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: June 18, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Pembrolizumab

Placebo

Belrestotug

Clinical Study ID

NCT06472076
213823
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate the efficacy and safety 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. Researchers will compare belrestotug plus dostarlimab with pembrolizumab plus placebo to see if there is meaningful improvement in progression free survival (PFS) and overall survival (OS).

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: 1000
Treatment Group(s): 4
Primary Treatment: Pembrolizumab
Phase: 3
Study Start date:
June 10, 2024
Estimated Completion Date:
September 19, 2029

Connect with a study center

  • GSK Investigational Site

    Florida, Buenos Aires 1602
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cipoletti, Rio Negro, Río Negro R8324CVE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Rosario, Santa Fe S2002
    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

    Ciudad Autonoma de Buenos Aires, C1056ABI
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cordoba, 5000
    Argentina

    Site Not Available

  • GSK Investigational Site

    Mendoza, M5500AYB
    Argentina

    Site Not Available

  • GSK Investigational Site

    Gent, 9000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Hasselt, 3500
    Belgium

    Site Not Available

  • GSK Investigational Site

    Namur, 5000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Salvador, Bahia 40414-120
    Brazil

    Site Not Available

  • GSK Investigational Site

    Fortaleza, Ceará 60336-232
    Brazil

    Site Not Available

  • GSK Investigational Site

    Vitória, Espírito Santo 29043-260
    Brazil

    Site Not Available

  • GSK Investigational Site

    Curitiba, Paraná 80810-050
    Brazil

    Site Not Available

  • GSK Investigational Site

    Londrina, Paraná 86015-520
    Brazil

    Site Not Available

  • GSK Investigational Site

    Belém, Pará 66.073-005
    Brazil

    Site Not Available

  • GSK Investigational Site

    Porto Velho, Rondônia 76.834-899
    Brazil

    Site Not Available

  • GSK Investigational Site

    Florianopolis, Santa Catarina 88034-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    Barretos, São Paulo 14784-400
    Brazil

    Site Not Available

  • GSK Investigational Site

    São José do Rio Preto, São Paulo 15090-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    São Paulo, 04312903
    Brazil

    Site Not Available

  • GSK Investigational Site

    Haskovo, 6300
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • GSK Investigational Site

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • GSK Investigational Site

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • GSK Investigational Site

    Dubrovnik, 20000
    Croatia

    Site Not Available

  • GSK Investigational Site

    Pula, 52100
    Croatia

    Site Not Available

  • GSK Investigational Site

    Rijeka,
    Croatia

    Site Not Available

  • GSK Investigational Site

    Sibenik, 22000
    Croatia

    Site Not Available

  • GSK Investigational Site

    Split, 21000
    Croatia

    Site Not Available

  • GSK Investigational Site

    Zagreb,
    Croatia

    Site Not Available

  • GSK Investigational Site

    Horovice, Stredocesky Kraj 268 31
    Czechia

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  • GSK Investigational Site

    Olomouc, 779 00
    Czechia

    Site Not Available

  • GSK Investigational Site

    Prague, 150 06
    Czechia

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  • GSK Investigational Site

    Tallinn, EE-13419
    Estonia

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    Tartu, 50501
    Estonia

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    Helsinki, 00180
    Finland

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  • GSK Investigational Site

    Kuopio, 70210
    Finland

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    Oulu, 90029
    Finland

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    Tampere, 33520
    Finland

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    Turku, 20520
    Finland

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  • GSK Investigational Site

    Vaasa, 65130
    Finland

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    Angers, 49000
    France

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  • GSK Investigational Site

    Boulogne-Billancourt, 92100
    France

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  • GSK Investigational Site

    Limoges Cedex, 87042
    France

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  • GSK Investigational Site

    Lorient, 56100
    France

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    Pessac, 33064
    France

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    Rennes Cedex 9, 35033
    France

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    Esslingen, Baden-Wuerttemberg 73730
    Germany

    Site Not Available

  • GSK Investigational Site

    Loewenstein, Baden-Wuerttemberg 74245
    Germany

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  • GSK Investigational Site

    Gauting, Bayern 82131
    Germany

    Site Not Available

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    Muenchen, Bayern 80336
    Germany

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    Frankfurt, Hessen 60488
    Germany

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    Essen, Nordrhein-Westfalen 45136
    Germany

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  • GSK Investigational Site

    Hemer, Nordrhein-Westfalen 58675
    Germany

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    Muenster, Nordrhein-Westfalen 48149
    Germany

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    Leipzig, Sachsen 04277
    Germany

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    Halle, Sachsen-Anhalt 06120
    Germany

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    Hamburg, 21075
    Germany

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    Athens, 11526
    Greece

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    Neo Faliro, 18547
    Greece

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    Piraeus, 18537
    Greece

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    Thessaloniki, 55236
    Greece

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    Kowloon,
    Hong Kong

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    Shatin,
    Hong Kong

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    Budapest, H-1122
    Hungary

    Site Not Available

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    Farkasgyepu, 8582
    Hungary

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    Gyor, 9024
    Hungary

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    Gyöngyös, 3200
    Hungary

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    Kaposvár, 7400
    Hungary

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    Tatabánya, 2800
    Hungary

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    Bangalore, Karnataka 560085
    India

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    Nashik, Maharashtra 422005
    India

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    Bhubaneshwar, Odisha 751019
    India

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    Chennai, Tamilnadu 600014
    India

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    Varanasi, Uttar Pradesh 221005
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    Ahmedabad, 380 016
    India

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    Gurgaon, 122001
    India

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  • GSK Investigational Site

    Kolkata, 700020
    India

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    Mumbai, 400012
    India

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    New Delhi, 110075
    India

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    Avellino, Campania 83100
    Italy

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    Meldola (FC), Emilia-Romagna 47014
    Italy

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  • GSK Investigational Site

    Roma, Lazio 00152
    Italy

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  • GSK Investigational Site

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • GSK Investigational Site

    Orbassano (TO), Piemonte 10043
    Italy

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  • GSK Investigational Site

    Bari, Puglia 70124
    Italy

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  • GSK Investigational Site

    Verona, Veneto 37134
    Italy

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    Bergamo, 24125
    Italy

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    Pesaro, 61122
    Italy

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  • GSK Investigational Site

    Aichi, 466-8560
    Japan

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  • GSK Investigational Site

    Chiba, 273-8588
    Japan

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  • GSK Investigational Site

    Ehime, 790-0024
    Japan

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  • GSK Investigational Site

    Fukuoka, 814-0180
    Japan

    Site Not Available

  • GSK Investigational Site

    Gifu, 503-8502
    Japan

    Site Not Available

  • GSK Investigational Site

    Gunma, 377-0280
    Japan

    Site Not Available

  • GSK Investigational Site

    Hiroshima, 737-0023
    Japan

    Site Not Available

  • GSK Investigational Site

    Hokkaido, 060-8648
    Japan

    Site Not Available

  • GSK Investigational Site

    Hyogo, 670-8520
    Japan

    Site Not Available

  • GSK Investigational Site

    Kanagawa, 236-0051
    Japan

    Site Not Available

  • GSK Investigational Site

    Kyoto, 612-8555
    Japan

    Site Not Available

  • GSK Investigational Site

    Mie, 515-8544
    Japan

    Site Not Available

  • GSK Investigational Site

    Miyagi, 981-0914
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Nagasaki, 852-8501
    Japan

    Site Not Available

  • GSK Investigational Site

    Niigata, 951-8566
    Japan

    Site Not Available

  • GSK Investigational Site

    Okayama, 710-8602
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka, 591-8555
    Japan

    Site Not Available

  • GSK Investigational Site

    Tochigi, 329-0498
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo, 104-0045
    Japan

    Site Not Available

  • GSK Investigational Site

    Tottori, 683-8504
    Japan

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  • GSK Investigational Site

    Wakayama, 641-8510
    Japan

    Site Not Available

  • GSK Investigational Site

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Incheon, 6510
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul, ?08308
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul,, 120-752
    Korea, Republic of

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  • GSK Investigational Site

    Suwon, 16247
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    La Paz, Baja California Sur 23040
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mexico City, Ciudad De Mexico 06700
    Mexico

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  • GSK Investigational Site

    Guadalajara, Jalisco 44280
    Mexico

    Site Not Available

  • GSK Investigational Site

    Ciudad Madero, Tamaulipas 89440
    Mexico

    Site Not Available

  • GSK Investigational Site

    San Luis Potosí, 78209
    Mexico

    Site Not Available

  • GSK Investigational Site

    Alkmaar, 1815 JD
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Den Haag, 2545 AA
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Enschede, 7512 KZ
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Rotterdam, 3045 PM
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Panama,
    Panama

    Site Not Available

  • GSK Investigational Site

    Manila, 1000
    Philippines

    Site Not Available

  • GSK Investigational Site

    Quezon City, 1102
    Philippines

    Site Not Available

  • GSK Investigational Site

    Bialystok, 15-540
    Poland

    Site Not Available

  • GSK Investigational Site

    Katowice, 40-514
    Poland

    Site Not Available

  • GSK Investigational Site

    Lodz, 90-338
    Poland

    Site Not Available

  • GSK Investigational Site

    Olsztyn, 10-357
    Poland

    Site Not Available

  • GSK Investigational Site

    Poznan, 60-569
    Poland

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  • 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, 200094
    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, 168583
    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

    Salamanca, Castilla Y Leon 37007
    Spain

    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 Coruña, 15009
    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

    Barcelona, 08023
    Spain

    Site Not Available

  • GSK Investigational Site

    Córdoba, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    Jaen, 23007
    Spain

    Site Not Available

  • GSK Investigational Site

    Jerez de la Frontera, 11407
    Spain

    Site Not Available

  • GSK Investigational Site

    La Coruña, 15006
    Spain

    Site Not Available

  • GSK Investigational Site

    Las Palmas de Gran Canaria, 35016
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28010
    Spain

    Site Not Available

  • GSK Investigational Site

    Málaga, 29016
    Spain

    Site Not Available

  • GSK Investigational Site

    Oviedo, 33006
    Spain

    Site Not Available

  • GSK Investigational Site

    Pamplona, 31008
    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

    Valladolid, 47003
    Spain

    Site Not Available

  • GSK Investigational Site

    Gävle, SE-801 87
    Sweden

    Site Not Available

  • GSK Investigational Site

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • GSK Investigational Site

    New Taipei City, 23561
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taipei, 112
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taoyuan City, 333
    Taiwan

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  • GSK Investigational Site

    Bangkok, 10400
    Thailand

    Site Not Available

  • GSK Investigational Site

    Chiang Mai, 50200
    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, 01250
    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

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