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Study on Continuing Nivolumab and Ipilimumab Treatment vs. Observation in Patients with Stage IV 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 Non-Small Cell Lung Cancer (NSCLC). The study is investigating the effects of two medications, YERVOY and OPDIVO, which are used together as a treatment. YERVOY contains the active substance ipilimumab, and OPDIVO contains nivolumab. Both medications are given as infusions, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to compare the continuation of treatment with these two medications against simply observing patients after an initial six-month treatment period. This is done to see if continuing the treatment provides better outcomes for patients with stage IV NSCLC, which is an advanced form of lung cancer. The study aims to understand if continuing the treatment helps in delaying the progression of the disease.

Participants in the study will first receive a combination of YERVOY and OPDIVO for six months. After this initial treatment, some participants will continue receiving the medications, while others will be observed without further treatment. The study will monitor the participants' health and the progression of their cancer over time. The goal is to determine the best approach for managing this type of lung cancer and to improve the quality of life and survival rates for patients.

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 phase

    The initial treatment phase involves the administration of two medications: nivolumab and ipilimumab. These medications are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.

    During this phase, the patient receives nivolumab at a concentration of 10 mg/mL and ipilimumab at a concentration of 5 mg/mL. The specific dosage and frequency of administration are determined by the healthcare provider based on individual patient needs.

    This phase lasts for a period of six months, during which the patient's response to the treatment is closely monitored.

  2. Step 2

    Randomization and observation

    After completing the initial six-month treatment phase, the patient enters the randomization stage. This involves being assigned to one of two groups: continuation of the immunotherapy or observation without further treatment.

    The decision on which group the patient is placed in is made randomly to ensure unbiased results in the study.

  3. Step 3

    Continuation phase (if applicable)

    If assigned to the continuation group, the patient continues to receive nivolumab and ipilimumab infusions. The frequency and dosage remain consistent with the initial treatment phase.

    The continuation phase lasts until there is evidence of disease progression or the patient experiences significant side effects that require discontinuation of the treatment.

  4. Step 4

    Observation phase (if applicable)

    If assigned to the observation group, the patient does not receive further treatment with nivolumab and ipilimumab.

    The patient's health and disease status are monitored regularly to track any changes or progression.

  5. Step 5

    Follow-up and monitoring

    Throughout the trial, regular follow-up visits are scheduled to assess the patient's health, monitor for any side effects, and evaluate the effectiveness of the treatment.

    These visits may include physical examinations, imaging tests such as CT or MRI scans, and laboratory tests to measure various health indicators.

Who can join the trial?

20 criteria

  • Must have signed a written consent form agreeing to participate in the study and follow the study's schedule and tests.
  • Must have available tumor samples for a specific test called PD-L1 immunohistochemistry analysis.
  • Must have a certain level of PD-L1 in the tumor, as determined by the study center.
  • Must have adequate biological functions, which include:
    • Creatinine Clearance (a measure of kidney function) of at least 50 mL/min.
    • Neutrophils (a type of white blood cell) of at least 1500/mm3.
    • Platelets (cells that help with blood clotting) of at least 100,000/mm3.
    • Hemoglobin (a protein in red blood cells) of at least 9g/dL.
    • AST and ALT (liver enzymes) less than 3 times the upper limit of normal, unless there are specific conditions like Gilbert syndrome or liver metastases.
    • Total bilirubin (a substance made by the liver) of 1.5 times the upper limit of normal, with exceptions for certain conditions.
    • Women who can have children and are sexually active must use effective birth control 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 drug.
    • Men who are sexually active with women who can have children must use effective birth control during the treatment and for 7 months after the last dose.
    • Inclusion in the study must be confirmed by a team of different specialists.
    • Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC), either squamous or non-squamous type.
    • Must have Stage IV disease, which means the cancer has spread to other parts of the body.
    • Must have an ECOG Performance Status of 0 or 1, which means the patient is fully active or has some symptoms but can still do light work.
    • Must not have lost more than 10% of body weight in the last 3 months.
    • Must not have received any previous systemic cancer treatment 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 using specific criteria.

Who cannot join the trial?

10 criteria

  • Patients who do not have non-small cell lung cancer cannot participate. This is a type of lung cancer that is different from small cell lung cancer.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may involve treatments that could affect the baby.
  • Patients who have other serious health conditions that could interfere with the study or make it unsafe for them to participate cannot join.
  • Patients who are currently participating in another clinical trial cannot join this study, as it could affect the results.
  • Patients who have had certain treatments recently, such as chemotherapy or radiation, may not be eligible to participate.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who have a history of certain medical conditions, such as severe heart disease, may not be eligible to participate.
  • Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, cannot join the study.
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Investigated drugs

  • Nivolumab

    is a type of immunotherapy used to treat certain types of cancer, including non-small cell lung cancer. It works by helping the immune system recognize and attack cancer cells more effectively.

  • Ipilimumab

    is another immunotherapy medication that is often used in combination with other treatments like Nivolumab. It helps to boost the immune system's response against cancer cells, making it harder for the cancer to grow and spread.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently used in the treatment of various cancers, including non-small cell lung cancer, and is well-documented in medical literature. The main therapeutic indication for Nivolumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking the PD-1 protein on immune cells, preventing cancer cells from evading immune detection. Nivolumab is classified as an immune checkpoint inhibitor.

  • Ipilimumab

    Ipilimumab is also administered via intravenous infusion in a healthcare facility. It is used in combination with other medications for the treatment of certain types of cancer, such as non-small cell lung cancer, and is supported by extensive research. The primary therapeutic use of Ipilimumab is to enhance the immune system's ability to fight cancer. It functions by targeting the CTLA-4 protein on T-cells, boosting the immune response against cancer cells. Ipilimumab is categorized as an immune checkpoint inhibitor.

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 form of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. It often progresses slowly compared to small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease advances, it may lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514586-20-01Protocol codeIFCT-1701Estimated enrolment1 360 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

sourced from the EU Clinical Trials Register and site verification

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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).