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Phase 3 Study of Subcutaneous Pembrolizumab with Hyaluronidase vs. Intravenous Pembrolizumab in Metastatic NSCLC with PD-L1 TPS ≥50%

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 a type of lung cancer known as metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have a high level of a protein called PD-L1. The study is comparing two forms of a treatment called pembrolizumab. One form is given as a shot under the skin, known as subcutaneous pembrolizumab combined with a substance called hyaluronidase (referred to as MK-3475A), and the other form is given directly into a vein, known as intravenous pembrolizumab.

The purpose of the study is to compare how the body absorbs and processes these two forms of pembrolizumab in patients who are receiving it as their first treatment for this type of lung cancer. Participants will receive either the subcutaneous or intravenous form of pembrolizumab, and the study will monitor how the drug behaves in the body over time. This includes looking at how much of the drug is present in the blood at different times and how long it stays in the body.

Throughout the study, researchers will also observe the overall health and quality of life of the participants, as well as any side effects they may experience. The study aims to provide valuable information on the safety and effectiveness of these two methods of administering pembrolizumab, which could help improve treatment options for patients with this type of lung cancer.

The research process

The trial runs in 1 step.

  1. Step 1

    Study participation and treatment assignment

    After joining the study, an assignment is made to receive one of two different ways of administering the medication pembrolizumab.

    One group receives pembrolizumab via intravenous infusion, which is a method where the medicine is delivered directly into a vein through a tube.

    The other group receives MK-3475A, which is pembrolizumab delivered via subcutaneous injection, meaning the medicine is injected into the fatty tissue just under the skin.

Who can join the trial?

7 criteria

  • You must have a confirmed diagnosis of non-small cell lung cancer, which is a common type of lung cancer that is not made of small, round cells.
  • Your cancer can be either squamous (cells that look flat like floor tiles) or nonsquamous (cells that do not have that flat appearance).
  • The cancer must have metastasized, which means it has spread from the original location in the lung to other parts of the body.
  • You must have a high level of PD-L1 TPS, which is a protein found on cancer cells; a score of 50% or higher means a large amount of this protein is present.
  • Your cancer must be measurable, meaning a doctor can clearly see and track the size of the tumors using medical imaging like X-rays or CT scans.
  • The study is open to both males and females.
  • You must fall within the specific age range required for this study.

Who cannot join the trial?

7 criteria

  • You cannot participate if you have small cell lung cancer, which is a different type of lung cancer, or if your tumor contains any of these cells.
  • You cannot participate if you have already received systemic anticancer therapy, which means medicine that travels through your whole body to treat cancer, for your current metastatic lung cancer.
  • You cannot participate if you have another known malignancy, which is another word for cancer, that is currently growing or has needed treatment in the last 3 years.
  • You cannot participate if you have CNS metastases, which means cancer that has spread to the central nervous system (the brain and spinal cord), or carcinomatous meningitis, which is when cancer cells spread to the fluid surrounding the brain and spinal cord.
  • You cannot participate if you have an active autoimmune disease, a condition where your body's immune system attacks its own healthy cells, that has required body-wide medicine in the last 2 years.
  • You cannot participate if you have a history of pneumonitis or interstitial lung disease, which are types of lung inflammation or scarring, that required steroids (strong medicines used to reduce inflammation) or if you currently have these conditions.
  • You cannot participate if you have an active infection that requires medicine to travel through your bloodstream to treat it.
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Investigated drugs

  • Pembrolizumab

    is an immunotherapy medication given through an intravenous infusion (directly into a vein) to help the body's immune system fight certain types of cancer.

  • MK-3475A

    is an immunotherapy medication given as a subcutaneous injection (under the skin) designed to help the body's immune system fight certain types of cancer.

What is already known about the treatment

  • Pembrolizumab

    This medication is an immunotherapy used to treat certain types of advanced cancers, such as metastatic non-small cell lung cancer. It is administered as a liquid through a needle into a vein during an intravenous infusion. This drug works by attaching to specific proteins on immune cells to help the body's own natural defenses recognize and attack cancer cells. It is officially classified as a checkpoint inhibitor in the field of cancer treatment.

  • Pembrolizumab

    This medication is an immunotherapy used to treat certain types of advanced cancers, such as metastatic non-small cell lung cancer. It is administered as a liquid through a needle injected just under the skin. This drug works by attaching to specific proteins on immune cells to help the body's own natural defenses recognize and attack cancer cells. It is officially classified as a checkpoint inhibitor in the field of cancer treatment.

Investigated diseases

Non-small cell lung cancer - This is a type of lung cancer that begins in the cells lining the inside of the lungs. It is the most common form of lung cancer and involves the rapid growth of abnormal cells. As the disease progresses, these cells can spread from the original site to other parts of the lungs or to distant organs in the body. The presence of specific proteins, such as PD-L1, on the surface of these cancer cells can influence how the disease behaves.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513165-39-00Protocol codeMK-3475A-F84Estimated enrolment98 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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