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Study on Patritumab Deruxtecan and Zirconium (89Zr) Patritumab Deruxtecan for Patients with Advanced EGFR Mutation Positive Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as EGFR mutation positive advanced stage non-small cell lung cancer (NSCLC). The study will use a treatment called Patritumab Deruxtecan, which is a special kind of medicine known as a monoclonal antibody. This medicine is designed to target specific proteins in cancer cells. In this trial, a version of this medicine that is labeled with a radioactive substance called Zirconium (89Zr) will also be used. This helps doctors see how the medicine is working inside the body using imaging techniques.

The purpose of the study is to find the best dose of the non-radioactive version of Patritumab Deruxtecan to use alongside the radioactive version for imaging purposes. This will help doctors get a clear picture of how the medicine is distributed in the body. The study will involve several groups of patients, each receiving different amounts of the non-radioactive medicine. Doctors will then use a type of scan called PET/CT to see how well the medicine is working in the body. This scan combines two imaging techniques to provide detailed pictures of the inside of the body.

Throughout the study, doctors will also measure how much of the radioactive medicine is taken up by the tumors. This is done both visually and by calculating a value known as the standardized uptake value (SUV), which helps in understanding how the tumors are responding to the treatment. The study aims to provide valuable information that could improve the way this type of lung cancer is treated in the future.

1 initial screening

The patient undergoes an initial screening to confirm eligibility for the trial. This includes providing informed consent and a tumor tissue specimen. A negative pregnancy test is required for females of childbearing potential.

The patient must have a confirmed diagnosis of advanced stage EGFR mutation positive NSCLC and meet specific health criteria, including adequate bone marrow reserve and organ function.

2 treatment preparation

The patient is prepared for treatment with patritumab deruxtecan and zirconium (89Zr) patritumab deruxtecan. These are administered as a powder or solution for infusion through an intravenous route.

The patient is informed about the need to use effective birth control during the treatment period and for a specified time after the last dose.

3 medication administration

The patient receives the medication through an intravenous infusion. The dose of non-radiolabeled patritumab deruxtecan is adjusted to achieve optimal imaging results.

The patient is monitored for any adverse reactions during and after the infusion.

4 imaging and monitoring

The patient undergoes PET/CT imaging to assess the uptake of 89Zr-patritumab deruxtecan in the body. This helps in visualizing the circulation and tumor lesions.

The imaging is conducted at specific intervals, such as day 3 or day 6 post-injection, to determine the optimal imaging dose.

5 follow-up and evaluation

The patient attends follow-up appointments to evaluate the treatment’s effectiveness and monitor for any side effects.

The patient’s health and response to the treatment are assessed regularly until the end of the trial period.

Who Can Join the Study?

  • You must agree to participate in the study by signing a consent form before any study-related procedures begin.
  • You need to provide a sample of your tumor tissue. This can be a new biopsy or a previously collected sample, as long as it was taken after your first treatment. The sample must have enough tumor tissue for analysis.
  • If you are a woman who can have children, you must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 7 months after the last dose of the study drug.
  • Women must not donate or use their eggs for personal use during the study and for at least 7 months after the last dose of the study drug.
  • If you are a man, you must be surgically sterile or agree to use effective birth control during the study and for at least 4 months after the last dose of the study drug.
  • Men must not freeze or donate sperm during the study and for at least 4 months after the last dose of the study drug.
  • You must have a confirmed diagnosis of advanced stage EGFR mutation positive NSCLC (a type of lung cancer) that cannot be treated with the intent to cure.
  • You must have measurable disease according to RECIST 1.1, which is a standard way to measure how well a cancer treatment is working.
  • You must have at least two lesions (areas of cancer) that are 2 cm or larger in size.
  • You must have received at least one treatment with EGFR TKI (a type of targeted therapy) for advanced stage NSCLC.
  • If your tumor has the T790M mutation, you must have been treated with a third-generation EGFR TKI.
  • You must be at least 18 years old.
  • You must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
  • You must have adequate bone marrow and organ function, as shown by specific blood test results within 14 days before starting the study. This includes having enough platelets, hemoglobin, and neutrophils, as well as normal kidney and liver function.

Who Cannot Join the Study?

  • Patients who do not have a positive test for the EGFR mutation in their advanced lung cancer. The EGFR mutation is a change in a gene that can affect how cancer grows.
  • Patients who are not in the specified age range for the study. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to undergo the specific imaging required for the study. This imaging helps doctors see how the treatment is working.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are not able to follow the study procedures or attend all required visits.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.05.2024

Trial locations

Investigated drugs:

Patritumab Deruxtecan is a medication being studied for its ability to help visualize certain types of cancer cells in the body. In this trial, it is used in two forms: a non-radiolabeled version and a radiolabeled version. The non-radiolabeled patritumab deruxtecan is given to patients to help determine the best dose that allows for clear imaging results. This helps doctors see how the medication interacts with cancer cells.

89Zr-Patritumab Deruxtecan is the radiolabeled version of patritumab deruxtecan. It is used in PET/CT scans to help doctors see where cancer cells are located in the body. The radiolabeling allows the medication to be visible on the scan, helping doctors to measure how much of the medication is taken up by the tumor. This information is important for understanding how the cancer is responding to the treatment.

Investigated diseases:

Non-Small Cell Lung Cancer with EGFR Mutation – This is a type of lung cancer characterized by the presence of mutations in the epidermal growth factor receptor (EGFR) gene. These mutations lead to uncontrolled cell growth and division, contributing to the development and progression of cancer. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. It is classified as “advanced stage” when it has spread beyond the lungs to other areas. The progression of this cancer can vary, but it often involves the growth of tumors in the lungs and potentially metastasis to other organs. Understanding the specific mutations, like EGFR, helps in studying the disease’s behavior and potential treatment approaches.

Trial ID:
2023-508233-14-00
Protocol code:
U31402-0002-CESR-MA
NCT ID:
NCT06222489
Trial Phase:
Therapeutic exploratory (Phase II)

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