Study of Pembrolizumab and Olaparib with Chemoradiation for Patients with Newly Diagnosed Limited-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 Limited-Stage Small Cell Lung Cancer (LS-SCLC). The study is investigating the effects of a combination of treatments, including Pembrolizumab (also known by its code name MK-3475), Olaparib (code name MK-7339), and standard chemoradiation therapy. Pembrolizumab is a medication that helps the immune system fight cancer, while Olaparib is a drug that targets cancer cells with specific genetic defects. The trial will also include a placebo group to compare the effectiveness of these treatments.

The purpose of the study is to evaluate how well these treatments work together in improving the survival of patients with LS-SCLC. Participants will receive either the combination of Pembrolizumab and Olaparib with chemoradiation therapy or chemoradiation therapy alone. The study will monitor the progression of the disease and overall survival rates. The trial will also assess the safety of the treatments by tracking any side effects experienced by participants.

Participants in the study will undergo regular assessments, including imaging tests like MRI or CT scans, to monitor the cancer’s response to treatment. The study will last for a period of time, during which participants will receive the assigned treatments and attend follow-up visits to evaluate their health and the effectiveness of the therapy. The goal is to determine if the combination of Pembrolizumab and Olaparib can provide better outcomes for patients with LS-SCLC compared to standard treatment alone.

1 initial treatment phase

The initial phase involves the administration of concurrent chemoradiation therapy. This means that chemotherapy and radiation therapy are given at the same time.

During this phase, the medications etoposide and carboplatin are administered through an intravenous infusion. This involves receiving the medication directly into the bloodstream through a vein.

The duration and frequency of this treatment are determined by the healthcare provider based on individual needs and response to treatment.

2 pembrolizumab treatment phase

Following the initial treatment phase, pembrolizumab is administered. This medication is given as an intravenous infusion.

The frequency and duration of pembrolizumab administration are specified by the healthcare provider, typically every three weeks.

3 combination treatment phase

In this phase, pembrolizumab is continued, and olaparib may be added. Olaparib is taken orally in the form of film-coated tablets.

The dosage and frequency of olaparib are determined by the healthcare provider, usually taken twice daily.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the response to treatment and any side effects.

This includes routine medical examinations, imaging tests, and laboratory tests as required by the study protocol.

Who Can Join the Study?

Participants must have a confirmed diagnosis of Small Cell Lung Cancer (SCLC), which is a type of lung cancer. The confirmation should be done through a test that examines cells or tissues.
Participants must have adequate organ function, meaning their organs are working well enough to handle the treatment.
Participants must be at least 18 years old when they agree to join the study.
Participants must not have received any previous treatment for their lung cancer, such as chemotherapy, radiation, or surgery.
Participants must have Limited-Stage SCLC, which means the cancer is in a stage that can be treated with radiation.
Participants must not have cancer that has spread to other parts of the body, as shown by specific scans like PET/CT, CT, or MRI.
Participants must have at least one measurable lesion, which is a tumor that can be measured to see if it changes during treatment.
Participants must not need surgery to remove the tumor during the study.
Participants must provide a sample of their tumor tissue before starting the treatment.
Participants must have an ECOG Performance score of 0 or 1, which is a way to measure how well they can perform daily activities. A score of 0 or 1 means they are fully active or have some symptoms but can still do light work.
Participants must have a life expectancy of at least 6 months.
Male and female participants who can have children must use birth control during the study and for a certain time after the study ends.
Male participants must not donate sperm during the study and for a certain time after the study ends.
Female participants must not breastfeed during the study and for a certain time after the study ends. The time varies depending on the treatment: 120 days for Pembrolizumab and 7 days for Olaparib.

Who Cannot Join the Study?

Participants who have received any previous treatment for their lung cancer cannot join the study. This means if you have already had any kind of therapy to treat your lung cancer, you are not eligible.
Participants with other serious health conditions that might interfere with the study or make it unsafe for them to participate may be excluded. This means if you have other major health issues, you might not be able to join.
Participants who are unable to follow the study procedures or attend the required visits may not be eligible. This means if you cannot commit to the study schedule, you might not be able to participate.
Participants who are pregnant or breastfeeding are not allowed to join the study. This is to ensure the safety of both the mother and the baby.
Participants who are part of another clinical trial at the same time are not eligible. This means if you are already participating in a different study, you cannot join this one.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Koranyi National Institute For Pulmonology	Budapest	Hungary
Katholieke Universiteit te Leuven	Leuven	Belgium
CHU Grenoble Alpes	La Tronche	France
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Orszagos Onkologiai Intezet	Budapest	Hungary
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Grand Hopital De Charleroi	Charleroi	Belgium
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Spitalul Municipal Ploiesti	Ploiesti	Romania
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.	Panagyurishte	Bulgaria
Henry Dunant Hospital Center	Athens	Greece
General University Hospital Of Larissa	Larissa	Greece
HIA Sainte Anne	Toulon	France
Ospedale San Raffaele S.r.l.	Milan	Italy
Tartu University Hospital	Tartu	Estonia
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Tuedogyogyintezet Toeroekbalint	Torokbalint	Hungary
Centre Hospitalier De Saint-Quentin	Saint Quentin	France
Hopital Prive Clairval	Marseille	France
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
CHU Bordeauxt	Bordeaux	France
Caqrdjzsr Uibwhcstvwzjzh Sacljkfiu	Woluwe-Saint-Lambert	Belgium
Vaovvwsdg ijnazpzy Vpaqdgip ucuwatzokvak lbytdmhlj Syquftbz kleuiye fpukbyjw Nhgqaekwjoob vfwvu ckbxino	Vilnius	Lithuania
Idcxkwsy Clfavi Ducquscetkqqjgzri	L'hospitalet De Llobregat	Spain
Bsbaiukxfyw Vfgyxzlay Onqauckmyjmx	Kecskemet	Hungary
Ldshb Guxbiqe Hjwaapbp Oa Arelse	Athens	Greece
Uaboixhtjw Gbyojyl Hkowlvar Oe Hhtezwakq	Heraklion	Greece
Gjmgutxtprnxyutpu Veamfpohp Pxxu Aslgcz Eifpmrkw Osipjo Kjeuxl	Gyor	Hungary
Hthexyam Vbcu dhiikged	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	11.12.2020
Bulgaria	Not recruiting	11.12.2020
Estonia	Not recruiting	11.12.2020
France	Not recruiting	11.12.2020
Greece	Not recruiting	11.12.2020
Hungary	Not recruiting	11.12.2020
Italy	Not recruiting	11.12.2020
Lithuania	Not recruiting	11.12.2020
Portugal	Not recruiting	11.12.2020
Romania	Not recruiting	11.12.2020
Spain	Not recruiting	11.12.2020

Trial locations

Investigated drugs:

Pembrolizumab (MK-3475) is a medication used in this trial to help the immune system detect and fight cancer cells. It is given to participants in combination with other treatments to see if it can improve outcomes for those with limited-stage small cell lung cancer.

Olaparib (MK-7339) is another medication being tested in this trial. It is used to see if it can enhance the effects of Pembrolizumab when given together after initial treatment. Olaparib works by interfering with the cancer cells’ ability to repair themselves, potentially leading to their destruction.

Concurrent Chemoradiation Therapy is a standard treatment for small cell lung cancer that combines chemotherapy and radiation therapy. This approach aims to kill cancer cells and shrink tumors by using drugs and high-energy rays. In this trial, it is used as a baseline treatment to compare the effectiveness of adding Pembrolizumab and Olaparib.

Investigated diseases:

Small cell lung cancer limited stage

Limited Stage-Small Cell Lung Cancer – This is a type of lung cancer characterized by the presence of small, round cancer cells that multiply quickly. It is termed “limited stage” when the cancer is confined to one side of the chest and can be treated with a single radiation field. The disease progresses rapidly, often spreading to other parts of the body if not treated promptly. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer grows, it can cause additional symptoms such as weight loss and fatigue. Early detection and intervention are crucial to managing the disease’s progression.

Trial ID:

2023-504959-27-00

Protocol code:

MK-7339-013

NCT ID:

NCT04624204

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab and Olaparib with Chemoradiation for Patients with Newly Diagnosed Limited-Stage Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?