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
Recruiting
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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

Start date
Dec 30, 2025
Status verified
Jan 2026
Primary completion
Aug 7, 2028
Completion
Oct 10, 2029

Study Design

Enrollment
40 participants (estimated)
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 29 months ]

Central Contacts

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