NSCLC
Conditions
Keywords
NSCLC, immunoPET, 18F-AraG, AraG, 89Zr-crefmirlimab, Crefmirlimab, tracers, PET tracers, [18F]F-AraG, [89Zr]Zr-Df-Crefmirlimab, IAB22M2C
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.
Interventions
DRUG[18F]F-AraG PET imaging
Patients will receive a static whole-body PET scan following a \[18F\]F-AraG injection.
DRUG[89Zr]Zr-Df-Crefmirlimab PET imaging
Patients will receive a static whole-body PET scan following a \[89Zr\]Zr-Df-Crefmirlimab injection.
Sponsors
Amsterdam UMC, location VUmc
Foundation for the National Institutes of Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 2 months | 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 |
| 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. | 6 months | The Pearson correlation coefficient between each tracer tumor uptake and the T cell features in regions of concordance and discordance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The Pearson correlation coefficient between each tracer tumor uptake and percentage of residual viable tumor cells (VTC) in regions of concordance and discordance and the maximal VTC of the entire tumor. The Pearson correlation coefficient between each tracer uptake and the T cell presence in resected lymph nodes (if present). |
Countries
Netherlands
Contacts
CONTACTMaarten Slebe, Msc.
CONTACTIdris Bahce, MD, PhD
PRINCIPAL_INVESTIGATORIdris Bahce, MD, PhD
Amsterdam UMC
Outcome results
None listed