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)

Last updated: June 12, 2026
Sponsor: GlaxoSmithKline
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

Belrestotug

Dostarlimab

Clinical Study ID

NCT06472076
213823
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate the safety and tolerability profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC.

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:
  1. Epidermal growth factor receptor (EGFR) mutations that are sensitive toavailable targeted inhibitor therapy

  2. Anaplastic lymphoma kinase (ALK) translocations that are sensitive to availabletargeted inhibitor therapy

  3. 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

Total Participants: 88
Treatment Group(s): 4
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 10, 2024
Estimated Completion Date:
August 30, 2027

Connect with a study center

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires 1425
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, 1425
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cipoletti Rio Negro, R8324CVE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1056ABI
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1426AGE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cordoba, 5000
    Argentina

    Site Not Available

  • GSK Investigational Site

    Córdoba, 5000
    Argentina

    Site Not Available

  • GSK Investigational Site

    Florida, 1602
    Argentina

    Site Not Available

  • GSK Investigational Site

    Mendoza, M5500AYB
    Argentina

    Site Not Available

  • GSK Investigational Site

    Rosario, S2002
    Argentina

    Site Not Available

  • GSK Investigational Site

    Rosario 3838583, S2002KDT
    Argentina

    Site Not Available

  • GSK Investigational Site

    San Miguel de Tucumán, T4000
    Argentina

    Site Not Available

  • GSK Investigational Site

    Hasselt, 3500
    Belgium

    Site Not Available

  • GSK Investigational Site

    Mont Gaston, 5530
    Belgium

    Site Not Available

  • GSK Investigational Site

    Florianopolis, Santa Catarina 88034-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    Barretos, 14784-400
    Brazil

    Site Not Available

  • GSK Investigational Site

    Belém, 66.073-005
    Brazil

    Site Not Available

  • GSK Investigational Site

    CuritibaPR, 80810-050
    Brazil

    Site Not Available

  • GSK Investigational Site

    Florianópolis, 88034-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    Fortaleza, 60336-232
    Brazil

    Site Not Available

  • GSK Investigational Site

    Londrina, 86015-520
    Brazil

    Site Not Available

  • GSK Investigational Site

    Porto VelhoRondOnia, 76.834-899
    Brazil

    Site Not Available

  • GSK Investigational Site

    SAo JosE Do Rio PretoSP, 15090-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    Salvador, 40414-120
    Brazil

    Site Not Available

  • GSK Investigational Site

    São Paulo, 04312903
    Brazil

    Site Not Available

  • GSK Investigational Site

    Vitória, 29043-260
    Brazil

    Site Not Available

  • GSK Investigational Site

    Haskovo, 6300
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • GSK Investigational Site

    Chengdu, 610000
    China

    Site Not Available

  • GSK Investigational Site

    Hangzhou, 310006
    China

    Site Not Available

  • GSK Investigational Site

    Hangzhou 1808926,
    China

    Site Not Available

  • GSK Investigational Site

    Hefei, 230001
    China

    Site Not Available

  • GSK Investigational Site

    Nanjing, 210006
    China

    Site Not Available

  • GSK Investigational Site

    Shanghai, 200030
    China

    Site Not Available

  • GSK Investigational Site

    Kuopio, 70210
    Finland

    Site Not Available

  • GSK Investigational Site

    Turku, 20520
    Finland

    Site Not Available

  • GSK Investigational Site

    Angers, 49000
    France

    Site Not Available

  • GSK Investigational Site

    Boulogne-Billancourt, 92100
    France

    Site Not Available

  • GSK Investigational Site

    Limoges, 87042
    France

    Site Not Available

  • GSK Investigational Site

    Lorient, 56100
    France

    Site Not Available

  • GSK Investigational Site

    Pessac, 33064
    France

    Site Not Available

  • GSK Investigational Site

    Rennes, 35033
    France

    Site Not Available

  • GSK Investigational Site

    Esslingen, Baden-Wuerttemberg 73730
    Germany

    Site Not Available

  • GSK Investigational Site

    Gauting, Bayern 82131
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenchen, Bayern 81925
    Germany

    Site Not Available

  • GSK Investigational Site

    Frankfurt, Hessen 60488
    Germany

    Site Not Available

  • GSK Investigational Site

    Halle, Sachsen-Anhalt 06120
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 20251
    Germany

    Site Not Available

  • GSK Investigational Site

    Athens, 115 27
    Greece

    Site Not Available

  • GSK Investigational Site

    Thessaloniki, 54622
    Greece

    Site Not Available

  • GSK Investigational Site

    Shatin,
    Hong Kong

    Site Not Available

  • GSK Investigational Site

    Gokul Shirgoan, Kolhapur 416234
    India

    Site Not Available

  • GSK Investigational Site

    Bhubaneshwar, Odisha 751019
    India

    Site Not Available

  • GSK Investigational Site

    Apex Wellness Hospital, 422005
    India

    Site Not Available

  • GSK Investigational Site

    Bangalore, 560085
    India

    Site Not Available

  • GSK Investigational Site

    Bangalore 1277333, 560085
    India

    Site Not Available

  • GSK Investigational Site

    Belagavi, 590010
    India

    Site Not Available

  • GSK Investigational Site

    Bhubaneswar, 751007
    India

    Site Not Available

  • GSK Investigational Site

    Gurgaon, 122001
    India

    Site Not Available

  • GSK Investigational Site

    New Delhi, 110075
    India

    Site Not Available

  • GSK Investigational Site

    Avellino, Campania 83100
    Italy

    Site Not Available

  • GSK Investigational Site

    Milano, Lombardia 20141
    Italy

    Site Not Available

  • GSK Investigational Site

    Bari, Puglia 70124
    Italy

    Site Not Available

  • GSK Investigational Site

    Verona, Veneto 37134
    Italy

    Site Not Available

  • GSK Investigational Site

    Aichi, 466-8560
    Japan

    Site Not Available

  • GSK Investigational Site

    Ehime, 790-0024
    Japan

    Site Not Available

  • GSK Investigational Site

    Fukuoka, 814-0180
    Japan

    Site Not Available

  • GSK Investigational Site

    Fukuoka 1863967, 814-0180
    Japan

    Site Not Available

  • GSK Investigational Site

    Hokkaido, 062-0931
    Japan

    Site Not Available

  • GSK Investigational Site

    Hyogo, 665-0827
    Japan

    Site Not Available

  • GSK Investigational Site

    Hyōgo, 665-0827
    Japan

    Site Not Available

  • GSK Investigational Site

    Hyōgo 2129969, 665-0827
    Japan

    Site Not Available

  • GSK Investigational Site

    Kyoto, 612-8555
    Japan

    Site Not Available

  • GSK Investigational Site

    Mie, 515-8544
    Japan

    Site Not Available

  • GSK Investigational Site

    Miyagi, 981-0914
    Japan

    Site Not Available

  • GSK Investigational Site

    Miyagi 1856813, 981-0914
    Japan

    Site Not Available

  • GSK Investigational Site

    Nagasaki, 852-8501
    Japan

    Site Not Available

  • GSK Investigational Site

    Niigata, 951-8566
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka, 596-8501
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka 1853909, 591-8555
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo, 162-8655
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo 1850147, 113-8603
    Japan

    Site Not Available

  • GSK Investigational Site

    Tottori, 683-8504
    Japan

    Site Not Available

  • GSK Investigational Site

    Wakayama, 641-8510
    Japan

    Site Not Available

  • GSK Investigational Site

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul, 08308
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Guadajalara, 44280
    Mexico

    Site Not Available

  • GSK Investigational Site

    La Paz BCS, 23040
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mexico City, 06700
    Mexico

    Site Not Available

  • GSK Investigational Site

    San Luis Potosí City, 78209
    Mexico

    Site Not Available

  • GSK Investigational Site

    Alkmaar, 1815 JD
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Enschede, 7512 KZ
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Panama,
    Panama

    Site Not Available

  • GSK Investigational Site

    Panama City,
    Panama

    Site Not Available

  • GSK Investigational Site

    Punta Pacifica Panama City Panama,
    Panama

    Site Not Available

  • GSK Investigational Site

    Manila, 1000
    Philippines

    Site Not Available

  • GSK Investigational Site

    Lodz, 90-338
    Poland

    Site Not Available

  • GSK Investigational Site

    Craiova, 200094
    Romania

    Site Not Available

  • GSK Investigational Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • GSK Investigational Site

    Singapore, 168583
    Singapore

    Site Not Available

  • GSK Investigational Site

    Daegu, 41404
    South Korea

    Site Not Available

  • GSK Investigational Site

    Incheon, 21565
    South Korea

    Site Not Available

  • GSK Investigational Site

    Seoul, 120-752
    South Korea

    Site Not Available

  • GSK Investigational Site

    Seoul 1835848, 08308
    South Korea

    Site Not Available

  • GSK Investigational Site

    A Coruña, 15006
    Spain

    Site Not Available

  • GSK Investigational Site

    Aravaca, 28013
    Spain

    Site Not Available

  • GSK Investigational Site

    BaracaldoVizcaya, 48903
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08003
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona 3128760, 08023
    Spain

    Site Not Available

  • GSK Investigational Site

    Jaén, 23007
    Spain

    Site Not Available

  • GSK Investigational Site

    Las Palmas de Gran Canar, 35016
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28033
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid 3117735, 28033
    Spain

    Site Not Available

  • GSK Investigational Site

    Oviedo, 33006
    Spain

    Site Not Available

  • GSK Investigational Site

    Pamplona, 31008
    Spain

    Site Not Available

  • GSK Investigational Site

    Salamanca, 37007
    Spain

    Site Not Available

  • GSK Investigational Site

    Santander, 39008
    Spain

    Site Not Available

  • GSK Investigational Site

    Seville, 41014
    Spain

    Site Not Available

  • GSK Investigational Site

    Valladolid, 47003
    Spain

    Site Not Available

  • GSK Investigational Site

    Gävle, SE-801 87
    Sweden

    Site Not Available

  • GSK Investigational Site

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Kaohsiung City, 807
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taipei, 23561
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Adana, 01250
    Turkey

    Site Not Available

  • GSK Investigational Site

    Ankara, 06560
    Turkey

    Site 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 States

    Site Not Available

  • GSK Investigational Site

    Honolulu, Hawaii 96819
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington 4297983, Kentucky 6254925 40503
    United States

    Site Not Available

  • GSK Investigational Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • GSK Investigational Site

    Olympia, Washington 98506
    United States

    Site Not Available

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