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Study on the Effect of Cemiplimab in Patients with Oligometastatic Non-Small Cell Lung Cancer After Radical Treatment

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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 the effects of a treatment for non-small cell lung cancer (NSCLC), which is a type of lung cancer. The treatment being tested is called cemiplimab, which is a medication given through an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. The study will compare the effects of cemiplimab to a placebo in patients who have a specific form of NSCLC known as oligometastatic, where the cancer has spread to a limited number of other areas in the body.

The purpose of the study is to determine if continuing treatment with cemiplimab for up to 12 months can help prevent the cancer from getting worse, which is referred to as progression-free survival. Participants in the study will have already received initial treatment with chemotherapy and cemiplimab or cemiplimab alone, and they will have undergone surgery or radiation therapy if needed. The study will involve regular monitoring of the patients' health and response to the treatment over the course of the study period.

Throughout the study, researchers will collect information on how long patients live without the cancer progressing, the time it takes for new cancerous areas to develop, and any side effects experienced. This information will help determine the effectiveness and safety of cemiplimab as a treatment option for patients with this type of lung cancer. The study aims to provide valuable insights into improving treatment strategies for patients with NSCLC.

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

    Joining the study

    Upon joining the study, confirmation of non-small cell lung cancer (NSCLC) is required. This involves a histologic or cytologic test to ensure eligibility.

    Participants must agree to use birth control measures during the study and for at least 6 months after the last dose of the study medication.

  2. Step 2

    Initial treatment phase

    The initial treatment involves 4 cycles of chemotherapy, which may include a drug called cemiplimab.

    The goal is to achieve stable disease, partial, or complete response before moving to the next phase.

  3. Step 3

    Randomization

    Participants who have not shown disease progression after the initial treatment are randomized to receive either cemiplimab or a placebo.

    Randomization is based on the response to the initial treatment and other health criteria.

  4. Step 4

    Consolidation treatment

    The consolidation treatment involves receiving cemiplimab or placebo through an intravenous infusion.

    This treatment is administered every 3 weeks for up to 12 months, depending on the participant's response and health status.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored for progression-free survival, overall survival, and any side effects.

    Regular assessments are conducted to track the time to disease progression and the development of new metastatic lesions.

  6. Step 6

    End of study participation

    The study participation concludes after the completion of the consolidation treatment or if the disease progresses.

    Participants may continue to be monitored for long-term outcomes and overall survival.

Who can join the trial?

14 criteria

  • Must have a confirmed diagnosis of **non-small cell lung cancer (NSCLC)**. If there are any small-cell elements, the patient cannot participate.
  • Patients who can have children should agree to use effective birth control during the study and for at least 6 months after the last dose of certain medications.
  • Women who are breastfeeding should stop nursing before starting the study treatment and for at least 6 months after the last dose of certain medications.
  • Must be able to give written consent to participate in the study, understanding all the requirements and restrictions.
  • At the time of randomization, the disease should be stable or showing improvement after initial treatment. Patients whose disease is getting worse cannot participate.
  • Must have a life expectancy of more than 12 weeks.
  • Liver function must be within certain limits, with specific levels of bilirubin and liver enzymes.
  • Kidney function must be adequate, with a **glomerular filtration rate (GFR)** of at least 30 mL/min.
  • Bone marrow function must be adequate, with specific levels of hemoglobin, white blood cells, and platelets.
  • Women of childbearing potential must have a negative pregnancy test before starting the treatment.
  • Must have a specific type of cancer spread, with no more than 5 metastases in up to 3 organs. Certain lymph nodes are not counted as metastases.
  • Must have measurable disease according to specific criteria.
  • Must be at least 18 years old at the time of registration.
  • Must have a good performance status, meaning they can carry out daily activities without significant limitations.

Who cannot join the trial?

9 criteria

  • Patients who have not been diagnosed with non-small cell lung cancer. This is a type of lung cancer that is different from small cell lung cancer.
  • Patients who have not reached stage IV of the disease. Stage IV means the cancer has spread to other parts of the body.
  • Patients who have not received platinum-based chemotherapy. This is a type of cancer treatment that uses drugs containing the metal platinum to kill cancer cells.
  • Patients who have not been treated with cemiplimab. Cemiplimab is a medication used to help the immune system fight cancer.
  • Patients who have not received radical treatment for their primary tumor and metastases. Radical treatment aims to remove or destroy all cancer cells.
  • Patients who have not achieved a complete response to treatment. A complete response means that all signs of cancer have disappeared.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial group. This refers to the specific group of patients the study is focusing on.
  • Patients who are not considered part of the vulnerable population. This includes groups of people who may need special protection or consideration in research.
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Investigated drugs

Cemiplimab is a medication used in this clinical trial to help treat patients with a specific type of lung cancer called non-small cell lung cancer (NSCLC). It is an immunotherapy drug, which means it works by helping the body's immune system fight the cancer cells. In this trial, cemiplimab is given to patients who have already received chemotherapy and have not shown any progression of their cancer. The goal is to see if continuing cemiplimab treatment can help prevent the cancer from getting worse.

What is already known about the treatment

Cemiplimab – Cemiplimab is administered as an intravenous infusion, typically given in a healthcare setting. It is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC), particularly in patients who have undergone radical treatment for synchronous oligometastatic disease. The main therapeutic indication for cemiplimab is to increase progression-free survival in these patients. At the molecular level, cemiplimab 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, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Non-small cell lung cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms like persistent cough, chest pain, and shortness of breath may develop. The progression of the disease can vary, with some cases advancing slowly and others more rapidly. It is often diagnosed at a later stage due to the subtlety of early symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-508741-40-00Protocol codeEORTC 2029-LCGEstimated enrolment142 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

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