NCT03563482

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PET scan	Tumor biopsy at baseline; PET scan performed after 8 weeks of treatment

Timeline

• Start date: 2017-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-06-20
• Last updated: 2022-04-28

Locations

1 site across 1 country: Italy