Phase
Condition
N/ATreatment
Placebo
Belrestotug
Dostarlimab
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
Ciudad Autonoma de Buenos Aires, Buenos Aires 1425
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, 1425
ArgentinaSite Not Available
GSK Investigational Site
Cipoletti Rio Negro, R8324CVE
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma de Bueno, C1056ABI
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, C1426AGE
ArgentinaSite Not Available
GSK Investigational Site
Cordoba, 5000
ArgentinaSite Not Available
GSK Investigational Site
Córdoba, 5000
ArgentinaSite Not Available
GSK Investigational Site
Florida, 1602
ArgentinaSite Not Available
GSK Investigational Site
Mendoza, M5500AYB
ArgentinaSite Not Available
GSK Investigational Site
Rosario, S2002
ArgentinaSite Not Available
GSK Investigational Site
Rosario 3838583, S2002KDT
ArgentinaSite Not Available
GSK Investigational Site
San Miguel de Tucumán, T4000
ArgentinaSite Not Available
GSK Investigational Site
Hasselt, 3500
BelgiumSite Not Available
GSK Investigational Site
Mont Gaston, 5530
BelgiumSite Not Available
GSK Investigational Site
Florianopolis, Santa Catarina 88034-000
BrazilSite Not Available
GSK Investigational Site
Barretos, 14784-400
BrazilSite Not Available
GSK Investigational Site
Belém, 66.073-005
BrazilSite Not Available
GSK Investigational Site
CuritibaPR, 80810-050
BrazilSite Not Available
GSK Investigational Site
Florianópolis, 88034-000
BrazilSite Not Available
GSK Investigational Site
Fortaleza, 60336-232
BrazilSite Not Available
GSK Investigational Site
Londrina, 86015-520
BrazilSite Not Available
GSK Investigational Site
Porto VelhoRondOnia, 76.834-899
BrazilSite Not Available
GSK Investigational Site
SAo JosE Do Rio PretoSP, 15090-000
BrazilSite Not Available
GSK Investigational Site
Salvador, 40414-120
BrazilSite Not Available
GSK Investigational Site
São Paulo, 04312903
BrazilSite Not Available
GSK Investigational Site
Vitória, 29043-260
BrazilSite Not Available
GSK Investigational Site
Haskovo, 6300
BulgariaSite Not Available
GSK Investigational Site
Plovdiv, 4004
BulgariaSite Not Available
GSK Investigational Site
Halifax, Nova Scotia B3H 1V7
CanadaSite Not Available
GSK Investigational Site
Chengdu, 610000
ChinaSite Not Available
GSK Investigational Site
Hangzhou, 310006
ChinaSite Not Available
GSK Investigational Site
Hangzhou 1808926,
ChinaSite Not Available
GSK Investigational Site
Hefei, 230001
ChinaSite Not Available
GSK Investigational Site
Nanjing, 210006
ChinaSite Not Available
GSK Investigational Site
Shanghai, 200030
ChinaSite Not Available
GSK Investigational Site
Kuopio, 70210
FinlandSite Not Available
GSK Investigational Site
Turku, 20520
FinlandSite Not Available
GSK Investigational Site
Angers, 49000
FranceSite Not Available
GSK Investigational Site
Boulogne-Billancourt, 92100
FranceSite Not Available
GSK Investigational Site
Limoges, 87042
FranceSite Not Available
GSK Investigational Site
Lorient, 56100
FranceSite Not Available
GSK Investigational Site
Pessac, 33064
FranceSite Not Available
GSK Investigational Site
Rennes, 35033
FranceSite Not Available
GSK Investigational Site
Esslingen, Baden-Wuerttemberg 73730
GermanySite Not Available
GSK Investigational Site
Gauting, Bayern 82131
GermanySite Not Available
GSK Investigational Site
Muenchen, Bayern 81925
GermanySite Not Available
GSK Investigational Site
Frankfurt, Hessen 60488
GermanySite Not Available
GSK Investigational Site
Halle, Sachsen-Anhalt 06120
GermanySite Not Available
GSK Investigational Site
Hamburg, 20251
GermanySite Not Available
GSK Investigational Site
Athens, 115 27
GreeceSite Not Available
GSK Investigational Site
Thessaloniki, 54622
GreeceSite Not Available
GSK Investigational Site
Shatin,
Hong KongSite Not Available
GSK Investigational Site
Gokul Shirgoan, Kolhapur 416234
IndiaSite Not Available
GSK Investigational Site
Bhubaneshwar, Odisha 751019
IndiaSite Not Available
GSK Investigational Site
Apex Wellness Hospital, 422005
IndiaSite Not Available
GSK Investigational Site
Bangalore, 560085
IndiaSite Not Available
GSK Investigational Site
Bangalore 1277333, 560085
IndiaSite Not Available
GSK Investigational Site
Belagavi, 590010
IndiaSite Not Available
GSK Investigational Site
Bhubaneswar, 751007
IndiaSite Not Available
GSK Investigational Site
Gurgaon, 122001
IndiaSite Not Available
GSK Investigational Site
New Delhi, 110075
IndiaSite Not Available
GSK Investigational Site
Avellino, Campania 83100
ItalySite Not Available
GSK Investigational Site
Milano, Lombardia 20141
ItalySite Not Available
GSK Investigational Site
Bari, Puglia 70124
ItalySite Not Available
GSK Investigational Site
Verona, Veneto 37134
ItalySite Not Available
GSK Investigational Site
Aichi, 466-8560
JapanSite Not Available
GSK Investigational Site
Ehime, 790-0024
JapanSite Not Available
GSK Investigational Site
Fukuoka, 814-0180
JapanSite Not Available
GSK Investigational Site
Fukuoka 1863967, 814-0180
JapanSite Not Available
GSK Investigational Site
Hokkaido, 062-0931
JapanSite Not Available
GSK Investigational Site
Hyogo, 665-0827
JapanSite Not Available
GSK Investigational Site
Hyōgo, 665-0827
JapanSite Not Available
GSK Investigational Site
Hyōgo 2129969, 665-0827
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
JapanSite Not Available
GSK Investigational Site
Miyagi 1856813, 981-0914
JapanSite Not Available
GSK Investigational Site
Nagasaki, 852-8501
JapanSite Not Available
GSK Investigational Site
Niigata, 951-8566
JapanSite Not Available
GSK Investigational Site
Osaka, 596-8501
JapanSite Not Available
GSK Investigational Site
Osaka 1853909, 591-8555
JapanSite Not Available
GSK Investigational Site
Tokyo, 162-8655
JapanSite Not Available
GSK Investigational Site
Tokyo 1850147, 113-8603
JapanSite Not Available
GSK Investigational Site
Tottori, 683-8504
JapanSite Not Available
GSK Investigational Site
Wakayama, 641-8510
JapanSite Not Available
GSK Investigational Site
Incheon, 21565
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, 08308
Korea, Republic ofSite Not Available
GSK Investigational Site
Guadajalara, 44280
MexicoSite Not Available
GSK Investigational Site
La Paz BCS, 23040
MexicoSite Not Available
GSK Investigational Site
Mexico City, 06700
MexicoSite Not Available
GSK Investigational Site
San Luis Potosí City, 78209
MexicoSite Not Available
GSK Investigational Site
Alkmaar, 1815 JD
NetherlandsSite Not Available
GSK Investigational Site
Enschede, 7512 KZ
NetherlandsSite Not Available
GSK Investigational Site
Panama,
PanamaSite Not Available
GSK Investigational Site
Panama City,
PanamaSite Not Available
GSK Investigational Site
Punta Pacifica Panama City Panama,
PanamaSite Not Available
GSK Investigational Site
Manila, 1000
PhilippinesSite Not Available
GSK Investigational Site
Lodz, 90-338
PolandSite Not Available
GSK Investigational Site
Craiova, 200094
RomaniaSite Not Available
GSK Investigational Site
Belgrade, 11000
SerbiaSite Not Available
GSK Investigational Site
Singapore, 168583
SingaporeSite Not Available
GSK Investigational Site
Daegu, 41404
South KoreaSite Not Available
GSK Investigational Site
Incheon, 21565
South KoreaSite Not Available
GSK Investigational Site
Seoul, 120-752
South KoreaSite Not Available
GSK Investigational Site
Seoul 1835848, 08308
South KoreaSite Not Available
GSK Investigational Site
A Coruña, 15006
SpainSite Not Available
GSK Investigational Site
Aravaca, 28013
SpainSite Not Available
GSK Investigational Site
BaracaldoVizcaya, 48903
SpainSite Not Available
GSK Investigational Site
Barcelona, 08003
SpainSite Not Available
GSK Investigational Site
Barcelona 3128760, 08023
SpainSite Not Available
GSK Investigational Site
Jaén, 23007
SpainSite Not Available
GSK Investigational Site
Las Palmas de Gran Canar, 35016
SpainSite Not Available
GSK Investigational Site
Madrid, 28033
SpainSite Not Available
GSK Investigational Site
Madrid 3117735, 28033
SpainSite Not Available
GSK Investigational Site
Oviedo, 33006
SpainSite Not Available
GSK Investigational Site
Pamplona, 31008
SpainSite Not Available
GSK Investigational Site
Salamanca, 37007
SpainSite Not Available
GSK Investigational Site
Santander, 39008
SpainSite Not Available
GSK Investigational Site
Seville, 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, 807
TaiwanSite Not Available
GSK Investigational Site
Kaohsiung City, 807
TaiwanSite Not Available
GSK Investigational Site
Taipei, 23561
TaiwanSite Not Available
GSK Investigational Site
Adana, 01250
TurkeySite Not Available
GSK Investigational Site
Ankara, 06560
TurkeySite Not Available
GSK Investigational Site
Adana, 1120
Turkey (Türkiye)Site Not Available
GSK Investigational Site
Ankara, 06560
Turkey (Türkiye)Site Not Available
GSK Investigational Site
Ankara 323786, 06800
Turkey (Türkiye)Site Not Available
GSK Investigational Site
Ocala, Florida 34474
United StatesSite Not Available
GSK Investigational Site
Honolulu, Hawaii 96819
United StatesSite Not Available
GSK Investigational Site
Lexington, Kentucky 40509
United StatesSite Not Available
GSK Investigational Site
Lexington 4297983, Kentucky 6254925 40503
United StatesSite Not Available
GSK Investigational Site
Omaha, Nebraska 68114
United StatesSite Not Available
GSK Investigational Site
Nashville, Tennessee 37203
United StatesSite Not Available
GSK Investigational Site
Fort Worth, Texas 76104
United StatesSite Not Available
GSK Investigational Site
Olympia, Washington 98506
United StatesSite Not Available

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