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

No sites found in this category

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
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland
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IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Klinik Hietzing	Vienna	Austria
Hopitaux Prives De Metz	Vantoux	France
University Hospital Olomouc	Olomouc	Czechia
Cardiomed S.R.L.	Cluj Napoca	Romania
Institut Sainte Catherine	Avignon	France
Cavdtnr Pbeaodoe Scdfmj	Sibiu	Romania
Czejqkl Oyojiavcv Ixb Ptfjx Frhjkrssbo Lwsaeowpcxy W Bbrzwmrpnv	Bydgoszcz	Poland
Ioxgnj Iiebsjsn Fgbbyzaezhisn Oxobkitcfrj	Rome	Italy
Cuccur Rfjhmuip Cxlrmpcl Dd Vghcac Stdrig	Verona	Italy
Owrsultaidvywb Lkst Gegj	Linz	Austria
Sge Woodzexubuwdi Ggff Gycd	Gera	Germany
Aytdzot Opeodubsvzs S Gyvkewgo Aqfifaydkd	Rome	Italy
Nljqmcym Inzrrvkgx Ok Tbacxolfgzzn Axc Lzfg Ddsfwviy	Warsaw	Poland
Kcyhmstkmld Nywb Kecetw Fgtszsmozlx	Vienna	Austria
Jeqizbjxjckszmmmvaya Vfluflgsi Hskgmzs Gjpr Khqghkzhoushvoycbfwae	Szolnok	Hungary
Morfexlis Sqalun	Bucharest	Romania
Rqrrmxiwkowu Cteoks Cssi Sjpypq	Floresti	Romania
Fugbmehfnx Isogl Sqe Ghpslrg Dnt Tlixwxv	Monza	Italy
Arzfrzn Shnys Soffosupg Tpushrzqucbt Dct Sxrsg Lakqw	Varese	Italy
Bypmfrmharbi Cnblsgg Opusznssx Ijp Miyda Sjgackokcssjszpuxq W Bdrvqxizwzv	Bialystok	Poland
Rqdnnpmfve Stbqjlm Sivugninsscomfk Inp Dym Wjdlvgbhzj Blxxnjayhupc	Grudziadz	Poland
Lezlo Mkc Sgmdtw	Bucharest	Romania
Hwyeoczn Qbjgqaalkun Mxllke	Malaga	Spain
Njrlzeenf Afww Onyharfixuyennoex afmt	Ostrava	Czechia
Guhpx Ghajkoumhdio fhem ogirsmtuplji Sfwvzva Dwwabete mbx	Dortmund	Germany
Kkdwfxykagu Belwfbkwt gpsqa	Solingen	Germany
Ubygmbwjxekuxhbmlxzuo Shlbwthpzbrppnwfhw Aaa	Kiel	Germany
Csxyjec Dl Ojrbqgzpz Sm Nbeppbgb Svuchu	Craiova	Romania
Mcmcwybou syywen	Horovice	Czechia
Bwyhtnzuurn Vyuunrmkd Oaneqpfhjppr	Kecskemet	Hungary
Fqaiisajqi Ivpft Pxnpjxehqsa Son Mhuxog	Pavia	Italy
Ctkmucl Ujvprlvvaggmnprhnxsr Bsvaxf Kkb	Berlin	Germany
Hzfruuqc Ujynqpeqcjteq Fmcvofizx Jepputt Dait	Madrid	Spain
Iruty Owrflofo Pqcfgyvubqb Ssm Mzgeqiy	Genoa	Italy
Ukdmqtsuiofw Di Sdkuuyfk Du Cnlzlebgbv	Santiago De Compostela	Spain
Hwtsgylk Uvyskkrpvjpmz Vgxtke Da Vsxvy	Sevilla	Spain
Oqddsnm Sxvxzv	Timisoara	Romania
Gnbxiwcwnskbvkfit Vhpmkfjic Pnst Aqwujx Ewgwmusd Oqrigi Kuxgjp	Gyor	Hungary
Zzpi Mkijxa Sdxsj Rscymq Kyvbfv	Zalaegerszeg	Hungary
Nwszbwku Iqlzeaap Oqwpbnsva Iwa Mcjoq Spccfouebmiyqotukfllkawfacsk Iimhxrcy Bbqrkawf	Cracow	Poland
Tkydpmheufshsxirc Tdxpjjlbczdyr	Torokbalint	Hungary
Azvuwec Opdkmqoxgcsyxzgazumxwqwjd Mnxlqdnw Dzdsl Cvsdmg	Novara	Italy
Odvz Ckbw Srrghf	Brasov	Romania
Woqsaffwwnkwr Cblaksi Pemttemqlvtd I Tmqyaazgfguufzc Ipm Ewwllek I Jcnoivx Zvyvschud	Poznan	Poland
Hkfigvc Pddjy Ctwhhseo	Marseille	France
Uafdfzxuzt Dyarx Sqjwr Dq Bekqdis	Brescia	Italy
Smpri Wgoc Wvsvod Gmzrvkkbjkulghcubc	Vienna	Austria
Kscaoekd Ecyqmlqvsbgfgzatekrhperk Hhldmylndqktbfgaa	Essen	Germany
Fvpvgscfjj Iyoojoovpa Idkggpqc Nvsjgvvwrdy Bjnpk	Milan	Italy
Hnbexlhe Vjel dcpwsdje	Barcelona	Spain
Wgazypfvuz Sormktv Ize Smgvrxm Pdo W Ppfrlfwtr	Przemysl	Poland
Cjthbt Hnvhjfliktz Dianvshhsblav Vehyou	La Roche sur Yon	France

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?

Who Can Join the Study?

Who Cannot Join the Study?