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

Not Applicable

• Conditions: Carcinoma, Non-Small-Cell Lung; Immunotherapy; Positron-Emission Tomography
• Interventions: Diagnostic Test: PET scan

• Registration Number: NCT03563482
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-28
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	PET scan	Biopsy and PET scan

Primary Outcome Measures

Name	Time	Method
Correlate the tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy.	Baseline	Standardized uptake value

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy