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Study Comparing Pembrolizumab Alone and with Sacituzumab Govitecan for Patients with Metastatic Non-Small Cell Lung Cancer with High PD-L1 Levels

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). The study is investigating the effectiveness of two treatments: Pembrolizumab, also known by its code name MK-3475, and Sacituzumab Govitecan. Pembrolizumab is a medication that helps the immune system fight cancer, while Sacituzumab Govitecan is another type of cancer treatment. The purpose of the study is to compare the effects of using Pembrolizumab alone versus using it in combination with Sacituzumab Govitecan.

Participants in the study will receive either Pembrolizumab by itself or a combination of Pembrolizumab and Sacituzumab Govitecan. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study will monitor how the cancer responds to these treatments over time, focusing on how long participants live without the cancer getting worse and their overall survival.

The trial will take place over a period of up to 24 months. During this time, participants will receive regular infusions and be closely monitored by healthcare professionals. The study aims to provide valuable information on the best treatment approach for patients with this type of lung cancer, helping to improve future care and outcomes for those affected by the disease.

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, the diagnosis of metastatic non-small cell lung cancer is confirmed. It is verified that specific therapies are not indicated as primary treatment.

    Tumor tissue is provided to demonstrate a PD-L1 tumor proportion score of 50% or more, assessed by a central laboratory.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to one of two treatment groups: one receiving pembrolizumab alone, and the other receiving a combination of pembrolizumab and sacituzumab govitecan.

  3. Step 3

    Treatment administration

    For those in the pembrolizumab group, the medication is administered as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

    For those in the combination group, both pembrolizumab and sacituzumab govitecan are administered as intravenous infusions. The specific dosages and frequencies are determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to assess progression-free survival and overall survival.

    Additional assessments include objective response, duration of response, and changes in quality of life and physical functioning.

  5. Step 5

    Completion of study

    The study is estimated to conclude by September 20, 2028. Participants continue to receive treatment and monitoring until the study's end or until specific criteria for discontinuation are met.

Who can join the trial?

5 criteria

  • The patient must have a confirmed diagnosis of **metastatic non-small cell lung cancer (NSCLC)**. This means the type of lung cancer has spread to other parts of the body.
  • The patient must have confirmation that certain treatments, specifically those targeting **epidermal growth factor receptor (EGFR)**, **anaplastic lymphoma kinase 1 (ALK-1)**, or **ROS proto-oncogene 1 (ROS-1)**, are not suitable as the main treatment. These are specific proteins or genes that can affect cancer growth.
  • The patient must provide a sample of their tumor tissue showing a **PD-L1 tumor proportion score (TPS)** of 50% or more. This score is determined by a test called **immunohistochemistry (IHC)**, which is done in a specialized lab. PD-L1 is a protein that can affect how the immune system responds to cancer.
  • The patient must have a life expectancy of at least 3 months, meaning they are expected to live for at least this amount of time.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

6 criteria

  • Patients with other types of cancer besides Metastatic Non-small Cell Lung Cancer cannot participate. This means the cancer has spread from the lung to other parts of the body.
  • Patients who have received certain treatments for their cancer recently may not be eligible. This includes treatments that could interfere with the study drugs.
  • Patients with serious health conditions that could affect their safety or the study results may be excluded. This includes conditions like severe heart disease or uncontrolled infections.
  • Patients who are pregnant or breastfeeding cannot participate, as the study drugs may affect the baby.
  • Patients who are unable to follow the study procedures or attend regular visits may not be eligible.
  • Patients who have had an allergic reaction to similar drugs in the past may be excluded to prevent any health risks.
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Investigated drugs

  • Pembrolizumab

    is a medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this trial, it is being tested both alone and in combination with another medication to see how effective it is in treating a specific type of lung cancer.

  • Sacituzumab Govitecan

    is a type of targeted cancer therapy. It combines an antibody with a chemotherapy drug, allowing it to deliver the chemotherapy directly to cancer cells. In this trial, it is being used in combination with pembrolizumab to determine if the combination is more effective than pembrolizumab alone in treating lung cancer.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently used in clinical trials as a treatment for metastatic non-small cell lung cancer. It is a well-established drug in medical literature, primarily used for its immune-boosting properties. Pembrolizumab works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor.

  • Sacituzumab Govitecan

    This medication is also administered intravenously and is being studied in combination with pembrolizumab for treating metastatic non-small cell lung cancer. It is an emerging drug in medical literature, known for its targeted approach to cancer therapy. Sacituzumab Govitecan is an antibody-drug conjugate that delivers a chemotherapy agent directly to cancer cells, minimizing damage to healthy cells. It is classified as an antineoplastic agent.

Investigated diseases

Metastatic Non-small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining 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 metastasize to other organs such as the brain, bones, or liver. Symptoms may include persistent cough, chest pain, shortness of breath, and unexplained weight loss. As the cancer spreads, it can lead to more severe symptoms and complications depending on the organs affected. The progression of the disease can vary greatly among individuals, influenced by factors such as the cancer's genetic makeup and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503501-11-00Protocol codeMK-3475-D46Estimated enrolment614 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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