Early Response Evaluation in NSCLC Patients Treated With Immunotherapy

October 6, 2023 updated by: The Netherlands Cancer Institute

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.

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..

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
18F-FDG PET-CT scan
Other Names:
  • Tracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of collected immune cells by FNA EBUS will be assesed using flow cytometry.
Time Frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
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.
Time Frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
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
Time Frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
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
Time Frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
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
Time Frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
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
Time Frame: Baseline and at the end of cycle 1 (each cycle is 14 days).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: J de Langen, MD, PhD, NKI-AvL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2018

Primary Completion (Actual)

May 22, 2020

Study Completion (Actual)

May 22, 2020

Study Registration Dates

First Submitted

November 9, 2018

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M17IPL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

to be decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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