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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Ente Ecclesiastico Ospedale Generale Regionale Miulli	Acquaviva Delle Fonti	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Ospedale Vito Fazzi Lecce	Lecce	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord	Pesaro	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda USL Toscana Centro	Prato	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Ikklc Ixczrqxt Faaiyujwhhart Oajrwmqgrrlo Incsjpsq Netpnyjpt tiqqwr Rgzven Etjqq	Rome	Italy
Ircurlwq Rdwchaurp Paa Ly Sxmhlf Dzs Tkfqtd Dsvy Alfrzfs Iddl Spuhor	Meldola	Italy
Amwblvj Uoo Ivvpb Db Rmpufi Emrlmx	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.02.2021

Trial locations

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.

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.

Trial ID:

2024-515555-38-01

Protocol code:

UNITO-001

NCT ID:

NCT04940637

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?