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A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
NCT05565378 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Dostarlimab
- DRUG Belrestotug
- DRUG Nelistotug
Study Locations (20)
Other
- GSK Investigational Site — Buenos Aires
- GSK Investigational Site — Cipoletti Rio Negro
- GSK Investigational Site — Ciudad Autonoma de Buenos Aire
- GSK Investigational Site — Ciudad Autonoma de Buenos Aire
- GSK Investigational Site — Florida
- GSK Investigational Site — Mar del Plata
- GSK Investigational Site — San Juan
- GSK Investigational Site — Santa Fe
- GSK Investigational Site — Wilrijk
- GSK Investigational Site — Barretos
- GSK Investigational Site — Porto Alegre
- GSK Investigational Site — São Paulo
- GSK Investigational Site — Vitória
- GSK Investigational Site — Oulu
- GSK Investigational Site — Tampere
- GSK Investigational Site — Turku
Florida
- GSK Investigational Site — Plantation
New Mexico
- GSK Investigational Site — Albuquerque
Tennessee
- GSK Investigational Site — Chattanooga
West Virginia
- GSK Investigational Site — Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2022-10-14 |
| Est. Completion | 2027-02-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05565378
The ClinicalTrials.gov registry entry for NCT05565378 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 351 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lung Cancer, Non-Small Cell appearing as the primary indexed condition, and to 4 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05565378 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Florida, New Mexico. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05565378 about?
NCT05565378 is a clinical study titled "A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic 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). Dru...
What is the current status of trial NCT05565378?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 351 participants. The study started on 2022-10-14. Estimated completion is 2027-02-26.
What conditions does trial NCT05565378 study?
This clinical trial studies the following conditions: Lung Cancer, Non-Small Cell. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05565378?
The interventions under investigation include: Pembrolizumab (DRUG), Dostarlimab (DRUG), Belrestotug (DRUG), Nelistotug (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05565378?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05565378 being conducted?
This trial has 20 study locations across Florida, New Mexico, Tennessee, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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