Study of Dostarlimab and Pembrolizumab Treatments with Biomarker Testing and PET Imaging in Recurrent Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are investigating how well certain biomarker tools can predict responses to standard treatments in people with recurrent non-small cell lung cancer NSCLC at advanced or metastatic stages. The study focuses on tools including Extracellular Vesicles EVs, Patient-derived Organoids PDOs, and PDL1 PET imaging to evaluate how these markers relate to treatment outcomes. This pilot and exploratory study involves participants who have had operable stage 1-3 NSCLC that recurred as advanced disease. Participants are randomly assigned to receive pembrolizumab or dostarlimab, with or without a platinum-based chemotherapy doublet PBCD consisting of pemetrexed plus carboplatin or cisplatin. Treatment is given as part of first-line systemic therapy for advancedmetastatic NSCLC. The study includes imaging with Zirconium-89 labelled PDL1 PET to assess immune markers and collects samples for PDO and EV analysis to monitor changes in PDL1 expression. During the trial, participants undergo tumor biopsies, imaging scans like CT or MRI, and blood sampling to evaluate biomarker changes and tumor response. Safety is monitored through reports of adverse events following the PET tracer injection and throughout the treatment period. The main outcome measured is the correlation between PDL1 changes in PDOs, EVs, and PET imaging with treatment response, with follow-up lasting up to around 34.5 months. Organ function and performance status are assessed regularly to ensure participant safety throughout the study.

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)