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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| c-FLIP expression on MDSC | Diagnostic Test | Longitudinal c-FLIP expression on circulating MDSC |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-control Rate (DCR) | Disease-control rate at 12 weeks based on basal c-FLIP expression on MDSC | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Median Progression-free Survival among subgroups defined according to c-FLIP expression in M-MDSC at baseline | 24 months |
| Overall Survival (OS) | Median overall survival among subgroups defined according to c-FLIP expression in M-MDSC at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients age ≥ 18 years with ECOG Performance Status of 0 to 2 who have previously untreated metastatic non-oncogene addicted PD-L1-selected NSCLC (TPS ≥50%)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilio Bria, Prof. | Contact | 0630155202 ext +39 | emilio.bria@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Emilio Bria | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24309938 | Background | Riley JS, Hutchinson R, McArt DG, Crawford N, Holohan C, Paul I, Van Schaeybroeck S, Salto-Tellez M, Johnston PG, Fennell DA, Gately K, O'Byrne K, Cummins R, Kay E, Hamilton P, Stasik I, Longley DB. Prognostic and therapeutic relevance of FLIP and procaspase-8 overexpression in non-small cell lung cancer. Cell Death Dis. 2013 Dec 5;4(12):e951. doi: 10.1038/cddis.2013.481. |
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| 24 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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