investigator's discretion. Objective disease control is defined as either a confirmed CR or PR, or stable disease (SD) lasting at least 12 weeks (84 days) as assessed by investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
6. Progression free survival as assessed by independent review committee (Time Frame - Baseline until PD or death within 84 days of last tumor assessment; assessed up to 20 months):
Progression free survival as assessed by independent review committee is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD (based on independent review) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
7. Progression free survival as assessed by investigator (Time Frame - Baseline until PD or death within 84 days of last tumor assessment; assessed up to 20 months):
Progression free survival as assessed by investigator is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD (as assessed by investigator) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
8. Overall survival (Time Frame - Baseline until death, assessed up to 20 months):
Overall survival is defined as the time (in months) from first trial treatment administration to the date of death.
9. Occurrence of Treatment emergent adverse event (TEAEs) and deaths (Time Frame - From the first dose of study drug administration until 33 days after the last dose of study drug administration, assessed up to 20 Months):
This outcome measure will be presented as the percentage of subjects with any (serious) adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.
10. Percentage of subjects with of markedly abnormal clinical laboratory tests, vital signs, Electrocardiogram (ECG) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (Time Frame - Baseline up to 20 months):
This outcome measure will be presented as the percentage of subjects with markedly abnormal vital sign measurements. Percentages are calculated using total number of subjects per treatment cohort as the denominator. Abnormalities in clinical laboratory tests will be measured as hematology and coagulation, biochemistry and urinalysis. Abnormalities in Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, body temperature as a part of vital signs; electrocardiogram (ECG) wave, body weight, and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), and clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis) will be assessed.
11. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (Time Frame - Baseline up to 20 months)
12. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) (Time Frame - Baseline up to 20 months)
13. EuroQol Five Dimension Five Level Scale (EQ5D5L) (Time Frame - Baseline up to 20 months)
14. Plasma concentrations of the drug (Time Frame - pre-dose, at 1.5 hours post-dose and at 4 hours post-dose on Cycle 1, Day 1 and on Cycle 2, Day 1)
15. Number of subjects with markedly abnormal clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis). (Time Frame - Baseline up to 20 months)
Geprüfte Regime
- Tepotinib:
Subjects will receive 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Quelle: ClinicalTrials.gov