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Study of cemiplimab treatment after surgery in patients with stage II-IIIA non-small cell lung cancer who have not received chemotherapy and have PD-L1 expression of 1% or higher

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) who have had their cancer surgically removed and are at stage II-IIIA of the disease. The study specifically looks at patients whose tumor cells show a certain protein marker called PD-L1. These patients have not received chemotherapy after their surgery.

The study will test a medication called cemiplimab (also known as LIBTAYO), which is given through an intravenous infusion. This medicine belongs to a group of drugs called immunotherapy, which helps the body's immune system fight cancer cells. The purpose is to determine if giving cemiplimab after surgery can help prevent the cancer from returning, compared to patients who receive no additional treatment after surgery.

During the study, participants will either receive cemiplimab treatment or be observed without treatment. The medication will be given through an infusion into a vein every few weeks. The total treatment period may last up to 42 weeks. Doctors will monitor the participants' health and check if the cancer returns during and after the treatment period.

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

    Initial treatment preparation

    Your participation begins after successful lung cancer surgery and confirmation of stage II-IIIA non-small cell lung cancer (NSCLC)

    A test will confirm if your tumor has a specific protein marker called PD-L1 at a level of 1% or higher

    Your tissue sample from surgery will be sent for additional testing to verify PD-L1 levels

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two groups:

    Group 1: Receiving cemiplimab treatment

    Group 2: Observation without additional treatment

  3. Step 3

    Treatment administration (if assigned to treatment group)

    LIBTAYO (cemiplimab) 350 mg will be given through an intravenous infusion (directly into your vein)

    The medication is first prepared as a solution from a concentrated form

    Regular health assessments will monitor your response to treatment

  4. Step 4

    Follow-up period

    Regular check-ups will track your recovery and any signs of disease return

    Your doctor will monitor for any side effects using a standardized rating system

    The study will continue until December 2030

  5. Step 5

    Health monitoring

    Regular assessments of your overall health status

    Tracking of any new health issues that may develop

    Documentation of your recovery progress

Who can join the trial?

12 criteria

  • You must be at least 18 years old
  • You must have had surgery to remove stage II-IIIA non-small cell lung cancer with clean surgical margins (meaning all visible cancer was removed)
  • Your tumor must show a specific protein marker called PD-L1 at a level of 1% or higher
  • You must be fully recovered from any surgery-related complications
  • You must not be suitable for or have refused standard chemotherapy treatment with platinum-based drugs due to either:
    • Your own choice to refuse this treatment
    • Your doctor's assessment that you are not fit for this treatment due to age (70 or older) or other health conditions
    • You must have a life expectancy of at least 3 months
    • Your major organs must be functioning properly
    • You must provide a tissue sample from your previous surgery for additional testing
    • You must provide written informed consent to participate
    • If you are a woman who can become pregnant, you must have a negative pregnancy test
    • Your cancer must not have returned after the surgery

Who cannot join the trial?

14 criteria

  • Prior treatment with any immunotherapy (medications that help your immune system fight cancer)
  • Active or untreated brain or spinal cord tumors
  • History of organ transplant
  • Active autoimmune disease (conditions where your immune system attacks your own body)
  • Ongoing infections requiring treatment
  • Previous cancer treatment within the last 3 years (except for certain skin cancers)
  • Known allergic reactions to similar medications
  • Uncontrolled heart, lung, liver, or kidney disease
  • Pregnancy or breastfeeding
  • Unable to undergo required medical tests and procedures
  • Current participation in other clinical trials
  • Use of systemic steroids (pills or injections that affect your whole body) or other medications that suppress the immune system
  • Serious medical conditions that could interfere with study participation
  • History of certain lung diseases that could affect study results
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Investigated drugs

Cemiplimab is a type of immunotherapy medication that helps your immune system fight cancer cells. It belongs to a group of drugs called PD-1 inhibitors. This medication works by blocking certain proteins that cancer cells use to hide from your immune system, allowing your body's natural defenses to better recognize and attack the cancer cells. It is used after surgery in patients with non-small cell lung cancer to help prevent the cancer from returning.

What is already known about the treatment

Cemiplimab - A monoclonal antibody immunotherapy drug administered through intravenous infusion, which works by targeting and blocking PD-L1 (programmed death-ligand 1) protein to enhance the immune system's ability to fight cancer cells. Currently used in clinical trials as an adjuvant treatment for patients with resected stage II-IIIA non-small cell lung cancer (NSCLC) who have PD-L1 expression of 1% or higher. This medication belongs to the class of immune checkpoint inhibitors and functions by preventing cancer cells from evading immune system detection, allowing the body's natural defenses to identify and destroy cancer cells more effectively.

Investigated diseases

Non-small cell lung cancer (NSCLC) - A type of lung cancer that begins in the large cells of the lung, including both squamous and non-squamous cells. It typically develops slowly and forms solid tumors in the lung tissue. The disease can progress through different stages, from stage I where cancer is localized, to stage IIIA where it has spread to nearby lymph nodes. NSCLC accounts for the majority of all lung cancer cases and can affect various parts of the lungs. The condition involves abnormal cell growth that can spread from its original location to surrounding tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519901-36-00Protocol codeETOP 27-23 ARCHEstimated enrolment390 patientsSponsorETOP IBCSG Partners Foundation

sourced from the EU Clinical Trials Register and site verification

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