Ongoing Clinical Trials for Pleural Mesothelioma
This article provides information about 2 ongoing clinical trials for pleural mesothelioma, a type of cancer affecting the lining of the lungs. These trials are investigating new imaging techniques and treatment combinations to improve diagnosis, staging, and treatment outcomes for patients with this condition.
Clinical trial locations
- Denmark
- Italy
Study on the Use of 68Ga-FAPI-46 and Fludeoxyglucose (18F) for Diagnosing Pleural Mesothelioma in Patients
This trial, taking place in Denmark, is investigating a new imaging method to help diagnose and stage pleural mesothelioma more accurately. The study compares two types of PET scans: one using a substance called 68Ga-FAPI-46 and another using Fludeoxyglucose (18F), which is the standard imaging substance used today.
Who can join: Patients who are 18 years or older with pleural lesions suspected to be mesothelioma and who are scheduled for a pleural biopsy can participate. A biopsy involves taking a small tissue sample from the lining of the lungs to check for disease. Participants must have had or be currently undergoing an FDG PET/CT scan as part of their diagnostic process. They must be physically and mentally able to participate and understand the study information well enough to provide informed consent.
Who cannot join: Patients who do not have a confirmed diagnosis of pleural mesothelioma, those outside the specified age range, or individuals who belong to vulnerable populations requiring special protection cannot participate in this trial.
What the trial aims to do: The main goal is to determine whether FAPI PET scanning provides better accuracy than traditional FDG PET scanning in diagnosing and staging the disease. Participants will undergo both types of scans, and doctors will compare the results to see which method shows cancer cells more clearly. The study will also track how the imaging results help in planning treatment and assessing how well the treatment works over time. After patients complete 2-3 rounds of cancer treatment, they will have another FAPI PET scan to evaluate changes in the tumor. A long-term follow-up over 10 years will track survival and disease progression.
Investigational approach: The study uses FAPI PET imaging as the main investigational tool. This involves injecting a special substance that highlights cancer cells during imaging, potentially making them easier to see than with traditional methods.
Study of Niraparib and Dostarlimab for Patients with Advanced Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma with Specific Genetic Mutations
This trial, conducted in Italy, is testing a combination of two medications for patients with advanced pleural mesothelioma or non-small cell lung cancer who have specific genetic features. The study will follow participants for up to 24 months to observe the effects of treatment.
Who can join: Patients between 18 and 75 years old with a diagnosis of mesothelioma or non-small cell lung cancer in an advanced stage can participate. The disease must have worsened after at least one previous treatment. Participants must have specific genetic changes in their DNA and a protein called PD-L1 at a level of 1% or more. The disease must be measurable using specific medical criteria, and participants must have good overall health status, meaning they are fully active or able to carry out light work. Patients must be willing to provide tissue samples for analysis and give informed consent.
Who cannot join: Patients with any other type of cancer besides pleural mesothelioma or non-small cell lung cancer, those outside the specified age range, or individuals who are part of vulnerable populations and unable to give consent cannot participate.
What the trial aims to do: The study aims to determine how well the combination of niraparib and dostarlimab works in treating these cancers. Researchers want to understand how long patients can live without their cancer getting worse, how their cancer responds to the treatment, and the overall safety of using these two medications together. Some participants may receive a placebo for comparison purposes.
Investigational drugs: Niraparib is taken as an oral capsule and works as a PARP inhibitor, blocking an enzyme that cancer cells need to repair their DNA. By preventing this repair, niraparib can help stop cancer cell growth and may lead to their death. Dostarlimab is given through an intravenous infusion directly into the bloodstream. It is an immunotherapy drug that helps the body’s immune system fight cancer by blocking a protein called PD-1, which cancer cells use to hide from the immune system. By blocking this protein, dostarlimab allows the immune system to better recognize and attack cancer cells.
Summary
Currently, there are 2 active clinical trials for pleural mesothelioma, taking place in Denmark and Italy. These trials represent different approaches to improving care for patients with this condition. The Danish trial focuses on improving diagnostic accuracy through advanced imaging techniques, specifically comparing FAPI PET scanning with traditional FDG PET scanning. The Italian trial takes a treatment-focused approach, testing a combination of two medications—niraparib and dostarlimab—for patients with advanced disease and specific genetic markers.
Notably, both trials require participants to meet specific criteria related to disease stage, genetic features, and overall health status. The Italian trial is particularly focused on patients whose cancer has progressed after previous treatment and who have particular genetic mutations and PD-L1 expression levels. These trials reflect ongoing efforts to develop more precise diagnostic tools and targeted treatment options for this challenging disease.
