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Study on MK-7684A and Docetaxel for Treating Metastatic Non-Small Cell Lung Cancer in Patients After Platinum Chemotherapy and Immunotherapy

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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 is investigating the effects of a new treatment called MK-7684A, which is a combination of two substances: pembrolizumab and vibostolimab. These substances are designed to help the immune system fight cancer. The trial will compare the effectiveness of MK-7684A when used alone and when combined with another medication called docetaxel, which is a standard treatment for NSCLC. Some participants will receive a placebo, which looks like the treatment but does not contain the active substances.

The purpose of the study is to see if MK-7684A, either alone or with docetaxel, can help stop or slow down the growth of NSCLC better than docetaxel alone. Participants in the study will be randomly assigned to one of the treatment groups. The study will monitor the participants over a period to observe how the cancer responds to the treatments. The trial will also look at the safety of the treatments and any side effects that may occur.

Throughout the study, participants will receive their treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will continue for a set period, and participants will have regular check-ups to assess their health and the progress of their cancer. The results of this study will help determine the potential benefits of MK-7684A for people with metastatic NSCLC.

The research process

The trial runs in 4 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, you will be randomly assigned to one of the treatment groups. This means you will either receive the new drug combination MK-7684A (which includes pembrolizumab and vibostolimab) plus docetaxel, or a placebo (a substance with no active drug) plus docetaxel, or docetaxel alone.

    The assignment is random, similar to flipping a coin, and neither you nor the study team will know which group you are in.

  2. Step 2

    Treatment administration

    If you are in the group receiving MK-7684A plus docetaxel, you will receive these medications through an intravenous infusion. This means the medication will be given directly into your vein through a needle.

    The frequency and dosage of the medications will be determined by the study protocol, and you will be informed about the schedule by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your health will be closely monitored. This includes regular visits to the study site for physical exams, blood tests, and imaging tests like CT or MRI scans to check the status of your cancer.

    These assessments are important to evaluate how the treatment is affecting your cancer and to monitor for any side effects.

  4. Step 4

    End of treatment

    The treatment will continue until your doctor determines it is no longer beneficial, or if you experience side effects that require stopping the treatment.

    After the treatment ends, you will have follow-up visits to monitor your health and gather information about your overall survival and any long-term effects of the treatment.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC). This means the cancer has spread to other parts of the body.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control or not have heterosexual intercourse during the study and for a certain period after the last dose of the study drug.
  • Must have adequate organ function, meaning the organs are working well enough to participate in the study.
  • Must have confirmation that certain targeted therapies, like those for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or reactive oxygen species (ROS) 1, are not suitable as the main treatment.
  • Must have disease progression after treatment with one prior anti-programmed cell death 1 (PD-1) or programmed cell death ligand 1 (PD-L1) therapy, which are types of cancer treatments.
  • Must have disease progression after platinum-based chemotherapy for metastatic disease.
  • Must have measurable disease, meaning there is at least one tumor that can be measured using a scan like a CT or MRI.
  • Must provide a sample of tumor tissue for PD-L1 biomarker analysis, which helps in understanding the cancer better.
  • Must have a life expectancy of at least 3 months.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, which indicates the level of daily functioning and ability to care for oneself.
  • Male participants must agree not to donate sperm and either not have heterosexual intercourse or use birth control during the study and for a certain period after the last dose of the study drug.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than Non-Small Cell Lung Cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or assessments.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications or similar drugs.
  • Patients who have received certain treatments for cancer recently.
  • Patients who have an active infection or other uncontrolled medical conditions.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

  • MK-7684A

    is an experimental medication being tested to see if it can help treat a type of lung cancer called metastatic non-small cell lung cancer. This medication is being studied to understand if it can stop or slow down the growth of cancer cells in patients who have already been treated with other cancer drugs, including chemotherapy and immunotherapy. Researchers are looking at how well this medication works in comparison to other treatments.

  • Docetaxel

    is a medication that is already used to treat various types of cancer, including lung cancer. It works by interfering with the growth and spread of cancer cells in the body. In this clinical trial, docetaxel is being used as a standard treatment to compare its effectiveness against the new experimental medication, MK-7684A, to see if the new treatment offers any additional benefits for patients with lung cancer.

What is already known about the treatment

MK-7684A – MK-7684A is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its effectiveness and safety in treating metastatic non-small cell lung cancer, particularly in patients whose disease has progressed after previous treatments. The main therapeutic indication for MK-7684A is to improve progression-free survival in these patients. At the molecular level, MK-7684A works by targeting specific proteins on cancer cells, helping the immune system to better recognize and attack these cells. It is classified pharmacologically as an immunotherapy agent, which means it helps the body's immune system fight cancer.

Investigated diseases

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer is a type of lung cancer that begins in the tissues of the lungs. It is the most common form of lung cancer, accounting for a majority of cases. The disease progresses as cancer cells grow and form tumors, which can spread to other parts of the body. As the cancer advances, it may invade nearby tissues and organs, leading to further complications. The progression of the disease can vary, with some tumors growing slowly while others may grow more rapidly. The spread of cancer cells to other parts of the body is known as metastasis, which can occur at different stages of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501252-28-00Protocol codeMK-7684A-002Estimated enrolment255 patientsSponsorMerck Sharp & Dohme LLC

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