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Evaluating shorter duration of pembrolizumab and pemetrexed treatment in patients with metastatic non-small cell lung cancer who have not progressed after 6 months

Fast replyRegistered 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 metastatic non-small cell lung cancer (NSCLC) who have been receiving initial treatment with medications that help the immune system fight cancer. The study uses two medications: pembrolizumab (KEYTRUDA), which works with the immune system to fight cancer cells, and pemetrexed (ALIMTA), a chemotherapy drug. Both medications are given through an intravenous infusion, which means they are delivered directly into a vein.

The purpose of this research is to determine if patients can benefit from a shorter duration of standard treatment while maintaining its effectiveness. The study involves patients who have been receiving treatment for about 6 months and whose cancer has not gotten worse during this time. These patients will continue receiving their current treatment for up to 18 months while being monitored for any changes in their condition.

During the study, doctors will regularly check how the cancer responds to treatment through various medical examinations. The medications will be given at specific doses - pembrolizumab at up to 200 mg per dose and pemetrexed at 500 mg per square meter of body surface area. The treatment will continue for up to 18 months, during which time patients will be monitored for any changes in their health and how well the treatment is working.

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 qualification

    Your eligibility for the trial will be confirmed if you have advanced, metastatic non-small cell lung cancer (stage IV)

    You must have received first-line treatment with immunotherapy or combined chemotherapy and immunotherapy for 6 months (plus/minus 2 weeks)

    Medical imaging must confirm that your disease is either stable or responding to current treatment

    The imaging results must be no older than 3 weeks at the time of entering the study

  2. Step 2

    Treatment administration

    You will receive two medications through intravenous infusion:

    KEYTRUDA (pembrolizumab) 25 mg/mL as a solution for infusion

    ALIMTA (pemetrexed) 500 mg as a solution for infusion

  3. Step 3

    Regular monitoring

    Your health status will be evaluated every 3 months

    At each visit, you will complete quality of life questionnaires

    Medical imaging will be performed to assess your response to treatment

    Any side effects will be recorded and classified according to standard criteria

  4. Step 4

    Study duration

    Your participation in the study will continue for up to 18 months after entering the trial

    During this time, you will be monitored for how your disease responds to treatment

    The overall study is planned to run from August 2025 to August 2031

Who can join the trial?

8 criteria

  • Must be an adult (18 years or older)
  • Must have advanced non-small cell lung cancer that has spread to other parts of the body (stage IV)
  • Must have been receiving first-line immunotherapy (treatment that helps your immune system fight cancer) or combination of chemotherapy and immunotherapy for about 6 months (plus or minus 2 weeks)
  • Must have a stable condition or showing improvement based on recent imaging tests (performed within the last 3 weeks)
  • Must be in relatively good physical condition, able to carry out daily activities (ECOG performance status between 0-2, which means being able to care for yourself and being up and about more than half of your waking hours)
  • Must be physically able and willing to continue current cancer treatment as determined by your doctor
  • Must sign an informed consent form indicating you understand and agree to participate in the trial
  • Both men and women may participate

Who cannot join the trial?

13 criteria

  • Age under 18 years old
  • Active autoimmune disease requiring systemic treatment
  • History of organ transplantation
  • Disease progression during the first 6 months of immunotherapy (treatment that helps your immune system fight cancer)
  • Presence of untreated brain metastases (cancer that has spread to the brain)
  • Previous treatment with experimental cancer therapies within 4 weeks before starting this study
  • Significant heart conditions or recent heart attack (within last 6 months)
  • Active or untreated infections, including tuberculosis (TB)
  • Known allergic reactions to study medications
  • Pregnant or breastfeeding women
  • Unable to provide informed consent
  • Participation in another clinical trial within the past 30 days
  • Active second cancer (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
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Investigated drugs

Chemotherapy is a type of cancer treatment that uses powerful drugs to kill cancer cells or stop them from growing and dividing. In this trial, it is used as part of the standard treatment for non-small cell lung cancer. Immunotherapy is a treatment that helps the body's immune system fight cancer. It works by boosting or changing how the immune system works so it can better find and destroy cancer cells. In this trial, it is combined with chemotherapy as part of the standard care for metastatic non-small cell lung cancer. Note: The specific chemotherapy and immunotherapy medications are not explicitly mentioned in the source data, but these are the main treatment types being studied in this de-escalation trial.

What is already known about the treatment

Since no specific medications are directly mentioned in the provided trial data, I can describe the typical medications used in standard [chemo]immunotherapy for NSCLC (Non-Small Cell Lung Cancer): Pembrolizumab – An immunotherapy medication administered through intravenous infusion that helps the immune system detect and fight cancer cells. This checkpoint inhibitor works by blocking the PD-1 pathway, enabling T-cells to recognize and attack cancer cells more effectively. It belongs to the class of monoclonal antibodies and is commonly used as first-line treatment for metastatic NSCLC, either alone or in combination with chemotherapy. Pemetrexed – A chemotherapy drug given through intravenous infusion that interferes with the growth of cancer cells by blocking several enzymes needed for cell replication. It belongs to the class of antifolate antineoplastic agents and is frequently used in combination with immunotherapy as first-line treatment for non-squamous NSCLC, working by disrupting cellular metabolism essential for cancer cell division. Carboplatin – A platinum-based chemotherapy medication administered intravenously that works by binding to DNA in cancer cells, preventing them from dividing and growing. It belongs to the platinum compounds class and is commonly used in combination with other drugs as part of first-line treatment for metastatic NSCLC, causing cell death in rapidly dividing cancer cells.

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 and form masses called tumors. NSCLC accounts for most lung cancer cases and typically grows and spreads more slowly than small cell lung cancer. When the cancer spreads beyond its original location to other parts of the body, it is called metastatic NSCLC. The disease can affect various parts of the lungs and may gradually impact breathing and other bodily functions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520792-67-00Protocol codeDIDaC/ NVALT35Estimated enrolment500 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

sourced from the EU Clinical Trials Register and site verification

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