Correlation of Metabolic Imaging With Immune Markers in NSCLC Candidate to Immunotherapy.

Study Overview
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Brief Summary
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The purpose of the present study is to prospectively investigate the correlation between the metabolic parameters on FDG-PET before and during immunotherapy treatment with the immune infiltrate and other tissue or circulating markers in a NSCLC patients candidate to immunotherapy.

Detailed Description
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This is an interventional prospective study without medication lasting 36 months, including an estimated period of 18 months for the enrolment and max 18 months of follow-up. All consecutive patients affected by NSCLC and referred for immunotherapy with the anti-PD-1 agent nivolumab, or other checkpoint inhibitors that may become available in the future, will be prospectively enrolled. The study cohort will consist of 40 patients. All patients will undergo the following steps: 1) selection based on eligibility criteria and informed consent; 2) baseline examinations (ceCT and 18F-FDG PET/CT); 3) tumor biopsy and blood sampling; 4) Immunotherapy with check-point inhibitors; 5) response evaluation after 8 weeks of treatment (ceCT and 18F-FDG PET/CT) and second blood sampling; 6) follow up.

Official Title
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Correlazione Dell'Imaging Metabolico Con l'Espressione Dei Marcatori Immunitari Nei Pazienti Con NSCLC Candidati All'Immunoterapia.

Conditions
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Carcinoma, Non-Small-Cell Lung, Positron-Emission Tomography, Immunotherapy

Intervention / Treatment
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* Diagnostic Test: PET scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with pathological diagnosis of NSCLC eligible for immunotherapy; obtained informed consent. Exclusion Criteria: age <18 years; pregnancy or breast-feeding.

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Biopsy and PET scan | Diagnostic Test: PET scan<br>* Tumor biopsy at baseline; PET scan performed after 8 weeks of treatment<br>* Other names: Biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate the tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy. | Standardized uptake value | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy. | Metabolic tumor burden | Before treatment | 
| Correlate immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy. | Tumor infiltrate | Baseline | 
| Evaluate the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy. | Standardized uptake value | After 8 weeks of treatment | 
| Quantify the variation of metabolic parameters on FDG-PET in patients with NSCLC before and 8 weeks after the first administration of immunotherapy. | Metabolic tumor burden | After 8 weeks of treatment | 
| Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy. | Tissue and blood samples | Baseline | 
| Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy. | Tissue and blood samples | 8 weeks after treatment |