Study Stopped
The study has been closed due to slow enrollment.
Early Response Evaluation in NSCLC Patients Treated With Immunotherapy
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.
1 other identifier
interventional
9
1 country
2
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 23, 2018
CompletedFirst Submitted
Initial submission to the registry
November 9, 2018
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2020
CompletedOctober 10, 2023
October 1, 2023
2.3 years
November 9, 2018
October 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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).
Study Arms (1)
Nivolumab
OTHERNivolumab 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Netherlands Cancer Institutelead
- Bristol-Myers Squibbcollaborator
Study Sites (2)
VU medical center
Amsterdam, 1007 MD, Netherlands
Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
Related Publications (1)
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.
PMID: 37123045DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J de Langen, MD, PhD
NKI-AvL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2018
First Posted
September 10, 2019
Study Start
January 23, 2018
Primary Completion
May 22, 2020
Study Completion
May 22, 2020
Last Updated
October 10, 2023
Record last verified: 2023-10