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Study on the Effectiveness of Cemiplimab, Carboplatin, and Paclitaxel for Unfit or Elderly Patients with Unresectable Stage III Non-Small Cell Lung Cancer

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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 a type of lung cancer known as unresectable stage III non-small cell lung cancer. The study aims to evaluate the effectiveness and safety of a treatment approach that combines medications and a specific type of radiation therapy. The medications involved in this study include LIBTAYO (also known as cemiplimab), CARBOPLATIN, and PACLITAXEL. LIBTAYO is a medication that helps the immune system fight cancer, while CARBOPLATIN and PACLITAXEL are chemotherapy drugs that help stop the growth of cancer cells.

The purpose of this study is to determine how well this combination of treatments works in patients with this type of lung cancer. Participants will receive these medications in a specific order, starting with the combination of chemotherapy and immunotherapy, followed by a type of radiation therapy called hypofractionated radiotherapy. This means the radiation is given in larger doses over a shorter period of time. The study will monitor how the cancer responds to the treatment and how long patients remain free from cancer progression.

Throughout the study, participants will be closely monitored for any side effects and changes in their health. The study will also assess the overall quality of life of the participants during and after the treatment. The goal is to find out if this treatment approach can improve the outcomes for patients with this challenging type of lung 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

    The initial phase involves the administration of cemiplimab, carboplatin, and paclitaxel. These medications are given as a concentrate for solution for infusion, which means they are administered directly into the bloodstream through a vein.

    The purpose of this phase is to prepare the body for the next stage of treatment by using a combination of chemotherapy and immunotherapy.

  2. Step 2

    Neoadjuvant chemoimmunotherapy

    This phase involves the continued use of the same medications: cemiplimab, carboplatin, and paclitaxel. The goal is to reduce the size of the cancer and enhance the body's immune response before proceeding to radiotherapy.

    The treatment is administered through intravenous infusion, which is a method of delivering medication directly into the bloodstream.

  3. Step 3

    Hypofractionated radiotherapy

    Following the chemoimmunotherapy, hypofractionated radiotherapy is administered. This involves delivering radiation in larger doses over a shorter period of time compared to traditional radiotherapy.

    The aim is to target the cancer cells more effectively while minimizing exposure to surrounding healthy tissue.

  4. Step 4

    Follow-up and monitoring

    After completing the treatment phases, regular follow-up appointments are scheduled to monitor the progression of the disease and assess the effectiveness of the treatment.

    These appointments may include imaging tests and evaluations of respiratory function to ensure the treatment is working as intended.

Who can join the trial?

18 criteria

  • Patients must have signed and dated a written informed consent form approved by the appropriate review board. This must be done before any study-related procedures that are not part of regular care.
  • Patients must have proper kidney and liver function, which includes:
    • Estimated creatinine clearance of at least 45 ml/min (a measure of kidney function).
    • Bilirubin levels no more than 1.5 times the upper limit of normal (a measure of liver function).
    • AST and ALT levels no more than 3 times the upper limit of normal (measures of liver enzymes).
    • Albumin levels of at least 28 g/dl (a protein made by the liver).
    • Participants must have national health insurance coverage.
    • Participants of childbearing potential and sexually active male participants must use an effective method of contraception during the treatment and for 6 months after the last dose.
    • Patients must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests.
    • Patients must be 18 years of age or older.
    • Patients must have a confirmed diagnosis of locally advanced stage IIIA, IIIB, or IIIC non-small cell lung cancer (NSCLC) that cannot be removed by surgery.
    • Patients over 70 years old must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1. Patients under 70 years old must have an ECOG PS of 0 to 1 and a score of at least 3 according to the Charlson comorbidity index, or an ECOG PS of 2.
    • Patients must be eligible for treatment with a combination of radiation and chemotherapy, as confirmed by a multidisciplinary committee.
    • Patients must have a measurable disease according to RECIST 1.1, which is a standard way to measure how well a cancer treatment works.
    • Patients must have proper lung function, which includes:
      • FEV1 (a measure of lung function) of at least 40% of the expected value.
      • DLCO (a measure of lung capacity) of at least 40%.
      • Patients must have proper bone marrow function, which includes:
        • Absolute neutrophil count (ANC) of at least 1.5 x 109/L (a type of white blood cell).
        • Platelet count of at least 100 x 109/L (cells that help with blood clotting).
        • Hemoglobin level of at least 9 g/dl (a protein in red blood cells that carries oxygen).

Who cannot join the trial?

9 criteria

  • Patients with other types of cancer besides **Non-Small Cell Lung Cancer**.
  • Patients whose cancer can be removed by surgery. **Unresectable** means the cancer cannot be surgically removed.
  • Patients who are not in **stage III** of Non-Small Cell Lung Cancer. **Stage III** means the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medications.
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Investigated drugs

  • Immunochemotherapy

    is a treatment that combines chemotherapy and immunotherapy. Chemotherapy uses drugs to kill cancer cells or stop them from growing, while immunotherapy helps the immune system recognize and attack cancer cells more effectively. This combination aims to enhance the overall effectiveness of cancer treatment.

  • Hypofractionated Radiotherapy

    is a type of radiation therapy where higher doses of radiation are given in fewer sessions. This approach can be more convenient for patients and may reduce the overall treatment time. It is used to target and destroy cancer cells in the body, particularly in cases where surgery is not an option.

What is already known about the treatment

  • Immunochemotherapy

    This treatment is administered intravenously and involves a combination of chemotherapy and immunotherapy. It is currently being studied in clinical trials for its effectiveness in treating unresectable stage III non-small cell lung cancer (NSCLC). The main therapeutic indication is to improve progression-free survival in patients with this type of lung cancer. The mechanism of action involves using chemotherapy to kill cancer cells and immunotherapy to boost the body's immune response against the cancer. It is classified under antineoplastic agents, which are drugs used to treat cancer.

  • Hypofractionated Radiotherapy

    This form of treatment is delivered through external beam radiation and involves giving higher doses of radiation over fewer sessions. It is being evaluated in clinical trials for its potential benefits in treating unresectable stage III non-small cell lung cancer. The primary therapeutic indication is to control tumor growth and improve patient outcomes. The mechanism of action involves damaging the DNA of cancer cells, leading to cell death. It falls under the category of radiation therapy, which is used to treat various types of cancer.

Investigated diseases

Unresectable Stage III Non-Small Cell Lung Cancer – This is a type of lung cancer that cannot be removed through surgery due to its advanced stage. It originates in the tissues of the lung and is characterized by the presence of large cells. In stage III, the cancer has spread to nearby lymph nodes or other parts of the chest. The disease progresses as the cancer cells grow and invade surrounding tissues, potentially affecting breathing and other lung functions. It is typically diagnosed when the tumor is too large or has spread too extensively to be surgically removed. The progression of the disease can vary, but it often involves the gradual worsening of symptoms related to lung function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517316-29-00Protocol codeIFCT-2401 SPORADICEstimated enrolment152 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

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