Evaluating T Cell Changes in Lung Cancer with PET Imaging

Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer

This study is testing two new imaging methods to see how T cells change in people with non-small cell lung cancer after they receive chemo-immunotherapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Amsterdam UMC, location VUmc (other)
• Drugs / interventions: prednisone
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT06457789 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the effectiveness of two novel PET tracers in evaluating T cell changes and activation in patients with non-small cell lung cancer (NSCLC) following chemo-immunotherapy. Participants will undergo two PET scans before their scheduled surgery, allowing researchers to compare the imaging results of the tracers against the pathological analysis of the resected tumor. The goal is to enhance understanding of how these imaging biomarkers can provide insights into treatment responses.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 with histologically confirmed NSCLC who are scheduled for surgical resection after receiving chemo-immunotherapy.

Not a fit: Patients who are deemed inoperable or have received recent vaccinations or systemic immunosuppressive treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring of treatment responses in NSCLC patients, potentially guiding more effective immunotherapy strategies.

How similar studies have performed: While the use of PET imaging in cancer treatment monitoring is established, the specific application of these novel tracers in NSCLC is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Amsterdam, North Holland

• Amsterdam UMC, location VUmc — Amsterdam, North Holland, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Idris Bahce, MD, PhD — Amsterdam UMC
• Study coordinator: Maarten Slebe, Msc.

Conditions: NSCLC, immunoPET, 18F-AraG, AraG, 89Zr-crefmirlimab, Crefmirlimab, tracers, PET tracers