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
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.
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 →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.
Exclusion Criteria:
Participants will be administered with pembrolizumab as monotherapy in a fixed dose.
Drug: Pembrolizumab
Participants will be administered with dostarlimab as monotherapy in a fixed dose.
Drug: Dostarlimab
Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose A).
Drug: Dostarlimab · Drug: Belrestotug
Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose B).
Drug: Dostarlimab · Drug: Belrestotug
Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose C).
Drug: Dostarlimab · Drug: Belrestotug
Participants will be administered with dostarlimab, fixed dose belrestotug, and fixed dose nelistotug
Drug: Dostarlimab · Drug: Belrestotug · Drug: Nelistotug
Pembrolizumab will be administered.
Dostarlimab will be administered
Also known as: GSK4057190
Belrestotug will be administered.
Also known as: EOS884448, GSK4428859A
Nelistotug will be administered.
Also known as: GSK6097608
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 228 weeks
Number of Participants with TEAEs or SAEs leading to dose modifications or treatment discontinuation
Time frame: Up to 228 weeks
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.
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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Carcinoma, Non-Small-Cell Lung→
GlaxoSmithKline