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Evaluation of recurrence‑free survival with cemiplimab immunotherapy in medically inoperable stage I non‑small cell lung cancer patients

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

The study focuses on people with Stage I non-small cell lung cancer, an early form of lung cancer that has not spread beyond the lung. The treatment being tested is an intravenous infusion of cemiplimab, a type of immunotherapy that helps the immune system recognize and attack cancer cells. This short course of drug treatment is used instead of the usual radiotherapy, and the main goal is to estimate recurrence‑free survival, meaning the length of time after treatment that the cancer does not come back.

Participants receive three cycles of the infusion, each given several weeks apart, and then are monitored for signs that the disease returns or worsens. Follow‑up includes regular scans and doctor visits to check for any new growths, side effects, or overall health changes. The study records the time until any cancer recurrence, any death related to the disease, and any serious side effects, using standard criteria such as RECIST 1.1 to measure tumor changes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After joining the study, you attend an initial clinic visit where baseline examinations are performed.

    The examinations include imaging of the chest, blood tests, and other evaluations to document the current status of the lung cancer.

  2. Step 2

    First cemiplimab infusion

    You receive the first dose of cemiplimab as libtayo 350 mg given by intravenous infusion.

    The infusion is administered in a clinical setting and you are observed for a short period after the treatment.

  3. Step 3

    Second cemiplimab infusion

    A second infusion of cemiplimab 350 mg is given by intravenous infusion according to the schedule defined by the study protocol.

    The same observation period follows each infusion.

  4. Step 4

    Third cemiplimab infusion

    The third and final infusion of cemiplimab 350 mg is administered by intravenous infusion.

    After this infusion, the treatment phase of the trial is completed.

  5. Step 5

    Post‑treatment follow‑up

    Regular follow‑up visits are scheduled to monitor for disease recurrence and any side effects.

    Follow‑up includes repeat imaging, blood tests, and clinical evaluation for up to 90 days after the last infusion.

  6. Step 6

    Final assessment

    At the end of the follow‑up period, a final assessment is performed to record the overall outcome of the study for you.

    The results contribute to the study’s primary and secondary objectives.

Who can join the trial?

10 criteria

  • Have a newly diagnosed lung cancer that is stage I (tumor 4 cm or smaller) confirmed by looking at tissue under a microscope, using the 9th AJCC/UICC staging classification system.
  • If you are a woman who could become pregnant, you must have a negative serum pregnancy test (blood test) taken within 72 hours before the first dose of the study drug.
  • Be willing and able to sign a written informed consent form agreeing to join the study.
  • Be at least 18 years old on the day you sign the consent form.
  • Have disease that can be measured on scans according to RECIST 1.1 (a set of rules doctors use to track tumor size).
  • Have an ECOG Performance Scale rating of 0, 1, or 2 (a simple way to describe how well you are able to carry out daily activities).
  • Undergo next‑generation sequencing (NGS) testing to look for specific gene changes called oncogenic driver alterations or mutations in the STK11 or KEAP1 genes; if this testing is not possible, you must have a smoking history of at least 10 pack‑years (for example, one pack a day for 10 years).
  • Have a PD‑L1 TPS (tumor proportion score) of at least 50%, which measures a protein on cancer cells that can affect treatment response.
  • Have a medical plan for SABR (stereotactic ablative radiotherapy, a precise form of radiation treatment) that has been approved by a multidisciplinary team of doctors.
  • Show adequate organ function based on lab tests performed within 14 days before starting treatment.

Who cannot join the trial?

17 criteria

  • Having a known genetic change (called a driver mutation) such as EGFR, ALK, HER2, RET, or ROS1 that makes the study drug less effective excludes you.
  • If you have an infection that needed a hospital stay or IV antibiotics within the two weeks before the first dose, you cannot join.
  • Uncontrolled infections like active or hidden tuberculosis, HIV, hepatitis B, hepatitis C, or any immune‑system deficiency keep you from participating.
  • Receiving a live vaccine (a vaccine that uses weakened live germs) within four weeks before starting the study drug is not allowed.
  • Getting a COVID‑19 vaccine less than one week before the planned start, or not being able to finish any needed COVID‑19 shots at least one week before, excludes you.
  • Any known allergy (hypersensitivity) to the study drug or its ingredients means you cannot take part.
  • Having major surgery, an open tissue biopsy, or a serious injury within four weeks before the first dose disqualifies you.
  • If you are currently breastfeeding or plan to breastfeed while in the study, you are excluded.
  • Women who could become pregnant (women of childbearing potential) or men who are not willing to use reliable birth control before, during, and for four months after the study drug cannot enroll.
  • Having a known mutation in the genes STK11 or KEAP1 that predicts a poor response to this type of treatment excludes you.
  • Being in another clinical trial, or having been in one, within four weeks before the first dose prevents participation.
  • Having previously received drugs that target the immune system in ways other than the study drug’s pathway (for example, anti‑CD137 or CTLA‑4 antibodies) excludes you.
  • Having another cancer that is getting worse or needs active treatment keeps you from joining.
  • Having symptoms of interstitial lung disease (a scarring condition of the lungs) or an active, non‑infectious lung inflammation (pneumonitis) excludes you.
  • Having certain heart or blood‑vessel problems, such as moderate to severe heart failure (New York Heart Association Class II‑IV), a heart attack or acute coronary syndrome within the past year, or a stroke or mini‑stroke (transient ischemic attack) within the past year, disqualifies you.
  • Needing ongoing high‑dose steroids (more than 10 mg of prednisone or equivalent every day) within one week before the first dose excludes you (short courses of up to two days are allowed).
  • Having a significant autoimmune disease that required strong immune‑suppressing medicines (except mild conditions like vitiligo, resolved childhood asthma, hormone‑treated thyroid disease, or psoriasis not needing systemic therapy) keeps you from participating.
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Investigated drugs

LIBTAYO is a medication that contains the active substance cemiplimab, a type of immune‑system protein called a monoclonal antibody. It works by blocking a signal (PD‑1) that cancer cells use to hide from the body’s immune defenses, helping the immune system to recognize and attack the lung cancer cells. In this study, patients receive LIBTAYO through an intravenous infusion, given in three treatment cycles, to try to keep the cancer from coming back after surgery.

What is already known about the treatment

LIBTAYO 350 mg concentrate for solution for infusion - Cemiplimab is given by intravenous infusion, where the concentrate is mixed with a fluid and delivered through a vein. It is an approved anti‑cancer drug that appears in many medical studies and is used for certain lung and skin cancers. It works by blocking the PD‑1 protein on immune cells, which helps the body’s immune system notice and fight tumor cells. It belongs to the class of monoclonal antibodies known as immune‑checkpoint inhibitors.

Investigated diseases

Stage I non-small cell lung cancer - This disease is an early form of lung cancer that starts in the cells lining the airways. At this stage the tumor is small and confined to the lung without spreading to nearby lymph nodes. Over time the cancer cells can grow larger and may invade surrounding lung tissue. If it continues to develop, it can spread to other parts of the chest or body, moving to more advanced stages. The progression is usually slow, but it can become faster depending on the tumor’s characteristics.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524305-32-00Protocol codeM25RIOEstimated enrolment30 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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