Carcinoma, Non-Small-Cell Lung, Immunotherapy, Positron-Emission Tomography
Conditions
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.
Interventions
DIAGNOSTIC_TESTPET scan
Tumor biopsy at baseline; PET scan performed after 8 weeks of treatment
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with pathological diagnosis of NSCLC eligible for immunotherapy; * obtained informed consent.
Exclusion criteria
* age \<18 years; * pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Tumor expression of immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy. | Before treatment | Metabolic tumor burden |
| Correlate immune markers with the metabolic characteristics on FDG-PET in patients with NSCLC candidates to immunotherapy. | Baseline | Tumor infiltrate |
| Evaluate other tissue or circulating markers in patients with NSCLC before and 8 weeks after the first administration of immunotherapy. | Baseline | Tissue and blood samples |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlate all defined parameters with response to treatment and outcome | 18 months of follow up | Response assessment and disease outcome |
Countries
Italy
Contacts
Primary ContactMichele Tedeschi, MD
Outcome results
None listed