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Study Comparing Subcutaneous Pembrolizumab with Hyaluronidase to Intravenous Pembrolizumab and Chemotherapy for First-line Treatment of 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 the treatment of 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 forms of the medication pembrolizumab, which is used to help the immune system fight cancer. One form is given as a subcutaneous injection, which means it is injected under the skin, and is known as MK-3475A. The other form is given as an intravenous infusion, meaning it is delivered directly into a vein. Both forms of pembrolizumab are administered alongside chemotherapy, which is a type of cancer treatment that uses drugs to destroy cancer cells.

The purpose of the study is to evaluate the safety and how the body processes these two forms of pembrolizumab when used as a first-line treatment, which means it is the first treatment given for this type of cancer. Participants in the study will receive either the subcutaneous or intravenous form of pembrolizumab, along with chemotherapy, and their health will be monitored over a period of time. The study will look at various factors, such as how much of the drug is present in the body at different times and any side effects that may occur.

Throughout the study, participants will receive regular medical check-ups and tests to monitor their response to the treatment. The study aims to provide valuable information on the effectiveness and safety of these treatment options for people with metastatic non-small cell lung cancer. This research could help improve treatment strategies and outcomes for patients with this condition 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, you will be informed about the trial's purpose and procedures. You will be asked to provide a tumor tissue sample, either from a previous biopsy or a new one, to confirm your diagnosis of non-small cell lung cancer.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your health status and ensure you meet the study's eligibility criteria. This includes confirming a life expectancy of at least three months.

  3. Step 3

    Treatment phase

    You will receive treatment with pembrolizumab, which is a medication administered either subcutaneously (under the skin) or intravenously (through a vein). The specific form and dosage will be determined by the study protocol.

    In addition to pembrolizumab, you will receive chemotherapy. The chemotherapy drugs may include cisplatin, carboplatin, paclitaxel, or pemetrexed, administered intravenously. The exact combination and schedule will be explained to you by the study team.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health and response to treatment will be closely monitored. This includes regular blood tests, imaging scans, and assessments of your overall well-being.

    You will be asked to report any side effects or changes in your health to the study team promptly.

  5. Step 5

    Completion of treatment

    Once the treatment phase is complete, you will undergo a final assessment to evaluate the outcomes of the study treatment.

    The study team will discuss the results with you and provide guidance on any further medical care you may need.

Who can join the trial?

5 criteria

  • Must have a confirmed diagnosis of **Non-small Cell Lung Cancer (NSCLC)**, which is a type of lung cancer.
  • Must provide a sample of tumor tissue. This can be from a previous sample or a new biopsy, which is a procedure to remove a small piece of tissue for testing. The sample should not be from an area that has been treated with radiation before.
  • Must have a life expectancy of at least **3 months**.
  • Open to both **male** and **female** participants.
  • Participants must be adults, as the study includes age ranges for adults.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have received treatment for their cancer before.
  • Patients with serious heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that need treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had an organ transplant.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients who are participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse.
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Investigated drugs

  • Pembrolizumab

    is a type of cancer treatment known as immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is given through an intravenous (IV) infusion, which means it is delivered directly into your bloodstream through a vein. This method allows the medication to circulate throughout your body and target cancer cells.

  • MK-3475A

    is a new formulation of pembrolizumab that is combined with an enzyme called hyaluronidase. This combination is designed to be given as a subcutaneous (SC) injection, which means it is injected under the skin. The addition of hyaluronidase helps the medication to be absorbed more easily when injected this way. The goal of using MK-3475A is to provide a more convenient way to receive pembrolizumab, potentially with fewer visits to the clinic compared to the IV method.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered either as a subcutaneous injection coformulated with hyaluronidase or as an intravenous infusion, and it is currently being studied in a Phase 3 clinical trial for its effectiveness and safety in treating metastatic non-small cell lung cancer. This medication is well-established in medical literature as an immune checkpoint inhibitor, primarily used for various cancers. It works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Pembrolizumab belongs to the pharmacological class of monoclonal antibodies, specifically designed to enhance the body's immune response against cancer.

Investigated diseases

Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the tissues of the lungs and has spread to other parts of the body. It is the most common form of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow uncontrollably and form tumors in the lungs. Over time, these cancer cells can invade nearby tissues and spread to distant organs, such as the brain, bones, and liver. The progression of the disease can lead to symptoms like persistent cough, chest pain, and difficulty breathing. As the cancer advances, it can significantly impact a person's quality of life and daily functioning.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501506-36-00Protocol codeMK3475A-D77Estimated enrolment393 patientsSponsorMerck Sharp & Dohme LLC

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