Phase
Condition
N/ATreatment
Pembrolizumab
Placebo
Belrestotug
Clinical Study ID
Ages > 18 All Genders
Study Summary
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:
Epidermal growth factor receptor (EGFR) mutations that are sensitive toavailable targeted inhibitor therapy
Anaplastic lymphoma kinase (ALK) translocations that are sensitive to availabletargeted inhibitor therapy
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
Connect with a study center
GSK Investigational Site
Florida, Buenos Aires 1602
ArgentinaSite Not Available
GSK Investigational Site
Cipoletti, Rio Negro, Río Negro R8324CVE
ArgentinaSite Not Available
GSK Investigational Site
Rosario, Santa Fe S2002
ArgentinaSite Not Available
GSK Investigational Site
San Miguel de Tucumán, Tucumán T4000
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1426AGE
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, C1056ABI
ArgentinaSite Not Available
GSK Investigational Site
Cordoba, 5000
ArgentinaSite Not Available
GSK Investigational Site
Mendoza, M5500AYB
ArgentinaSite Not Available
GSK Investigational Site
Gent, 9000
BelgiumSite Not Available
GSK Investigational Site
Hasselt, 3500
BelgiumSite Not Available
GSK Investigational Site
Namur, 5000
BelgiumSite Not Available
GSK Investigational Site
Salvador, Bahia 40414-120
BrazilSite Not Available
GSK Investigational Site
Fortaleza, Ceará 60336-232
BrazilSite Not Available
GSK Investigational Site
Vitória, Espírito Santo 29043-260
BrazilSite Not Available
GSK Investigational Site
Curitiba, Paraná 80810-050
BrazilSite Not Available
GSK Investigational Site
Londrina, Paraná 86015-520
BrazilSite Not Available
GSK Investigational Site
Belém, Pará 66.073-005
BrazilSite Not Available
GSK Investigational Site
Porto Velho, Rondônia 76.834-899
BrazilSite Not Available
GSK Investigational Site
Florianopolis, Santa Catarina 88034-000
BrazilSite Not Available
GSK Investigational Site
Barretos, São Paulo 14784-400
BrazilSite Not Available
GSK Investigational Site
São José do Rio Preto, São Paulo 15090-000
BrazilSite Not Available
GSK Investigational Site
São Paulo, 04312903
BrazilSite Not Available
GSK Investigational Site
Haskovo, 6300
BulgariaSite Not Available
GSK Investigational Site
Plovdiv, 4000
BulgariaSite Not Available
GSK Investigational Site
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
GSK Investigational Site
Winnipeg, Manitoba R3E 0V9
CanadaSite Not Available
GSK Investigational Site
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
GSK Investigational Site
Dubrovnik, 20000
CroatiaSite Not Available
GSK Investigational Site
Pula, 52100
CroatiaSite Not Available
GSK Investigational Site
Rijeka,
CroatiaSite Not Available
GSK Investigational Site
Sibenik, 22000
CroatiaSite Not Available
GSK Investigational Site
Split, 21000
CroatiaSite Not Available
GSK Investigational Site
Zagreb,
CroatiaSite Not Available
GSK Investigational Site
Horovice, Stredocesky Kraj 268 31
CzechiaSite Not Available
GSK Investigational Site
Olomouc, 779 00
CzechiaSite Not Available
GSK Investigational Site
Prague, 150 06
CzechiaSite Not Available
GSK Investigational Site
Tallinn, EE-13419
EstoniaSite Not Available
GSK Investigational Site
Tartu, 50501
EstoniaSite Not Available
GSK Investigational Site
Helsinki, 00180
FinlandSite Not Available
GSK Investigational Site
Kuopio, 70210
FinlandSite Not Available
GSK Investigational Site
Oulu, 90029
FinlandSite Not Available
GSK Investigational Site
Tampere, 33520
FinlandSite Not Available
GSK Investigational Site
Turku, 20520
FinlandSite Not Available
GSK Investigational Site
Vaasa, 65130
FinlandSite Not Available
GSK Investigational Site
Angers, 49000
FranceSite Not Available
GSK Investigational Site
Boulogne-Billancourt, 92100
FranceSite Not Available
GSK Investigational Site
Limoges Cedex, 87042
FranceSite Not Available
GSK Investigational Site
Lorient, 56100
FranceSite Not Available
GSK Investigational Site
Pessac, 33064
FranceSite Not Available
GSK Investigational Site
Rennes Cedex 9, 35033
FranceSite Not Available
GSK Investigational Site
Esslingen, Baden-Wuerttemberg 73730
GermanySite Not Available
GSK Investigational Site
Loewenstein, Baden-Wuerttemberg 74245
GermanySite Not Available
GSK Investigational Site
Gauting, Bayern 82131
GermanySite Not Available
GSK Investigational Site
Muenchen, Bayern 80336
GermanySite Not Available
GSK Investigational Site
Frankfurt, Hessen 60488
GermanySite Not Available
GSK Investigational Site
Essen, Nordrhein-Westfalen 45136
GermanySite Not Available
GSK Investigational Site
Hemer, Nordrhein-Westfalen 58675
GermanySite Not Available
GSK Investigational Site
Muenster, Nordrhein-Westfalen 48149
GermanySite Not Available
GSK Investigational Site
Leipzig, Sachsen 04277
GermanySite Not Available
GSK Investigational Site
Halle, Sachsen-Anhalt 06120
GermanySite Not Available
GSK Investigational Site
Hamburg, 21075
GermanySite Not Available
GSK Investigational Site
Athens, 11526
GreeceSite Not Available
GSK Investigational Site
Neo Faliro, 18547
GreeceSite Not Available
GSK Investigational Site
Piraeus, 18537
GreeceSite Not Available
GSK Investigational Site
Thessaloniki, 55236
GreeceSite Not Available
GSK Investigational Site
Kowloon,
Hong KongSite Not Available
GSK Investigational Site
Shatin,
Hong KongSite Not Available
GSK Investigational Site
Budapest, H-1122
HungarySite Not Available
GSK Investigational Site
Farkasgyepu, 8582
HungarySite Not Available
GSK Investigational Site
Gyor, 9024
HungarySite Not Available
GSK Investigational Site
Gyöngyös, 3200
HungarySite Not Available
GSK Investigational Site
Kaposvár, 7400
HungarySite Not Available
GSK Investigational Site
Tatabánya, 2800
HungarySite Not Available
GSK Investigational Site
Bangalore, Karnataka 560085
IndiaSite Not Available
GSK Investigational Site
Nashik, Maharashtra 422005
IndiaSite Not Available
GSK Investigational Site
Bhubaneshwar, Odisha 751019
IndiaSite Not Available
GSK Investigational Site
Chennai, Tamilnadu 600014
IndiaSite Not Available
GSK Investigational Site
Varanasi, Uttar Pradesh 221005
IndiaSite Not Available
GSK Investigational Site
Ahmedabad, 380 016
IndiaSite Not Available
GSK Investigational Site
Gurgaon, 122001
IndiaSite Not Available
GSK Investigational Site
Kolkata, 700020
IndiaSite Not Available
GSK Investigational Site
Mumbai, 400012
IndiaSite Not Available
GSK Investigational Site
New Delhi, 110075
IndiaSite Not Available
GSK Investigational Site
Avellino, Campania 83100
ItalySite Not Available
GSK Investigational Site
Meldola (FC), Emilia-Romagna 47014
ItalySite Not Available
GSK Investigational Site
Roma, Lazio 00152
ItalySite Not Available
GSK Investigational Site
Milano, Lombardia 20133
ItalySite Not Available
GSK Investigational Site
Orbassano (TO), Piemonte 10043
ItalySite Not Available
GSK Investigational Site
Bari, Puglia 70124
ItalySite Not Available
GSK Investigational Site
Verona, Veneto 37134
ItalySite Not Available
GSK Investigational Site
Bergamo, 24125
ItalySite Not Available
GSK Investigational Site
Pesaro, 61122
ItalySite Not Available
GSK Investigational Site
Aichi, 466-8560
JapanSite Not Available
GSK Investigational Site
Chiba, 273-8588
JapanSite Not Available
GSK Investigational Site
Ehime, 790-0024
JapanSite Not Available
GSK Investigational Site
Fukuoka, 814-0180
JapanSite Not Available
GSK Investigational Site
Gifu, 503-8502
JapanSite Not Available
GSK Investigational Site
Gunma, 377-0280
JapanSite Not Available
GSK Investigational Site
Hiroshima, 737-0023
JapanSite Not Available
GSK Investigational Site
Hokkaido, 060-8648
JapanSite Not Available
GSK Investigational Site
Hyogo, 670-8520
JapanSite Not Available
GSK Investigational Site
Kanagawa, 236-0051
JapanSite Not Available
GSK Investigational Site
Kyoto, 612-8555
JapanSite Not Available
GSK Investigational Site
Mie, 515-8544
JapanSite Not Available
GSK Investigational Site
Miyagi, 981-0914
JapanActive - Recruiting
GSK Investigational Site
Nagasaki, 852-8501
JapanSite Not Available
GSK Investigational Site
Niigata, 951-8566
JapanSite Not Available
GSK Investigational Site
Okayama, 710-8602
JapanSite Not Available
GSK Investigational Site
Osaka, 591-8555
JapanSite Not Available
GSK Investigational Site
Tochigi, 329-0498
JapanSite Not Available
GSK Investigational Site
Tokyo, 104-0045
JapanSite Not Available
GSK Investigational Site
Tottori, 683-8504
JapanSite Not Available
GSK Investigational Site
Wakayama, 641-8510
JapanSite Not Available
GSK Investigational Site
Daegu, 41404
Korea, Republic ofSite Not Available
GSK Investigational Site
Incheon, 6510
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, ?08308
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul,, 120-752
Korea, Republic ofSite Not Available
GSK Investigational Site
Suwon, 16247
Korea, Republic ofSite Not Available
GSK Investigational Site
La Paz, Baja California Sur 23040
MexicoSite Not Available
GSK Investigational Site
Mexico City, Ciudad De Mexico 06700
MexicoSite Not Available
GSK Investigational Site
Guadalajara, Jalisco 44280
MexicoSite Not Available
GSK Investigational Site
Ciudad Madero, Tamaulipas 89440
MexicoSite Not Available
GSK Investigational Site
San Luis Potosí, 78209
MexicoSite Not Available
GSK Investigational Site
Alkmaar, 1815 JD
NetherlandsSite Not Available
GSK Investigational Site
Den Haag, 2545 AA
NetherlandsSite Not Available
GSK Investigational Site
Enschede, 7512 KZ
NetherlandsSite Not Available
GSK Investigational Site
Rotterdam, 3045 PM
NetherlandsSite Not Available
GSK Investigational Site
Panama,
PanamaSite Not Available
GSK Investigational Site
Manila, 1000
PhilippinesSite Not Available
GSK Investigational Site
Quezon City, 1102
PhilippinesSite Not Available
GSK Investigational Site
Bialystok, 15-540
PolandSite Not Available
GSK Investigational Site
Katowice, 40-514
PolandSite Not Available
GSK Investigational Site
Lodz, 90-338
PolandSite Not Available
GSK Investigational Site
Olsztyn, 10-357
PolandSite Not Available
GSK Investigational Site
Poznan, 60-569
PolandSite Not Available
GSK Investigational Site
Przemysl, 37-700
PolandSite Not Available
GSK Investigational Site
Rzeszow, 35-055
PolandSite Not Available
GSK Investigational Site
Warszawa, 02-507
PolandSite Not Available
GSK Investigational Site
Alcabideche, 2755-009
PortugalSite Not Available
GSK Investigational Site
Lisboa, 1769-001
PortugalSite Not Available
GSK Investigational Site
Matosinhos, 4464-509
PortugalSite Not Available
GSK Investigational Site
Porto, 4100-180
PortugalSite Not Available
GSK Investigational Site
Oradea, Bihor 410169
RomaniaSite Not Available
GSK Investigational Site
Bucuresti, 013812
RomaniaSite Not Available
GSK Investigational Site
Cluj-Napoca, 400015
RomaniaSite Not Available
GSK Investigational Site
Craiova, 200094
RomaniaSite Not Available
GSK Investigational Site
Iasi, 700483
RomaniaSite Not Available
GSK Investigational Site
Pitesti, 110184
RomaniaSite Not Available
GSK Investigational Site
Suceava, 720214
RomaniaSite Not Available
GSK Investigational Site
Belgrade, 11000
SerbiaSite Not Available
GSK Investigational Site
Kragujevac, 34000
SerbiaSite Not Available
GSK Investigational Site
Nis, 18000
SerbiaSite Not Available
GSK Investigational Site
Sremska Kamenica, 21204
SerbiaSite Not Available
GSK Investigational Site
Singapore, 168583
SingaporeSite Not Available
GSK Investigational Site
Bratislava, 833 10
SlovakiaSite Not Available
GSK Investigational Site
Komárno, 94505
SlovakiaSite Not Available
GSK Investigational Site
Martin, 036 59
SlovakiaSite Not Available
GSK Investigational Site
Golnik, 4204
SloveniaSite Not Available
GSK Investigational Site
Ljubljana, 1000
SloveniaSite Not Available
GSK Investigational Site
Maribor, 2000
SloveniaSite Not Available
GSK Investigational Site
Salamanca, Castilla Y Leon 37007
SpainSite Not Available
GSK Investigational Site
Majadahonda, Madrid 28222
SpainSite Not Available
GSK Investigational Site
Cartagena, Murcia 30202
SpainSite Not Available
GSK Investigational Site
A Coruña, 15009
SpainSite Not Available
GSK Investigational Site
Aravaca - Madrid, 28013
SpainSite Not Available
GSK Investigational Site
Baracaldo/Vizcaya, 48903
SpainSite Not Available
GSK Investigational Site
Barcelona, 08023
SpainSite Not Available
GSK Investigational Site
Córdoba, 14004
SpainSite Not Available
GSK Investigational Site
Jaen, 23007
SpainSite Not Available
GSK Investigational Site
Jerez de la Frontera, 11407
SpainSite Not Available
GSK Investigational Site
La Coruña, 15006
SpainSite Not Available
GSK Investigational Site
Las Palmas de Gran Canaria, 35016
SpainSite Not Available
GSK Investigational Site
Madrid, 28010
SpainSite Not Available
GSK Investigational Site
Málaga, 29016
SpainSite Not Available
GSK Investigational Site
Oviedo, 33006
SpainSite Not Available
GSK Investigational Site
Pamplona, 31008
SpainSite Not Available
GSK Investigational Site
Santander (Cantabria), 39008
SpainSite Not Available
GSK Investigational Site
Sevilla, 41014
SpainSite Not Available
GSK Investigational Site
Valladolid, 47003
SpainSite Not Available
GSK Investigational Site
Gävle, SE-801 87
SwedenSite Not Available
GSK Investigational Site
Kaohsiung, 833
TaiwanSite Not Available
GSK Investigational Site
New Taipei City, 23561
TaiwanSite Not Available
GSK Investigational Site
Taipei, 112
TaiwanSite Not Available
GSK Investigational Site
Taoyuan City, 333
TaiwanSite Not Available
GSK Investigational Site
Bangkok, 10400
ThailandSite Not Available
GSK Investigational Site
Chiang Mai, 50200
ThailandSite Not Available
GSK Investigational Site
Khon Kaen, 40002
ThailandSite Not Available
GSK Investigational Site
Songkla, 90110
ThailandSite Not Available
GSK Investigational Site
Adana, 01250
TurkeySite Not Available
GSK Investigational Site
Ankara, 06800
TurkeySite Not Available
GSK Investigational Site
Istanbul, 34722
TurkeySite Not Available
GSK Investigational Site
Izmir, 35530
TurkeySite Not Available
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