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

Обзор

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.

Вмешательства

• Препарат [18F]F-AraG PET imaging
  Patients will receive a static whole-body PET scan following a \[18F\]F-AraG injection.
• Препарат [89Zr]Zr-Df-Crefmirlimab PET imaging
  Patients will receive a static whole-body PET scan following a \[89Zr\]Zr-Df-Crefmirlimab injection.

Первичные конечные точки

• 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. [Срок оценки: 2 months]
• 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. [Срок оценки: 6 months]

Вторичные конечные точки (1)

• 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. [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC, location VUmc — Amsterdam

Идентификаторы

NCT: NCT06457789 · 2023-509486-20-00 · 2023-509486-20-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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