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Study of reduced pembrolizumab dosing compared to standard dose in patients with advanced 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 study focuses on patients with Non-small cell lung cancer (NSCLC) in advanced stages. The research examines the effectiveness of different dosing approaches of pembrolizumab, a medication used in cancer treatment that works by helping the immune system fight cancer cells. The study aims to determine if using a reduced dose of pembrolizumab can be as effective as the standard dose in treating advanced lung cancer.

The treatment involves giving pembrolizumab through intravenous infusion, which means the medication is delivered directly into a vein. The medication will be administered over a period of up to 24 months. During the study, some patients will receive the standard dose of pembrolizumab (up to 400 mg), while others will receive a reduced dose of the same medication.

The study will monitor how patients respond to different doses of pembrolizumab by tracking their overall health and survival over time. Throughout the treatment period, participants will need to attend regular medical visits for check-ups and monitoring. The medication being studied, pembrolizumab (also known as Keytruda), is already approved for treating certain types of 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

    You will receive pembrolizumab (KEYTRUDA) through an intravenous infusion (delivered directly into your vein)

    The treatment is administered as a solution with a concentration of 25 mg/mL

    The treatment is intended for advanced non-small cell lung cancer (NSCLC)

  2. Step 2

    Treatment duration

    Your participation in the study will continue until December 31, 2027

    The primary goal is to evaluate your overall survival rate after one year of treatment

    During the treatment period, you will need to attend scheduled medical visits and undergo laboratory testing

  3. Step 3

    Contraception requirements

    If you are a woman who can become pregnant, you must use effective contraception during treatment and for 5 months after the last dose

    If you are a male participant with female partners who can become pregnant, you must use effective contraception during treatment and for 7 months after the last dose

    Male participants should not donate sperm during the treatment period and for 7 months after the last dose

  4. Step 4

    Ongoing requirements

    Regular attendance at scheduled medical visits is required

    Compliance with all laboratory testing as scheduled by your healthcare team

    You must not be breastfeeding during the study period

Who can join the trial?

9 criteria

  • Must be at least 18 years old
  • Must have confirmed advanced or recurrent non-small cell lung cancer (NSCLC) that can be treated with pembrolizumab (a type of immunotherapy medication)
  • Must have known PD-L1 status (a protein marker that helps determine if immunotherapy might work) from tissue or cell samples
  • Must be willing and able to attend all scheduled visits, follow treatment plans, and complete required laboratory tests
  • Must sign an informed consent form before any study procedures begin
  • Women must not be breastfeeding
  • Women who can become pregnant must agree to use effective contraception during treatment and for 5 months after the last dose of pembrolizumab
  • Men who are sexually active with women who can become pregnant must:
    • Use effective contraception during treatment and for 7 months after the last dose
    • Agree not to donate sperm during this period

Who cannot join the trial?

14 criteria

  • Active or untreated brain metastases (cancer that has spread to the brain)
  • History of autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Current use of systemic corticosteroids (medications that reduce inflammation) or other immunosuppressive medications
  • Active hepatitis B or C infection
  • Known history of HIV infection
  • Active tuberculosis infection
  • Previous treatment with any immunotherapy (treatments that help your immune system fight cancer)
  • Other active malignancy (cancer) requiring treatment
  • Severe heart conditions including uncontrolled high blood pressure
  • Pregnant or breastfeeding women
  • Known allergy or sensitivity to study medications
  • Participation in another clinical trial within the past 30 days
  • Any condition that would interfere with the safety of the patient or the quality of the study data
  • Unable to give informed consent
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Investigated drugs

Pembrolizumab is a type of immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune cells) from attacking cancer cells. By blocking this protein, pembrolizumab allows the immune system to better recognize and destroy cancer cells. This medication is commonly used to treat non-small cell lung cancer (NSCLC) and is typically given through an intravenous (IV) infusion.

What is already known about the treatment

Pembrolizumab - An immunotherapy medication administered through intravenous infusion that belongs to the class of PD-1 inhibitors used in cancer treatment. This monoclonal antibody works by blocking the PD-1 protein on T cells, enabling the immune system to better recognize and attack cancer cells, particularly in advanced non-small cell lung cancer (NSCLC). Currently established as a standard treatment option in oncology, pembrolizumab has shown significant effectiveness in improving overall survival rates for NSCLC patients, with ongoing clinical trials exploring optimal dosing strategies to enhance cost-effectiveness while maintaining therapeutic benefits.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) - A type of lung cancer that begins in the cells of the lungs and can spread to other parts of the body. It develops when healthy cells in the lung tissue begin to grow uncontrollably, forming masses called tumors. NSCLC accounts for most lung cancer cases and typically grows and spreads more slowly than small cell lung cancer. Advanced NSCLC refers to cancer that has spread beyond its original location to other parts of the body. The disease can affect breathing, cause chest pain, and lead to persistent coughing.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516195-15-00Protocol code108439Estimated enrolment750 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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