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

Istituto Clinico Humanitas

Status: Unknown

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

Treatments: Diagnostic Test: PET scan

Study type: Interventional

Funder types: Other

Identifiers

NCT03563482

1670

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with pathological diagnosis of NSCLC eligible for immunotherapy;
• obtained informed consent.

Exclusion criteria

• age <18 years;
• pregnancy or breast-feeding.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Experimental

Experimental group

Description:

Biopsy and PET scan

Treatment:

Diagnostic Test: PET scan