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Study on PET Tracers [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab for Evaluating T Cell Activation in Non-Small Cell Lung Cancer Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Non-Small Cell Lung Cancer (NSCLC), a common type of lung cancer. The study will use two special imaging agents, 89Zr-Df-crefmirlimab and 18F-F-AraG, to help understand how the body's immune cells, specifically T cells, respond to cancer treatment. These agents are given through an intravenous (IV) solution, which means they are administered directly into the bloodstream.

The purpose of the study is to evaluate how these imaging agents can show changes in T cells and their activation in response to immunotherapy, a type of cancer treatment that helps the immune system fight cancer. The study will involve patients with NSCLC who are scheduled to have surgery after receiving chemotherapy and immunotherapy. The imaging agents will be used to take pictures of the tumors and areas rich in T cells, like lymph nodes, before surgery. This will help researchers see how well the imaging agents can detect T cell activity and changes in the tumors.

Throughout the study, participants will receive the imaging agents and undergo imaging scans to capture detailed pictures of their tumors and T cell-rich areas. These scans will help researchers understand the relationship between the presence of T cells and the changes in the tumors. The study aims to provide valuable insights into how the immune system interacts with cancer and how imaging can be used to monitor treatment responses in NSCLC.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of non-small cell lung cancer and planned surgery after chemotherapy and immunotherapy.

    Written informed consent is required to participate.

  2. Step 2

    Initial assessment

    An initial assessment involves imaging tests to evaluate the cancer and surrounding tissues.

    This includes a PET/CT scan to measure the uptake of specific tracers in tumors and T-cell rich organs.

  3. Step 3

    Tracer administration

    Two tracers, [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab, are administered to assess T-cell activity and tumor characteristics.

    These tracers are given through an intravenous infusion.

  4. Step 4

    Follow-up imaging

    Follow-up imaging is conducted to observe the spatial correlation of tracer uptake in tumors and lymph nodes.

    This helps in understanding the relationship between tracer uptake and T-cell activity.

  5. Step 5

    Surgery preparation

    Preparation for surgery involves routine preoperative assessments to ensure readiness for the procedure.

    This includes evaluating pulmonary function and overall health status.

  6. Step 6

    Surgery

    Surgery is performed to remove the tumor and affected lymph nodes.

    The resected tissues are analyzed to measure T-cell activation and the presence of cancer cells.

  7. Step 7

    Post-surgery evaluation

    Post-surgery evaluation includes analyzing the correlation between preoperative tracer uptake and T-cell features in the resected tissues.

    This helps in assessing the effectiveness of the treatment and the immune response.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of Non-Small Cell Lung Carcinoma (NSCLC). This means that a doctor has checked the lung tissue and confirmed this type of lung cancer.
  • The cancer must be at a stage between T1-4N0-2, with a tumor size of at least 2 centimeters, as seen on a special scan called FDG PET/CT. This scan helps doctors see the size and spread of the cancer.
  • The patient should be planning to have surgery to remove the cancer after receiving chemotherapy and immunotherapy, which are treatments to help fight cancer.
  • The patient must be willing and able to sign a document called informed consent, which shows they understand the study and agree to participate.
  • The patient must be over 18 years old on the day they sign the informed consent.
  • The patient must have a cancer that can be measured using a standard called RECIST 1.1, which is a way to track the size of tumors.
  • The patient must have an ECOG performance status of 0-1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • The patient must be considered fit for surgery based on tests that check lung function and/or exercise ability.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Non-Small Cell Lung Carcinoma cannot participate. This is a type of lung cancer.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.
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Verified sites

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  • Responsive

    Amsterdam UMC

    The NetherlandsAmsterdam, The Netherlands

Trial locations

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Investigated drugs

  • [18F]F-AraG

    is a PET tracer used in this clinical trial to help visualize and measure T cell activation in the body. It is particularly focused on identifying changes in T cells within tumors and lymph nodes. This tracer helps researchers understand how the immune system is responding to immunotherapy treatments in patients with non-small cell lung cancer.

  • [89Zr]Zr-Df-Crefmirlimab

    is another PET tracer used in the study. It is designed to target and highlight areas in the body where T cells are present, such as tumors and lymph nodes. By using this tracer, researchers aim to assess the presence and activity of CD8+ T cells, which are crucial for the immune response against cancer. This information is valuable for evaluating how well the immunotherapy is working in treating the cancer.

What is already known about the treatment

  • [18F]F-AraG

    This medication is administered as an injection and is used in PET imaging to evaluate T cell changes and activation in patients with non-small cell lung carcinoma. It is currently being studied in clinical trials to assess its effectiveness in predicting responses to immunotherapy. The main therapeutic indication is to provide imaging that helps in understanding the immune response in cancer treatment. At the molecular level, [18F]F-AraG works by targeting activated T cells, allowing for visualization of immune activity. It is classified as a radiopharmaceutical used in diagnostic imaging.

  • [89Zr]Zr-Df-Crefmirlimab

    This medication is also administered via injection and is used in PET imaging to assess T cell activation in non-small cell lung carcinoma. It is under investigation in clinical trials to determine its role in evaluating treatment responses to immunotherapy. The primary therapeutic indication is to visualize immune cell activity in tumors and lymph nodes. The mechanism of action involves binding to specific immune cells, enabling the detection of immune responses at the molecular level. It is classified as a radiopharmaceutical for diagnostic purposes.

Investigated diseases

Non-Small Cell Lung Carcinoma – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the cells lining the lungs and can spread to other parts of the body. As it progresses, it may cause symptoms like persistent cough, chest pain, and difficulty breathing. The growth rate and spread can vary depending on the specific subtype and individual factors. Early stages may not show symptoms, making it challenging to detect without screening.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-509486-20-00Protocol code2023-509486-20-00Estimated enrolment34 patientsSponsorAmsterdam UMC

sourced from the EU Clinical Trials Register and site verification

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