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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

7 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • MK-2870

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic non-small cell lung cancer (NSCLC). It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication is for patients with NSCLC who have a PD-L1 TPS of 50% or higher. MK-2870 works by targeting specific proteins on cancer cells, helping the immune system to better recognize and attack these cells. It is classified as an immunotherapy agent.

  • Pembrolizumab

    This medication is administered intravenously and is well-established in medical literature as an effective treatment for various cancers, including metastatic non-small cell lung cancer (NSCLC). It is primarily used for patients with NSCLC who have a PD-L1 TPS of 50% or higher. Pembrolizumab works by blocking a protein called PD-1 on immune cells, enhancing the body's immune response against cancer cells. It is classified as a checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503376-24-00Protocol codeMK-2870-007Estimated enrolment651 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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