Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer

NSCLC Clinical Trial

— iRelate  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457789
• Other study ID #: 2023-509486-20-00
• Secondary ID: 2023-509486-20-0
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2028

Study information

• Verified date: June 2024
• Source: Amsterdam UMC, location VUmc
• Contact: Maarten Slebe, Msc.
• Phone: +31204445242
• Email: m.slebe[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: July 2028
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• [18F]F-AraG PET imaging
Patients will receive a static whole-body PET scan following a [18F]F-AraG injection.
• [89Zr]Zr-Df-Crefmirlimab PET imaging
Patients will receive a static whole-body PET scan following a [89Zr]Zr-Df-Crefmirlimab injection.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VUmc	Amsterdam	North Holland

Sponsors (2)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	Foundation for the National Institutes of Health

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	The Pearson correlation coefficient between PET uptake and immune profile of the TME for tumor and T-cell rich organs. The Pearson correlation coefficient between PET uptake and immune profile of PBMCs for tumor + T-cell rich organs.	6 months
Other	To quantify inter- and intra-tumoral heterogeneity of PET tracer uptake.	Voxel intensities for [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab PET images will be plotted against each other by means of scatter plots and joint histograms/kernel density plots to illustrate the degree of agreement in spatial distribution of both tracers with the VOIs.	2 months
Other	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.	The spatial overlap of the regions of uptake for the FDG, [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab PET tracers will be assessed using the Dice Similarity Coefficient (DSC) method.	4 months
Primary	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.	The spatial overlap of the regions of uptake for both PET tracers will be assessed using the Dice Similarity Coefficient (DSC) as an established method	2 months
Primary	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.	The Pearson correlation coefficient between each tracer tumor uptake and the T cell features in regions of concordance and discordance.	6 months
Secondary	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.	The Pearson correlation coefficient between each tracer tumor uptake and percentage of residual viable tumor cells (VTC) in regions of concordance and discordance and the maximal VTC of the entire tumor. The Pearson correlation coefficient between each tracer uptake and the T cell presence in resected lymph nodes (if present).	6 months