Clinical trial NCT06457789: Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer
Official title: Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NSCLC
Keywords: NSCLC
immunoPET
18F-AraG
AraG
89Zr-crefmirlimab
Crefmirlimab
tracers
PET tracers
[18F]F-AraG
[89Zr]Zr-Df-Crefmirlimab
IAB22M2C
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Foundation for the National Institutes of Health
First posted: 2024-06-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The iRelate is a PET imaging trial to compare two upcoming and promising T cell PET tracers. Following chemo-immuno therapy, as part of standard care, NSCLC patients will be recruited to receive two PET scans, shortly before their surgery. Both PET scans will be compared to each other, as well as compared to the pathological analysis of the resected tumor.

This study will provide detailed information on the unique as well as additive capacities of imaging biomarkers derived from the immune cell targeting PET tracers.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed NSCLC
* T1-4N0-2, lesion size of ≥2cm, at time of the restaging FDG PET/CT
* Planned to undergo resection after chemo-IO according to routine treatment guidelines
* Willing and able to provide written informed consent for the trial
* Above 18 years of age on day of signing informed consent
* Have measurable disease based on RECIST 1.1
* Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing

Exclusion Criteria:

* Patients deemed inoperable
* Patients who have received a splenectomy
* Patients who have received any vaccination within 14 days of enrollment
* Patients with a condition requiring systemic treatment with either corticosteroids (\&gt; 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid \&gt;10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.

Primary outcomes:
measure: To measure the spatial correlation of PET uptake of [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab in tumors and T-cell rich organs such as lymph nodes prior to resection.
timeFrame: 2 months
measure: To measure the strength of correlation between the presence of CD8+ cells and T cell activation features in the resected tumor and lymph nodes with preoperative uptake of [89Zr]Zr-Df-Crefmirlimab and [18F]F-AraG, respectively.
timeFrame: 6 months
Secondary outcomes:
measure: To measure the strength of correlation of pathological response (i.e., the residual viable tumor cells percentage) in the resected tumor with preoperative uptake of [89Zr]Zr-Df-Crefmirlimab and [18F]F-AraG.
timeFrame: 6 months
Other outcomes:
measure: To explore the association of PET uptake of both tracers in tumor and T-cell rich organs such as lymph nodes with: The immune profile of the TME and resected lymph nodes beyond T cells. The immune profile of peripheral blood mononuclear cells (PBMCs)
timeFrame: 6 months
measure: To quantify inter- and intra-tumoral heterogeneity of PET tracer uptake.
timeFrame: 2 months
measure: To assess the relationship of metabolically active areas as assessed by [18F]F-FDG PET with areas of uptake derived from [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab PET.
timeFrame: 4 months
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
state: North Holland
Study officials:
affiliation: Amsterdam UMC
name: Idris Bahce, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: