Lung Cancer, Non-Small CellPhase 3NCT06472076
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)
A Phase 3 study testing Dostarlimab, Belrestotug and Pembrolizumab in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 108 sites in 21 countries.
Trial 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. 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?
- Dostarlimab, Belrestotug and Pembrolizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 108 sitesin 21 countries
- Study dates
- 10 Jun 2024to 30 Aug 2027
- Phase
- Phase 3
- 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
- Has a 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
- 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
Who cannot join
- Has NSCLC with a tumor that harbors any of the following molecular alterations:
- Epidermal growth factor receptor (EGFR) mutations that are sensitive to available targeted inhibitor therapy
- Anaplastic lymphoma kinase (ALK) translocations 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.
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
108 sites in 21 countries.
108 sites in 21 countries
Spain18 sites
GSK Investigational Site
A Coruña, 15006
GSK Investigational Site
Aravaca, 28013
GSK Investigational Site
BaracaldoVizcaya, 48903
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08023
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Jaén, 23007
GSK Investigational Site
Las Palmas de Gran Canar, 35016
GSK Investigational Site
Madrid, 28010
GSK Investigational Site
Madrid, 28033
GSK Investigational Site
Madrid, 28222
GSK Investigational Site
Oviedo, 33006
GSK Investigational Site
Pamplona, 31008
GSK Investigational Site
Salamanca, 37007
GSK Investigational Site
Santander, 39008
GSK Investigational Site
Seville, 41014
GSK Investigational Site
Valladolid, 47003
Japan15 sites
GSK Investigational Site
Aichi, 466-8560
GSK Investigational Site
Ehime, 790-0024
GSK Investigational Site
Fukuoka, 814-0180
GSK Investigational Site
Hokkaido, 062-0931
GSK Investigational Site
Hyōgo, 665-0827
GSK Investigational Site
Kyoto, 612-8555
GSK Investigational Site
Mie, 515-8544
GSK Investigational Site
Miyagi, 981-0914
GSK Investigational Site
Nagasaki, 852-8501
GSK Investigational Site
Niigata, 951-8566
GSK Investigational Site
Osaka, 596-8501
GSK Investigational Site
Tokyo, 104-0045
GSK Investigational Site
Tokyo, 162-8655
GSK Investigational Site
Tottori, 683-8504
GSK Investigational Site
Wakayama, 641-8510
Brazil11 sites
GSK Investigational Site
Barretos, 14784-400
GSK Investigational Site
Belém, 66.073-005
GSK Investigational Site
CuritibaPR, 80810-050
GSK Investigational Site
Florianópolis, 88034-000
GSK Investigational Site
Fortaleza, 60336-232
GSK Investigational Site
Londrina, 86015-520
GSK Investigational Site
Porto VelhoRondOnia, 76.834-899
GSK Investigational Site
Salvador, 40414-120
GSK Investigational Site
SAo JosE Do Rio PretoSP, 15090-000
GSK Investigational Site
São Paulo, 04312903
GSK Investigational Site
Vitória, 29043-260
Argentina9 sites
GSK Investigational Site
Buenos Aires, 1425
GSK Investigational Site
Cipoletti Rio Negro, R8324CVE
GSK Investigational Site
Ciudad Autonoma de Bueno, C1056ABI
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, C1426AGE
GSK Investigational Site
Córdoba, 5000
GSK Investigational Site
Florida, 1602
GSK Investigational Site
Mendoza, M5500AYB
GSK Investigational Site
Rosario, S2002
GSK Investigational Site
San Miguel de Tucumán, T4000
United States8 sites
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Honolulu, Hawaii, 96819
GSK Investigational Site
Lexington, Kentucky, 40503
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Ocala, Florida, 34474
GSK Investigational Site
Olympia, Washington, 98506
GSK Investigational Site
Omaha, Nebraska, 68114
India7 sites
GSK Investigational Site
Apex Wellness Hospital, 422005
GSK Investigational Site
Bangalore, 560085
GSK Investigational Site
Belagavi, 590010
GSK Investigational Site
Bhubaneswar, 751007
GSK Investigational Site
Gokul Shirgoan, Kolhapur, 416234
GSK Investigational Site
Gūrgaon, 122001
GSK Investigational Site
New Delhi, 110075
China6 sites
GSK Investigational Site
Chengdu, 610000
GSK Investigational Site
Hangzhou, 310006
GSK Investigational Site
Hangzhou
GSK Investigational Site
Hefei, 230001
GSK Investigational Site
Nanjing, 210006
GSK Investigational Site
Shanghai, 200030
France6 sites
GSK Investigational Site
Angers, 49000
GSK Investigational Site
Boulogne-Billancourt, 92100
GSK Investigational Site
Limoges, 87042
GSK Investigational Site
Lorient, 56100
GSK Investigational Site
Pessac, 33064
GSK Investigational Site
Rennes, 35033
South Korea6 sites
GSK Investigational Site
Daegu, 41404
GSK Investigational Site
Incheon, 21565
GSK Investigational Site
Seoul, 02841
GSK Investigational Site
Seoul, 05505
GSK Investigational Site
Seoul, 08308
GSK Investigational Site
Seoul, 120-752
Mexico4 sites
GSK Investigational Site
Guadajalara, 44280
GSK Investigational Site
La Paz BCS, 23040
GSK Investigational Site
Mexico City, 06700
GSK Investigational Site
San Luis Potosí City, 78209
Belgium2 sites
GSK Investigational Site
Hasselt, 3500
GSK Investigational Site
Mont Gaston, 5530
Bulgaria2 sites
GSK Investigational Site
Haskovo, 6300
GSK Investigational Site
Plovdiv, 4004
Finland2 sites
GSK Investigational Site
Kuopio, 70210
GSK Investigational Site
Turku, 20520
Netherlands2 sites
GSK Investigational Site
Alkmaar, 1815 JD
GSK Investigational Site
Enschede, 7512 KZ
Panama2 sites
GSK Investigational Site
Panama City
GSK Investigational Site
Punta Pacifica Panama City Panama
Taiwan2 sites
GSK Investigational Site
Kaohsiung City, 807
GSK Investigational Site
Taipei, 23561
Turkey (Türkiye)2 sites
GSK Investigational Site
Adana, 1120
GSK Investigational Site
Ankara, 06560
About this study
Official title: A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)
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.
- Conditions
- Lung Cancer, Non-Small Cell
- Being tested
- Dostarlimab, Belrestotug, Pembrolizumab, Placebo
- Keywords
- Belrestotug, GSK4428859A, EOS-448, Dostarlimab, Pembrolizumab, PD-L1 selected NSCLC
- 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.
DostarlimabBiological
Dostarlimab will be administered.
BelrestotugBiological
Belrestotug will be administered.
PembrolizumabBiological
Pembrolizumab will be administered.
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Dostarlimab plus belrestotug | Experimental | Not described Receives: Biological: Dostarlimab; Biological: Belrestotug |
| Pembrolizumab plus placebo | Active comparator | Not described Receives: Biological: Pembrolizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to approximately 138 weeks
Number of Participants with TEAEs or SAEs leading to dose withdrawals or treatment discontinuation
Measured: Up to approximately 138 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start10 Jun 2024
- Primary completion30 Jun 2026
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-Small CellStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iTeos Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472076
- Sponsor's protocol ID
- 213823
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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/
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)
- ClinicalTrials.gov ID
- NCT06472076
- Acronym / sponsor ID
- 213823
- Conditions
- Lung Cancer, Non-Small Cell
- Keywords
- Belrestotug, GSK4428859A, EOS-448, Dostarlimab, Pembrolizumab, PD-L1 selected NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- iTeos Therapeutics
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dostarlimab plus belrestotug | Experimental | Biological: Dostarlimab, Biological: Belrestotug |
| Pembrolizumab plus placebo | Active comparator | Biological: Pembrolizumab, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a 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
- 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
Key exclusion criteria (17 listed)
- Has NSCLC with a tumor that harbors any of the following molecular alterations:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DostarlimabDostarlimab will be administered. | Biological | Dostarlimab plus belrestotug |
| BelrestotugBelrestotug will be administered. | Biological | Dostarlimab plus belrestotug |
| PembrolizumabPembrolizumab will be administered. | Biological | Pembrolizumab plus placebo |
| PlaceboPlacebo will be administered. | Drug | Pembrolizumab plus placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to approximately 138 weeks
Number of Participants with TEAEs or SAEs leading to dose withdrawals or treatment discontinuation
Time frame: Up to approximately 138 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
108 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dostarlimab, Belrestotug and Pembrolizumab in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 108 sites in 21 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 7 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 108 sites in Spain, Japan, Brazil, Argentina, United States and 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 approximately 138 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?
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 21 Jul 2026.