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Study Comparing Subcutaneous and Intravenous 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 the treatment of metastatic non-small cell lung cancer (NSCLC), which is a type of lung cancer that has spread to other parts of the body. The study is investigating the use of a medication called pembrolizumab, also known by its code name MK-3475, in combination with chemotherapy drugs. The chemotherapy drugs involved in this study include cisplatin, carboplatin, paclitaxel, paclitaxel albumin-bound, and pemetrexed. Pembrolizumab is a type of treatment known as immunotherapy, which helps the immune system fight cancer.

The purpose of this study is to compare two different ways of giving pembrolizumab: as a subcutaneous injection (under the skin) and as an intravenous infusion (through a vein). Participants will receive pembrolizumab along with one of the chemotherapy drugs as part of their first-line treatment, which means it is the first treatment given for their cancer. The study will help determine how the body processes pembrolizumab when given in these two different ways and will also look at the safety of these treatments.

Participants in the study will receive treatment over a period of time, with regular visits to the clinic for their medication and monitoring. The study will track how well the cancer responds to the treatment and any side effects that may occur. This information will help doctors understand the best way to use pembrolizumab in combination with chemotherapy for treating metastatic non-small cell lung cancer.

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

    Initial treatment phase

    The study begins with the administration of pembrolizumab, a medication used to treat certain types of cancer. It is given either as a subcutaneous injection or an intravenous infusion. The method of administration is determined by the study group to which the participant is assigned.

    In addition to pembrolizumab, participants receive a combination of chemotherapy drugs. These include cisplatin or carboplatin, and paclitaxel or paclitaxel albumin-bound. These drugs are administered through intravenous infusion.

    The treatment is repeated in cycles, with each cycle lasting three weeks. The exact dosage and frequency depend on the specific protocol of the study.

  2. Step 2

    Monitoring and assessment

    Throughout the trial, regular monitoring is conducted to assess the body's response to the treatment. This includes measuring the concentration of pembrolizumab in the blood at various points, such as at the end of the first and sixth cycles.

    Participants undergo imaging tests to evaluate the size and progression of the cancer. These tests help determine the objective response rate, which is the percentage of participants whose cancer shrinks or disappears after treatment.

  3. Step 3

    Safety evaluation

    The safety of the treatment is closely monitored. Any side effects or adverse events experienced by participants are recorded and evaluated.

    Participants are assessed for the presence of anti-drug antibodies, which can develop in response to pembrolizumab and potentially affect its effectiveness.

  4. Step 4

    Long-term follow-up

    After completing the treatment cycles, participants enter a follow-up phase. This phase involves regular check-ups to monitor overall health and any long-term effects of the treatment.

    The study aims to measure progression-free survival and overall survival, which are indicators of how long participants live without the cancer worsening and the overall length of survival, respectively.

Who can join the trial?

10 criteria

  • The patient 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.
  • The patient must have **adequate organ function**, meaning their organs are working well enough to participate in the study.
  • The patient must have **Stage IV NSCLC**, which means the cancer has spread to other parts of the body.
  • The patient must have confirmation that certain treatments, like those targeting **EGFR, ALK, or ROS1**, are not suitable for their type of lung cancer.
  • The patient must not have received previous treatments that affect the whole body for their metastatic NSCLC. If they had treatments before, it must have been at least 12 months before the cancer spread.
  • The patient must have an **ECOG performance score** of 0 or 1, which indicates they are fully active or have some symptoms but can still carry out light work.
  • Male patients must agree to use contraception unless they are confirmed to be **azoospermic**, meaning they do not produce sperm.
  • Female patients must not be pregnant or breastfeeding. If they can have children, they must agree to use contraception.
  • The patient must have **measurable disease** according to specific criteria used to evaluate tumors.
  • The patient must provide a sample of their tumor tissue for testing before being randomly assigned to a treatment group.

Who cannot join the trial?

3 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.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • Pembrolizumab

    This medication is used to treat certain types of cancer by helping the immune system fight cancer cells. In this trial, it is being studied in two different forms of administration: subcutaneous (under the skin) and intravenous (into a vein). The goal is to compare how the body absorbs and processes the medication in these two forms.

  • Platinum Doublet Chemotherapy

    This is a combination of two chemotherapy drugs that are often used together to treat lung cancer. These medications work by killing or stopping the growth of cancer cells. In this trial, platinum doublet chemotherapy is used alongside pembrolizumab to see how effective the combination is in treating metastatic non-small-cell lung cancer.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered either subcutaneously or intravenously, depending on the specific treatment protocol. It is currently being studied in clinical trials for its effectiveness and safety in treating metastatic non-small cell lung cancer, both squamous and nonsquamous types. The medication works by blocking a specific protein on immune cells, which helps the immune system to better identify and attack cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy used in cancer treatment.

Investigated diseases

Metastatic (stage IV) squamous or nonsquamous non-small cell lung cancer (NSCLC) – This is a type of lung cancer that has spread beyond the lungs to other parts of the body. It originates in the cells lining the airways and can be classified into squamous or nonsquamous types based on the cell characteristics. As the disease progresses, it can invade nearby tissues and organs, leading to a range of symptoms such as persistent cough, chest pain, and difficulty breathing. The cancer cells can travel through the bloodstream or lymphatic system, forming new tumors in distant organs. This stage of cancer is considered advanced, as it indicates that the cancer has metastasized, or spread, beyond its original site.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508308-40-00Protocol codeMK-3475-A86Estimated enrolment531 patientsSponsorMerck Sharp & Dohme LLC

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