CClinicalTrials.gg
Active, not recruitingNCT05565378Updated Jun 15, 2026

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

A Phase 2 interventional study of Pembrolizumab and Dostarlimab in Lung Cancer, Non-Small Cell, sponsored by GlaxoSmithKline. Active, not recruiting at 99 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
351
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will monitor the safety of novel immunotherapy combinations in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells [TC]/ Tumor proportion score [TPS] >= 50%), previously untreated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.

02

Conditions studied

  • Lung Cancer, Non-Small Cell

Keywords

  • Belrestotug
  • Dostarlimab
  • EOS884448
  • GSK6097608
  • GSK4428859A
  • Nelistotug
  • Non-small-cell lung cancer
  • Pembrolizumab
  • Programmed death ligand 1
  • Programmed death protein 1 Inhibitor
  • Immunotherapy
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 351 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without 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 years prior 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 criteria

Exclusion Criteria:

  • Has NSCLC with a tumor that harbors any of the following molecular alterations: EGFR and /or ALK translocations mutations that are sensitive to available targeted inhibitor therapy, 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.
  • Had major surgery within 4 weeks or lung radiation of >30 Gy therapy within 6 months prior 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 disease under study within the last 5 years (clinical exceptions apply as per protocol)
  • Symptomatic, untreated, or actively progressing, brain metastases or any leptomeningeal disease (regardless of symptomatology, treatment status, or stability)
  • Autoimmune disease or syndrome that required systemic treatment within the past 2 years
  • Receiving systemic steroid therapy \<= 3 days prior to first dose of study intervention 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 induced pneumonitis, 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 B surface antigen, or hepatitis C
  • Has advanced, symptomatic, or visceral spread and is considered to be at imminent risk of life-threatening complications (including, but not limited to, massive uncontrolled effusions [e.g., pleural, pericardial, peritoneal])
  • Is currently participating in or has participated in a study of an investigational therapy within 4 weeks prior to the first dose of study intervention
  • Has a history of allogeneic tissue/stem cell transplant or solid organ transplant
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
351 participants (actual)

Study arms

  • Active comparator
    Pembrolizumab Monotherapy

    Participants will be administered with pembrolizumab as monotherapy in a fixed dose.

    Drug: Pembrolizumab

  • Experimental
    Dostarlimab Monotherapy

    Participants will be administered with dostarlimab as monotherapy in a fixed dose.

    Drug: Dostarlimab

  • Experimental
    Substudy 1A

    Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose A).

    Drug: Dostarlimab · Drug: Belrestotug

  • Experimental
    Substudy 1B

    Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose B).

    Drug: Dostarlimab · Drug: Belrestotug

  • Experimental
    Substudy 1C

    Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose C).

    Drug: Dostarlimab · Drug: Belrestotug

  • Experimental
    Substudy 2A

    Participants will be administered with dostarlimab, fixed dose belrestotug, and fixed dose nelistotug

    Drug: Dostarlimab · Drug: Belrestotug · Drug: Nelistotug

Interventions

  • DrugPembrolizumab

    Pembrolizumab will be administered.

  • DrugDostarlimab

    Dostarlimab will be administered

    Also known as: GSK4057190

  • DrugBelrestotug

    Belrestotug will be administered.

    Also known as: EOS884448, GSK4428859A

  • DrugNelistotug

    Nelistotug will be administered.

    Also known as: GSK6097608

06

What researchers measure

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 228 weeks

  2. Number of Participants with TEAEs or SAEs leading to dose modifications or treatment discontinuation

    Time frame: Up to 228 weeks

07

Study locations

99 sites
  • GSK Investigational Site
    Plantation, Florida 33322, United States
  • GSK Investigational Site
    Albuquerque, New Mexico 87131, United States
  • GSK Investigational Site
    Chattanooga, Tennessee 37404, United States
  • GSK Investigational Site
    Morgantown, West Virginia 26506, United States
  • GSK Investigational Site
    Buenos Aires, C1426ABP, Argentina
  • GSK Investigational Site
    Cipoletti Rio Negro, R8324CVE, Argentina
  • GSK Investigational Site
    Ciudad Autonoma de Buenos Aire, C1414DRK, Argentina
  • GSK Investigational Site
    Ciudad Autonoma de Buenos Aire, C1426AGE, Argentina
  • GSK Investigational Site
    Florida, 1602, Argentina
  • GSK Investigational Site
    Mar del Plata, 7600, Argentina
  • GSK Investigational Site
    San Juan, J5402DIL, Argentina
  • GSK Investigational Site
    Santa Fe, 3000, Argentina
  • GSK Investigational Site
    Wilrijk, 2650, Belgium
  • GSK Investigational Site
    Barretos, 14784-400, Brazil
  • GSK Investigational Site
    Porto Alegre, 90610-000, Brazil
  • GSK Investigational Site
    São Paulo, 01246-000, Brazil
  • GSK Investigational Site
    Vitória, 29043-260, Brazil
  • GSK Investigational Site
    Oulu, 90220, Finland
  • GSK Investigational Site
    Tampere, 33520, Finland
  • GSK Investigational Site
    Turku, 20520, Finland
  • GSK Investigational Site
    Vaasa, 65130, Finland
  • GSK Investigational Site
    Bordeaux, 33076, France
  • GSK Investigational Site
    Caen, 14033, France
  • GSK Investigational Site
    Marseille, 13009, France
  • GSK Investigational Site
    Quimper, 29107, France
  • GSK Investigational Site
    Strasbourg, 67091, France
  • GSK Investigational Site
    Berlin, 13125, Germany
  • GSK Investigational Site
    Essen, 45147, Germany
  • GSK Investigational Site
    Großhansdorf, 22927, Germany
  • GSK Investigational Site
    Heidelberg, 69126, Germany
  • GSK Investigational Site
    Jena, 07747, Germany
  • GSK Investigational Site
    Athens, 11528, Greece
  • GSK Investigational Site
    Haidari - Athens, 12462, Greece
  • GSK Investigational Site
    Larissa, 41110, Greece
  • GSK Investigational Site
    PapagosAthens, 115 27, Greece
  • GSK Investigational Site
    Pylaia Thessaloniki, 57001, Greece
  • GSK Investigational Site
    Thessaloniki, 54645, Greece
  • GSK Investigational Site
    Thessaloniki, 57010, Greece
  • GSK Investigational Site
    Budapest, H-1121, Hungary
  • GSK Investigational Site
    Gyöngyös, 3200, Hungary
  • GSK Investigational Site
    Tatabánya, 2800, Hungary
  • GSK Investigational Site
    Avellino, 83100, Italy
  • GSK Investigational Site
    Bergamo, 24125, Italy
  • GSK Investigational Site
    Genova, 16132, Italy
  • GSK Investigational Site
    Pisa, 57124, Italy
  • GSK Investigational Site
    Verona, 37045, Italy
  • GSK Investigational Site
    Chiba, 277-8577, Japan
  • GSK Investigational Site
    Fukuoka, 812-8582, Japan
  • GSK Investigational Site
    Hyōgo, 673-8558, Japan
  • GSK Investigational Site
    Kanagawa, 241-8515, Japan
  • GSK Investigational Site
    Osaka, 590-0197, Japan
  • GSK Investigational Site
    Saitama, 350-1298, Japan
  • GSK Investigational Site
    Guadajalara, 44280, Mexico
  • GSK Investigational Site
    San Luis Potosí City, 78209, Mexico
  • GSK Investigational Site
    Enschede, 7512 KZ, Netherlands
  • GSK Investigational Site
    Groningen, 9728 NZ, Netherlands
  • GSK Investigational Site
    Leeuwarden, 8934 AD, Netherlands
  • GSK Investigational Site
    Utrecht, 3543 AZ, Netherlands
  • GSK Investigational Site
    Lublin, 20-954, Poland
  • GSK Investigational Site
    Prabuty, 82-550, Poland
  • GSK Investigational Site
    Siedlce, 08-110, Poland
  • GSK Investigational Site
    Gaia, 4434-502, Portugal
  • GSK Investigational Site
    Guimarães, 4835-044, Portugal
  • GSK Investigational Site
    Lisbon, 1500-650, Portugal
  • GSK Investigational Site
    Lisbon, 1998-018, Portugal
  • GSK Investigational Site
    Porto, 4200-072, Portugal
  • GSK Investigational Site
    Cape Town, 7570, South Africa
  • GSK Investigational Site
    Parktown, 2193, South Africa
  • GSK Investigational Site
    Incheon, 21565, South Korea
  • GSK Investigational Site
    Seoul, 03080, South Korea
  • GSK Investigational Site
    Seoul, 03722, South Korea
  • GSK Investigational Site
    Suwon Gyeonggi-do, 442-723, South Korea
  • GSK Investigational Site
    Badajoz, 06080, Spain
  • GSK Investigational Site
    Badalona, 08916, Spain
  • GSK Investigational Site
    Barcelona, 08035, Spain
  • GSK Investigational Site
    Barcelona, 08907, Spain
  • GSK Investigational Site
    Las Palmas de Gran Canar, 35016, Spain
  • GSK Investigational Site
    Madrid, 28027, Spain
  • GSK Investigational Site
    Madrid, 28041, Spain
  • GSK Investigational Site
    Madrid, 28046, Spain
  • GSK Investigational Site
    Málaga, 29010, Spain
  • GSK Investigational Site
    PamplonaNavarra, 28027, Spain
  • GSK Investigational Site
    Valencia, 46009, Spain
  • GSK Investigational Site
    Valencia, 46026, Spain
  • GSK Investigational Site
    Bangkok, 10210, Thailand
  • GSK Investigational Site
    Chiang Mai, 50200, Thailand
  • GSK Investigational Site
    Kho Hong Hat Yai, 90110, Thailand
  • GSK Investigational Site
    Khon Kaen, 40002, Thailand
  • GSK Investigational Site
    Pathum Thani, 12120, Thailand
  • GSK Investigational Site
    Samsun, Atakum 55200, Turkey (Türkiye)
  • GSK Investigational Site
    Ankara, 06680, Turkey (Türkiye)
  • GSK Investigational Site
    Ankara, 06800, Turkey (Türkiye)
  • GSK Investigational Site
    Antalya, 07070, Turkey (Türkiye)
  • GSK Investigational Site
    Istanbul, 34214, Turkey (Türkiye)
  • GSK Investigational Site
    Abu Dhabi, 51900, United Arab Emirates
  • GSK Investigational Site
    Abu Dhabi, United Arab Emirates
  • GSK Investigational Site
    Middlesbrough, TS4 3BW, United Kingdom
  • GSK Investigational Site
    Middlesex, HA6 2RN, United Kingdom
  • GSK Investigational Site
    Wolverhampton, WV10 0QP, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05565378
Lead sponsor
GlaxoSmithKline
Collaborators
iTeos Therapeutics
Responsible party
Sponsor
First posted
Oct 4, 2022
Start date
Oct 14, 2022
Primary completion
Nov 9, 2026 (estimated)
Completion
Dec 6, 2027 (estimated)
Last update
Jun 15, 2026

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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