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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dual T cell PET imaging

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

Group Type EXPERIMENTAL

[18F]F-AraG PET imaging

Intervention Type DRUG

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

[89Zr]Zr-Df-Crefmirlimab PET imaging

Intervention Type DRUG

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

Interventions

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[18F]F-AraG PET imaging

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

Intervention Type DRUG

[89Zr]Zr-Df-Crefmirlimab PET imaging

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No