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)
NCT ID: NCT06472076
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
88 participants
INTERVENTIONAL
2024-06-10
2027-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dostarlimab plus belrestotug
Dostarlimab
Dostarlimab will be administered.
Belrestotug
Belrestotug will be administered.
Pembrolizumab plus placebo
Pembrolizumab
Pembrolizumab will be administered.
Placebo
Placebo will be administered.
Interventions
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Dostarlimab
Dostarlimab will be administered.
Belrestotug
Belrestotug will be administered.
Pembrolizumab
Pembrolizumab will be administered.
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* Has not received prior systemic therapy for their locally advanced or metastatic NSCLC.
* Provides a fresh tumor tissue sample obtained at the time of or after the initial diagnosis 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 0 or 1.
* Has adequate organ function
Exclusion Criteria
1. Epidermal growth factor receptor (EGFR) mutations that are sensitive to available targeted inhibitor therapy
2. Anaplastic lymphoma kinase (ALK) translocations that are sensitive to available targeted inhibitor therapy
3. Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first line treatment of locally advanced or metastatic NSCLC.
* Has had surgery within 4 weeks of the first dose of study intervention and has not recovered from AEs (i.e., has any ongoing surgery-related events ≥ Grade 1)/complications related to surgery or has received lung radiation therapy of \>30 gray (Gy) within 6 months
* Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoglobulin and ITIM domain (TIGIT), or other checkpoint pathways.
* Has never smoked, defined as smoking \<100 tobacco cigarettes in a lifetime.
* Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome.
* Has symptomatic, untreated, or actively progressin g brain metastases or leptomeningeal disease
* Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years.
* Has received any live vaccine within 30 days prior to first dose of study intervention.
* Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, 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 requiring intervention/treatment in the last 6 months.
* Has severe infection or complication thereof 4 weeks prior to randomisation including active tuberculosis.
* Has a history of allogeneic tissue/stem cell transplant or solid organ transplant.
18 Years
ALL
No
Sponsors
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iTeos Therapeutics
INDUSTRY
GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Ocala, Florida, United States
GSK Investigational Site
Honolulu, Hawaii, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Lexington, Kentucky, United States
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Ann Arbor, Michigan, United States
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Omaha, Nebraska, United States
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Nashville, Tennessee, United States
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Fort Worth, Texas, United States
GSK Investigational Site
Olympia, Washington, United States
GSK Investigational Site
Buenos Aires, , Argentina
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Cipoletti Rio Negro, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad Autonoma de Bueno, , Argentina
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Córdoba, , Argentina
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Florida, , Argentina
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Mendoza, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Hasselt, , Belgium
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Mont Gaston, , Belgium
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Barretos, , Brazil
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Belém, , Brazil
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CuritibaPR, , Brazil
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Florianópolis, , Brazil
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Fortaleza, , Brazil
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Londrina, , Brazil
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Porto VelhoRondOnia, , Brazil
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Salvador, , Brazil
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SAo JosE Do Rio PretoSP, , Brazil
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São Paulo, , Brazil
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Vitória, , Brazil
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Haskovo, , Bulgaria
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Plovdiv, , Bulgaria
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Halifax, Nova Scotia, Canada
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Chengdu, , China
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Hangzhou, , China
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Hangzhou, , China
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Hefei, , China
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Nanjing, , China
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Shanghai, , China
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Kuopio, , Finland
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Turku, , Finland
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Angers, , France
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Boulogne-Billancourt, , France
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Limoges, , France
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Lorient, , France
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Pessac, , France
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Rennes, , France
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Hamburg, , Germany
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Shatin, , Hong Kong
GSK Investigational Site
Gokul Shirgoan, Kolhapur, India
GSK Investigational Site
Ahmedabad-380016, , India
GSK Investigational Site
Apex Wellness Hospital, , India
GSK Investigational Site
Bangalore, , India
GSK Investigational Site
Bangalore, , India
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Belagavi, , India
GSK Investigational Site
Bhubaneshwar, , India
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Bhubaneswar, , India
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Gurgaon, , India
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Kolkata, , India
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New Delhi, , India
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Aichi, , Japan
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Chiba, , Japan
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Ehime, , Japan
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Ehime, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Gifu, , Japan
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Gunma, , Japan
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Hiroshima, , Japan
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Hokkaido, , Japan
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Hyōgo, , Japan
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Hyōgo, , Japan
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Kanagawa, , Japan
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Kyoto, , Japan
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Mie, , Japan
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Miyagi, , Japan
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Miyagi, , Japan
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Nagasaki, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Tochigi, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tokyo, , Japan
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Tottori, , Japan
GSK Investigational Site
Wakayama, , Japan
GSK Investigational Site
Guadajalara, , Mexico
GSK Investigational Site
La Paz BCS, , Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
San Luis Potosí City, , Mexico
GSK Investigational Site
Alkmaar, , Netherlands
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Enschede, , Netherlands
GSK Investigational Site
Panama City, , Panama
GSK Investigational Site
Punta Pacifica Panama City Panama, , Panama
GSK Investigational Site
Daegu, , South Korea
GSK Investigational Site
Incheon, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
A Coruña, , Spain
GSK Investigational Site
Aravaca, , Spain
GSK Investigational Site
BaracaldoVizcaya, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Cartagena Murcia, , Spain
GSK Investigational Site
Córdoba, , Spain
GSK Investigational Site
Jaén, , Spain
GSK Investigational Site
Las Palmas de Gran Canar, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Málaga, , Spain
GSK Investigational Site
Oviedo, , Spain
GSK Investigational Site
Pamplona, , Spain
GSK Investigational Site
Salamanca, , Spain
GSK Investigational Site
Santander, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Valladolid, , Spain
GSK Investigational Site
Gävle, , Sweden
GSK Investigational Site
Kaohsiung City, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Adana, , Turkey (Türkiye)
GSK Investigational Site
Ankara, , Turkey (Türkiye)
GSK Investigational Site
Ankara, , Turkey (Türkiye)
GSK Investigational Site
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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213823
Identifier Type: -
Identifier Source: org_study_id
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