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Recruiting Phase 1, Phase 2 NCT06405230

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)

Trial Parameters

Condition Lung Cancer, Non-Small Cell
Sponsor GlaxoSmithKline
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 40
Sex ALL
Min Age 30 Years
Max Age N/A
Start Date 2025-12-30
Completion 2028-08-07
Interventions
PembrolizumabDostarlimabPemetrexed+ (carboplatin or cisplatin)

Brief 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 Criteria

Inclusion Criteria: * Participants must have histologically- or cytologically documented NSCLC who present with recurrent advanced or metastatic disease after initial diagnosis of Stage 1-3 lung cancer * Participants must have been initially diagnosed with operable Stage 1-3 NSCLC and received curative resection ± (neo) adjuvant treatment * Identifiable PDL1 status prior to randomisation * Participants must have biopsy-confirmed recurrence of their initial NSCLC with advanced/metastatic presentation * Has at least 1 measurable (target) lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version (v) 1.1 by Computed tomography (CT) or magnetic resonance imaging (MRI). Measurable lesions that have been previously irradiated are not considered measurable and cannot be target lesions * Participants must be deemed by investigator to be appropriate to receive 1L systemic therapy (i.e., anti-PD1 ± PBCD) * Participants must have had tissue submitted for attempted PDO generation. (

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