Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer
Recruiting · NCT06457789 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
[18F]F-AraG PET imaging[89Zr]Zr-Df-Crefmirlimab PET imaging
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Amsterdam UMC, location VUmc - Amsterdam, North Holland, Netherlands