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

NCT06457789 | Recruiting

• 1 other identifier: 2023-509486-20-00
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Keywords

NSCLC; immunoPET; 18F-AraG; AraG; 89Zr-crefmirlimab; Crefmirlimab; tracers; PET tracers; [18F]F-AraG; [89Zr]Zr-Df-Crefmirlimab; IAB22M2C

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• 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.

  6 months

Other Outcomes (3)

• 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)

  6 months

• To quantify inter- and intra-tumoral heterogeneity of PET tracer uptake.

  2 months

• 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.

  4 months

Study Arms (1)

Dual T cell PET imaging

EXPERIMENTAL

Patients will receive PET imaging with two different T-cell targeting tracers.

Drug: [18F]F-AraG PET imaging; Drug: [89Zr]Zr-Df-Crefmirlimab PET imaging

Interventions

[18F]F-AraG PET imaging DRUG

Patients will receive a static whole-body PET scan following a \[18F\]F-AraG injection.

Dual T cell PET imaging

[89Zr]Zr-Df-Crefmirlimab PET imaging DRUG

Patients will receive a static whole-body PET scan following a \[89Zr\]Zr-Df-Crefmirlimab injection.

Dual T cell PET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Foundation for the National Institutes of Health: collaborator

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Study Officials

• Idris Bahce, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maarten Slebe, Msc.

CONTACT

+31204445242; m.slebe@amsterdamumc.nl

Idris Bahce, MD, PhD

CONTACT

+31204444444; i.bahce@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 13, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

NL (1)