RecruitingPhase 1Phase 2NCT06405230

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

A Pilot/Exploratory Translational Study to Evaluate Response to Dostarlimab and Pembrolizumab in Extracellular Vesicles (EVs) or Patient-derived Organoids (PDOs) and by Zirconium-89 Labelled Programmed Death Ligand 1 Positron Emission Tomography in Participants With Recurrent Non-small Cell Lung Cancer


Sponsor

GlaxoSmithKline

Enrollment

40 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to investigate the utility of biomarker tools Extracellular Vesicles (EVs), Patient-derived organoid (PDOs), and PDL1 PET imaging for predicting how participants with recurrent NSCLC respond to standard of care treatment in the advanced/metastatic stages.


Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a predictive tool called a "patient-derived organoid" (PDO) — a mini-tumor grown in a lab from the patient's own cancer cells — can predict how well a patient with recurrent advanced non-small cell lung cancer (NSCLC) will respond to immunotherapy or chemotherapy as their first-line treatment. **You may be eligible if...** - You have been diagnosed with NSCLC that initially started at a resectable stage (Stage I–III) and has now returned as advanced or metastatic disease - You originally had your tumor removed by surgery - Your cancer recurrence has been confirmed by biopsy - You have at least one measurable lesion on a scan - Your doctor considers you suitable for first-line treatment with immunotherapy (with or without chemotherapy) - You have had tissue submitted for an attempt to grow PDOs in the lab - You are HIV-positive participants may be eligible if on stable antiretroviral therapy **You may NOT be eligible if...** - Your cancer did not start at a surgically resectable stage - Your cancer recurrence cannot be confirmed by biopsy - You are not a candidate for first-line systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPembrolizumab

Pembrolizumab will be administered.

BIOLOGICALDostarlimab

Dostarlimab will be administered.

DRUGPemetrexed+ (carboplatin or cisplatin)

PBCD consisting of pemetrexed+ (carboplatin or cisplatin) will be administered.


Locations(1)

GSK Investigational Site

London, United Kingdom

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NCT06405230


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