- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04475939
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer (ZEAL-1L)
February 2, 2024 updated by: GlaxoSmithKline
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)
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).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
666
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, C1426AGE
- GSK Investigational Site
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Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
- GSK Investigational Site
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Cordoba, Argentina, X5004FHP
- GSK Investigational Site
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
- GSK Investigational Site
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1125ABD
- GSK Investigational Site
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Florida, Buenos Aires, Argentina, 1602
- GSK Investigational Site
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La Plata, Buenos Aires, Argentina, 1900
- GSK Investigational Site
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Río Negro
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Cipoletti, Río Negro, Argentina, R8324CVE
- GSK Investigational Site
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DSV
- GSK Investigational Site
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- GSK Investigational Site
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Tasmania
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Hobart, Tasmania, Australia, 7000
- GSK Investigational Site
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Victoria
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Ballarat, Victoria, Australia, 3350
- GSK Investigational Site
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Heidelberg, Victoria, Australia, 3084
- GSK Investigational Site
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Brussels, Belgium, 1200
- GSK Investigational Site
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Edegem, Belgium, 2650
- GSK Investigational Site
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Leuven, Belgium, 3000
- GSK Investigational Site
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Roeselaere, Belgium, 8800
- GSK Investigational Site
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Rio de Janeiro, Brazil, 22250-905
- GSK Investigational Site
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São Paulo, Brazil, 01308-901
- GSK Investigational Site
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São Paulo, Brazil, 01509-010
- GSK Investigational Site
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Espírito Santo
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Cachoeiro Do Itapemirim, Espírito Santo, Brazil, 29308-014
- GSK Investigational Site
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30110-022
- GSK Investigational Site
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Uberlândia, Minas Gerais, Brazil, 38408-150
- GSK Investigational Site
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Paraná
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Curitiba, Paraná, Brazil, 80040-170
- GSK Investigational Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
- GSK Investigational Site
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Panagyurishte, Bulgaria, 4500
- GSK Investigational Site
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Pleven, Bulgaria, 5800
- GSK Investigational Site
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Plovdiv, Bulgaria, 4004
- GSK Investigational Site
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Ruse, Bulgaria, 7002
- GSK Investigational Site
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Sofia, Bulgaria, 1632
- GSK Investigational Site
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Región De La Araucania
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Temuco, Región De La Araucania, Chile, 5360000
- GSK Investigational Site
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Región Metro De Santiago
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Providencia, Región Metro De Santiago, Chile, 7500653
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 7500921
- GSK Investigational Site
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Bogota, Colombia, 5600520
- GSK Investigational Site
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Monteria, Colombia, 230018
- GSK Investigational Site
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Brest cedex, France, 29609
- GSK Investigational Site
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Créteil cedex, France, 94010
- GSK Investigational Site
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Grenoble cedex 9, France, 38043
- GSK Investigational Site
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Lille cedex, France, 59037
- GSK Investigational Site
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Nantes cedex 1, France, 44093
- GSK Investigational Site
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Paris, France, 75018
- GSK Investigational Site
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Paris, France, 75014
- GSK Investigational Site
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Rennes Cedex 9, France, 35033
- GSK Investigational Site
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Strasbourg, France, 67200
- GSK Investigational Site
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Toulon cedex, France, 83056
- GSK Investigational Site
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Toulouse cedex 9, France, 31059
- GSK Investigational Site
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Berlin, Germany, 13125
- GSK Investigational Site
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Hamburg, Germany, 20251
- GSK Investigational Site
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Baden-Wuerttemberg
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Heidelberg, Baden-Wuerttemberg, Germany, 69126
- GSK Investigational Site
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Stuttgart, Baden-Wuerttemberg, Germany, 70376
- GSK Investigational Site
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Bayern
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Gauting, Bayern, Germany, 82131
- GSK Investigational Site
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Muenchen, Bayern, Germany, 80336
- GSK Investigational Site
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Muenchen, Bayern, Germany, 81925
- GSK Investigational Site
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Hessen
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Frankfurt, Hessen, Germany, 60488
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Germany, 30459
- GSK Investigational Site
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Nordrhein-Westfalen
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Bonn, Nordrhein-Westfalen, Germany, 53113
- GSK Investigational Site
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Essen, Nordrhein-Westfalen, Germany, 45147
- GSK Investigational Site
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Hemer, Nordrhein-Westfalen, Germany, 58675
- GSK Investigational Site
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Velbert, Nordrhein-Westfalen, Germany, 42551
- GSK Investigational Site
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Sachsen-Anhalt
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Halle, Sachsen-Anhalt, Germany, 06120
- GSK Investigational Site
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Schleswig-Holstein
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Grosshansdorf, Schleswig-Holstein, Germany, 22927
- GSK Investigational Site
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Thueringen
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Jena, Thueringen, Germany, 07747
- GSK Investigational Site
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Athens, Greece, 115 27
- GSK Investigational Site
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Athens, Greece, 11528
- GSK Investigational Site
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Athens, Greece, 185 37
- GSK Investigational Site
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Athens, Greece, 12462
- GSK Investigational Site
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Athens, Greece, 11526
- GSK Investigational Site
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Athens, Greece, 15562
- GSK Investigational Site
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Heraklion,Crete, Greece, 71110
- GSK Investigational Site
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Larisa, Greece, 41110
- GSK Investigational Site
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Maroussi, Greece, 15125
- GSK Investigational Site
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N. Faliro, Greece, 185 47
- GSK Investigational Site
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Patra, Greece, 26500
- GSK Investigational Site
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Rio/Patras, Greece, 26500
- GSK Investigational Site
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Thessaloniki, Greece, 57010
- GSK Investigational Site
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Thessaloniki, Greece, 57001
- GSK Investigational Site
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Thessaloniki, Greece, 54007
- GSK Investigational Site
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Thessaloniki, Greece, 54645
- GSK Investigational Site
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Thessaloniki, Greece, 54622
- GSK Investigational Site
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Budapest, Hungary, 1083
- GSK Investigational Site
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Budapest, Hungary, H-1122
- GSK Investigational Site
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Gyöngyös, Hungary, 3200
- GSK Investigational Site
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Tatabánya, Hungary, 2800
- GSK Investigational Site
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Törökbálint, Hungary, 2045
- GSK Investigational Site
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Zalaegerszeg, Hungary, 8900
- GSK Investigational Site
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Cork, Ireland, T12 DFK4
- GSK Investigational Site
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Dublin, Ireland, 8
- GSK Investigational Site
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Campania
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Avellino, Campania, Italy, 83100
- GSK Investigational Site
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Napoli, Campania, Italy, 80131
- GSK Investigational Site
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Friuli-Venezia-Giulia
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Aviano, Friuli-Venezia-Giulia, Italy, 33081
- GSK Investigational Site
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Lazio
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Roma, Lazio, Italy, 00168
- GSK Investigational Site
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Lombardia
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Milano, Lombardia, Italy, 20132
- GSK Investigational Site
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Milano, Lombardia, Italy, 20122
- GSK Investigational Site
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Milano, Lombardia, Italy, 20133
- GSK Investigational Site
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Monza, Lombardia, Italy, 20900
- GSK Investigational Site
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Piemonte
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Orbassano (TO), Piemonte, Italy, 10043
- GSK Investigational Site
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Puglia
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Bari, Puglia, Italy, 70124
- GSK Investigational Site
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Sicilia
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Catania, Sicilia, Italy, 95123
- GSK Investigational Site
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Toscana
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Firenze, Toscana, Italy, 50134
- GSK Investigational Site
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Pisa, Toscana, Italy, 56124
- GSK Investigational Site
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Veneto
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Legnago (VR), Veneto, Italy, 37045
- GSK Investigational Site
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Gyeonggi-do, Korea, Republic of, 463-712
- GSK Investigational Site
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- GSK Investigational Site
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Seoul, Korea, Republic of, 05505
- GSK Investigational Site
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Seoul, Korea, Republic of, ?08308
- GSK Investigational Site
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Suwon-Si, Korea, Republic of, 443-721
- GSK Investigational Site
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Mexico City, Mexico, CP 14080
- GSK Investigational Site
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Puebla, Mexico, 72560
- GSK Investigational Site
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Ciudad De Mexico
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Mexico, Ciudad De Mexico, Mexico, 03100
- GSK Investigational Site
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Mexico City, Ciudad De Mexico, Mexico, 06700
- GSK Investigational Site
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- GSK Investigational Site
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Amersfoort, Netherlands, 3813 TZ
- GSK Investigational Site
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Amsterdam, Netherlands, 1066 CX
- GSK Investigational Site
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Den Bosch, Netherlands, 5223 GZ
- GSK Investigational Site
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Enschede, Netherlands, 7512 KZ
- GSK Investigational Site
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Maastricht, Netherlands, 6229 HX
- GSK Investigational Site
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Utrecht, Netherlands, 3543 AZ
- GSK Investigational Site
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Zwolle, Netherlands, 8025 AB
- GSK Investigational Site
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Drammen, Norway, N-3004
- GSK Investigational Site
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Lørenskog, Norway, 1470
- GSK Investigational Site
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Oslo, Norway, N-0450
- GSK Investigational Site
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Lima, Peru, Lima 34
- GSK Investigational Site
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Bialystok, Poland, 15-540
- GSK Investigational Site
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Lodz, Poland, 90-338
- GSK Investigational Site
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Olsztyn, Poland, 10-357
- GSK Investigational Site
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Bucharest, Romania, 011654
- GSK Investigational Site
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Bucuresti, Romania, 022328
- GSK Investigational Site
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Cluj-Napoca, Romania, 400015
- GSK Investigational Site
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Craiova, Romania, 200542
- GSK Investigational Site
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Iasi, Romania, 700483
- GSK Investigational Site
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Satu Mare, Romania, 440055
- GSK Investigational Site
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Timisoara, Romania, 300239
- GSK Investigational Site
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Moscow, Russian Federation, 105 229
- GSK Investigational Site
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Moscow, Russian Federation, 121309
- GSK Investigational Site
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Nizhniy Novgorod, Russian Federation, 603081
- GSK Investigational Site
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Omsk, Russian Federation, 644013
- GSK Investigational Site
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Saint-Petersburg, Russian Federation, 197022
- GSK Investigational Site
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St. Petersburg, Russian Federation, 197758
- GSK Investigational Site
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Barcelona, Spain, 08025
- GSK Investigational Site
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Barcelona, Spain, 08036
- GSK Investigational Site
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Barcelona, Spain, 08035
- GSK Investigational Site
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Cordoba, Spain, 140044
- GSK Investigational Site
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Girona, Spain, 17007
- GSK Investigational Site
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La Coruña, Spain, 15006
- GSK Investigational Site
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Las Palmas De Gran Canaria, Spain, 35016
- GSK Investigational Site
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Madrid, Spain, 28041
- GSK Investigational Site
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Madrid, Spain, 28009
- GSK Investigational Site
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Madrid, Spain, 28046
- GSK Investigational Site
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Madrid, Spain, 28027
- GSK Investigational Site
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Madrid, Spain, 28050
- GSK Investigational Site
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Majadahonda (Madrid), Spain, 28222
- GSK Investigational Site
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Málaga, Spain, 29010
- GSK Investigational Site
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Pamplona, Spain, 31008
- GSK Investigational Site
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Santander, Spain, 39008
- GSK Investigational Site
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Zaragoza, Spain, 50009
- GSK Investigational Site
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Gävle, Sweden, SE-801 87
- GSK Investigational Site
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Stockholm, Sweden, SE-171 76
- GSK Investigational Site
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Uppsala, Sweden, SE-751 85
- GSK Investigational Site
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Lausanne, Switzerland, 1011
- GSK Investigational Site
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Ankara, Turkey, 06100
- GSK Investigational Site
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Ankara, Turkey, 06010
- GSK Investigational Site
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Ankara, Turkey, 06520
- GSK Investigational Site
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Edirne, Turkey, 22030
- GSK Investigational Site
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Istanbul, Turkey, 34662
- GSK Investigational Site
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Bournemouth, United Kingdom, BH7 7DW
- GSK Investigational Site
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Dundee, United Kingdom, DD1 9SY
- GSK Investigational Site
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Oxford, United Kingdom, OX3 7LJ
- GSK Investigational Site
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Wrexham, United Kingdom, LL13 7TD
- GSK Investigational Site
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Middlesex
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Northwood, Middlesex, United Kingdom, HA6 2RN
- GSK Investigational Site
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California
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Fullerton, California, United States, 92835
- GSK Investigational Site
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Los Angeles, California, United States, 90017
- GSK Investigational Site
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Colorado
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Lone Tree, Colorado, United States, 80128
- GSK Investigational Site
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Connecticut
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Norwich, Connecticut, United States, 06360
- GSK Investigational Site
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Florida
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Fleming Island, Florida, United States, 32003
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30322
- GSK Investigational Site
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Newnan, Georgia, United States, 30265
- GSK Investigational Site
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Illinois
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Niles, Illinois, United States, 60714
- GSK Investigational Site
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Iowa
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Iowa City, Iowa, United States, 52242
- GSK Investigational Site
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- GSK Investigational Site
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New York
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New York, New York, United States, 10016
- GSK Investigational Site
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New York, New York, United States, 10016-4744
- GSK Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28207
- GSK Investigational Site
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- GSK Investigational Site
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South Carolina
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Greenville, South Carolina, United States, 29607
- GSK Investigational Site
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- GSK Investigational Site
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Nashville, Tennessee, United States, 37203
- GSK Investigational Site
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Texas
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Dallas, Texas, United States, 75246
- GSK Investigational Site
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San Antonio, Texas, United States, 78217
- GSK Investigational Site
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Sugar Land, Texas, United States, 77479
- GSK Investigational Site
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Waco, Texas, United States, 76712
- GSK Investigational Site
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Virginia
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Fairfax, Virginia, United States, 22030
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 for which an approved targeted therapy is available in the 1L induction/maintenance therapy setting).
- Has advanced (Stage IIIB or Stage IIIC, not amenable to definitive chemoradiotherapy) or metastatic (Stage IV) 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 90 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Participants receiving niraparib plus pembrolizumab
Eligible participants will receive niraparib along with pembrolizumab.
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Niraparib will be administered
Pembrolizumab will be administered
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Placebo Comparator: Participants receiving placebo plus pembrolizumab
Eligible participants will receive matching placebo along with pembrolizumab.
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Pembrolizumab will be administered
Matching placebo will be administered
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 in overall population
Time Frame: Up to approximately 3 years
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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.
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Up to approximately 3 years
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Overall survival (OS) in overall population
Time Frame: Up to approximately 5 years
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OS is defined as the time from randomization to the date of death due to any cause.
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Up to approximately 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to progression (TTP)
Time Frame: Up to approximately 3 years
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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.
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Up to approximately 3 years
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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)
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The EORTC QLQ-LC13 is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer participants.
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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)
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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
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AEs, SAEs and AESIs will be collected.
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Up to approximately 3 years
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Plasma concentrations of niraparib
Time Frame: Up to approximately 3 years
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Blood samples will be collected to assess the plasma concentrations of niraparib.
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Up to approximately 3 years
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PFS assessed by BICR using RECIST v 1.1 in non-squamous histology (NSQ) population
Time Frame: Up to approximately 3 years
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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
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Up to approximately 3 years
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PFS assessed by BICR using RECIST v 1.1 in complete and partial response (CR/PR) population
Time Frame: Up to approximately 3 years
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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
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Up to approximately 3 years
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OS in NSQ population
Time Frame: Up to approximately 5 years
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OS is defined as the time from randomization to the date of death due to any cause.
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Up to approximately 5 years
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OS in CR/PR population
Time Frame: Up to approximately 5 years
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OS is defined as the time from randomization to the date of death due to any cause
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Up to approximately 5 years
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PFS by investigator assessment using RECIST v1.1
Time Frame: Up to approximately 3 years
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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.
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Up to approximately 3 years
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CNS PFS as assessed by BICR using RANO-BM
Time Frame: Up to approximately 3 years
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PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR using RANO-BM criteria.
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Up to approximately 3 years
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PFS as assessed by BICR using RECIST v1.1 by programmed cell death-ligand 1 (PD-L1) status
Time Frame: Up to approximately 3 years
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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% and not evaluable (NE) versus more than or equal to [>=]1%).
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Up to approximately 3 years
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OS by PD-L1 status
Time Frame: Up to approximately 5 years
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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% and NE versus >=1%).
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Up to approximately 5 years
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Time to Deterioration (TTD) in Lung Symptoms
Time Frame: Up to approximately 3 years
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TTD is defined as the time from randomization to meaningful deterioration as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13-item lung cancer-specific module (EORTC QLQ-LC13) questionnaire.
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Up to approximately 3 years
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Change from Baseline in Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-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)
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EORTC QLQ-C30 is a validated questionnaire to assess overall health-related quality of life in participants with cancer.
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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 26, 2020
Primary Completion (Estimated)
December 20, 2024
Study Completion (Estimated)
February 19, 2025
Study Registration Dates
First Submitted
July 14, 2020
First Submitted That Met QC Criteria
July 14, 2020
First Posted (Actual)
July 17, 2020
Study Record Updates
Last Update Posted (Actual)
February 5, 2024
Last Update Submitted That Met QC Criteria
February 2, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Poly(ADP-ribose) Polymerase Inhibitors
- Immune Checkpoint Inhibitors
- Pembrolizumab
- Niraparib
Other Study ID Numbers
- 213400
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal.
Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD Sharing Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD Sharing Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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