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Study of Niraparib and Dostarlimab for Patients with Advanced Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma with Specific Genetic Mutations

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 two types of cancer: non-small cell lung cancer and pleural mesothelioma. These are serious conditions where cancer cells form in the tissues of the lung or the lining of the chest. The study is testing a combination of two medications, niraparib and dostarlimab. Niraparib is taken as a capsule, while dostarlimab is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to see how well this combination of medications works in patients who have these cancers and specific genetic features, such as being positive for PD-L1 expression and having mutations in the HRR genes. PD-L1 is a protein that can affect the immune system's ability to fight cancer, and HRR genes are involved in repairing DNA. The study will follow participants over a period of up to 24 months to observe the effects of the treatment.

Participants in the study will receive the medications and be monitored regularly to assess their health and the progression of their cancer. The study aims 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 niraparib and dostarlimab together. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment. The study will help determine if this combination of medications can be a beneficial treatment option for these types of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history, current health status, and previous treatments.
A tissue biopsy may be required to analyze biological material and confirm specific genetic markers.
Step 2
Treatment initiation
The treatment involves two medications: niraparib and dostarlimab.
Niraparib is taken orally. The dosage and frequency will be determined by the study team based on individual health needs.
Dostarlimab is administered through an intravenous infusion. The frequency and duration of the infusion will be specified by the study team.
Step 3
Regular monitoring
Regular monitoring is conducted to evaluate the response to treatment. This includes physical examinations, blood tests, and imaging studies.
The study team will assess the progression of the disease and any side effects experienced during the treatment.
Step 4
Follow-up visits
Scheduled follow-up visits are necessary to track the long-term effects of the treatment.
These visits will help in understanding the overall survival and safety of the medication combination.
Step 5
End of study
The study is estimated to conclude by December 31, 2025.
Final assessments will be conducted to gather comprehensive data on the treatment's effectiveness and safety.

Who can join the trial?

9 criteria

Diagnosis of Mesothelioma or non-small cell lung cancer with specific genetic markers (EGFR, ALK, ROS1) in an advanced stage.
The disease has worsened after at least one previous treatment.
Presence of specific genetic changes in DNA and a protein called PD-L1 at a level of 1% or more.
Willingness to provide informed consent, which means understanding the study and agreeing to participate.
Age between 18 and 75 years old.
The disease can be measured using specific medical criteria known as RECIST.
Agreement to allow analysis of biological material, such as a tissue sample from a biopsy.
Good overall health status, indicated by a performance status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Having organs that are functioning well enough to participate in the study.

Who cannot join the trial?

3 criteria

Patients with any other type of cancer besides pleural mesothelioma or non-small cell lung cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
A.O.U. Policlinico G. Martino Di Messina
Messina, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Verified
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Varese, Italy

Trial locations

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Investigated drugs

Niraparib
is a type of medication known as a PARP inhibitor. It works by blocking an enzyme that cancer cells need to repair their DNA. By preventing this repair, niraparib can help stop the growth of cancer cells and may lead to their death. In this trial, it is being used to treat patients with advanced non-small cell lung cancer or malignant pleural mesothelioma, especially those with specific genetic mutations.
Dostarlimab
is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a protein called PD-1, which is used by cancer cells to hide from the immune system. By blocking this protein, dostarlimab allows the immune system to better recognize and attack cancer cells. This medication is being tested in the trial for its effectiveness in treating patients with certain types of lung cancer and mesothelioma.

What is already known about the treatment

Niraparib
Niraparib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating advanced non-small cell lung cancer and malignant pleural mesothelioma. The main therapeutic indication for niraparib is its potential to improve progression-free survival in patients with these cancers. At the molecular level, niraparib works by inhibiting a protein called PARP, which helps repair damaged DNA in cells, thereby preventing cancer cells from repairing themselves and continuing to grow. It is classified as a PARP inhibitor in pharmacology.
Dostarlimab
Dostarlimab is administered intravenously, meaning it is given directly into a vein through an injection. It is being investigated in clinical trials for its role in treating advanced non-small cell lung cancer and malignant pleural mesothelioma. The main therapeutic indication for dostarlimab is its potential to enhance the immune system's ability to fight cancer by targeting PD-L1, a protein that helps cancer cells evade immune detection. Dostarlimab is classified as an immune checkpoint inhibitor, which helps the immune system recognize and attack cancer cells more effectively.

Investigated diseases

Pleural Mesothelioma
Pleural Mesothelioma is a type of cancer that occurs in the thin layer of tissue covering the lungs and chest wall, known as the pleura. It is primarily caused by exposure to asbestos fibers, which can lead to inflammation and scarring over time. The disease progresses as cancerous cells form in the pleura, leading to thickening of the tissue and fluid buildup around the lungs. This can cause symptoms such as chest pain, shortness of breath, and persistent cough. As the disease advances, it may spread to other parts of the body, including the abdomen and other organs. The progression can vary, but it typically involves increasing difficulty in breathing and chest discomfort.
Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer (NSCLC) is the most common type of lung cancer, accounting for a majority of cases. It begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. The disease progresses as these cancerous cells multiply and form tumors, which can interfere with normal lung function. Symptoms may include a persistent cough, coughing up blood, chest pain, and difficulty breathing. As NSCLC advances, it can spread to nearby lymph nodes and other organs, such as the brain, liver, and bones. The progression of the disease can lead to increased respiratory issues and general decline in health.