Early Response Evaluation in NSCLC Patients Treated With Immunotherapy

NSCLC, Stage IV Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04082988
• Other study ID #: M17IPL
• Status: Terminated
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: May 22, 2020

Study information

• Verified date: October 2023
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 22, 2020
• Est. primary completion date: May 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• NSCLC, Stage IV

Intervention

Diagnostic Test:
• 18F-FDG PET-CT
18F-FDG PET-CT scan

Locations

Country	Name	City	State
Netherlands	VU medical center	Amsterdam
Netherlands	Leiden University Medical Center	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Bristol-Myers Squibb

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).