A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)

Last updated: September 3, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

Belrestotug

Dostarlimab

Clinical Study ID

NCT06472076
213823
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate the safety and tolerability profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a histologically or cytologically confirmed diagnosis of locally advanced,unresectable NSCLC (not eligible for curative surgery and/or definitive radiotherapywith or without chemotherapy), or Metastatic NSCLC

  • Has not received prior systemic therapy for their locally advanced or metastaticNSCLC.

  • Provides a fresh tumor tissue sample obtained at the time of or after the initialdiagnosis of locally advanced or metastatic NSCLC.

  • Has a PD-L1-high (Tumor cells [TC] ≥50%) tumor

  • Has measurable disease (at least 1 target lesion) based on RECIST 1.1

  • Has an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0or 1.

  • Has adequate organ function

Exclusion

Exclusion Criteria:

  • Has NSCLC with a tumor that harbors any of the following molecular alterations:
  1. Epidermal growth factor receptor (EGFR) mutations that are sensitive toavailable targeted inhibitor therapy

  2. Anaplastic lymphoma kinase (ALK) translocations that are sensitive to availabletargeted inhibitor therapy

  3. Any other known genomic aberrations or oncogenic driver mutations for which alocally approved targeted therapy is available for first line treatment oflocally advanced or metastatic NSCLC.

  • Has had surgery within 4 weeks of the first dose of study intervention and has notrecovered from AEs (i.e., has any ongoing surgery-related events ≥ Grade 1)/complications related to surgery or has received lung radiation therapy of >30gray (Gy) within 6 months

  • Has received prior therapy with any immune checkpoint inhibitors, includingantibodies or drugs targeting PD-(L)1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoglobulin and ITIM domain (TIGIT), or other checkpointpathways.

  • Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime.

  • Has an invasive malignancy or history of invasive malignancy other than the diseaseunder study within the last 5 years, with the exception of those with a negligiblerisk of metastasis or death and/or treated with expected curative outcome.

  • Has symptomatic, untreated, or actively progressin g brain metastases orleptomeningeal disease

  • Has autoimmune disease or syndrome (current or history thereof) that requiredsystemic treatment within the past 2 years.

  • Has received any live vaccine within 30 days prior to first dose of studyintervention.

  • Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug inducedpneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis.

  • Has symptomatic ascites, pleural effusion, or pericardial effusion.

  • Has active inflammatory bowel disease

  • Has a history of significant acute or chronic cardiac diagnosis requiringintervention/treatment in the last 6 months.

  • Has severe infection or complication thereof 4 weeks prior to randomisationincluding active tuberculosis.

  • Has a history of allogeneic tissue/stem cell transplant or solid organ transplant.

Study Design

Total Participants: 88
Treatment Group(s): 4
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 10, 2024
Estimated Completion Date:
February 02, 2027

Connect with a study center

  • GSK Investigational Site

    Cipoletti, Rio Negro, Río Negro R8324CVE
    Argentina

    Site Not Available

  • GSK Investigational Site

    San Miguel de Tucumán, Tucumán T4000
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, C1426AGE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires 3435910, 1425
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cipoletti Rio Negro, R8324CVE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1056ABI
    Argentina

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  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1426AGE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, 1425
    Argentina

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  • GSK Investigational Site

    Cordoba, 5000
    Argentina

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  • GSK Investigational Site

    Córdoba 3860259, 5000
    Argentina

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    Florida, 1602
    Argentina

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    Florida 3433908, 1602
    Argentina

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    Mendoza, M5500AYB
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    Mendoza 3844421, M5500AYB
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    Rosario, S2002
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    Rosario 3838583, S2002KDT
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    San Miguel de TucumAn, T4000
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    San Miguel de Tucumán 3836873, T4000
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    Gent, 9000
    Belgium

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    Hasselt, 3500
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    Hasselt 2796491, 3500
    Belgium

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    Mont Gaston, 5530
    Belgium

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    Namur, 5000
    Belgium

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    Curitiba, Paraná 80810-050
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    Belém, Pará 66.073-005
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    Porto Velho, Rondônia 76.834-899
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    São José do Rio Preto, São Paulo 15090-000
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    Barretos, 14784-400
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    Barretos 3470451, 14784-400
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    BelEm, 66.073-005
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    Belém 3405870, 66.073-005
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    CuritibaPR, 80810-050
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    Florianopolis, 88034-000
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    Florianópolis 3463237, 88034-000
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    Fortaleza, 60336-232
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    Fortaleza 3399415, 60336-232
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    Londrina, 86015-520
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    Londrina 3458449, 86015-520
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    Porto VelhoRondOnia, 76.834-899
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    SAo JosE Do Rio PretoSP, 15090-000
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    Salvador, 40414-120
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    Salvador 3450554, 40414-120
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    Sao Paulo, 04312903
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    São Paulo, 04312903
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    São Paulo 3448439, 04312903
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    VitOria, 29043-260
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    Vitória 3444924, 29043-260
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    Haskovo, 6300
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    Hefei 1808722, 230001
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    Pula, 52100
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    Helsinki, 00180
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    Kuopio, 70210
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    Kuopio 650224, 70210
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    Oulu, 90029
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    Tampere, 33520
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    Vaasa, 65130
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    Angers, 49000
    France

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    Angers 3037656, 49000
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    Angers cedex 9, 49000
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    Boulogne Billancourt, 92100
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    Boulogne-Billancourt, 92100
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    Boulogne-Billancourt 3031137, 92100
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    Limoges 2998286, 87042
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    Limoges Cedex, 87042
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    Lorient, 56100
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    Lorient 2997577, 56100
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    Pessac, 33064
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    Pessac 2987805, 33064
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    Pessac cedex, 33064
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    Rennes, 35033
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    Rennes 2983990, 35033
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    Rennes Cedex 9, 35033
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    Loewenstein, Baden-Wuerttemberg 74245
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    Essen, Nordrhein-Westfalen 45136
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    Hemer, Nordrhein-Westfalen 58675
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    Muenster, Nordrhein-Westfalen 48149
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    Leipzig, Sachsen 04277
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    Esslingen, 73730
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    Frankfurt, 60488
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    Gauting, 82131
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    Halle, 06120
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    Hamburg, 20251
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    Hamburg 2911298, 20251
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    Neo Faliro, 18547
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    Piraeus, 18537
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    Thessaloniki, 57010
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    Kowloon,
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    Shatin,
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    Shatin 1818920,
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    Budapest, H-1122
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    Gyor, 9024
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    Gyöngyös, 3200
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    Kaposvár, 7400
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    Tatabánya, 2800
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    VeszprEm, 8582
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    Gokul Shirgoan, Kolhapur 416234
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    Nashik, Maharashtra 422005
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    Chennai, Tamilnadu 600014
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    Varanasi, Uttar Pradesh 221005
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    Ahmedabad, 380 016
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    Ahmedabad-380016, 380 016
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    Apex Wellness Hospital, 422005
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    Bangalore, 560085
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    Bangalore 1277333, 560085
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    Belagavi, 590010
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    Belagavi 1276533, 590010
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    Bhubaneshwar, 751007
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    Bhubaneswar, 751019
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    Bhubaneswar 1275817, 751019
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    Gurgaon, 122001
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    Gūrgaon 10330624, 122001
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    Kolkata, 700020
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    Kolkata 1275004, 700020
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    Mumbai, 400012
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    New Delhi, 110075
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    New Delhi 1261481, 110075
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    Meldola (FC), Emilia-Romagna 47014
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    Roma, Lazio 00152
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    Orbassano (TO), Piemonte 10043
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    Avellino, 83100
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    Bari, 70124
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    Bergamo, 24125
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    Meldola FC, 47014
    Italy

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    Milano, 20141
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    Pesaro, 61122
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    Verona, 37134
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    Aichi, 466-8560
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    Aichi 11192139, 466-8560
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    Chiba, 273-8588
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    Chiba 2113015, 273-8588
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    Ehime, 790-0024
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    Fukuoka, 812-8582
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    Fukuoka 1863967, 814-0180
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    Gifu, 503-8502
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    Gifu 1863641, 503-8502
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    Gunma, 377-0280
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    Hiroshima, 737-0023
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    Hiroshima 1862415, 737-0023
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    Hokkaido, 062-0931
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    Hyogo, 670-8520
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    Hyōgo 2129969, 665-0827
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    Kanagawa, 236-0051
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    Kanagawa 1860292, 236-0051
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    Kyoto, 612-8555
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    Kyoto 1857910, 612-8555
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    Mie, 515-8544
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    Mie 1857357, 515-8544
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    Miyagi, 981-1293
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    Miyagi 1856813, 981-0914
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    Nagasaki, 852-8501
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    Nagasaki 1856177, 852-8501
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    Niigata, 951-8566
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    Niigata 1855431, 951-8566
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    Okayama, 710-8602
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    Okayama 1854383, 710-8602
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    Osaka, 596-8501
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    Osaka 1853909, 591-8555
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    Tochigi, 329-0498
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    Tochigi 1850311, 329-0498
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    Tokyo, 113-8603
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    Tokyo 1850147, 113-8603
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    Wakayama 1926004, 641-8510
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    Daegu, 41404
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    Incheon, 6510
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    Seoul, 120-752
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    Seoul,, 120-752
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    Suwon Gyeonggi-do, 16247
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    La Paz, Baja California Sur 23040
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    Alkmaar 2759899, 1815 JD
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    Enschede, 7512 KZ
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    Enschede 2756071, 7512 KZ
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    Rotterdam, 3045 PM
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    Panama,
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    Site Not Available

  • GSK Investigational Site

    Poznan, 60-569
    Poland

    Site Not Available

  • GSK Investigational Site

    Przemysl, 37-700
    Poland

    Site Not Available

  • GSK Investigational Site

    Rzeszow, 35-055
    Poland

    Site Not Available

  • GSK Investigational Site

    Warszawa, 02-507
    Poland

    Site Not Available

  • GSK Investigational Site

    Alcabideche, 2755-009
    Portugal

    Site Not Available

  • GSK Investigational Site

    Lisboa, 1769-001
    Portugal

    Site Not Available

  • GSK Investigational Site

    Matosinhos, 4464-509
    Portugal

    Site Not Available

  • GSK Investigational Site

    Porto, 4100-180
    Portugal

    Site Not Available

  • GSK Investigational Site

    Oradea, Bihor 410169
    Romania

    Site Not Available

  • GSK Investigational Site

    Bucuresti, 013812
    Romania

    Site Not Available

  • GSK Investigational Site

    Cluj-Napoca, 400015
    Romania

    Site Not Available

  • GSK Investigational Site

    Craiova, 200347
    Romania

    Site Not Available

  • GSK Investigational Site

    Iasi, 700483
    Romania

    Site Not Available

  • GSK Investigational Site

    Pitesti, 110184
    Romania

    Site Not Available

  • GSK Investigational Site

    Suceava, 720214
    Romania

    Site Not Available

  • GSK Investigational Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • GSK Investigational Site

    Kragujevac, 34000
    Serbia

    Site Not Available

  • GSK Investigational Site

    Nis, 18000
    Serbia

    Site Not Available

  • GSK Investigational Site

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • GSK Investigational Site

    Singapore, 308433
    Singapore

    Site Not Available

  • GSK Investigational Site

    Bratislava, 833 10
    Slovakia

    Site Not Available

  • GSK Investigational Site

    Komárno, 94505
    Slovakia

    Site Not Available

  • GSK Investigational Site

    Martin, 036 59
    Slovakia

    Site Not Available

  • GSK Investigational Site

    Golnik, 4204
    Slovenia

    Site Not Available

  • GSK Investigational Site

    Ljubljana, 1000
    Slovenia

    Site Not Available

  • GSK Investigational Site

    Maribor, 2000
    Slovenia

    Site Not Available

  • GSK Investigational Site

    Daegu 1835329, 41404
    South Korea

    Site Not Available

  • GSK Investigational Site

    Incheon 1843564, 21565
    South Korea

    Site Not Available

  • GSK Investigational Site

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • GSK Investigational Site

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • GSK Investigational Site

    Cartagena, Murcia 30202
    Spain

    Site Not Available

  • GSK Investigational Site

    A CoruNa, 15006
    Spain

    Site Not Available

  • GSK Investigational Site

    A Coruña, 15009
    Spain

    Site Not Available

  • GSK Investigational Site

    A Coruña 3119841, 15006
    Spain

    Site Not Available

  • GSK Investigational Site

    Aravaca, 28013
    Spain

    Site Not Available

  • GSK Investigational Site

    Aravaca 3129827, 28013
    Spain

    Site Not Available

  • GSK Investigational Site

    Aravaca - Madrid, 28013
    Spain

    Site Not Available

  • GSK Investigational Site

    Baracaldo/Vizcaya, 48903
    Spain

    Site Not Available

  • GSK Investigational Site

    BaracaldoVizcaya, 48903
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08035
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona 3128760, 08003
    Spain

    Site Not Available

  • GSK Investigational Site

    COrdoba, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    Cartagena Murcia, 30202
    Spain

    Site Not Available

  • GSK Investigational Site

    Córdoba, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    Jaen, 23007
    Spain

    Site Not Available

  • GSK Investigational Site

    Jaén 2516395, 23007
    Spain

    Site Not Available

  • GSK Investigational Site

    Jerez de la Frontera, 11407
    Spain

    Site Not Available

  • GSK Investigational Site

    La CoruNa, 15009
    Spain

    Site Not Available

  • GSK Investigational Site

    La Coruña, 15006
    Spain

    Site Not Available

  • GSK Investigational Site

    Las Palmas de Gran Canar, 35016
    Spain

    Site Not Available

  • GSK Investigational Site

    Las Palmas de Gran Canaria, 35016
    Spain

    Site Not Available

  • GSK Investigational Site

    MAlaga, 29016
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28222
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid 3117735, 28222
    Spain

    Site Not Available

  • GSK Investigational Site

    Málaga, 29016
    Spain

    Site Not Available

  • GSK Investigational Site

    Málaga 2514256, 29016
    Spain

    Site Not Available

  • GSK Investigational Site

    Oviedo, 33006
    Spain

    Site Not Available

  • GSK Investigational Site

    Oviedo 3114711, 33006
    Spain

    Site Not Available

  • GSK Investigational Site

    Pamplona, 31008
    Spain

    Site Not Available

  • GSK Investigational Site

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • GSK Investigational Site

    Salamanca, 37007
    Spain

    Site Not Available

  • GSK Investigational Site

    Salamanca 3111108, 37007
    Spain

    Site Not Available

  • GSK Investigational Site

    Santander, 39008
    Spain

    Site Not Available

  • GSK Investigational Site

    Santander 3109718, 39008
    Spain

    Site Not Available

  • GSK Investigational Site

    Santander (Cantabria), 39008
    Spain

    Site Not Available

  • GSK Investigational Site

    Sevilla, 41014
    Spain

    Site Not Available

  • GSK Investigational Site

    Seville 2510911, 41014
    Spain

    Site Not Available

  • GSK Investigational Site

    Valladolid, 47003
    Spain

    Site Not Available

  • GSK Investigational Site

    Valladolid 3106672, 47003
    Spain

    Site Not Available

  • GSK Investigational Site

    Gavle, SE-801 87
    Sweden

    Site Not Available

  • GSK Investigational Site

    Gävle, SE-801 87
    Sweden

    Site Not Available

  • GSK Investigational Site

    Gävle 2712414, SE-801 87
    Sweden

    Site Not Available

  • GSK Investigational Site

    Stockholm, 171 64
    Sweden

    Site Not Available

  • GSK Investigational Site

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Kaohsiung City 1673820, 807
    Taiwan

    Site Not Available

  • GSK Investigational Site

    New Taipei City, 23561
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taipei, 23561
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taipei 1668341, 23561
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Bangkok, 10400
    Thailand

    Site Not Available

  • GSK Investigational Site

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • GSK Investigational Site

    Kho Hong Hat Yai, 90110
    Thailand

    Site Not Available

  • GSK Investigational Site

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • GSK Investigational Site

    Songkla, 90110
    Thailand

    Site Not Available

  • GSK Investigational Site

    Adana, 1120
    Turkey

    Site Not Available

  • GSK Investigational Site

    Ankara, 06800
    Turkey

    Site Not Available

  • GSK Investigational Site

    Istanbul, 34722
    Turkey

    Site Not Available

  • GSK Investigational Site

    Izmir, 35530
    Turkey

    Site Not Available

  • GSK Investigational Site

    Adana 325363, 1120
    Turkey (Türkiye)

    Site Not Available

  • GSK Investigational Site

    Ankara 323786, 06560
    Turkey (Türkiye)

    Site Not Available

  • GSK Investigational Site

    Istanbul 745044, 34722
    Turkey (Türkiye)

    Site Not Available

  • GSK Investigational Site

    Ocala, Florida 34474
    United States

    Site Not Available

  • GSK Investigational Site

    Ocala 4166673, Florida 4155751 34474
    United States

    Site Not Available

  • GSK Investigational Site

    Honolulu, Hawaii 96819
    United States

    Site Not Available

  • GSK Investigational Site

    Honolulu 5856195, Hawaii 5855797 96819
    United States

    Site Not Available

  • GSK Investigational Site

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington 4297983, Kentucky 6254925 40509
    United States

    Site Not Available

  • GSK Investigational Site

    Ann Arbor 4984247, Michigan 5001836 48106
    United States

    Site Not Available

  • GSK Investigational Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • GSK Investigational Site

    Omaha 5074472, Nebraska 5073708 68114
    United States

    Site Not Available

  • GSK Investigational Site

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • GSK Investigational Site

    Fredericksburg, Virginia 22408
    United States

    Site Not Available

  • GSK Investigational Site

    Olympia, Washington 98506
    United States

    Site Not Available

  • GSK Investigational Site

    Olympia 5805687, Washington 5815135 98506
    United States

    Site Not Available

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