Prospective, observational, multi-site, single arm, exploratory pilot study, designed to prospectively assess the relationship between basal c-FLIP expression in M-MDSCs with clinical outcomes in patients treated with anti-PD-L1 monotherapy in a 1L mNSCLC setting, as well as evaluate changes in c-FLIP during treatment and correlate those changes with clinical outcomes.
Study Type
OBSERVATIONAL
Enrollment
107
Longitudinal c-FLIP expression on circulating MDSC
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Disease-control Rate (DCR)
Disease-control rate at 12 weeks based on basal c-FLIP expression on MDSC
Time frame: 24 months
Progression-free survival (PFS)
Median Progression-free Survival among subgroups defined according to c-FLIP expression in M-MDSC at baseline
Time frame: 24 months
Overall Survival (OS)
Median overall survival among subgroups defined according to c-FLIP expression in M-MDSC at baseline.
Time frame: 24 months
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