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Lung Cancer, Non-Small CellPhase 2NCT05565378

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

A Phase 2 study testing Pembrolizumab, Dostarlimab and Belrestotug in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 99 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non-Small Cell
What is being tested?
Pembrolizumab, Dostarlimab and Belrestotug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
99 sitesin 22 countries
Study dates
14 Oct 2022to 6 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

99 sites in 22 countries.

99 sites in 22 countries

Spain12 sites

  • GSK Investigational Site

    Badajoz, 06080

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Las Palmas de Gran Canar, 35016

  • GSK Investigational Site

    Madrid, 28027

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    PamplonaNavarra, 28027

  • GSK Investigational Site

    Valencia, 46009

  • GSK Investigational Site

    Valencia, 46026

Other trials in Spain

Argentina8 sites

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Cipoletti Rio Negro, R8324CVE

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1414DRK

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1426AGE

  • GSK Investigational Site

    Florida, 1602

  • GSK Investigational Site

    Mar del Plata, 7600

  • GSK Investigational Site

    San Juan, J5402DIL

  • GSK Investigational Site

    Santa Fe, 3000

Other trials in Argentina

Greece7 sites

  • GSK Investigational Site

    Athens, 11528

  • GSK Investigational Site

    Haidari - Athens, 12462

  • GSK Investigational Site

    Larissa, 41110

  • GSK Investigational Site

    PapagosAthens, 115 27

  • GSK Investigational Site

    Pylaia Thessaloniki, 57001

  • GSK Investigational Site

    Thessaloniki, 54645

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Japan6 sites

  • GSK Investigational Site

    Chiba, 277-8577

  • GSK Investigational Site

    Fukuoka, 812-8582

  • GSK Investigational Site

    Hyōgo, 673-8558

  • GSK Investigational Site

    Kanagawa, 241-8515

  • GSK Investigational Site

    Osaka, 590-0197

  • GSK Investigational Site

    Saitama, 350-1298

Other trials in Japan

France5 sites

  • GSK Investigational Site

    Bordeaux, 33076

  • GSK Investigational Site

    Caen, 14033

  • GSK Investigational Site

    Marseille, 13009

  • GSK Investigational Site

    Quimper, 29107

  • GSK Investigational Site

    Strasbourg, 67091

Other trials in France

Germany5 sites

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Essen, 45147

  • GSK Investigational Site

    Großhansdorf, 22927

  • GSK Investigational Site

    Heidelberg, 69126

  • GSK Investigational Site

    Jena, 07747

Other trials in Germany

Italy5 sites

  • GSK Investigational Site

    Avellino, 83100

  • GSK Investigational Site

    Bergamo, 24125

  • GSK Investigational Site

    Genova, 16132

  • GSK Investigational Site

    Pisa, 57124

  • GSK Investigational Site

    Verona, 37045

Other trials in Italy

Portugal5 sites

  • GSK Investigational Site

    Gaia, 4434-502

  • GSK Investigational Site

    Guimarães, 4835-044

  • GSK Investigational Site

    Lisbon, 1500-650

  • GSK Investigational Site

    Lisbon, 1998-018

  • GSK Investigational Site

    Porto, 4200-072

Other trials in Portugal

Thailand5 sites

  • GSK Investigational Site

    Bangkok, 10210

  • GSK Investigational Site

    Chiang Mai, 50200

  • GSK Investigational Site

    Kho Hong Hat Yai, 90110

  • GSK Investigational Site

    Khon Kaen, 40002

  • GSK Investigational Site

    Pathum Thani, 12120

Other trials in Thailand

Turkey (Türkiye)5 sites

  • GSK Investigational Site

    Ankara, 06680

  • GSK Investigational Site

    Ankara, 06800

  • GSK Investigational Site

    Antalya, 07070

  • GSK Investigational Site

    Istanbul, 34214

  • GSK Investigational Site

    Samsun, Atakum, 55200

Other trials in Turkey (Türkiye)

United States4 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131

  • GSK Investigational Site

    Chattanooga, Tennessee, 37404

  • GSK Investigational Site

    Morgantown, West Virginia, 26506

  • GSK Investigational Site

    Plantation, Florida, 33322

Other trials in United States

Brazil4 sites

  • GSK Investigational Site

    Barretos, 14784-400

  • GSK Investigational Site

    Porto Alegre, 90610-000

  • GSK Investigational Site

    São Paulo, 01246-000

  • GSK Investigational Site

    Vitória, 29043-260

Other trials in Brazil

Finland4 sites

  • GSK Investigational Site

    Oulu, 90220

  • GSK Investigational Site

    Tampere, 33520

  • GSK Investigational Site

    Turku, 20520

  • GSK Investigational Site

    Vaasa, 65130

Other trials in Finland

Netherlands4 sites

  • GSK Investigational Site

    Enschede, 7512 KZ

  • GSK Investigational Site

    Groningen, 9728 NZ

  • GSK Investigational Site

    Leeuwarden, 8934 AD

  • GSK Investigational Site

    Utrecht, 3543 AZ

Other trials in Netherlands

South Korea4 sites

  • GSK Investigational Site

    Incheon, 21565

  • GSK Investigational Site

    Seoul, 03080

  • GSK Investigational Site

    Seoul, 03722

  • GSK Investigational Site

    Suwon Gyeonggi-do, 442-723

Other trials in South Korea

Hungary3 sites

  • GSK Investigational Site

    Budapest, H-1121

  • GSK Investigational Site

    Gyöngyös, 3200

  • GSK Investigational Site

    Tatabánya, 2800

Other trials in Hungary

Poland3 sites

  • GSK Investigational Site

    Lublin, 20-954

  • GSK Investigational Site

    Prabuty, 82-550

  • GSK Investigational Site

    Siedlce, 08-110

Other trials in Poland

United Kingdom3 sites

  • GSK Investigational Site

    Middlesbrough, TS4 3BW

  • GSK Investigational Site

    Middlesex, HA6 2RN

  • GSK Investigational Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Mexico2 sites

  • GSK Investigational Site

    Guadajalara, 44280

  • GSK Investigational Site

    San Luis Potosí City, 78209

Other trials in Mexico

South Africa2 sites

  • GSK Investigational Site

    Cape Town, 7570

  • GSK Investigational Site

    Parktown, 2193

Other trials in South Africa

United Arab Emirates2 sites

  • GSK Investigational Site

    Abu Dhabi, 51900

  • GSK Investigational Site

    Abu Dhabi

Other trials in United Arab Emirates

Belgium1 site

  • GSK Investigational Site

    Wilrijk, 2650

Other trials in Belgium

About this study

Official title: A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer

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.

Being tested
Pembrolizumab, Dostarlimab, Belrestotug, Nelistotug
Keywords
Belrestotug, Dostarlimab, EOS884448, GSK6097608, GSK4428859A, Nelistotug, Non-small-cell lung cancer, Pembrolizumab, Programmed death ligand 1, Programmed death protein 1 Inhibitor, Immunotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Pembrolizumab will be administered.

  • DostarlimabDrug

    Also called GSK4057190

    Dostarlimab will be administered

  • BelrestotugDrug

    Also called EOS884448, GSK4428859A

    Belrestotug will be administered.

  • NelistotugDrug

    Also called GSK6097608

    Nelistotug will be administered.

Study groups in NCT05565378
Study groupRoleWhat they receive
Pembrolizumab MonotherapyActive comparatorParticipants will be administered with pembrolizumab as monotherapy in a fixed dose.
Receives: Drug: Pembrolizumab
Dostarlimab MonotherapyExperimentalParticipants will be administered with dostarlimab as monotherapy in a fixed dose.
Receives: Drug: Dostarlimab
Substudy 1AExperimentalParticipants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose A).
Receives: Drug: Dostarlimab; Drug: Belrestotug
Substudy 1BExperimentalParticipants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose B).
Receives: Drug: Dostarlimab; Drug: Belrestotug
Substudy 1CExperimentalParticipants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose C).
Receives: Drug: Dostarlimab; Drug: Belrestotug
Substudy 2AExperimentalParticipants will be administered with dostarlimab, fixed dose belrestotug, and fixed dose nelistotug
Receives: Drug: Dostarlimab; Drug: Belrestotug; Drug: Nelistotug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 228 weeks

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

    Measured: Up to 228 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start14 Oct 2022
  3. Primary completion9 Nov 2026 (estimated)
  4. Study completion6 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05565378
Sponsor's protocol ID
213824
Other IDs
2021-005115-32, GALAXIES LUNG-201
Status last verified
Jun 2026
First submitted
30 Sep 2022
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Dostarlimab and Belrestotug in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 99 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in Spain, Argentina, Greece, Japan, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to 228 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05565378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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