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The study has been closed due to slow enrollment.
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab | Other | Nivolumab treatment according to label: 3 mg/kg nivolumab IV Q2W, 240mg Q2W or 480mg Q4W as an IV infusion until disease progression or unacceptable toxicity. FDG PET-CT will be performed at baseline and between 7 and 14 days after treatment initiation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FDG PET-CT | Diagnostic Test | 18F-FDG PET-CT scan |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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. | 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. | 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. | Baseline and at the end of cycle 1 (each cycle is 14 days). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J de Langen, MD, PhD | NKI-AvL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU medical center | Amsterdam | 1007 MD | Netherlands | |||
| Leiden University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37123045 | Derived | Borm FJ, Smit J, Bakker J, Wondergem M, Smit EF, de Langen AJ, de Gruijl TD. Early response evaluation of PD-1 blockade in NSCLC patients through FDG-PET-CT and T cell profiling of tumor-draining lymph nodes. Oncoimmunology. 2023 Apr 26;12(1):2204745. doi: 10.1080/2162402X.2023.2204745. eCollection 2023. |
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to be decided
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Leiden |
| 2333 ZA |
| Netherlands |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |