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

Amsterdam UMC, location VUmc

Status: Enrolling

Conditions: NSCLC

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06457789

2023-509486-20-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Dual T cell PET imaging

Experimental group

Description:

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

Treatment:

Drug: [18F]F-AraG PET imaging

Drug: [89Zr]Zr-Df-Crefmirlimab PET imaging