Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer (iRelate)
- Conditions
- Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Therapeutic area: Diseases [C] - Neoplasms [C04]on-Small Cell Lung Carcinoma
- Registration Number
- CTIS2023-509486-20-00
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 34
To be eligible to participate in this study, a patient must meet all of the following criteria: 1. Histologically confirmed NSCLC 2. T1-4N0-2, lesion size of =2cm, at time of the restaging FDG PET/CT 3. Planned to undergo resection after chemo-IO according to routine treatment guidelines 4. Willing and able to provide written informed consent for the trial 5. Above 18 years of age on day of signing informed consent 6. Have measurable disease based on RECIST 1.15 7. Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing
A patient who meets any of the following criteria will be excluded from participation in this study: 1. Patients deemed inoperable 2. 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. 3. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 4. Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method