Study of MK-2870 and Chemotherapy for Patients with Advanced EGFR-Mutated Non-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 Non-small Cell Lung Cancer (NSCLC) that has a specific mutation called EGFR-mutated. The study is comparing a new treatment called MK-2870 with a standard chemotherapy treatment known as platinum-based doublet chemotherapy. The chemotherapy includes drugs like carboplatin and pemetrexed, which are commonly used to treat this type of cancer. The purpose of the study is to see how well MK-2870 works compared to the standard chemotherapy in terms of how long patients live without the cancer getting worse and overall survival.

Participants in the study will receive either MK-2870 or the standard chemotherapy. MK-2870 is given as an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The study will last for a period of up to 72 weeks, during which the effects of the treatments will be monitored. The study will also look at other aspects such as the response rate to the treatment, the duration of the response, and changes in quality of life related to symptoms like cough and chest pain.

In addition to MK-2870 and the chemotherapy drugs, other medications may be used in the study, including H2-Receptor antagonists, glucocorticoids, antihistamines, and a combination of buclizine hydrochloride, paracetamol, and codeine phosphate. These medications are used to manage side effects or other conditions that may arise during the treatment. The study aims to provide valuable information on the effectiveness and safety of MK-2870 compared to the current standard treatment for patients with this type of lung cancer.

1 joining the study

Upon joining the study, a diagnosis of advanced non-small cell lung cancer (NSCLC) with specific genetic mutations is confirmed.

Eligibility is determined based on recovery from previous treatments, viral infection status, and overall health condition.

2 treatment assignment

Participants are randomly assigned to receive either MK-2870 or a combination of chemotherapy drugs known as platinum doublets.

The objective is to compare the effectiveness of MK-2870 with the chemotherapy regimen.

3 treatment administration

For those receiving MK-2870, the medication is administered as a powder for solution for injection through an intravenous infusion.

Participants receiving chemotherapy will be given a combination of pemetrexed and carboplatin through intravenous infusion.

4 monitoring and assessments

Regular assessments are conducted to monitor progression-free survival and overall survival.

Additional evaluations include response rate, duration of response, and changes in quality of life indicators such as global health status, breathing difficulties, cough, and chest pain.

5 adverse events monitoring

Participants are monitored for any adverse events that may occur during the study.

The number of participants experiencing adverse events and those discontinuing treatment due to adverse events are recorded.

6 study completion

The study is estimated to conclude by June 14, 2030.

Final assessments will be conducted to evaluate the long-term outcomes of the treatments.

Who Can Join the Study?

  • You must have a confirmed diagnosis of advanced-stage non-small cell lung cancer (NSCLC), which is a type of lung cancer.
  • If you had side effects from previous cancer treatments, they must have improved to a mild level or returned to how they were before treatment.
  • If you have Hepatitis B, you can participate if you have been on antiviral treatment for at least 4 weeks and the virus is not detectable in your blood.
  • If you have had Hepatitis C, you can participate if the virus is not detectable in your blood.
  • If you have HIV, you can participate if your HIV is well controlled with medication.
  • You should have a life expectancy of at least 3 months.
  • Both men and women can participate.

Who Cannot Join the Study?

  • Patients with a different type of lung cancer that is not Non-small Cell Lung Cancer (NSCLC) with an EGFR mutation cannot participate. EGFR mutation refers to a change in a specific gene that can affect how cancer grows.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not included in this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Karolinska University Hospital Solna Sweden
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hopital Prive Clairval Marseille France
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Ihaoqijj Cbrnyr Dxtdzwfcgdydfdify L'hospitalet De Llobregat Spain
Ndwharfw Imtefubv Ovokxlilf Iyx Mnlnw Szbjhpxoidixggydrygruthhzmsm Ibrbzklo Biblfbaq Cracow Poland
Holzkgcf Ulrfyhknsujibi Ssrqlmkkko &lvmpno Hrvzvrq dd Hrtvoxlzycm STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
20.05.2024
Italy Italy
Recruiting
20.05.2024
Poland Poland
Not recruiting
20.05.2024
Spain Spain
Not recruiting
20.05.2024
Sweden Sweden
Not recruiting
20.05.2024

Trial locations

MK-2870 is an investigational medication being studied for its effectiveness in treating advanced non-squamous non-small cell lung cancer (NSCLC) in patients who have specific genetic mutations (EGFR mutations) and have not responded to previous treatments. This medication is being compared to standard chemotherapy treatments to see if it can help patients live longer or slow down the progression of their cancer.

Platinum-based doublet chemotherapy is a standard treatment for advanced non-squamous non-small cell lung cancer. It involves using two chemotherapy drugs, one of which is a platinum compound, to try to stop the cancer cells from growing and dividing. This treatment is being used as a comparison to see how well MK-2870 works in treating this type of lung cancer.

Non-small Cell Lung Cancer (NSCLC), EGFR-mutated – This is a type of lung cancer characterized by mutations in the epidermal growth factor receptor (EGFR) gene. It is the most common form of lung cancer, accounting for a significant majority of cases. The disease typically begins in the cells lining the lungs and can spread to other parts of the body. EGFR mutations lead to uncontrolled cell growth and division, contributing to tumor development. As the cancer progresses, it may cause symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some cases advancing more rapidly than others.

Trial ID:
2023-504910-31-00
Protocol code:
MK-2870-009
Trial Phase:
Therapeutic confirmatory (Phase III)

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