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)

Sponsor
GlaxoSmithKline
Study ID
NCT06405230
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Lung Cancer, Non-Small Cell

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab will be administered.
  • Dostarlimab — BIOLOGICAL
    Dostarlimab will be administered.
  • Pemetrexed+ (carboplatin or cisplatin) — DRUG
    PBCD consisting of pemetrexed+ (carboplatin or cisplatin) will be administered.

Study Details

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.

Key Dates

First listed
May 8, 2024
Start date
Oct 10, 2025
Status verified
Aug 2026
Primary completion
Jul 13, 2026
Completion
Jul 13, 2026

Study Design

Enrollment
2 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab ± Platinum-based chemotherapy doublet (PBCD)
    Participants will receive pembrolizumab with or without PBCD.
  • Experimental: Dostarlimab ± PBCD
    Participants will receive dostarlimab with or without PBCD.

Primary Outcome Measure

Spearman's rank correlation coefficient between treatment-induced PDL1 modulation in, 1o PDOs and/or extracellular vesicles (EVs) and PET after treatment [ Time Frame: Up to approximately 9 months ]

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