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JOURNAL ONKOLOGIE – STUDIE
ZEAL-1L

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT04475939

Studienbeginn:
Oktober 2020

Letztes Update:
02.06.2021

Wirkstoff:
Niraparib, Pembrolizumab, Placebo

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
GlaxoSmithKline

Collaborator:
-

Studienleiter

GSK Clinical Trials
Study Director
GlaxoSmithKline

Kontakt

EU GSK Clinical Trials Call Center
Kontakt:
Phone: +44 (0) 20 89904466
E-Mail: GSKClinicalSupportHD@gsk.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 102)

GSK Investigational Site
69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
70376 Stuttgart
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
82131 Gauting
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
80336 Muenchen
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
60488 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
30459 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
53113 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
06120 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
22927 Grosshansdorf
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
07747 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
80128 Lone Tree
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
06360 Norwich
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
30322 Atlanta
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
60714 Niles
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
60077 Skokie
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
01655 Worcester
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
28204 Charlotte
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
97401 Eugene
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
29607 Greenville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
37203 Nashville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
75075-7787 Plano
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
78217 San Antonio
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
75090 Sherman
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
77479 Sugar Land
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
76712 Waco
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
22036 Fairfax
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
C1012AAR Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
1602 Florida
ArgentinaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
R8324CVE Cipoletti
ArgentinaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
S2000DSV Rosario
ArgentinaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
S2000KZE Rosario
ArgentinaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
2148 Blacktown
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
7000 Hobart
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
3350 Ballarat
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
3084 Heidelberg
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
29308-014 Cachoeiro Do Itapemirim
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
30110-022 Belo Horizonte
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
80530-010 Curitiba
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
90610-000 Porto Alegre
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
94010 Créteil cedex
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
38043 Grenoble cedex 9
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
59037 Lille cedex
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
44093 Nantes cedex 1
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
75014 Paris
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
75018 Paris
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
35033 Rennes Cedex 9
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
83100 Avellino
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
80131 Napoli
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
00168 Roma
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
20122 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
20133 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
10043 Orbassano (TO)
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
70124 Bari
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
50134 Firenze
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
56124 Pisa
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
37045 Legnago (VR)
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
3813 TZ Amersfoort
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
1066 CX Amsterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
7512 KZ Enschede
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
3543 AZ Utrecht
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
8025 AB Zwolle
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
1470 Lørenskog
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Studien-Informationen

Brief Summary:

This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus

pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with

advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease

(SD), partial response (PR), or complete response (CR) following completion of standard of

care first-line platinum-based induction chemotherapy with pembrolizumab. The primary

hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib

plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free

survival (PFS) and Overall survival (OS).

Ein-/Ausschlusskriterien

Inclusion criteria:

- Participant must be >=18 years of age.

- Has a histologically or cytologically confirmed diagnosis of NSCLC without known

targetable driver alteration (either non-squamous or squamous histology; mixed

histology is allowed).

- Has advanced (Stage IIIB not amenable to definitive chemoradiotherapy or Stage IIIC)

or metastatic (Stage IV) NSCLC.

- Has completed at least 4 but no more than 6 cycles of standard of care first-line

platinum-based induction chemotherapy with pembrolizumab.

- Has SD, PR, or CR of the NSCLC per Investigator's assessment after completion of 4 to

6 cycles of standard of care first-line platinum-based induction chemotherapy with

pembrolizumab.

- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Has a life expectancy of at least 12 weeks.

- Has adequate organ and bone marrow function.

- Must submit tumor specimens.

- Must be able to swallow and retain orally administered study treatment.

- A female is eligible to participate if she is not pregnant or breastfeeding, and must

follow contraceptive guidance during the treatment period and 180 days afterwards.

- A male is eligible to participate if he agrees to contraceptive guidance and refrains

from sperm donation during the intervention period and for at least 180 days after the

last dose of study treatment.

- Is able to understand the study procedures and agrees to participate in the study by

providing written informed consent. Participants must be informed that their

participation is voluntary. Participants will be required to sign a statement of

informed consent to participate in the study.

Exclusion criteria:

- Has mixed small cell lung cancer or sarcomatoid variant NSCLC.

- Has received prior Poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor(s)

in prior lines of treatment.

- Has systolic blood pressure (BP) >140 millimeters of mercury (mmHg) or diastolic BP

>90 mmHg.

- Has any clinically significant gastrointestinal abnormalities that may alter

absorption such as malabsorption syndrome or major resection of the stomach and/or

bowels.

- Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or

radiographic signs of CNS hemorrhage.

- Has received colony-stimulating factors (granulocyte macrophage colony-stimulating

factor or recombinant erythropoietin) within 4 weeks prior to the first dose of study

treatment.

- Has an active or previously documented autoimmune or inflammatory disorder.

- Is receiving chronic systemic steroids (prednisone >20 mg per day) other than

intermittent use of bronchodilators, inhaled steroids, or local steroid.

- Has other active concomitant malignancy that warrants systemic, biologic, or hormonal

therapy.

- Is pregnant, breastfeeding, or expecting to conceive children while receiving study

treatment and/or for up to 180 days after the last dose of study treatment.

- Has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).

- Has a known history of active tuberculosis.

- Has current active pneumonitis within 90 days of planned start of the study or a known

history of interstitial lung disease, drug-related pneumonitis, or radiation

pneumonitis requiring steroid treatment.

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 (Time Frame - Up to approximately 3 years):
PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR or death from any cause in the absence of progression, whichever occurs first.

2. Overall survival (OS) (Time Frame - Up to approximately 5 years):
OS is defined as the time from randomization to the date of death due to any cause.

Secondary outcome:

1. Time to progression (TTP) (Time Frame - Up to approximately 3 years):
TTP in the Central nervous system (CNS) is defined as the time from the date of randomization until the earliest date of documented PD in the CNS, based on BICR assessment using response assessment in neuro-oncology brain metastases (RANO-BM) criteria.

2. PFS by investigator assessment (Time Frame - Up to approximately 3 years):
PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by the Investigator using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first.

3. PFS by programmed cell death-ligand 1 (PD-L1) status (Time Frame - Up to approximately 3 years):
PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PFS will be assessed by PD-L1 status (PD-L1 tumor cells [TCs] less than [<]1% versus more than or equal to [>=]1%).

4. OS by PD-L1 status (Time Frame - Up to approximately 5 years):
OS is defined as the time from randomization to the date of death due to any cause. OS will be assessed by PD-L1 status (PD-L1-TCs <1% versus >=1%).

5. Time to Deterioration (TTD) in Lung Symptoms (Time Frame - Up to approximately 3 years):
TTD is defined as the time from randomization to meaningful deterioration as measured by (EORTC QLQ-LC13) questionnaire.

6. Change from Baseline in Health-related quality of life (HRQoL) and symptoms by EORTC 30-item Core module (EORTC QLQ-C30) (Scores on a scale) (Time Frame - Baseline, Day 1 in Cycles 1, 2, 3, 4, 5 (Each cycle is of 21 Days); thereafter every 2 cycles until 90 days after last treatment dose (up to approximately 3 years)):
EORTC QLQ-C30 is a validated questionnaire to assess overall health-related quality of life in participants with cancer.

7. Change from Baseline in HRQoL and symptoms by EORTC QLQ-LC13 (Scores on a scale) (Time Frame - Baseline, Day 1 in Cycles 1, 2, 3, 4, 5 (Each cycle is of 21 Days); thereafter every 2 cycles until 90 days after last treatment dose (up to approximately 3 years)):
The EORTC QLQ-LC13 is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer participants.

8. Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) (Time Frame - Up to approximately 3 years):
AEs, SAEs and AESIs will be collected.

9. Plasma concentrations of niraparib (Time Frame - Up to approximately 3 years):
Blood samples will be collected to assess the plasma concentrations of niraparib.

Studien-Arme

  • Experimental: Participants receiving niraparib plus pembrolizumab
    Eligible participants will receive niraparib along with pembrolizumab.
  • Placebo Comparator: Participants receiving placebo plus pembrolizumab
    Eligible participants will receive matching placebo along with pembrolizumab.

Geprüfte Regime

  • Niraparib:
    Niraparib will be administered
  • Pembrolizumab:
    Pembrolizumab will be administered
  • Placebo:
    Matching placebo will be administered

Quelle: ClinicalTrials.gov


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