Studieoverzicht

Study name: iRelate

Histology NSCLC
Tumor stage Stage I - III
Host / recruiting sites Amsterdam UMC
Enrollment Recruiting
Therapy line First line (1L)
Design

A single-center, single arm imaging trial

Intervention

All patients will receive one [18F]F-AraG PET and one [89Zr]Zr-Df-Crefmirlimab PET scanning procedures according to the institutional protocols

Key outcome parameters

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

Key inclusion criteria

o Adults (18-64 years)
o Able to give consent
o Signed informed consent
o Patients who have an indication for a standard FDG PET-CT scan
o For sub-study 2 (breath hold PET), patients with NSCLC, stage 2 or higher

Key exclusion criteria

o Patients deemed inoperable
o Patients who have received a splenectomy
o Patients who have received any vaccination within 14 days of enrollment
o 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.
o Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
o Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.

Contact information