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Trial Title:
Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer
NCT ID:
NCT06457789
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
NSCLC
immunoPET
18F-AraG
AraG
89Zr-crefmirlimab
Crefmirlimab
tracers
PET tracers
[18F]F-AraG
[89Zr]Zr-Df-Crefmirlimab
IAB22M2C
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[18F]F-AraG PET imaging
Description:
Patients will receive a static whole-body PET scan following a [18F]F-AraG injection.
Arm group label:
Dual T cell PET imaging
Intervention type:
Drug
Intervention name:
[89Zr]Zr-Df-Crefmirlimab PET imaging
Description:
Patients will receive a static whole-body PET scan following a [89Zr]Zr-Df-Crefmirlimab
injection.
Arm group label:
Dual T cell PET imaging
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amsterdam UMC, location VUmc
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Contact:
Last name:
Maarten Slebe, Msc
Phone:
+31204445242
Email:
m.slebe@amsterdamumc.nl
Contact backup:
Last name:
Idris Bahce, MD, PhD
Phone:
+31204444444
Email:
i.bahce@amsterdamumc.nl
Investigator:
Last name:
Idris Bahce, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Maarten Slebe, Msc
Email:
Sub-Investigator
Start date:
July 2024
Completion date:
July 2028
Lead sponsor:
Agency:
Amsterdam UMC, location VUmc
Agency class:
Other
Collaborator:
Agency:
Foundation for the National Institutes of Health
Agency class:
Other
Source:
Amsterdam UMC, location VUmc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06457789
