lung cancer lung malignancy
Conditions
Interventions
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For each tumor, a volume of interest (VOI) will be drawn on the PET scan images and standard uptake values (SUVmax, SUVmean, SUVpeak), metabolically active tumor volume (MATV) and total lesion glycolysis (TLG) will be measured and the change in parameter values calculated and related to treatment outcome in terms of PFS and OS; response evaluation criteria in solid tumors). Change in the percentage, activation status and ratio of selected immune cells in PBMC's and if avaible in TDLNs will be calculated and related to the PET results and outcome in terms PFS and OS. | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
The Netherlands
Outcome results
None listed