NL-OMON48669CompletedNot Applicable
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. - Early response evaluation in NSCLC patients treated with immunotherapy
Antoni van Leeuwenhoek Ziekenhuis0 sites50 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 64 (—)
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.
Investigators
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