Study Comparing MK-2870 and Pembrolizumab Combination to Pembrolizumab Alone for Patients with Metastatic Non-Small Cell Lung Cancer with High PD-L1 Levels

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as metastatic non-small cell lung cancer (NSCLC). The study aims to compare the effectiveness of a new treatment combination of two medications, MK-2870 and pembrolizumab, against the use of pembrolizumab alone. Pembrolizumab is a medication that helps the immune system fight cancer cells, and MK-2870 is a new drug being tested for its potential to enhance this effect.

The purpose of the study is to see if the combination of MK-2870 and pembrolizumab can improve the overall survival of patients compared to using pembrolizumab by itself. Participants in the study will receive either the combination treatment or pembrolizumab alone. The study will monitor the participants over a period to assess their response to the treatment and any side effects they may experience.

Throughout the study, participants will receive regular check-ups and assessments to track their health and the progression of their cancer. The study will also look at other factors such as the time it takes for the cancer to progress, the response of the cancer to the treatment, and the quality of life of the participants. This research is important for understanding how to better treat metastatic non-small cell lung cancer and improve outcomes for patients with this condition.

1 joining the study

Upon joining the study, a diagnosis of metastatic non-small cell lung cancer (NSCLC) must be confirmed through specific tests.

Eligibility is determined by the presence of certain proteins in the tumor and overall health status.

2 randomization

Participants are randomly assigned to one of two groups: one receiving a combination of MK-2870 and pembrolizumab, and the other receiving pembrolizumab alone.

3 treatment administration

The treatment involves intravenous infusions of the assigned medication.

MK-2870 is administered as a powder for solution, while pembrolizumab is given as a solution for infusion.

The frequency and dosage are determined by the study protocol and medical team.

4 monitoring and assessments

Regular monitoring of health status and response to treatment is conducted.

Assessments include overall survival, progression-free survival, and quality of life evaluations.

5 completion of treatment

The treatment phase continues until the study’s end date or until it is determined that the treatment is no longer beneficial.

Participants may discontinue treatment if adverse effects occur.

6 follow-up

After completing the treatment phase, follow-up visits are scheduled to monitor long-term health outcomes and any lasting effects of the treatment.

Who Can Join the Study?

  • Must have a confirmed diagnosis of a type of lung cancer called non-small cell lung cancer (NSCLC), which can be either squamous or nonsquamous. This confirmation is done through specific tests called histology or cytology.
  • Must not need specific treatments that target certain proteins, such as EGFR, ALK, or ROS1, as the main treatment.
  • Must provide a sample of the tumor that shows a protein called PD-L1 is present in at least 50% of the tumor cells. This is checked using a special test called immunohistochemistry (IHC).
  • Must have an ECOG performance status of 0 to 1, which is a scale used to assess how well a person can perform daily activities. This assessment should be done within 7 days before joining the study.
  • Must have a life expectancy of at least 3 months.
  • If the participant has HIV, it must be well controlled with medication known as antiretroviral therapy (ART).

Who Cannot Join the Study?

  • Patients with other types of cancer besides metastatic non-small cell lung cancer (NSCLC) cannot participate. Metastatic means the cancer has spread to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate in the study.
  • Patients who have participated in another clinical trial recently may not be eligible to join this study.
  • Patients with certain medical conditions or who are taking medications that could interfere with the study treatment may be excluded.
  • Patients who have had a severe allergic reaction to similar medications in the past may not be able to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Centre Hospitalier Universitaire De Poitiers Poitiers France
Isala Klinieken Stichting Zwolle The Netherlands
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
SRH Wald-Klinikum Gera GmbH Gera Germany
Amphia Hospital Breda The Netherlands
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Studienzentrum Onkologie Ravensburg GmbH Ravensburg Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Servico de Saude da Regiao Autonoma Da Madeira EPERAM Funchal Portugal
Nemocnice AGEL Ostrava-Vitkovice a.s. Ostrava Czechia
Hospital Universitario Nuestra Senora De Candelaria Santa Cruz De Tenerife Spain
Clinique de l’Europe Amiens France
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Aalborg University Hospital Aalborg Denmark
Centre Hospitalier De La Cote Basque Bayonne France
Hopital Saint Joseph Marseille France
Hospital Cuf Tejo S.A. Lisbon Portugal
Muenchen Klinik gGmbH Munich Germany
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Immobiliere De Nancy Nancy France
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Les Hopitaux Nord-Ouest Villefranche sur Saône France
Ijijmbfq Rmdspwul Ds Cethtf Dl Mxeotloegds Montpellier France
Suducsvs Knaimgdbrnz Bzdbyjknq Frjh Dvi Gefewrclwr Muoan Moers Germany
Hlixhemk Uvexavclnjvby Db Lt Pzgnleml Madrid Spain
Nlmsfjfp Iihtuzyui Oe Tkxdngjialvk Azg Lyac Dgsomosi Warsaw Poland
Ruowmfwblc Skywmex Sxbpiyzuvucpmnr Ity Dxq Wnpqolgfhs Bspcjsghoddk Grudziadz Poland
Hvhvukdd Uukwfxmbzymjs Rnotojnu Dp Maucfw Malaga Spain
Mnkutsddh sexgln Horovice Czechia
Cyswsd Hfkzdzeyfvi Ex Ulxyrwnhaikat Dw Lykewpp Limoges France
Iadoznsq Rmpredbvj Pbw Lv Schvmq Djv Tewqdw Duju Ahjmdqz Imcd Snhwdm Meldola Italy
Shb Evsaacmiq Hkpgpzjn Ttnzket Tilburg The Netherlands
Uorysemzivhchugrbiujb Mhxbyrsv Akb Munster Germany
Niggryyu Ivjfcgav Okwizoxha Ipi Mnpbt Sifrmpdtnydlaqbzxwejtzpepmqb Isvoepqr Bphqmkyt Cracow Poland
Kbqefwtv drz Utjgykmtdnse Mjmbxqwl Ayt Munich Germany
Agmqqhj Ovmlmkkzeiu Pjvz Gdfxsebr Xnxkl Bergamo Italy
Ulkvlsgqau Mhsdc Ghqjhkb Oa Czgzifwie Catanzaro Italy
Hrumtifa Vckk dpuxrsik Barcelona Spain
Hmdrlbzb Uuuddsndfygws dj A Cbqzpu A Coruna Galicia Spain
Woybjhpmxi Sinkpvd Iaz Sdlahmg Pan W Pwielatlz Przemysl Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
19.02.2024
Denmark Denmark
Recruiting
19.02.2024
France France
Recruiting
19.02.2024
Germany Germany
Recruiting
19.02.2024
Italy Italy
Recruiting
19.02.2024
Poland Poland
Recruiting
19.02.2024
Portugal Portugal
Recruiting
19.02.2024
Spain Spain
Recruiting
19.02.2024
The Netherlands The Netherlands
Recruiting
19.02.2024

Trial locations

MK-2870 is an investigational medication being studied for its potential to treat metastatic non-small cell lung cancer. It is being tested in combination with another medication to see if it can improve outcomes for patients with this type of cancer.

Pembrolizumab is a medication used to treat various types of cancer, including non-small cell lung cancer. It works by helping the immune system recognize and attack cancer cells. In this study, it is being used both alone and in combination with MK-2870 to determine the best treatment approach for patients with a specific type of lung cancer.

Metastatic Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that begins in the cells lining the lungs and has spread to other parts of the body. It is the most common type of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors in the lungs, which can then metastasize to other organs such as the brain, bones, or liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the cancer advances, it can lead to more severe respiratory issues and systemic symptoms like weight loss and fatigue. The progression of the disease can vary greatly among individuals, depending on factors like the cancer’s genetic makeup and the patient’s overall health.

Trial ID:
2023-503376-24-00
Protocol code:
MK-2870-007
NCT ID:
NCT06170788
Trial Phase:
Therapeutic confirmatory (Phase III)

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