Study of Pembrolizumab, Carboplatin, and Paclitaxel for Patients with Metastatic Squamous Non-small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC), a type of lung cancer that has spread to other parts of the body. The study involves several medications, including Pembrolizumab, also known by its code name MK-3475, which is given as an infusion into the vein. Another medication used in the study is Olaparib, taken as a tablet by mouth. Additionally, the study includes Carboplatin and Paclitaxel, which are also given as infusions, and a version of Paclitaxel that is bound to a protein called albumin, known as Paclitaxel Albumin-Bound. A placebo is also used in the study.

The purpose of the study is to compare the effectiveness of Pembrolizumab combined with Olaparib against Pembrolizumab combined with a placebo in treating this type of lung cancer. The study aims to see how these treatments affect the time patients live without the cancer getting worse and their overall survival. Participants will receive the treatments over a period of time, and their health will be monitored to assess the effects of the medications.

Throughout the study, participants will receive regular check-ups and assessments to monitor their response to the treatment and any side effects they may experience. The study is designed to provide valuable information on the potential benefits and risks of using these medications in combination for treating Metastatic Squamous Non-small Cell Lung Cancer.

1 initial treatment phase

Receive an intravenous infusion of pembrolizumab (KEYTRUDA 25 mg/mL) in combination with carboplatin and paclitaxel or paclitaxel albumin-bound. This phase involves regular hospital visits for the administration of these medications.

The frequency and duration of this phase depend on the specific treatment plan and response to the medications.

2 maintenance phase

Continue with pembrolizumab treatment. Additionally, receive either olaparib or a placebo orally. The choice between olaparib and placebo is determined by the study design.

This phase aims to maintain the effects of the initial treatment and is expected to continue until disease progression or unacceptable side effects occur.

3 monitoring and follow-up

Undergo regular assessments to monitor the response to treatment and any side effects. These assessments may include imaging tests and laboratory evaluations.

The frequency of these assessments is determined by the study protocol and the healthcare provider’s recommendations.

Who Can Join the Study?

Have a confirmed diagnosis of squamous non-small cell lung cancer (NSCLC), which is a type of lung cancer.
Be in Stage IV of squamous NSCLC, meaning the cancer has spread to other parts of the body.
Have a measurable disease based on specific medical guidelines called RECIST 1.1, which helps doctors assess the size of tumors.
Have not received any previous treatment for their advanced or metastatic NSCLC.
Provide a sample of tumor tissue, either from a previous biopsy or a new one, that has not been treated with radiation. This sample must be approved by a central laboratory before starting the study.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
Have a life expectancy of at least 3 months.
Have adequate organ function, meaning the organs are working well enough to handle the treatment.
Male participants must not donate sperm during the treatment and for 180 days after.
Male and female participants who can have children must use birth control during the treatment and for 180 days after.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not fully recovered from previous cancer treatments.
Patients with serious heart problems.
Patients with active infections that require treatment.
Patients who are pregnant or breastfeeding.
Patients who have had another cancer in the past, unless it was treated and has not come back for a long time.
Patients who have a known allergy to the study drugs.
Patients who are taking other medications that might interfere with the study drugs.
Patients with certain medical conditions that might make it unsafe to participate.
Patients who have participated in another clinical trial recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Lungenfachklinik	Immenhausen	Germany

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Hospital Universitario 12 De Octubre	Madrid	Spain
Krankenhaus Nord Klinik Floridsdorf	Vienna	Austria
Hospital Universitario De Jaen	Jaen	Spain
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Szpital Rejonowy Im. Dr Jozefa Rostka W Raciborzu	Raciborz	Poland
Ovidius Clinical Hospital S.R.L.	Ovidiu	Romania
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Med Polonia Sp. z o.o.	Poznan	Poland
Oncomed S.R.L.	Timisoara	Romania
Hopitaux Prives De Metz	Vantoux	France
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
Cardiomed S.R.L.	Cluj Napoca	Romania
Spitalul De Oncologie Monza S.R.L.	Bucharest	Romania
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospitalier De Pau	Pau	France
Ogepsvgdrkybhg Lhje Guzw	Linz	Austria
Ikxiabqu Cymakt Dtnzzqcfojmakuczl	L'hospitalet De Llobregat	Spain
Cygtws Hnxmwgplvni Dg Cwilio	Chauny	France
Pvczebtilgd Lkemsxjh &mxwjdetblnqakljrcih Rnkds Krufmdtwmgi	Konin	Poland
Nhxfwdxu Ipoiaena Ondhdpdgu Ipz Mtnpq Srojivwejyuntsoklzofwikbxmqh Injgagsz Bcgwfkzm	Cracow	Poland
Khuhyiak dhg Ubacjtghehli Mdkmzgrs Adw	Munich	Germany
Hfsrvzwn Di Lr Shwde Cgxb I Sitb Pol	Barcelona	Spain
Kfjdowfv Ehyipyzkaytoxjxapqjwmjvd Hmlulrrzwvcgcqobz	Essen	Germany
Kwuutiglb Sniflvo Shrwsnyseuocels iw Jkqd Pmbdr Iz	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	28.06.2019
France	Not recruiting	28.06.2019
Germany	Not recruiting	28.06.2019
Poland	Not recruiting	28.06.2019
Romania	Not recruiting	28.06.2019
Spain	Not recruiting	28.06.2019

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this study to help the body’s immune system fight cancer cells. It is often used in combination with other treatments to improve its effectiveness in treating certain types of cancer, such as metastatic squamous non-small cell lung cancer.

Carboplatin is a chemotherapy drug that works by stopping the growth of cancer cells. It is used in combination with other medications to treat various types of cancer, including lung cancer.

Paclitaxel is another chemotherapy medication that helps stop cancer cells from dividing and growing. It is used in combination with other drugs to treat different types of cancer, including lung cancer.

Nab-paclitaxel is a form of paclitaxel that is bound to a protein called albumin. This formulation helps deliver the medication more effectively to the cancer cells and is used in combination with other treatments for lung cancer.

Olaparib is a medication used as a maintenance therapy in this study. It works by blocking certain enzymes that cancer cells need to repair themselves, which can help slow down or stop the growth of cancer. It is used after initial treatment to help keep the cancer from coming back.

Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that begins in the squamous cells, which are flat cells that line the inside of the airways in the lungs. It is classified as non-small cell lung cancer, which is the most common type of lung cancer. When it becomes metastatic, it means the cancer has spread from the lungs to other parts of the body. The progression of this disease involves the growth and spread of cancerous cells, which can invade nearby tissues and organs. As the disease advances, it can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. The progression can vary greatly among individuals, depending on various factors including the stage at diagnosis and overall health.

Trial ID:

2023-508449-41-00

Protocol code:

MK-7339-008

NCT ID:

NCT03976362

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab, Carboplatin, and Paclitaxel for Patients with Metastatic Squamous Non-small Cell Lung Cancer

What is this study about?

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