WHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC

Study Overview
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Brief Summary
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Response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.

Detailed Description
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Interventional study of patients with inoperable lung cancer of non small cell type undergoing 1st treatment of either chemotherapy or immunotherapy. Patients are evaluated with FDG-PET/ct and blood analyses og circulating tumor DNA and cancer markers to determine early response. PET-CT are preceded before and after treatment is given; day 0 before treatment, day 2 after treatment and day 21 just before second treatment. At every FDG-PET/ct scan blood are examined for circulating tumor DNA (ctDNA) and potentially cancer markers by White genome sequencing. In total 3 PET-CT scans and 4 blood samples are performed. The result are compared with the standard CT scan after 2-3 cycles of treatment. Blood analyses are repeated after 2-3 cycles to observe any changes.

Official Title
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WHENII - Early Response Evaluation With 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose(FDG)- Positrons Emissions Tomography(PET)/CT and Liquid Biopsy in Patients With NSCLC (Non Small Cell Lung Cancer)

Conditions
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Non Small Cell Lung Cancer, Circulating Tumor Cell, Circulating Tumor DNA

Intervention / Treatment
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* Device: PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with non-small cell lung cancer (NSCLC) who is about to start treatment with chemo- or immune therapy. No prior treatment of the one given. Measurable decease according to RECIST criteria Age > 18 years Performance status 0-2 (0-1 for immunotherapy) Understands and reads danish Exclusion Criteria: Poor performance status Secondary active cancer Pregnancy Dysregulated diabetes mellitus
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All patients<br>Both patients receiving chemotherapy and immunotherapy are observed during the same intervention with PET/CT and liquid biopsy. No primary comparison are made between the groups. | Device: PET/CT<br>* 3 extra scans with FDG-PET/CT and 4 blood samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation of changes in metabolism in cancer cells during first treatment with chemotherapy or immunotherapy. | Measure changes in standardized uptake value (SUV) in tumorcells by FDG-PET. | 3 months | 
| Observation of changes in circulating tumor DNA during first treatment. | Measure changes in the amount of free circulating DNA | 3 months | 
| Observation of changes in circulating tumor DNA during first treatment. | Measure changes in cancer DNA by whole genome sequencing on free circulating DNA. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early response evaluation, immunotherapy, chemotherapy, liquid biopsy, FDG-PET/CT