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Study Comparing MK-7684A with Chemotherapy to Pembrolizumab with Chemotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

Verified siteRegistered drugNo placebo
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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 treatments for Metastatic Non-Small Cell Lung Cancer, a type of lung cancer that has spread to other parts of the body. The study is comparing two treatment options. The first option is a combination of a new drug called MK-7684A, which is a coformulation of Pembrolizumab and Vibostolimab, along with chemotherapy. The second option is Pembrolizumab combined with chemotherapy. Chemotherapy involves using drugs to kill cancer cells and is a common treatment for various types of cancer.

The purpose of this study is to compare the effectiveness of these two treatment options in terms of how long patients live. Participants will receive their assigned treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period to monitor their health and any changes in their condition. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, researchers will collect information on various aspects of the participants' health, including their overall survival, progression of the disease, and quality of life. This information will help determine which treatment option is more effective for patients with Metastatic Non-Small Cell Lung Cancer. The study aims to provide valuable insights that could improve treatment strategies for this type of cancer in the future.

The research process

The trial runs in 5 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 Stage IV non-small cell lung cancer (NSCLC) is confirmed. This is a type of lung cancer that has spread to other parts of the body.

    Eligibility is determined based on specific criteria, including not having received prior treatment for metastatic NSCLC and having a life expectancy of at least 3 months.

  2. Step 2

    Treatment initiation

    The treatment involves receiving medications through an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.

    The medications used include pembrolizumab and vibostolimab in combination with chemotherapy drugs such as paclitaxel, carboplatin, and cisplatin.

  3. Step 3

    Treatment schedule

    The treatment is administered in cycles. Each cycle typically lasts for a few weeks, during which the medications are given on specific days followed by a rest period.

    The exact schedule and dosage depend on the specific treatment plan designed for the individual.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment. This includes imaging tests to measure the size of the cancer and blood tests to check overall health.

    Quality of life is also evaluated using questionnaires that assess physical functioning, pain, and other symptoms.

  5. Step 5

    End of treatment

    The treatment continues until the cancer progresses, unacceptable side effects occur, or the study ends.

    The estimated end date for the study is October 25, 2027.

Who can join the trial?

6 criteria

  • Must have a confirmed diagnosis of **Stage IV** squamous or non-squamous **NSCLC**. **NSCLC** stands for **Non-Small Cell Lung Cancer**, and **Stage IV** means the cancer has spread to other parts of the body.
  • Must not have received any previous treatment for **metastatic NSCLC**. **Metastatic** means the cancer has spread from its original location to other parts of the body.
  • Must have a disease that can be measured based on **RECIST 1.1**. This is a set of guidelines used to measure how well a cancer treatment is working.
  • Must have a life expectancy of at least 3 months.
  • For males: Must use contraception unless confirmed to be **azoospermic**. **Azoospermic** means having no sperm in the semen.
  • For females: Women who can have children must use a highly effective method of contraception.

Who cannot join the trial?

6 criteria

  • Patients with other types of cancer besides Metastatic Non-Small Cell Lung Cancer 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 typically defined by the study.
  • Patients who are part of a vulnerable population, which may include groups like pregnant women or those unable to give consent, cannot participate.
  • Patients who have medical conditions or are taking medications that might interfere with the study treatment cannot participate.
  • Patients who have previously received certain treatments that could affect the study results cannot participate.
  • Patients who are unable to follow the study procedures or attend required visits cannot participate.
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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 against certain types of cancer, such as non-small cell lung cancer.

  • Vibostolimab

    is part of a coformulation with pembrolizumab in this study. It is designed to work alongside pembrolizumab to enhance the immune response against cancer cells, potentially improving treatment outcomes for patients with metastatic non-small cell lung cancer.

  • MK-7684A

    is the code name for the coformulation of pembrolizumab and vibostolimab. This combination is being tested to see if it provides better results when used with chemotherapy compared to pembrolizumab with chemotherapy alone.

  • Chemotherapy

    refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used in combination with other medications to treat metastatic non-small cell lung cancer, aiming to improve survival rates and reduce cancer progression.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is used in combination with chemotherapy for treating metastatic non-small cell lung cancer. It is well-established in medical literature as an effective immunotherapy agent. Pembrolizumab works by blocking a specific protein on immune cells, allowing the immune system to better attack cancer cells. It is classified as a monoclonal antibody and is widely used in cancer treatment.

  • Vibostolimab

    This medication is also administered intravenously and is being studied in combination with pembrolizumab and chemotherapy for the treatment of metastatic non-small cell lung cancer. It is currently under investigation in clinical trials and is not yet widely used in standard medical practice. Vibostolimab targets specific immune checkpoints, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells of 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 spread to lymph nodes and other organs such as the brain, bones, and liver. Symptoms may include a persistent cough, chest pain, shortness of breath, and unexplained weight loss. As the cancer spreads, it can cause additional symptoms depending on the organs affected. The progression of the disease can vary greatly among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506074-12-00Protocol codeMK-7684A-007Estimated enrolment739 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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