Phase
Condition
N/ATreatment
Dostarlimab
Belrestotug
GSK6097608
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of locally advanced unresectableNSCLC not eligible for curative surgery and/or definitive radiotherapy with orwithout chemotherapy or metastatic NSCLC (squamous or non squamous)
No prior systemic therapy for their locally advanced or metastatic NSCLC
Provides a fresh tumor tissue sample or archival sample collected within 2 yearsprior to screening
PD-L1-high (TC/TPS >= 50%) tumor
Measurable disease based on RECIST 1.1, as determined by the investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Adequate Baseline organ function
Female participants of childbearing potential must use adequate contraception
Exclusion
Exclusion Criteria:
Presence of Epidermal growth factor receptor (EGFR) mutations, Anaplastic lymphomakinase (ALK) translocations, or other known genomic aberrations or oncogenic drivermutations for which a locally approved targeted therapy is available.
Has NSCLC with a tumor that harbors any of the following molecular alterations: EGFRand /or ALK translocations mutations that are sensitive to available targetedinhibitor therapy, Any other known genomic aberrations or oncogenic driver mutationsfor which a locally approved targeted therapy is available for first-line treatmentof locally advanced or metastatic NSCLC.
Had major surgery within 4 weeks or lung radiation of >30 Gy therapy within 6 monthsprior to the first dose of study intervention
Received prior therapy with any immune checkpoint inhibitors
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 (clinical exceptions apply as per protocol)
Symptomatic, untreated, or actively progressing, brain metastases or anyleptomeningeal disease (regardless of symptomatology, treatment status, orstability)
Autoimmune disease or syndrome that required systemic treatment within the past 2years
Receiving systemic steroid therapy <= 3 days prior to first dose of studyintervention or any form of immunosuppressive medication
Received any live vaccine <= 30 days prior to first dose of study intervention
Any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug inducedpneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
History or evidence of cardiac abnormalities
Current unstable liver or biliary disease
Severe infection within 4 weeks prior to the first dose of study intervention
Positive for tuberculosis, human immunodeficiency virus (HIV) infection, hepatitis Bsurface antigen, or hepatitis C
Has advanced, symptomatic, or visceral spread and is considered to be at imminentrisk of life-threatening complications (including, but not limited to, massiveuncontrolled effusions [e.g., pleural, pericardial, peritoneal])
Is currently participating in or has participated in a study of an investigationaltherapy within 4 weeks prior to the first dose of study intervention
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 Buenos Aires, Buenos Aires C1430EGF
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires 1425
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP
ArgentinaSite Not Available
GSK Investigational Site
Cipoletti, Rio Negro, Río Negro R8324CVE
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1426ABP
ArgentinaSite Not Available
GSK Investigational Site
Cipoletti Rio Negro, R8324CVE
ArgentinaSite Not Available
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire, C1426ABP
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, 1414
ArgentinaSite Not Available
GSK Investigational Site
Florida, 1602
ArgentinaSite Not Available
GSK Investigational Site
Mar del Plata, 7600
ArgentinaSite Not Available
GSK Investigational Site
San Juan, J5402DIL
ArgentinaSite Not Available
GSK Investigational Site
Santa Fe, 3000
ArgentinaSite Not Available
GSK Investigational Site
Edegem, 2650
BelgiumSite Not Available
GSK Investigational Site
Wilrijk, 2650
BelgiumSite Not Available
GSK Investigational Site
Vitória, Espírito Santo 29043-260
BrazilSite Not Available
GSK Investigational Site
Bela Vista, São Paulo 01323-001
BrazilSite Not Available
GSK Investigational Site
Barretos, 14784-400
BrazilSite Not Available
GSK Investigational Site
Porto Alegre, 90610-000
BrazilSite Not Available
GSK Investigational Site
Sao Paulo, 01246-000
BrazilSite Not Available
GSK Investigational Site
São Paulo, 01246-000
BrazilSite Not Available
GSK Investigational Site
VitOria, 29043-260
BrazilSite 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
Bordeaux, 33076
FranceSite Not Available
GSK Investigational Site
Bordeaux Cedex, 33076
FranceSite Not Available
GSK Investigational Site
Caen Cedex 9, 14033
FranceSite Not Available
GSK Investigational Site
Marseille, 13009
FranceSite Not Available
GSK Investigational Site
Montpellier Cedex, 34298
FranceSite Not Available
GSK Investigational Site
Quimper cedex, 29107
FranceSite Not Available
GSK Investigational Site
Strasbourg, 67091
FranceSite Not Available
GSK Investigational Site
Strasbourg Cedex, 67091
FranceSite Not Available
GSK Investigational Site
Dresden, Sachsen 01307
GermanySite Not Available
GSK Investigational Site
Berlin, 13125
GermanySite Not Available
GSK Investigational Site
Essen, 45147
GermanySite Not Available
GSK Investigational Site
Grosshansdorf, 22927
GermanySite Not Available
GSK Investigational Site
Heidelberg, 69126
GermanySite Not Available
GSK Investigational Site
Jena, 07747
GermanySite Not Available
GSK Investigational Site
Athens, 11528
GreeceSite Not Available
GSK Investigational Site
Haidari - Athens, 12462
GreeceSite Not Available
GSK Investigational Site
Larisa, 41110
GreeceSite Not Available
GSK Investigational Site
Larissa, 41110
GreeceSite Not Available
GSK Investigational Site
PapagosAthens, 115 27
GreeceSite Not Available
GSK Investigational Site
Pylaia Thessaloniki, 57001
GreeceSite Not Available
GSK Investigational Site
Thessaloniki, 54645
GreeceSite Not Available
GSK Investigational Site
Budapest, H-1121
HungarySite Not Available
GSK Investigational Site
Farkasgyepű, 8552
HungarySite Not Available
GSK Investigational Site
GyOngyOs, 3200
HungarySite Not Available
GSK Investigational Site
Gyöngyös, 3200
HungarySite Not Available
GSK Investigational Site
TOrOkbAlint, 2045
HungarySite Not Available
GSK Investigational Site
TatabAnya, 2800
HungarySite Not Available
GSK Investigational Site
Tatabánya, 2800
HungarySite Not Available
GSK Investigational Site
Törökbálint, 2045
HungarySite Not Available
GSK Investigational Site
Roma, Lazio 00144
ItalySite Not Available
GSK Investigational Site
Livorno, Toscana 57124
ItalySite Not Available
GSK Investigational Site
Legnago (VR), Veneto 37045
ItalySite Not Available
GSK Investigational Site
Avellino, 83100
ItalySite Not Available
GSK Investigational Site
Bergamo, 24125
ItalySite Not Available
GSK Investigational Site
Campania, 83100
ItalySite Not Available
GSK Investigational Site
Firenze, 50134
ItalySite Not Available
GSK Investigational Site
Genova, 16132
ItalySite Not Available
GSK Investigational Site
Pisa, 57124
ItalySite Not Available
GSK Investigational Site
Verona, 37045
ItalySite Not Available
GSK Investigational Site
Chiba, 277-8577
JapanSite Not Available
GSK Investigational Site
Fukuoka, 812-8582
JapanSite Not Available
GSK Investigational Site
Hyogo, 673-8558
JapanSite Not Available
GSK Investigational Site
Kanagawa, 241-8515
JapanSite Not Available
GSK Investigational Site
Osaka, 589-8511
JapanSite Not Available
GSK Investigational Site
Saitama, 350-1298
JapanSite Not Available
GSK Investigational Site
Incheon, 21565
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, 03722
Korea, Republic ofSite Not Available
GSK Investigational Site
Suwon Gyeonggi-do, 442-723
Korea, Republic ofSite Not Available
GSK Investigational Site
Suwon, Gyeonggi-do, 442-723
Korea, Republic ofSite Not Available
GSK Investigational Site
Toluca de Lerdo, Estado De México 50120
MexicoSite Not Available
GSK Investigational Site
Estado de Mexico, 50120
MexicoSite Not Available
GSK Investigational Site
Guadalajara, 44280
MexicoSite Not Available
GSK Investigational Site
San Luis PotosI, 78209
MexicoSite Not Available
GSK Investigational Site
San Luis Potosí, 78209
MexicoSite Not Available
GSK Investigational Site
Enschede, 7512 KZ
NetherlandsSite Not Available
GSK Investigational Site
Groningen, 9728 NZ
NetherlandsSite Not Available
GSK Investigational Site
Leeuwarden, 8934 AD
NetherlandsSite Not Available
GSK Investigational Site
Utrecht, 3543 AZ
NetherlandsSite Not Available
GSK Investigational Site
Lublin, 20-954
PolandSite Not Available
GSK Investigational Site
Olsztyn, 10-288
PolandSite Not Available
GSK Investigational Site
Prabuty, 82-550
PolandSite Not Available
GSK Investigational Site
Siedlce, 08-110
PolandSite Not Available
GSK Investigational Site
Wroclaw, 53-439
PolandSite Not Available
GSK Investigational Site
Gaia, 4434-502
PortugalSite Not Available
GSK Investigational Site
GuimarAes, 4835-044
PortugalSite Not Available
GSK Investigational Site
Guimarães, 4835-044
PortugalSite Not Available
GSK Investigational Site
Lisboa, 1500-650
PortugalSite Not Available
GSK Investigational Site
Porto, 4200-072
PortugalSite Not Available
GSK Investigational Site
Vila Nova de Gaia, 4434-502
PortugalSite Not Available
GSK Investigational Site
Kraaifontein, Western Province 7570
South AfricaSite Not Available
GSK Investigational Site
Cape Town, 7570
South AfricaSite Not Available
GSK Investigational Site
Parktown, 2193
South AfricaSite Not Available
GSK Investigational Site
Pretoria, 0001
South AfricaSite Not Available
GSK Investigational Site
Badajoz, 06080
SpainSite Not Available
GSK Investigational Site
Badalona, 08916
SpainSite Not Available
GSK Investigational Site
Barcelona, 08035
SpainSite Not Available
GSK Investigational Site
L'Hospitalet de Llobregat, 08907
SpainSite Not Available
GSK Investigational Site
Las Palmas De Gran Canar, 35016
SpainSite Not Available
GSK Investigational Site
Las Palmas De Gran Canaria, 35016
SpainSite Not Available
GSK Investigational Site
Madrid, 28041
SpainSite Not Available
GSK Investigational Site
Malaga, 29010
SpainSite Not Available
GSK Investigational Site
Málaga, 29010
SpainSite Not Available
GSK Investigational Site
PamplonaNavarra, 28027
SpainSite Not Available
GSK Investigational Site
Pozuelo De AlarcOn Madr, 28223
SpainSite Not Available
GSK Investigational Site
Pozuelo De Alarcón. Madrid., 28223
SpainSite Not Available
GSK Investigational Site
Valencia, 46009
SpainSite Not Available
GSK Investigational Site
Bangkok, 10210
ThailandSite Not Available
GSK Investigational Site
Chiangmai, 50200
ThailandSite Not Available
GSK Investigational Site
Khlong Luang, 12120
ThailandSite Not Available
GSK Investigational Site
Kho Hong Hat Yai, 90110
ThailandSite Not Available
GSK Investigational Site
Khon Kaen, 40002
ThailandSite Not Available
GSK Investigational Site
Pathumthani, 12120
ThailandSite Not Available
GSK Investigational Site
Songkla, 90110
ThailandSite Not Available
GSK Investigational Site
Samsun, Atakum 55200
TurkeySite Not Available
GSK Investigational Site
Ankara, 06680
TurkeySite Not Available
GSK Investigational Site
Antalya, 07070
TurkeySite Not Available
GSK Investigational Site
Edirne, 22020
TurkeySite Not Available
GSK Investigational Site
Istanbul, 34214
TurkeySite Not Available
GSK Investigational Site
Abu Dhabi, 51900
United Arab EmiratesSite Not Available
GSK Investigational Site
Abu-Dhabi, 51900
United Arab EmiratesSite Not Available
GSK Investigational Site
Al-Ain,
United Arab EmiratesSite Not Available
GSK Investigational Site
Dubai,
United Arab EmiratesSite Not Available
GSK Investigational Site
Northwood, Middlesex HA6 2RN
United KingdomSite Not Available
GSK Investigational Site
Middlesbrough, TS4 3BW
United KingdomSite Not Available
GSK Investigational Site
Middlesex, HA6 2RN
United KingdomSite Not Available
GSK Investigational Site
Wolverhampton, WV10 0QP
United KingdomSite Not Available
GSK Investigational Site
Los Angeles, California 90017
United StatesSite Not Available
GSK Investigational Site
Plantation, Florida 33322
United StatesSite Not Available
GSK Investigational Site
Baltimore, Maryland 21215
United StatesSite Not Available
GSK Investigational Site
Boston, Massachusetts 02118-2905
United StatesSite Not Available
GSK Investigational Site
Morristown, New Jersey 07962
United StatesSite Not Available
GSK Investigational Site
Albuquerque, New Mexico 87131
United StatesSite Not Available
GSK Investigational Site
Bryn Mawr, Pennsylvania 19010
United StatesSite Not Available
GSK Investigational Site
Media, Pennsylvania 19063
United StatesSite Not Available
GSK Investigational Site
Paoli, Pennsylvania 19301
United StatesSite Not Available
GSK Investigational Site
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
GSK Investigational Site
Wynnewood, Pennsylvania 19096
United StatesSite Not Available
GSK Investigational Site
Chattanooga, Tennessee 37404
United StatesSite Not Available
GSK Investigational Site
Nashville, Tennessee 37203
United StatesSite Not Available
GSK Investigational Site
Morgantown, West Virginia 26506
United StatesSite Not Available
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