cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors

Study Overview
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Brief Summary
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The response rate of immune checkpoint inhibitors remains relatively low and the identification of the new predictive biomarkers is necessary. The rare population of cDC1 is very interesting, as its mouse counterparts is essential for the cross presentation of tumor-associated antigens, tumor immunity and response to immunotherapies. Their role in humans has not been studied. This proposal aims to study the prognostic role of cDC1 in a cohort of patients with advanced NSCLC, possibly demonstrating their positive predictive value of immune checkpoint inhibitors response.

Detailed Description
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Multicenter study aiming to collect patient's clinical data retrospectively and their histological samples prospectively. The cohort will include: 30 patients PD-L1 > 50% treated with pembrolizumab in first line and having a progression free survival ≥ 3 months 30 patients PD-L1 > 50% treated with pembrolizumab in first line and having a progression free survival < 3 months 30 patients PD-L1 < 50% treated with cisplatin-based chemotherapy in first line

Official Title
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cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Other: This is a non-interventional study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NSCLC diagnosis Advanced disease (Stage III-IV) according to the TNM 7th/8th classification Patients have to have performed pembrolizumab in first line if PD-L1 ≥ 50% or cisplastin-based chemotherapy if PD-L1 < 50% FFPE material available from diagnostic sample Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cDC-1 positive<br>cDC-1 positive patients according to RNAseq and in situ analysis | Other: This is a non-interventional study<br>* This is a non-interventional study<br>|
| cDC-1 negative<br>cDC-1 negative patients according to RNAseq and in situ analysis | Other: This is a non-interventional study<br>* This is a non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | To validate the cDC1 infiltration as predictive biomarker of pembrolizumab response | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | To compare the overall response rate (ORR) of cDC1-positive patients to cDC1 negative ones within those treated with pembrolizumab and on the entire cohort | 1 year | 
| Time to treatment failure (TTF) | To compare the time of treatment failure (TTF) on CDC1-positive patients to negatives ones within those treated with pembrolizumaband on the entire cohort | 1 year |