A pilot study with biomarker exploration.50 patients with stage IV non-small cell lung cancer (NSCLC) that are eligible for treatment with nivolumab. Patients will undergo a 18F-FDG-PET/CT and EBUS-FNA of the lymph nodes and have blood drawn before and after immune checkpoint inhibitor treatment to compare tumor FDG uptake and to identify changes in the immune effector cell subsets in TDLNs. Blood will be drawn in parallel to compare the distribution of immune effector cell subsets before and after treatment initiation. Because of the possible burden for patients, the EBUS-FNA is not mandatory to complete the study and is there for an exploratory objective. Also blood will be drawn for a tumor mutational burden at baseline. The first six patients will undergo a dynamic PET-CT scan in addition to a static scan to study the influence of possible immunotherapy induced changes to the body distribution and kinetics of FDG..
Early response evaluation with 18F-FDG PET/CT and immunological profiling of circulating immune cells and tumor-draining lymph nodes in non-small cell lung cancer patients treated with immunotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
9
18F-FDG PET-CT scan
VU medical center
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
The change in the percentages of selected immune cell parameters (CD4+ T, CD8+ T cells) after immunotherapy treatment as compared to baseline will be calculated
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
The change in the percentages of selected immune cell parameters (CD8+ T cells) after immunotherapy treatment as compared to baseline will be calculated
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
FDG PET-CT analysis
Parameter change (SUVpeak) between both scans will be measured.
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
FDG PET-CT analysis
Parameter change (SUVmax) between both scans will be measured.
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
FDG PET-CT analysis
Parameter change (SUVmean) between both scans will be measured.
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
Peripheral blood mononuclear cells will be isolated and counted using FACS
PBMC's will be counted at two timepoints. Change between both timepoints will be assessed.
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
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