TerminatedNCT04082988Updated Oct 10, 2023

Early Response Evaluation in NSCLC Patients Treated With Immunotherapy

An interventional study of 18F-FDG PET-CT in NSCLC, Stage IV, sponsored by The Netherlands Cancer Institute. Terminated at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Diagnostic

Why this study was terminated

The study has been closed due to slow enrollment.

From the registry’s dates

Registered 9 months after the study started (first participant enrolled Jan 2018, registered Nov 2018).

Phase: Not applicable
Study type: Interventional
Enrollment: 9
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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..

Read the 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.

Conditions studied

NSCLC, Stage IV

Browse trials for

Carcinoma, Non-Small-Cell Lung 6,641

Keywords

PD-L1 expression
eligible for treatment with nivolumab

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 9 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

The Netherlands Cancer Institute is the lead sponsor of 230 studies on the registry; 66 are open to participants now.

Browse The Netherlands Cancer Institute studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 9 participants (actual)

Study arms

Other
Nivolumab
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
Diagnostic Test: 18F-FDG PET-CT

Interventions

Diagnostic test18F-FDG PET-CT
18F-FDG PET-CT scan
Also known as: Tracer

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and at the end of cycle 1 (each cycle is 14 days).

Study locations

2 sites

VU medical center
Amsterdam, 1007 MD, Netherlands
Leiden University Medical Center
Leiden, 2333 ZA, Netherlands

References and documents

Publications

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. PubMed 37123045 ↗

Individual participant data

Plan to share: Undecided — to be decided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04082988
Lead sponsor: The Netherlands Cancer Institute
Collaborators: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Sep 10, 2019
Start date: Jan 23, 2018
Primary completion: May 22, 2020
Completion: May 22, 2020
Last update: Oct 10, 2023

Study contacts

J de Langen, MD, PhD

principal investigator · NKI-AvL

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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