Phase
Condition
N/ATreatment
Belrestotug
Dostarlimab
Placebo
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
Cipoletti, Rio Negro, Río Negro R8324CVE
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
Cipoletti Rio Negro, R8324CVE
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma De Bueno, C1056ABI
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, C1426AGE
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, 1425
ArgentinaActive - Recruiting
GSK Investigational Site
Cordoba, 5000
ArgentinaActive - Recruiting
GSK Investigational Site
Florida, 1602
ArgentinaActive - Recruiting
GSK Investigational Site
Mendoza, M5500AYB
ArgentinaActive - Recruiting
GSK Investigational Site
Rosario, S2002
ArgentinaActive - Recruiting
GSK Investigational Site
San Miguel de TucumAn, T4000
ArgentinaActive - Recruiting
GSK Investigational Site
Gent, 9000
BelgiumActive - Recruiting
GSK Investigational Site
Hasselt, 3500
BelgiumActive - Recruiting
GSK Investigational Site
Mont Gaston, 5530
BelgiumActive - Recruiting
GSK Investigational Site
Namur, 5000
BelgiumSite 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
Belém, Pará 66.073-005
BrazilSite Not Available
GSK Investigational Site
Porto Velho, Rondônia 76.834-899
BrazilSite Not Available
GSK Investigational Site
São José do Rio Preto, São Paulo 15090-000
BrazilSite Not Available
GSK Investigational Site
Barretos, 14784-400
BrazilActive - Recruiting
GSK Investigational Site
BelEm, 66.073-005
BrazilActive - Recruiting
GSK Investigational Site
CuritibaPR, 80810-050
BrazilActive - Recruiting
GSK Investigational Site
Florianopolis, 88034-000
BrazilActive - Recruiting
GSK Investigational Site
Fortaleza, 60336-232
BrazilActive - Recruiting
GSK Investigational Site
Londrina, 86015-520
BrazilActive - Recruiting
GSK Investigational Site
Porto VelhoRondOnia, 76.834-899
BrazilActive - Recruiting
GSK Investigational Site
SAo JosE Do Rio PretoSP, 15090-000
BrazilActive - Recruiting
GSK Investigational Site
Salvador, 40414-120
BrazilActive - Recruiting
GSK Investigational Site
Sao Paulo, 04312903
BrazilActive - Recruiting
GSK Investigational Site
São Paulo, 04312903
BrazilSite Not Available
GSK Investigational Site
VitOria, 29043-260
BrazilActive - Recruiting
GSK Investigational Site
Haskovo, 6300
BulgariaActive - Recruiting
GSK Investigational Site
Plovdiv, 4004
BulgariaActive - Recruiting
GSK Investigational Site
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
GSK Investigational Site
Winnipeg, Manitoba R3E 0V9
CanadaSite Not Available
GSK Investigational Site
Halifax, Nova Scotia B3H 1V7
CanadaActive - Recruiting
GSK Investigational Site
Chongqing, Chongqing 400030
ChinaActive - Recruiting
GSK Investigational Site
Chengdu, 610000
ChinaActive - Recruiting
GSK Investigational Site
Hangzhou, 310006
ChinaActive - Recruiting
GSK Investigational Site
Hefei, 230001
ChinaActive - Recruiting
GSK Investigational Site
Nanjing, 210006
ChinaActive - Recruiting
GSK Investigational Site
Nanning, 530021
ChinaActive - Recruiting
GSK Investigational Site
Nantong,
ChinaActive - Recruiting
GSK Investigational Site
Shanghai, 200030
ChinaActive - Recruiting
GSK Investigational Site
Suzhou, 215004
ChinaActive - Recruiting
GSK Investigational Site
Taizhou, 317000
ChinaActive - Recruiting
GSK Investigational Site
Wei Fang,
ChinaActive - Recruiting
GSK Investigational Site
Wuhan, 430030
ChinaActive - Recruiting
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
FinlandActive - Recruiting
GSK Investigational Site
Kuopio, 70210
FinlandActive - Recruiting
GSK Investigational Site
Oulu, 90029
FinlandActive - Recruiting
GSK Investigational Site
Tampere, 33520
FinlandActive - Recruiting
GSK Investigational Site
Turku, 20520
FinlandActive - Recruiting
GSK Investigational Site
Vaasa, 65130
FinlandActive - Recruiting
GSK Investigational Site
Angers, 49000
FranceSite Not Available
GSK Investigational Site
Angers cedex 9, 49000
FranceActive - Recruiting
GSK Investigational Site
Boulogne Billancourt, 92100
FranceActive - Recruiting
GSK Investigational Site
Boulogne-Billancourt, 92100
FranceSite Not Available
GSK Investigational Site
Limoges Cedex, 87042
FranceActive - Recruiting
GSK Investigational Site
Lorient, 56100
FranceActive - Recruiting
GSK Investigational Site
Pessac, 33064
FranceSite Not Available
GSK Investigational Site
Pessac cedex, 33064
FranceActive - Recruiting
GSK Investigational Site
Rennes, 35033
FranceActive - Recruiting
GSK Investigational Site
Rennes Cedex 9, 35033
FranceSite Not Available
GSK Investigational Site
Loewenstein, Baden-Wuerttemberg 74245
GermanySite Not Available
GSK Investigational Site
Muenchen, Bayern 80336
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
Esslingen, 73730
GermanyActive - Recruiting
GSK Investigational Site
Frankfurt, 60488
GermanyActive - Recruiting
GSK Investigational Site
Gauting, 82131
GermanyActive - Recruiting
GSK Investigational Site
Halle, 06120
GermanyActive - Recruiting
GSK Investigational Site
Hamburg, 20251
GermanyActive - Recruiting
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, 57010
GreeceSite Not Available
GSK Investigational Site
Kowloon,
Hong KongSite Not Available
GSK Investigational Site
Shatin,
Hong KongActive - Recruiting
GSK Investigational Site
Budapest, H-1122
HungarySite Not Available
GSK Investigational Site
Farkasgyepu, 8582
HungarySite Not Available
GSK Investigational Site
GyOngyOs, 3200
HungaryActive - Recruiting
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
VeszprEm, 8582
HungaryActive - Recruiting
GSK Investigational Site
Gokul Shirgoan, Kolhapur 416234
IndiaActive - Recruiting
GSK Investigational Site
Nashik, Maharashtra 422005
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
Ahmedabad-380016, 380 016
IndiaActive - Recruiting
GSK Investigational Site
Apex Wellness Hospital, 422005
IndiaActive - Recruiting
GSK Investigational Site
Bangalore, 560085
IndiaActive - Recruiting
GSK Investigational Site
Belagavi, 590010
IndiaActive - Recruiting
GSK Investigational Site
Bhubaneshwar, 751007
IndiaActive - Recruiting
GSK Investigational Site
Bhubaneswar, 751019
IndiaActive - Recruiting
GSK Investigational Site
Gurgaon, 122001
IndiaActive - Recruiting
GSK Investigational Site
Kolkata, 700020
IndiaActive - Recruiting
GSK Investigational Site
Mumbai, 400012
IndiaSite Not Available
GSK Investigational Site
New Delhi, 110075
IndiaActive - Recruiting
GSK Investigational Site
Meldola (FC), Emilia-Romagna 47014
ItalySite Not Available
GSK Investigational Site
Roma, Lazio 00152
ItalySite Not Available
GSK Investigational Site
Orbassano (TO), Piemonte 10043
ItalySite Not Available
GSK Investigational Site
Avellino, 83100
ItalyActive - Recruiting
GSK Investigational Site
Bari, 70124
ItalyActive - Recruiting
GSK Investigational Site
Bergamo, 24125
ItalySite Not Available
GSK Investigational Site
Meldola FC, 47014
ItalyActive - Recruiting
GSK Investigational Site
Milano, 20141
ItalyActive - Recruiting
GSK Investigational Site
Pesaro, 61122
ItalyActive - Recruiting
GSK Investigational Site
Verona, 37134
ItalyActive - Recruiting
GSK Investigational Site
Aichi, 466-8560
JapanActive - Recruiting
GSK Investigational Site
Chiba, 273-8588
JapanActive - Recruiting
GSK Investigational Site
Ehime, 791-0280
JapanActive - Recruiting
GSK Investigational Site
Fukuoka, 814-0180
JapanActive - Recruiting
GSK Investigational Site
Gifu, 503-8502
JapanActive - Recruiting
GSK Investigational Site
Gunma, 377-0280
JapanActive - Recruiting
GSK Investigational Site
Hiroshima, 737-0023
JapanActive - Recruiting
GSK Investigational Site
Hokkaido, 062-0931
JapanActive - Recruiting
GSK Investigational Site
Hyogo, 665-0827
JapanActive - Recruiting
GSK Investigational Site
Kanagawa, 236-0051
JapanActive - Recruiting
GSK Investigational Site
Kyoto, 612-8555
JapanActive - Recruiting
GSK Investigational Site
Mie, 515-8544
JapanActive - Recruiting
GSK Investigational Site
Miyagi, 981-0914
JapanActive - Recruiting
GSK Investigational Site
Nagasaki, 852-8501
JapanActive - Recruiting
GSK Investigational Site
Niigata, 951-8566
JapanActive - Recruiting
GSK Investigational Site
Okayama, 710-8602
JapanActive - Recruiting
GSK Investigational Site
Osaka, 591-8555
JapanActive - Recruiting
GSK Investigational Site
Tochigi, 329-0498
JapanActive - Recruiting
GSK Investigational Site
Tokyo, 113-8603
JapanActive - Recruiting
GSK Investigational Site
Tottori, 683-8504
JapanActive - Recruiting
GSK Investigational Site
Wakayama, 641-8510
JapanActive - Recruiting
GSK Investigational Site
Daegu, 41404
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Incheon, 21565
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Seoul, 120-752
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Seoul,, 120-752
Korea, Republic ofSite Not Available
GSK Investigational Site
Suwon, 16247
Korea, Republic ofSite Not Available
GSK Investigational Site
Suwon Gyeonggi-do, 16247
Korea, Republic ofActive - Recruiting
GSK Investigational Site
La Paz, Baja California Sur 23040
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
Guadajalara, 44280
MexicoActive - Recruiting
GSK Investigational Site
La Paz BCS, 23040
MexicoActive - Recruiting
GSK Investigational Site
Mexico City, 06700
MexicoActive - Recruiting
GSK Investigational Site
San Luis PotosI, 78209
MexicoActive - Recruiting
GSK Investigational Site
San Luis Potosí, 78209
MexicoSite Not Available
GSK Investigational Site
Tamaulipas, 89440
MexicoActive - Recruiting
GSK Investigational Site
Alkmaar, 1815 JD
NetherlandsActive - Recruiting
GSK Investigational Site
Den Haag, 2545 AA
NetherlandsActive - Recruiting
GSK Investigational Site
Enschede, 7512 KZ
NetherlandsActive - Recruiting
GSK Investigational Site
Rotterdam, 3045 PM
NetherlandsActive - Recruiting
GSK Investigational Site
Panama,
PanamaActive - Recruiting
GSK Investigational Site
Punta Pacifica Panama City Panama,
PanamaActive - Recruiting
GSK Investigational Site
Iloilo City, 5000
PhilippinesActive - Recruiting
GSK Investigational Site
Manila, 1000
PhilippinesActive - Recruiting
GSK Investigational Site
Quezon City, 1102
PhilippinesSite Not Available
GSK Investigational Site
Bialystok, 15-540
PolandActive - Recruiting
GSK Investigational Site
Katowice, 40-514
PolandActive - Recruiting
GSK Investigational Site
Lodz, 93-513
PolandSite Not Available
GSK Investigational Site
Olsztyn, 10-357
PolandSite Not Available
GSK Investigational Site
Poznan, 60-569
PolandActive - Recruiting
GSK Investigational Site
Przemysl, 37-700
PolandActive - Recruiting
GSK Investigational Site
Rzeszow, 35-055
PolandActive - Recruiting
GSK Investigational Site
Warszawa, 02-507
PolandSite Not Available
GSK Investigational Site
Alcabideche, 2755-009
PortugalActive - Recruiting
GSK Investigational Site
Lisboa, 1769-001
PortugalActive - Recruiting
GSK Investigational Site
Matosinhos, 4464-509
PortugalActive - Recruiting
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, 200347
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, 308433
SingaporeActive - Recruiting
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
Majadahonda, Madrid 28222
SpainSite Not Available
GSK Investigational Site
Cartagena, Murcia 30202
SpainSite Not Available
GSK Investigational Site
A CoruNa, 15006
SpainActive - Recruiting
GSK Investigational Site
A Coruña, 15009
SpainSite Not Available
GSK Investigational Site
Aravaca, 28013
SpainActive - Recruiting
GSK Investigational Site
Aravaca - Madrid, 28013
SpainSite Not Available
GSK Investigational Site
Baracaldo/Vizcaya, 48903
SpainSite Not Available
GSK Investigational Site
BaracaldoVizcaya, 48903
SpainActive - Recruiting
GSK Investigational Site
Barcelona, 08023
SpainActive - Recruiting
GSK Investigational Site
COrdoba, 14004
SpainActive - Recruiting
GSK Investigational Site
Cartagena Murcia, 30202
SpainActive - Recruiting
GSK Investigational Site
Córdoba, 14004
SpainSite Not Available
GSK Investigational Site
Jaen, 23007
SpainActive - Recruiting
GSK Investigational Site
Jerez de la Frontera, 11407
SpainActive - Recruiting
GSK Investigational Site
La CoruNa, 15009
SpainActive - Recruiting
GSK Investigational Site
La Coruña, 15006
SpainSite Not Available
GSK Investigational Site
Las Palmas De Gran Canar, 35016
SpainActive - Recruiting
GSK Investigational Site
Las Palmas de Gran Canaria, 35016
SpainSite Not Available
GSK Investigational Site
MAlaga, 29016
SpainActive - Recruiting
GSK Investigational Site
Madrid, 28222
SpainActive - Recruiting
GSK Investigational Site
Málaga, 29016
SpainSite Not Available
GSK Investigational Site
Oviedo, 33006
SpainActive - Recruiting
GSK Investigational Site
Pamplona, 31008
SpainActive - Recruiting
GSK Investigational Site
Salamanca, 37007
SpainActive - Recruiting
GSK Investigational Site
Santander, 39008
SpainActive - Recruiting
GSK Investigational Site
Santander (Cantabria), 39008
SpainSite Not Available
GSK Investigational Site
Sevilla, 41014
SpainActive - Recruiting
GSK Investigational Site
Valladolid, 47003
SpainActive - Recruiting
GSK Investigational Site
Gavle, SE-801 87
SwedenActive - Recruiting
GSK Investigational Site
Gävle, SE-801 87
SwedenSite Not Available
GSK Investigational Site
Stockholm, 171 64
SwedenActive - Recruiting
GSK Investigational Site
Kaohsiung, 833
TaiwanActive - Recruiting
GSK Investigational Site
New Taipei City, 23561
TaiwanSite Not Available
GSK Investigational Site
Taipei, 100
TaiwanActive - Recruiting
GSK Investigational Site
Taoyuan, 333
TaiwanActive - Recruiting
GSK Investigational Site
Taoyuan City, 333
TaiwanSite Not Available
GSK Investigational Site
Bangkok, 10400
ThailandSite Not Available
GSK Investigational Site
Chiang Mai, 50200
ThailandActive - Recruiting
GSK Investigational Site
Kho Hong Hat Yai, 90110
ThailandActive - Recruiting
GSK Investigational Site
Khon Kaen, 40002
ThailandActive - Recruiting
GSK Investigational Site
Songkla, 90110
ThailandSite Not Available
GSK Investigational Site
Adana, 1120
TurkeyActive - Recruiting
GSK Investigational Site
Ankara, 06800
TurkeyActive - Recruiting
GSK Investigational Site
Istanbul, 34722
TurkeyActive - Recruiting
GSK Investigational Site
Izmir, 35530
TurkeySite Not Available
GSK Investigational Site
Ocala, Florida 34474
United StatesActive - Recruiting
GSK Investigational Site
Honolulu, Hawaii 96819
United StatesActive - Recruiting
GSK Investigational Site
Edgewood, Kentucky 41017
United StatesActive - Recruiting
GSK Investigational Site
Lexington, Kentucky 40509
United StatesActive - Recruiting
GSK Investigational Site
Omaha, Nebraska 68114
United StatesActive - Recruiting
GSK Investigational Site
Chattanooga, Tennessee 37404
United StatesActive - Recruiting
GSK Investigational Site
Nashville, Tennessee 37203
United StatesActive - Recruiting
GSK Investigational Site
Fort Worth, Texas 76104
United StatesActive - Recruiting
GSK Investigational Site
Fredericksburg, Virginia 22408
United StatesActive - Recruiting
GSK Investigational Site
Olympia, Washington 98506
United StatesActive - Recruiting
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