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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Pembrolizumab will be administered.
Dostarlimab will be administered.
PBCD consisting of pemetrexed+ (carboplatin or cisplatin) will be administered.
GSK Investigational Site
London, United Kingdom
RECRUITINGSpearman's rank correlation coefficient between treatment-induced PDL1 modulation in, 1o PDOs and/or extracellular vesicles (EVs) and PET after treatment
The primary endpoint is the correlation between "treatment-induced change in PDL1 in PDOs which will be evaluated as the ratio of PDL1 positive cells before and after treatment using flow cytometry and multiplex immunofluorescence analysis" AND/OR "treatment-induced change in PDL1 in EVs which will be evaluated as the ratio of PDL1 positive cells before and after treatment using flow cytometry and multiplex immunofluorescence analysis" and "changes in PET which will be evaluated as the percentage difference in PDL1-PET standard uptake volume (SUV) uptake in lesions from the baseline to on-treatment" using the formula for Spearman's rank correlation coefficient. The Spearmans rank correlation coefficient can take values from +1 to -1 where a value of +1 indicates a perfect positive association, a value of 0 indicates no association and a value of -1 indicates a perfect negative association.
Time frame: Up to approximately 29 months
Spearman's rank correlation coefficient between treatment-induced PDL1 modulation in 1o PDOs and tumour response to anti- Programmed death 1 (PD1) based first line (1L) advanced/metastatic NSCLC treatment
The secondary endpoint is the correlation between "treatment-induced change in PDL1 in PDOs which will be evaluated as the ratio of PDL1 positive cells before and after treatment using flow cytometry and multiplex immunofluorescence analysis" AND "tumor response rate which will be assessed based on RECIST v1.1 per investigator assessment" using the formula for Spearman's rank correlation coefficient. The Spearmans rank correlation coefficient can take values from +1 to -1 where a value of +1 indicates a perfect positive association, a value of 0 indicates no association and a value of -1 indicates a perfect negative association.
Time frame: Up to approximately 34.5 months
Spearman's rank correlation coefficient between treatment-induced PDL1 modulation in EVs and tumour response to anti- Programmed death 1 (PD1) based first line (1L) advanced/metastatic NSCLC treatment
The secondary endpoint is the correlation between "treatment-induced change in PDL1 in EVs which will be evaluated as the ratio of PDL1 positive cells before and after treatment using flow cytometry and multiplex immunofluorescence analysis" AND "tumor response rate which will be assessed based on RECIST v1.1 per investigator assessment" using the formula for Spearman's rank correlation coefficient. The Spearmans rank correlation coefficient can take values from +1 to -1 where a value of +1 indicates a perfect positive association, a value of 0 indicates no association and a value of -1 indicates a perfect negative association.
Time frame: Up to approximately 34.5 months
Spearman's rank correlation coefficient between treatment-induced PDL1 modulation by PET and radiological tumour response to anti-PD1 based 1L advanced/metastatic NSCLC treatment
The secondary endpoint is the correlation between "changes in PET which will be evaluated as the percentage difference in PDL1-PET standard uptake volume (SUV) uptake in lesions from the baseline to on-treatment" AND "tumor response rate which will be assessed based on RECIST v1.1 per investigator assessment" using the formula for Spearman's rank correlation coefficient. The Spearmans rank correlation coefficient can take values from +1 to -1 where a value of +1 indicates a perfect positive association, a value of 0 indicates no association and a value of -1 indicates a perfect negative association.
Time frame: Up to approximately 34.5 months
Number of participants with adverse events (AEs) and serious adverse events (SAEs) following Zirconium-89 (89Zr-durvalumab)-PET radiotracer injection
Time frame: Up to Week 4
Number of participants with treatment emergent AEs (TEAEs), immune-related AEs, and SAEs by severity
Time frame: Up to approximately 34.5 months
Number of participants with TEAEs or SAEs, leading to dose delays, withdrawals, or death
Time frame: Up to approximately 34.5 months
Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters
Time frame: Up to approximately 34.5 months
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