Study of Pembrolizumab and MK-2870 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 will explore the effectiveness of a combination of medications, including pembrolizumab, carboplatin, and taxane (either paclitaxel or nab-paclitaxel). Additionally, the trial will investigate the use of pembrolizumab with or without a maintenance treatment called MK-2870, also known as sacituzumab tirumotecan.

The purpose of the study is to compare the overall survival of patients receiving these treatments. Participants will receive the medications through an intravenous infusion, which means the drugs are delivered directly into the bloodstream through a vein. The study will be conducted over a period of time, with regular monitoring to assess the effects of the treatment. Participants will be closely observed for any side effects or changes in their condition.

This trial aims to provide valuable information on the potential benefits and risks of these treatments for patients with metastatic squamous NSCLC. By participating in the study, researchers hope to gain insights that could lead to improved treatment options for this type of lung cancer in the future.

1 initiation of treatment

Upon joining the study, the treatment begins with the administration of pembrolizumab in combination with either carboplatin and paclitaxel or nab-paclitaxel. These medications are given through an intravenous infusion.

The initial phase involves receiving these medications as part of the first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC).

2 induction phase

During the induction phase, the combination of pembrolizumab with carboplatin and taxane (either paclitaxel or nab-paclitaxel) is continued.

This phase is designed to assess the initial response to the treatment and typically lasts for several weeks.

3 evaluation

After the induction phase, an evaluation is conducted to determine the response to the treatment. This involves imaging studies to assess the size and spread of the cancer.

The evaluation helps in deciding whether to continue with the current treatment plan or make adjustments.

4 maintenance phase

If the cancer has not progressed, the treatment may continue with pembrolizumab alone or in combination with MK-2870 as a maintenance therapy.

The maintenance phase aims to sustain the response achieved during the induction phase and is continued until disease progression or unacceptable side effects occur.

5 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to track the effectiveness of the treatment and any side effects experienced.

Follow-up visits include physical examinations, imaging studies, and laboratory tests to ensure the safety and well-being of the participant.

Who Can Join the Study?

Participants must have a confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) at Stage IV, which is an advanced stage of lung cancer.
The disease must be measurable according to specific criteria used to evaluate tumors, known as RECIST 1.1.
If participants have had side effects from previous cancer treatments, these side effects must have improved to a mild level or returned to their usual state. If the side effects are related to hormones and are being treated with hormone replacement, participants can still join.
Participants with HIV must have their condition well controlled with medication.
Participants should have a life expectancy of at least 3 months.
Participants must have a performance status of 0 to 1, which means they are fully active or have some symptoms but can still carry out light work. This is assessed within 7 days before joining the study.
Participants with hepatitis B can join if they have been on antiviral therapy for at least 4 weeks and have no detectable virus in their blood.
Participants with a history of hepatitis C can join if they have no detectable virus in their blood at screening and have completed antiviral therapy at least 4 weeks before joining the study.
Participants must not have any progression of their lung cancer after completing the initial part of the study, as confirmed by an independent review using RECIST 1.1 criteria, with a scan done at Week 12 before starting the maintenance phase.
Both male and female participants are eligible to join the study.

Who Cannot Join the Study?

Participants who have already received treatment for their lung cancer cannot join the study. This means if you have had any therapy for your lung cancer before, you are not eligible.
Individuals with a different type of lung cancer than the one specified in the study are not eligible. The study is only for a specific type called metastatic squamous Non-small Cell Lung Cancer (NSCLC).
People who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Participants who are part of a vulnerable population, which means groups that might need special protection, are not eligible for this study.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
IRCCS Humanitas Research Hospital	Rozzano	Italy
Koranyi National Institute For Pulmonology	Budapest	Hungary
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland

Other Sites

Site Name	City	Country
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
SRH Wald-Klinikum Gera GmbH	Gera	Germany
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Krankenhaus Nord Klinik Floridsdorf	Vienna	Austria
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Medicover S.R.L.	Bucharest	Romania
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku	Bialystok	Poland
Lotus Med S.R.L.	Bucharest	Romania
Hospital Quironsalud Malaga	Malaga	Spain
Nemocnice AGEL Ostrava-Vitkovice a.s.	Ostrava	Czechia
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH	Dortmund	Germany
Krankenhaus Bethanien gGmbH	Solingen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
Oncomed S.R.L.	Timisoara	Romania
Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Hungary
Klinik Hietzing	Vienna	Austria
Hopitaux Prives De Metz	Vantoux	France
Tuedogyogyintezet Toeroekbalint	Torokbalint	Hungary
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Onco Card S.R.L.	Brasov	Romania
University Hospital Olomouc	Olomouc	Czechia
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Cardiomed S.R.L.	Cluj Napoca	Romania
Hopital Prive Clairval	Marseille	France
Universita Degli Studi Di Brescia	Brescia	Italy
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Institut Sainte Catherine	Avignon	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Cpqhejb Pnjfacun Suihyq	Sibiu	Romania
Iuthyx Iqwpllgn Fwbumhhwbpjex Okoinvttffj	Rome	Italy
Ozxvxzzhirolls Lozw Gvov	Linz	Austria
Acubrgw Ojecmtnrnoy S Gnssirtc Auvbqmqkup	Rome	Italy
Ndtktiqp Iuiynjtvm Ow Tcmfbzfeddkb Asl Ltxs Duicereu	Warsaw	Poland
Rrptzkbbnc Sihfuhh Sfikusjinqbbley Iua Dde Wqfwzcxanf Bgvkxidiqfxp	Grudziadz	Poland
Sqsycew Svwrmwntwcchrqc Idh Hesrirv Ksfexynjqanxl W Giacuwfvf	Gorlice	Poland
Mrbmcwoor scmayi	Horovice	Czechia
Botadqlojtd Vmdtrlowx Ogqgbxrnsivj	Kecskemet	Hungary
Gfrfdzqcxtosghbfo Vfolqbcfu Pdsx Arqxqq Ejbygbxy Ogczkt Kclbou	Gyor	Hungary
Nzwmhuhu Ivbjvfoj Onkcwyuho Iuf Mdicf Srmcyihaqgufxzrxfcfxqaisenpg Ijxferqb Booibdgc	Cracow	Poland
Kjtcwiuw Emqotgbmankwjpvqblvmjwsb Habstqsikytjurinm	Essen	Germany
Hwlkrgxo Vepn dkvcjqcr	Barcelona	Spain
Wilmcugmwy Sicwnaa Ifl Sayfhzn Pse W Pdtovfvsw	Przemysl	Poland

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	11.06.2024
Czechia	Recruiting	11.06.2024
France	Recruiting	11.06.2024
Germany	Recruiting	11.06.2024
Hungary	Recruiting	11.06.2024
Ireland	Recruiting	11.06.2024
Italy	Recruiting	11.06.2024
Poland	Recruiting	11.06.2024
Romania	Recruiting	11.06.2024
Spain	Recruiting	11.06.2024

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this trial to help the 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 drug more effectively to cancer cells and is used in combination with other treatments for certain cancers.

MK-2870 is an investigational drug being studied in this trial. It is used as a maintenance therapy to see if it can help improve outcomes for patients with metastatic squamous non-small cell lung cancer when used alongside pembrolizumab.

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 is metastatic, it means the cancer has spread from the lungs to other parts of the body. The disease progresses as cancer cells grow uncontrollably and form tumors, which can invade nearby tissues and organs. As the cancer advances, it can cause symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, and it often requires ongoing monitoring and management.

Trial ID:

2023-510128-66-00

Protocol code:

MK-2870-023

NCT ID:

NCT06422143

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab and MK-2870 for Patients with Metastatic Squamous Non-small Cell Lung Cancer

What is this study about?

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