Last updated: 04/03/2026 16:10:33

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants with Advanced/Metastatic Non-Small Cell Lung CancerZEAL-1L

GSK study ID
213400
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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)
Trial description: 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 (SoC 1L) 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Progression-free survival (PFS) assessed by blinded independent central review (BICR) - Complete and Partial Response (CR/PR) Population

Timeframe: Up to 52 months

Secondary outcomes:

Progression-free survival (PFS) assessed by BICR - Intent-to-Treat (ITT) Population

Timeframe: Up to 52 months

Overall Survival (OS) - CR/PR Population

Timeframe: Up to 52 months

Overall Survival (OS) - ITT Population

Timeframe: Up to 52 months

Time to Progression (TTP) in the central nervous system (CNS) assessed by BICR using RANO-BM criteria

Timeframe: At Month 6, 12, 18, 24, 30, 36, 42 and 48

Progression-free survival (PFS) as assessed by the Investigator using RECIST v1.1

Timeframe: Up to 52 months

CNS‑PFS as assessed by BICR using RANO-BM criteria

Timeframe: At Month 6, 12, 18, 24, 30, 36, 42 and 48

Progression-free survival (PFS) by programmed cell death-ligand 1 (PD‑L1) status

Timeframe: Up to 52 months

Overall Survival by programmed cell death-ligand 1 (PD‑L1) status

Timeframe: Up to 52 months

Number of participants with Minimally Clinically Important Difference (MCID) Status in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)

Timeframe: Baseline (Predose); Day (D) 1 of Cycle (C)2, C3, C4, C5–C67 (odd cycles only); End of Treatment (EoT, up to approx 49 months); Safety follow-up (SFU) 1 & 2 (up to approx 50 & 52 months)

Changes from baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13-item lung cancer-specific module (EORTC QLQ-LC13)

Timeframe: Baseline (Predose); Day (D) 1 of Cycle (C)2, C3, C4, C5–C67 (odd cycles only); EoT (up to approx 49 months); Safety follow-up (SFU) 1 & 2 (up to approx 50 & 52 months)

Time to Deterioration (TTD) in EORTC Cancer Quality of Life Questionnaire LC13 (EORTC QLQ-LC13)

Timeframe: Up to 52 months

Number of participants with Treatment emergent (TE) adverse events (AEs), serious TEAEs and Adverse Events of Special Interest (AESIs)

Timeframe: Up to 52 months

Plasma concentrations of niraparib

Timeframe: Cycle 1 Day 1 (pre‑dose, 3 h), Cycle 1 Day 15 (pre‑dose, 3 h), Cycle 2 Day 1 (pre‑dose, 3 h), Cycle 4 Day 1 (pre‑dose), Cycle 7 Day 1 (pre‑dose), and End of Treatment (pre‑dose); up to approximately 49 months

Interventions:
  • Drug: Niraparib
  • Biological/vaccine: Pembrolizumab
  • Drug: Placebo
  • Enrollment:
    666
    Primary completion date:
    2025-26-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Lung Cancer, Non-Small Cell
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    October 2020 to March 2026
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ballarat, VIC, Australia, 3350
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bucuresti, Romania, 011654
    Status
    Study Complete
    Location
    GSK Investigational Site
    Craiova, Romania, 200542
    Status
    Study Complete
    Location
    GSK Investigational Site
    Santander, Spain, 39008
    Status
    Study Complete
    Location
    GSK Investigational Site
    Omsk, Unmapped, 644013
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Germany, 13125
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dundee, Unmapped, DD1 9SY
    Status
    Study Complete
    Location
    GSK Investigational Site
    Drammen, Norway, N-3004
    Status
    Study Complete
    Location
    GSK Investigational Site
    Oslo, Norway, N-0450
    Status
    Study Complete
    Location
    GSK Investigational Site
    Moscow, Unmapped, 121309
    Status
    Study Complete
    Location
    GSK Investigational Site
    Halle, Germany, 06120
    Status
    Unmapped
    Location
    GSK Investigational Site
    Madrid, Spain, 28050
    Status
    Study Complete
    Location
    GSK Investigational Site
    STOCKHOLM, Sweden, SE-171 76
    Status
    Study Complete
    Location
    GSK Investigational Site
    Stuttgart, Germany, 70376
    Status
    Unmapped
    Location
    GSK Investigational Site
    Madrid, Spain, 28046
    Status
    Study Complete
    Location
    GSK Investigational Site
    Verona, Italy, 37045
    Status
    Study Complete
    Location
    GSK Investigational Site
    Avellino, Italy, 83100
    Status
    Study Complete
    Location
    GSK Investigational Site
    PamplonaNavarra, Spain, 31008
    Status
    Study Complete
    Location
    GSK Investigational Site
    Grosshansdorf, Germany, 22927
    Status
    Unmapped
    Location
    GSK Investigational Site
    Milano, Italy, 20133
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28222
    Status
    Study Complete
    Location
    GSK Investigational Site
    Zaragoza, Spain, 50009
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08025
    Status
    Study Complete
    Location
    GSK Investigational Site
    Florida, Argentina, 1602
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hobart, TAS, Australia, 7000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Frankfurt, Germany, 60488
    Status
    Study Complete
    Location
    GSK Investigational Site
    AMERSFOORT, Netherlands, 3813 TZ
    Status
    Unmapped
    Location
    GSK Investigational Site
    Barcelona, Spain, 08035
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gerona, Spain, 17007
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28009
    Status
    Study Complete
    Location
    GSK Investigational Site
    Malaga, Spain, 29010
    Status
    Study Complete
    Location
    GSK Investigational Site
    AMSTERDAM, Netherlands, 1066 CX
    Status
    Unmapped
    Location
    GSK Investigational Site
    Atlanta, GA, Unmapped, 30322
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08036
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cachoeiro do Itapemirim, Brazil, 29308-014
    Status
    Study Complete
    Location
    GSK Investigational Site
    CrEteil cedex, France, 94010
    Status
    Study Complete
    Location
    GSK Investigational Site
    ENSCHEDE, Netherlands, 7512 KZ
    Status
    Unmapped
    Location
    GSK Investigational Site
    Firenze, Italy, 50134
    Status
    Study Complete
    Location
    GSK Investigational Site
    GRENOBLE CEDEX 9, France, 38043
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hannover, Germany, 30459
    Status
    Study Complete
    Location
    GSK Investigational Site
    A CoruNa, Spain, 15006
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lille, France, 59037
    Status
    Study Complete
    Location
    GSK Investigational Site
    Milano, Italy, 20122
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saint-Herblain, France, 44093
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nashville, TN, Unmapped, 37203
    Status
    Study Complete
    Location
    GSK Investigational Site
    Middlesex, Unmapped, HA6 2RN
    Status
    Study Complete
    Location
    GSK Investigational Site
    San Antonio, TX, Unmapped, 78217
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saint-Petersburg, Unmapped, 197758
    Status
    Study Complete
    Location
    GSK Investigational Site
    Worcester, MA, Unmapped, 01655
    Status
    Study Complete
    Location
    GSK Investigational Site
    ZWOLLE, Netherlands, 8025 AB
    Status
    Unmapped
    Location
    GSK Investigational Site
    Pisa, Italy, 56124
    Status
    Study Complete
    Location
    GSK Investigational Site
    Roma, Italy, 00168
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gauting, Germany, 82131
    Status
    Unmapped
    Location
    GSK Investigational Site
    Rennes, France, 35033
    Status
    Study Complete
    Location
    GSK Investigational Site
    Curitiba, Brazil, 80040-170
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cipoletti Rio Negro, Argentina, R8324CVE
    Status
    Study Complete
    Location
    GSK Investigational Site
    Heidelberg, VIC, Australia, 3084
    Status
    Study Complete
    Location
    GSK Investigational Site
    Oxford, Unmapped, OX3 7LJ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Heidelberg, Germany, 69126
    Status
    Unmapped
    Location
    GSK Investigational Site
    Madrid, Spain, 28027
    Status
    Study Complete
    Location
    GSK Investigational Site
    Las Palmas De Gran Canar, Spain, 35016
    Status
    Study Complete
    Location
    GSK Investigational Site
    Porto Alegre, Brazil, 90610-000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Jena, Germany, 07747
    Status
    Unmapped
    Location
    GSK Investigational Site
    Toulouse cedex 9, France, 31059
    Status
    Study Complete
    Location
    GSK Investigational Site
    Los Angeles, CA, Unmapped, 90017
    Status
    Study Complete
    Location
    GSK Investigational Site
    New York, NY, Unmapped, 10016-4744
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cordoba, Argentina, X5004FHP
    Status
    Study Complete
    Location
    GSK Investigational Site
    Aviano PN, Italy, 33081
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dallas, TX, Unmapped, 75246
    Status
    Study Complete
    Location
    GSK Investigational Site
    La Plata, Argentina, 1900
    Status
    Study Complete
    Location
    GSK Investigational Site
    Milano, Italy, 20132
    Status
    Study Complete
    Location
    GSK Investigational Site
    Strasbourg, France, 67200
    Status
    Study Complete
    Location
    GSK Investigational Site
    Patras, Greece, 26500
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mineola, NY, Unmapped, 10016
    Status
    Study Complete
    Location
    GSK Investigational Site
    Chattanooga, TN, Unmapped, 37404
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tallahassee, Florida, Unmapped, 32003
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 15562
    Status
    Study Complete
    Location
    GSK Investigational Site
    MAASTRICHT, Netherlands, 6229 HX
    Status
    Unmapped
    Location
    GSK Investigational Site
    SAo Paulo, Brazil, 01308-901
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bruxelles, Belgium, 1200
    Status
    Study Complete
    Location
    GSK Investigational Site
    Leuven, Belgium, 3000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Thessaloniki, Greece, 54622
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pylaia Thessaloniki, Greece, 57001
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sao Paulo, Brazil, 01509-010
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Athens, Greece, 11528
    Status
    Study Complete
    Location
    GSK Investigational Site
    Thessaloniki, Greece, 57010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Monteria, Colombia, 230018
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mexico City, Mexico, 06700
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ruse, Bulgaria, 7002
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lausanne, Switzerland, 1011
    Status
    Study Complete
    Location
    GSK Investigational Site
    Edegem, Belgium, 2650
    Status
    Study Complete
    Location
    GSK Investigational Site
    Panagyurishte, Bulgaria, 4500
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 185 37
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rio Patras, Greece, 26500
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sofia, Bulgaria, 1632
    Status
    Study Complete
    Location
    GSK Investigational Site
    UPPSALA, Sweden, SE-751 85
    Status
    Study Complete
    Location
    GSK Investigational Site
    Puebla Puebla, Mexico, 72560
    Status
    Study Complete
    Location
    GSK Investigational Site
    Thessaloniki, Greece, 54007
    Status
    Study Complete
    Location
    GSK Investigational Site
    TatabAnya, Hungary, 2800
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mexico City, Mexico, 03100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Moscow, Unmapped, 105 229
    Status
    Study Complete
    Location
    GSK Investigational Site
    Temuco, Chile, 5360000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 12462
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seongnam-si, Unmapped, 463-712
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hemer, Germany, 58675
    Status
    Unmapped
    Location
    GSK Investigational Site
    Seoul, Unmapped, 08308
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seoul, Unmapped, 05505
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ankara, Turkey, 06010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ankara, Turkey, 06520
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bialystok, Poland, 15-540
    Status
    Study Complete
    Location
    GSK Investigational Site
    BOGOTA, Colombia, 5600520
    Status
    Study Complete
    Location
    GSK Investigational Site
    Budapest, Hungary, 1083
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ciudad Autonoma de Buenos Aire, Argentina, C1426AGE
    Status
    Study Complete
    Location
    GSK Investigational Site
    Buenos Aires, Argentina, C1125ABD
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cordoba, Spain, 140044
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cork, Ireland, T12 DFK4
    Status
    Study Complete
    Location
    GSK Investigational Site
    Edirne, Turkey, 22030
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lima, Peru, Lima 34
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lodz, Poland, 90-338
    Status
    Study Complete
    Location
    GSK Investigational Site
    Muenchen, Germany, 81925
    Status
    Unmapped
    Location
    GSK Investigational Site
    Olsztyn, Poland, 10-357
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seongnam-si Gyeonggi-do, Unmapped, 13620
    Status
    Study Complete
    Location
    GSK Investigational Site
    Suwon Kyunggi-do, Unmapped, 443-721
    Status
    Study Complete
    Location
    GSK Investigational Site
    TOrOkbAlint, Hungary, 2045
    Status
    Study Complete
    Location
    GSK Investigational Site
    Fullerton, CA, Unmapped, 92835
    Status
    Study Complete
    Location
    GSK Investigational Site
    Santiago, Chile, 7500653
    Status
    Study Complete
    Location
    GSK Investigational Site
    Newnan, GA, Unmapped, 30265
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ankara, Turkey, 06100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 115 27
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 11526
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bari, Italy, 70124
    Status
    Study Complete
    Location
    GSK Investigational Site
    Belo Horizonte, Brazil, 30110-022
    Status
    Study Complete
    Location
    GSK Investigational Site
    Blacktown, NSW, Australia, 2148
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bonn, Germany, 53113
    Status
    Unmapped
    Location
    GSK Investigational Site
    Bournemouth, Unmapped, BH7 7DW
    Status
    Study Complete
    Location
    GSK Investigational Site
    Brest cedex, France, 29609
    Status
    Study Complete
    Location
    GSK Investigational Site
    Budapest, Hungary, H-1122
    Status
    Study Complete
    Location
    GSK Investigational Site
    Catania, Italy, 95123
    Status
    Study Complete
    Location
    GSK Investigational Site
    Charlotte, NC, Unmapped, 28207
    Status
    Study Complete
    Location
    GSK Investigational Site
    BUENOS AIRES, Argentina, C1426ABP
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cluj-Napoca, Romania, 400015
    Status
    Study Complete
    Location
    GSK Investigational Site
    DEN BOSCH, Netherlands, 5223 GZ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dublin, Ireland, 8
    Status
    Study Complete
    Location
    GSK Investigational Site
    Essen, Germany, 45147
    Status
    Unmapped
    Location
    GSK Investigational Site
    Fairfax, VA, Unmapped, 22031
    Status
    Study Complete
    Location
    GSK Investigational Site
    GyOngyOs, Hungary, 3200
    Status
    Study Complete
    Location
    GSK Investigational Site
    GAVLE, Sweden, SE-801 87
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hamburg, Germany, 20251
    Status
    Unmapped
    Location
    GSK Investigational Site
    Heraklion Crete, Greece, 71110
    Status
    Study Complete
    Location
    GSK Investigational Site
    Iasi, Romania, 700483
    Status
    Study Complete
    Location
    GSK Investigational Site
    Iowa City, IA, Unmapped, 52242
    Status
    Study Complete
    Location
    GSK Investigational Site
    Istanbul, Turkey, 34662
    Status
    Study Complete
    Location
    GSK Investigational Site
    Larissa, Greece, 41110
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lone Tree, CO, Unmapped, 80128
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lrenskog, Norway, 1470
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28041
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 15125
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mexico City, Mexico, CP 14080
    Status
    Study Complete
    Location
    GSK Investigational Site
    Monterrey, Mexico, 64460
    Status
    Study Complete
    Location
    GSK Investigational Site
    Monza, Italy, 20900
    Status
    Study Complete
    Location
    GSK Investigational Site
    MUnchen, Germany, 80336
    Status
    Unmapped
    Location
    GSK Investigational Site
    Neo Faliro, Greece, 185 47
    Status
    Study Complete
    Location
    GSK Investigational Site
    Napoli, Italy, 80131
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nizhniy Novgorod, Unmapped, 603081
    Status
    Study Complete
    Location
    GSK Investigational Site
    Norwich, CT, Unmapped, 06360
    Status
    Study Complete
    Location
    GSK Investigational Site
    Orbassano TO, Italy, 10043
    Status
    Study Complete
    Location
    GSK Investigational Site
    Paris, France, 75014
    Status
    Study Complete
    Location
    GSK Investigational Site
    Paris, France, 75018
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pleven, Bulgaria, 5800
    Status
    Study Complete
    Location
    GSK Investigational Site
    Plovdiv, Bulgaria, 4004
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rio de Janeiro, Brazil, 22250-905
    Status
    Study Complete
    Location
    GSK Investigational Site
    Roeselare, Belgium, 8800
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rosario, Argentina, S2000DSV
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saint-Petersburg, Unmapped, 197022
    Status
    Study Complete
    Location
    GSK Investigational Site
    Satu Mare, Romania, 440055
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sugar Land, TX, Unmapped, 77479
    Status
    Study Complete
    Location
    GSK Investigational Site
    Thessaloniki, Greece, 54645
    Status
    Study Complete
    Location
    GSK Investigational Site
    Timisoara, Romania, 300239
    Status
    Study Complete
    Location
    GSK Investigational Site
    Toulon cedex, France, 83056
    Status
    Study Complete
    Location
    GSK Investigational Site
    UTRECHT, Netherlands, 3543 AZ
    Status
    Unmapped
    Location
    GSK Investigational Site
    UberlAndia, Brazil, 38408-150
    Status
    Study Complete
    Location
    GSK Investigational Site
    Velbert, Germany, 42551
    Status
    Unmapped
    Location
    GSK Investigational Site
    Waco, TX, Unmapped, 76712
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wrexham, Unmapped, LL13 7TD
    Status
    Study Complete
    Location
    GSK Investigational Site
    Niles, IL, Unmapped, 60714
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pittsburgh, PA, Unmapped, 15212
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ames, IA, Unmapped, 50010
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Ann Arbor, MI, Unmapped, 48106
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Athens, Greece, 15123
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Eugene, OR, Unmapped, 97401
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Greenville, SC, Unmapped, 29607
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Houston, TX, Unmapped, 77030
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Morristown, NJ, Unmapped, 07962
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Naucalpan, Mexico, 53100
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Plano, TX, Unmapped, 75075-7787
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Portland, OR, Unmapped, 97213
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Sacramento, CA, Unmapped, 95816
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Salvador, Brazil, 41252-190
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Santa Rosa, CA, Unmapped, 95403-1757
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Skokie, IL, Unmapped, 60077
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Tacoma, WA, Unmapped, 98405
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Whittier, CA, Unmapped, 90603
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Zalaegerszeg, Hungary, 8900
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Sherman, TX, Unmapped, 75090
    Status
    Terminated/Withdrawn

    Study documents

    Protocol
    Available language(s): English
    Statistical analysis plan
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Recruitment complete
    Actual primary completion date
    2025-26-02
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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