Study on Niraparib with Immunotherapy for Patients with SLFN11-Positive Extensive-Stage Small Cell 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 extensive-disease small cell lung cancer (ED-SCLC), which shows high levels of a protein called SLFN11. The study is testing the effects of adding a medication called niraparib to a treatment plan that includes a type of medicine known as an anti-PD-L1 antibody. These antibodies, such as atezolizumab and durvalumab, are used to help the immune system fight cancer. Niraparib is a tablet that works by blocking certain enzymes in cancer cells, which may help stop the cancer from growing.

The purpose of this study is to see how effective the combination of niraparib and anti-PD-L1 antibodies is in treating patients with this specific type of lung cancer. Patients who participate in the study will receive the treatment over a period of time, and their health will be monitored to see how the cancer responds. The study will also compare the effects of the treatment with a placebo to better understand its benefits.

Participants will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein, and they will also take niraparib in tablet form. The study aims to provide more information on how well this combination works in preventing the cancer from getting worse and improving overall survival rates. The results will help determine if this treatment approach can be a beneficial option for patients with this type of lung cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of extensive-disease small cell lung cancer with high SLFN11 expression.

A written informed consent for trial participation is required before any trial-related intervention.

2 initial treatment phase

Patients must have completed standard first-line chemo-immunotherapy, which includes 4 cycles of platinum-etoposide chemotherapy combined with an anti-PD-L1 antibody, either atezolizumab or durvalumab.

Eligibility for maintenance treatment with immune-checkpoint inhibition is assessed.

3 maintenance treatment

The maintenance phase involves the administration of niraparib in combination with an anti-PD-L1 antibody.

Niraparib is taken orally in tablet form. The specific dosage and frequency are determined by the study protocol.

The anti-PD-L1 antibody, either atezolizumab or durvalumab, is administered through intravenous infusion.

4 monitoring and assessment

Regular monitoring is conducted to assess the progression-free survival rate at 3 months, as well as overall survival and disease control rate.

Adverse events are monitored according to established criteria.

5 completion of the study

The study is estimated to conclude by January 1, 2026.

Final assessments are conducted to evaluate the efficacy of the treatment regimen.

Who Can Join the Study?

The patient must have a type of lung cancer called extensive-disease small cell lung cancer (ED-SCLC), which is confirmed through specific tests.
The patient must have a high level of a protein called SLFN11 in their tumor cells. This is checked in a special laboratory.
The patient must have already received a standard treatment that includes a combination of chemotherapy and a type of medicine called an anti-PD-L1 antibody. This treatment should have been given in 4 cycles.
The patient’s cancer must not have gotten worse after the standard treatment, according to specific medical guidelines.
The patient must be suitable for ongoing treatment with medicines that help the immune system fight cancer.
The patient must have normal blood, kidney, and liver function.
The patient must have an ECOG performance status of 0 to 2, which is a scale used to assess how well a patient can perform daily activities.
The patient must be at least 18 years old.
The patient must sign a written consent form to participate in the trial, and this must be done before any trial-related activities begin.

Who Cannot Join the Study?

Patients who have not been diagnosed with extensive-disease small cell lung cancer. This is a type of lung cancer that has spread widely in the body.
Patients whose cancer does not show high SLFN11-expression. This refers to a specific protein level in the cancer cells.
Patients whose cancer has progressed after receiving the standard first-line treatment, which includes a combination of chemotherapy and immunotherapy.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medisprof S.R.L.	Cluj Napoca	Romania

Other Sites

Site Name	City	Country
Centre Hospitalier D Avignon	Avignon	France
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Hospital Universitario De Jaen	Jaen	Spain
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Imblkqcs Rvmxrjjgx Pfi Lm Stejgp Dbd Tkkfpy Dvaz Axsiuza Iwkw Scfscl	Meldola	Italy
Kjbbmawg dxu Ugtywosxwzsr Mmfgbbwl Aah	Munich	Germany
Cgaccf Lrag Bhffei	Lyon	France
Cfjslg Hrkvdspbxmq Rutzywgl Dyktvklvifzkho	Angers	France
Hmnfflpe Uyucuxlhftbkh dc A Cgequi	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.01.2024
Germany	Recruiting	01.01.2024
Italy	Recruiting	01.01.2024
Romania	Not recruiting	01.01.2024
Spain	Recruiting	01.01.2024

Trial locations

Investigated drugs:

Niraparib is a medication used in this trial to see if it can help improve the treatment of small cell lung cancer. It is being added to the usual maintenance treatment to see if it can make the treatment more effective for patients whose cancer has not worsened after initial therapy.

Anti-PD-L1 Monoclonal Antibody is a type of medication that helps the immune system fight cancer. In this trial, it is used as a maintenance treatment to help keep the cancer from coming back or getting worse after the initial treatment.

Investigated diseases:

Extensive-disease small cell lung cancer – This is a type of lung cancer characterized by the rapid growth and spread of cancer cells originating in the lung tissues. It is known for its aggressive nature and tendency to metastasize quickly to other parts of the body, including the brain, liver, and bones. The disease often presents with symptoms such as coughing, chest pain, and difficulty breathing. As it progresses, patients may experience weight loss, fatigue, and neurological symptoms if the cancer spreads to the brain. The term “extensive-disease” indicates that the cancer has spread beyond the lung to other areas. This form of cancer is typically diagnosed at an advanced stage due to its rapid progression.

Trial ID:

2022-502092-33-00

Protocol code:

ETOP 23-22 RAISE

NCT ID:

NCT05718323

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Niraparib with Immunotherapy for Patients with SLFN11-Positive Extensive-Stage Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?