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Study on Maintenance Treatment with Pembrolizumab and Pemetrexed for Stage IV Non-Small Cell Lung Cancer Patients After Initial Chemotherapy and Immunotherapy

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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 treatments for stage IV Non-Small Cell Lung Cancer (NSCLC), a type of lung cancer that has spread to other parts of the body. The study is evaluating the effectiveness of a medication called pembrolizumab, which is also known by the brand name Keytruda. Pembrolizumab is a type of immunotherapy, which means it helps the body's immune system fight cancer. In this trial, pembrolizumab may be used alone or in combination with another medication called pemetrexed, which is a chemotherapy drug. The study will also compare these treatments to a placebo, which is a substance with no active medication, to see how well they work in controlling the disease.

The purpose of the study is to determine how effective pembrolizumab is when used as a maintenance treatment after an initial six months of chemotherapy combined with pembrolizumab. The chemotherapy used in the initial treatment includes drugs like carboplatin, cisplatin, and paclitaxel, which are common medications used to treat various cancers. The study will observe patients to see if continuing pembrolizumab helps in maintaining disease control compared to stopping treatment after the initial phase.

Participants in the study will receive treatment through infusions, which means the medication is given directly into the bloodstream. The study will last for several months, and patients will be monitored regularly to assess their response to the treatment. The goal is to find out if pembrolizumab can help patients live longer and maintain a better quality of life compared to those who do not continue with the treatment after the initial phase. The study will also look at how the treatment affects different subtypes of NSCLC, such as squamous and non-squamous cell carcinoma, and how it relates to specific tumor characteristics like PD-L1 expression, which is a protein that can affect how the immune system responds to 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

    Upon joining the study, the initial treatment phase begins. This phase involves a combination of medications administered through an infusion. The medications include pemetrexed, carboplatin, paclitaxel, cisplatin, and pembrolizumab. These medications are given to help control the cancer.

    The treatment is administered over a period of six months. During this time, the patient will receive these medications at regular intervals as determined by the study protocol.

  2. Step 2

    Maintenance phase

    After completing the initial six-month treatment phase, the patient enters the maintenance phase. In this phase, the patient may continue to receive pembrolizumab with or without pemetrexed, depending on the type of lung cancer.

    The maintenance treatment continues until the cancer progresses or the patient experiences significant side effects. Alternatively, the patient may be placed under observation without receiving further treatment, depending on the study's randomization process.

  3. Step 3

    Regular monitoring

    Throughout the trial, the patient will undergo regular monitoring. This includes scheduled visits to the clinic for health assessments, laboratory tests, and imaging studies such as CT or MRI scans to evaluate the cancer's response to treatment.

    The monitoring helps ensure the patient's safety and allows the study team to track the effectiveness of the treatment.

  4. Step 4

    End of trial participation

    The trial participation concludes when the patient completes the treatment protocol, the cancer progresses, or the patient decides to withdraw from the study.

    At the end of the trial, the patient will have a final assessment to evaluate their overall health and the outcomes of the treatment received during the study.

Who can join the trial?

19 criteria

  • Must have signed a written informed consent form, agreeing to participate in the study and follow the study procedures.
  • Must have a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC), which means the cancer has spread to other parts of the body.
  • Must have a PD-L1 tumor content assessment, which is a test to check for a specific protein in the cancer cells.
  • Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, indicating the ability to carry out daily activities with little or no assistance.
  • Must not have lost more than 10% of body weight in the last 3 months.
  • Must not have received any prior systemic anticancer therapy for advanced or metastatic disease.
  • Must be between 18 and 74 years old.
  • Must have a life expectancy of more than 3 months.
  • Must have measurable tumor disease as determined by a CT or MRI scan, following specific criteria.
  • Must have adequate tumor tissue available for analysis. This means having enough cancer tissue from a biopsy for testing.
  • Must have adequate biological functions, including:
    • Creatinine Clearance of at least 45 mL/min, which is a measure of kidney function.
    • Neutrophils count of at least 1500/mm3, which are a type of white blood cell important for fighting infections.
    • Platelets count of at least 100,000/mm3, which are cells that help with blood clotting.
    • Hemoglobin level of at least 9g/dL, which is a protein in red blood cells that carries oxygen.
    • AST and ALT levels less than 3 times the upper limit of normal, which are liver enzymes.
    • Total bilirubin level less than 2 times the upper limit of normal, which is a substance made by the liver.
    • Women of childbearing potential must use effective contraception starting 28 days before the first dose and continuing for 6 months after the last dose. They must also have a negative pregnancy test before starting the study.
    • Men who are sexually active with women of childbearing potential must use effective contraception during the study and for 6 months after the last dose.
    • Must have national health insurance coverage.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than non-small cell lung cancer.
  • Patients who have not completed a 6-month induction treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who are pregnant or breastfeeding.
  • Patients who have another serious medical condition that might interfere with the study.
  • Patients who are taking medications that might interfere with the study treatment.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a known allergy to the study medication.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy used in this clinical trial. It works by helping your immune system recognize and attack cancer cells. In this study, pembrolizumab is given to patients with stage IV Non-Small Cell Lung Cancer (NSCLC) who have already received an initial treatment with chemotherapy and pembrolizumab. The goal is to see if continuing pembrolizumab can help control the cancer for a longer period.

  • Pemetrexed

    is a chemotherapy drug used in this trial for patients with non-squamous Non-Small Cell Lung Cancer (NSCLC). It works by interfering with the growth of cancer cells, slowing down or stopping their spread. In this study, pemetrexed may be given alongside pembrolizumab or during the observation period to see if it helps maintain control over the cancer after the initial treatment phase.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating stage IV non-small cell lung cancer (NSCLC) after initial treatment with chemotherapy and immunotherapy. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on immune cells, which helps the immune system to better detect and fight cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can invade nearby tissues and spread to other parts of the body, a process known as metastasis. NSCLC often grows and spreads more slowly than small cell lung cancer, which is another major type of lung cancer. The progression of NSCLC can vary depending on the subtype and other factors, such as genetic mutations and environmental influences. Early stages may not show symptoms, but as it advances, symptoms like persistent cough, chest pain, and difficulty breathing may occur.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-515945-40-00Protocol codeIFCT-2103Estimated enrolment1 250 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).