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

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

NCT ID: NCT04475939

Condition: Lung Cancer, Non-Small Cell

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Niraparib

Conditions: Keywords:
Niraparib
Pembrolizumab
Maintenance therapy
Chemotherapy
Platinum-based

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Multicenter, randomized, double-blind, placebo-controlled study.

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Masking description: The participant, Investigator, study staff, and the Sponsor study team will be blinded.

Intervention:

Intervention type: Drug
Intervention name: Niraparib
Description: Niraparib will be administered
Arm group label: Participants receiving niraparib plus pembrolizumab

Intervention type: Drug
Intervention name: Pembrolizumab
Description: Pembrolizumab will be administered
Arm group label: Participants receiving niraparib plus pembrolizumab
Arm group label: Participants receiving placebo plus pembrolizumab

Intervention type: Drug
Intervention name: Placebo
Description: Matching placebo will be administered
Arm group label: Participants receiving placebo plus pembrolizumab

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).

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: GSK Investigational Site

Address:
City: Fullerton
Zip: 92835
Country: United States

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Address:
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Address:
City: Lone Tree
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City: Norwich
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City: Fleming Island
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City: Newnan
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City: Niles
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City: Iowa City
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City: Worcester
Zip: 01655
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Address:
City: New York
Zip: 10016-4744
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Address:
City: New York
Zip: 10016
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Facility:
Name: GSK Investigational Site

Address:
City: Charlotte
Zip: 28207
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Pittsburgh
Zip: 15212
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Facility:
Name: GSK Investigational Site

Address:
City: Greenville
Zip: 29607
Country: United States

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Address:
City: Chattanooga
Zip: 37404
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Name: GSK Investigational Site

Address:
City: Nashville
Zip: 37203
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Facility:
Name: GSK Investigational Site

Address:
City: Dallas
Zip: 75246
Country: United States

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Address:
City: San Antonio
Zip: 78217
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Address:
City: Sugar Land
Zip: 77479
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Facility:
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Address:
City: Waco
Zip: 76712
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Facility:
Name: GSK Investigational Site

Address:
City: Fairfax
Zip: 22030
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Facility:
Name: GSK Investigational Site

Address:
City: Ciudad Autonoma de Buenos Aires
Zip: C1012AAR
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Ciudad Autónoma de Buenos Aires
Zip: C1125ABD
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Florida
Zip: 1602
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: La Plata
Zip: 1900
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Name: GSK Investigational Site

Address:
City: Cipoletti
Zip: R8324CVE
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Rosario
Zip: S2000DSV
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Buenos Aires
Zip: C1426AGE
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Ciudad Autónoma de Buenos Aires
Zip: C1426ABP
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Cordoba
Zip: X5004FHP
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Blacktown
Zip: 2148
Country: Australia

Facility:
Name: GSK Investigational Site

Address:
City: Hobart
Zip: 7000
Country: Australia

Facility:
Name: GSK Investigational Site

Address:
City: Ballarat
Zip: 3350
Country: Australia

Facility:
Name: GSK Investigational Site

Address:
City: Heidelberg
Zip: 3084
Country: Australia

Facility:
Name: GSK Investigational Site

Address:
City: Brussels
Zip: 1200
Country: Belgium

Facility:
Name: GSK Investigational Site

Address:
City: Edegem
Zip: 2650
Country: Belgium

Facility:
Name: GSK Investigational Site

Address:
City: Leuven
Zip: 3000
Country: Belgium

Facility:
Name: GSK Investigational Site

Address:
City: Roeselaere
Zip: 8800
Country: Belgium

Facility:
Name: GSK Investigational Site

Address:
City: Cachoeiro Do Itapemirim
Zip: 29308-014
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Belo Horizonte
Zip: 30110-022
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Uberlândia
Zip: 38408-150
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Curitiba
Zip: 80040-170
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Porto Alegre
Zip: 90610-000
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Rio de Janeiro
Zip: 22250-905
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: São Paulo
Zip: 01308-901
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: São Paulo
Zip: 01509-010
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Panagyurishte
Zip: 4500
Country: Bulgaria

Facility:
Name: GSK Investigational Site

Address:
City: Pleven
Zip: 5800
Country: Bulgaria

Facility:
Name: GSK Investigational Site

Address:
City: Plovdiv
Zip: 4004
Country: Bulgaria

Facility:
Name: GSK Investigational Site

Address:
City: Ruse
Zip: 7002
Country: Bulgaria

Facility:
Name: GSK Investigational Site

Address:
City: Sofia
Zip: 1632
Country: Bulgaria

Facility:
Name: GSK Investigational Site

Address:
City: Temuco
Zip: 5360000
Country: Chile

Facility:
Name: GSK Investigational Site

Address:
City: Providencia
Zip: 7500653
Country: Chile

Facility:
Name: GSK Investigational Site

Address:
City: Santiago
Zip: 7500921
Country: Chile

Facility:
Name: GSK Investigational Site

Address:
City: Bogota
Zip: 5600520
Country: Colombia

Facility:
Name: GSK Investigational Site

Address:
City: Monteria
Zip: 230018
Country: Colombia

Facility:
Name: GSK Investigational Site

Address:
City: Brest cedex
Zip: 29609
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Créteil cedex
Zip: 94010
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Grenoble cedex 9
Zip: 38043
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Lille cedex
Zip: 59037
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Nantes cedex 1
Zip: 44093
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Paris
Zip: 75014
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Paris
Zip: 75018
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Rennes Cedex 9
Zip: 35033
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Strasbourg
Zip: 67200
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Toulon cedex
Zip: 83056
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Toulouse cedex 9
Zip: 31059
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Heidelberg
Zip: 69126
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Stuttgart
Zip: 70376
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Gauting
Zip: 82131
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Muenchen
Zip: 80336
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Muenchen
Zip: 81925
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Frankfurt
Zip: 60488
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Hannover
Zip: 30459
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Bonn
Zip: 53113
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Essen
Zip: 45147
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Hemer
Zip: 58675
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Velbert
Zip: 42551
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Halle
Zip: 06120
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Grosshansdorf
Zip: 22927
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Jena
Zip: 07747
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Berlin
Zip: 13125
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Hamburg
Zip: 20251
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Athens
Zip: 115 27
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Athens
Zip: 11526
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Athens
Zip: 11528
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Athens
Zip: 12462
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Athens
Zip: 15562
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Athens
Zip: 185 37
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Heraklion,Crete
Zip: 71110
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Larisa
Zip: 41110
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Maroussi
Zip: 15125
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: N. Faliro
Zip: 185 47
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Patra
Zip: 26500
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Rio/Patras
Zip: 26500
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Thessaloniki
Zip: 54007
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Thessaloniki
Zip: 54622
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Thessaloniki
Zip: 54645
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Thessaloniki
Zip: 57001
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Thessaloniki
Zip: 57010
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Budapest
Zip: 1083
Country: Hungary

Facility:
Name: GSK Investigational Site

Address:
City: Budapest
Zip: H-1122
Country: Hungary

Facility:
Name: GSK Investigational Site

Address:
City: Gyöngyös
Zip: 3200
Country: Hungary

Facility:
Name: GSK Investigational Site

Address:
City: Tatabánya
Zip: 2800
Country: Hungary

Facility:
Name: GSK Investigational Site

Address:
City: Törökbálint
Zip: 2045
Country: Hungary

Facility:
Name: GSK Investigational Site

Address:
City: Zalaegerszeg
Zip: 8900
Country: Hungary

Facility:
Name: GSK Investigational Site

Address:
City: Cork
Zip: T12 DFK4
Country: Ireland

Facility:
Name: GSK Investigational Site

Address:
City: Dublin
Zip: 8
Country: Ireland

Facility:
Name: GSK Investigational Site

Address:
City: Avellino
Zip: 83100
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Napoli
Zip: 80131
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Aviano
Zip: 33081
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Milano
Zip: 20122
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Milano
Zip: 20132
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Milano
Zip: 20133
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Monza
Zip: 20900
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Orbassano (TO)
Zip: 10043
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Bari
Zip: 70124
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Catania
Zip: 95123
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Firenze
Zip: 50134
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Pisa
Zip: 56124
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Legnago (VR)
Zip: 37045
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Gyeonggi-do
Zip: 463-712
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seongnam-si, Gyeonggi-do
Zip: 13620
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seoul
Zip: ?08308
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Suwon-Si
Zip: 443-721
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Mexico City
Zip: 06700
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Mexico
Zip: 03100
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Monterrey
Zip: 64460
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Mexico City
Zip: CP 14080
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Puebla
Zip: 72560
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Amersfoort
Zip: 3813 TZ
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Amsterdam
Zip: 1066 CX
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Den Bosch
Zip: 5223 GZ
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Enschede
Zip: 7512 KZ
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Maastricht
Zip: 6229 HX
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Utrecht
Zip: 3543 AZ
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Zwolle
Zip: 8025 AB
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Drammen
Zip: N-3004
Country: Norway

Facility:
Name: GSK Investigational Site

Address:
City: Lørenskog
Zip: 1470
Country: Norway

Facility:
Name: GSK Investigational Site

Address:
City: Oslo
Zip: N-0450
Country: Norway

Facility:
Name: GSK Investigational Site

Address:
City: Lima
Zip: Lima 34
Country: Peru

Facility:
Name: GSK Investigational Site

Address:
City: Bialystok
Zip: 15-540
Country: Poland

Facility:
Name: GSK Investigational Site

Address:
City: Lodz
Zip: 90-338
Country: Poland

Facility:
Name: GSK Investigational Site

Address:
City: Olsztyn
Zip: 10-357
Country: Poland

Facility:
Name: GSK Investigational Site

Address:
City: Bucharest
Zip: 011654
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Bucuresti
Zip: 022328
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Cluj-Napoca
Zip: 400015
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Craiova
Zip: 200542
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Iasi
Zip: 700483
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Satu Mare
Zip: 440055
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Timisoara
Zip: 300239
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Moscow
Zip: 105 229
Country: Russian Federation

Facility:
Name: GSK Investigational Site

Address:
City: Moscow
Zip: 121309
Country: Russian Federation

Facility:
Name: GSK Investigational Site

Address:
City: Nizhniy Novgorod
Zip: 603081
Country: Russian Federation

Facility:
Name: GSK Investigational Site

Address:
City: Omsk
Zip: 644013
Country: Russian Federation

Facility:
Name: GSK Investigational Site

Address:
City: Saint-Petersburg
Zip: 197022
Country: Russian Federation

Facility:
Name: GSK Investigational Site

Address:
City: St. Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: GSK Investigational Site

Address:
City: Barcelona
Zip: 08025
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Cordoba
Zip: 140044
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Girona
Zip: 17007
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: La Coruña
Zip: 15006
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Las Palmas De Gran Canaria
Zip: 35016
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28009
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28027
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28050
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Majadahonda (Madrid)
Zip: 28222
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Málaga
Zip: 29010
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Pamplona
Zip: 31008
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Santander
Zip: 39008
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Zaragoza
Zip: 50009
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Gävle
Zip: SE-801 87
Country: Sweden

Facility:
Name: GSK Investigational Site

Address:
City: Stockholm
Zip: SE-171 76
Country: Sweden

Facility:
Name: GSK Investigational Site

Address:
City: Uppsala
Zip: SE-751 85
Country: Sweden

Facility:
Name: GSK Investigational Site

Address:
City: Lausanne
Zip: 1011
Country: Switzerland

Facility:
Name: GSK Investigational Site

Address:
City: Ankara
Zip: 06010
Country: Turkey

Facility:
Name: GSK Investigational Site

Address:
City: Ankara
Zip: 06100
Country: Turkey

Facility:
Name: GSK Investigational Site

Address:
City: Ankara
Zip: 06520
Country: Turkey

Facility:
Name: GSK Investigational Site

Address:
City: Edirne
Zip: 22030
Country: Turkey

Facility:
Name: GSK Investigational Site

Address:
City: Istanbul
Zip: 34662
Country: Turkey

Facility:
Name: GSK Investigational Site

Address:
City: Northwood
Zip: HA6 2RN
Country: United Kingdom

Facility:
Name: GSK Investigational Site

Address:
City: Bournemouth
Zip: BH7 7DW
Country: United Kingdom

Facility:
Name: GSK Investigational Site

Address:
City: Dundee
Zip: DD1 9SY
Country: United Kingdom

Facility:
Name: GSK Investigational Site

Address:
City: Oxford
Zip: OX3 7LJ
Country: United Kingdom

Facility:
Name: GSK Investigational Site

Address:
City: Wrexham
Zip: LL13 7TD
Country: United Kingdom

Start date: October 26, 2020

Completion date: February 19, 2025

Lead sponsor:
Agency: GlaxoSmithKline
Agency class: Industry

Source: GlaxoSmithKline

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04475939