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.

Completed

Conditions: lung cancer
lung malignancy
10038666

Registration Number: NL-OMON48669

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
* willing and able to provide written informed consent for the study.
* * 18 years of age on day of signing informed consent.
* confirmed diagnosis of NSCLC.
* Histological tumor biopsy for PD-L1 IHC assessment (DAKO assay) available.
* Eligible for first line chemo-immunotherapy or 2nd line and beyond PD-(L)1
immunotherapy monotherapy.
* Measurable disease according to RECIST v1.1.
* WHO performance status of 0*2.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* Has had prior chemotherapy, targeted small molecule therapy, or radiation
therapy within 2 weeks prior to the baseline PET-scan.
* Has an active infection or had an active infection within 2 weeks prior to
baseline PET-scan.
* Has a known history of hypersensitivity to contrast material.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For each tumor, a volume of interest (VOI) will be drawn on the PET scan images<br /><br>and standard uptake values (SUVmax, SUVmean, SUVpeak), metabolically active<br /><br>tumor volume (MATV) and total lesion glycolysis (TLG) will be measured and the<br /><br>change in parameter values calculated and related to treatment outcome in terms<br /><br>of PFS and OS; response evaluation criteria in solid tumors). Change in the<br /><br>percentage, activation status and ratio of selected immune cells in PBMC's and<br /><br>if avaible in TDLNs will be calculated and related to the PET results and<br /><br>outcome in terms PFS and OS.</p><br>

Secondary Outcome Measures