Clinical trial NCT04082988: Early Response Evaluation in NSCLC Patients Treated With Immunotherapy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: NSCLC, Stage IV
Keywords: PD-L1 expression
eligible for treatment with nivolumab
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2019-09-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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..

Detailed description: 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.

Eligibility criteria: Inclusion 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.
* Ipsilateral hilar or mediastinal lymph node with a short axis diameter ≥1 cm.
* Eligible and planned to receive nivolumab according to EMA label and national guidelines.
* Measurable disease according to RECIST v1.1.
* WHO performance status of 0-2.

Exclusion Criteria:

* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to 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.
* Isolated distant relapse after curative intent treatment for stage I-III NSCLC.

Primary outcomes:
measure: Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
timeFrame: Baseline and at the end of cycle 1 (each cycle is 14 days).
measure: Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
timeFrame: Baseline and at the end of cycle 1 (each cycle is 14 days).
measure: FDG PET-CT analysis
timeFrame: Baseline and at the end of cycle 1 (each cycle is 14 days).
measure: FDG PET-CT analysis
timeFrame: Baseline and at the end of cycle 1 (each cycle is 14 days).
measure: FDG PET-CT analysis
timeFrame: Baseline and at the end of cycle 1 (each cycle is 14 days).
measure: Peripheral blood mononuclear cells will be isolated and counted using FACS
timeFrame: Baseline and at the end of cycle 1 (each cycle is 14 days).
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU medical center
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: NKI-AvL
name: J de Langen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: