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Study Comparing Nivolumab and Ipilimumab with Chemotherapy to Chemotherapy Alone for 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 treatments for Stage IV Non-Small Cell Lung Cancer (NSCLC). The study is comparing the effectiveness of a combination of two medications, nivolumab and ipilimumab, along with chemotherapy, against chemotherapy alone. Nivolumab and ipilimumab are types of medications known as immunotherapies, which help the body's immune system fight cancer. Chemotherapy is a common cancer treatment that uses drugs to kill cancer cells.

The purpose of this study is to see if the combination of nivolumab and ipilimumab with chemotherapy is more effective than chemotherapy alone for patients with Stage IV NSCLC. Participants in the study will receive either the combination treatment or chemotherapy by itself. The study will monitor the participants over time to assess the effectiveness of the treatments in terms of survival and response to the therapy.

Throughout the study, participants will receive their treatments through an intravenous (IV) infusion, which means the medication is given directly into a vein. The study aims to provide valuable information on whether adding nivolumab and ipilimumab to chemotherapy can improve outcomes for patients with advanced lung cancer. The trial is expected to continue until 2025, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatment combinations.

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

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose, which is to compare the effectiveness of a combination of medications with standard chemotherapy in treating stage IV non-small cell lung cancer.

    The patient will be required to provide consent to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes a pregnancy test for women of childbearing potential and discussions about contraception requirements for both men and women during and after the treatment period.

  3. Step 3

    Treatment phase

    The treatment phase involves receiving medications through intravenous infusion. The medications include nivolumab, ipilimumab, and chemotherapy drugs such as paclitaxel, cisplatin, carboplatin, and pemetrexed.

    The specific combination and schedule of these medications will be determined by the study protocol. The patient will receive these treatments as part of the study's regimen.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient's health and response to treatment will be closely monitored. This includes regular check-ups and assessments to evaluate the effectiveness of the treatment and any side effects.

    The study aims to measure outcomes such as overall survival and progression-free survival.

  5. Step 5

    Completion of the study

    Upon completion of the treatment phase, the patient will undergo a final assessment to gather data on the treatment's impact.

    The study is expected to conclude by December 2025, at which point the collected data will be analyzed to determine the efficacy of the treatment combinations.

Who can join the trial?

6 criteria

  • Participants must have **Stage IV Non-Small Cell Lung Cancer (NSCLC)**. This means the cancer has spread to other parts of the body.
  • Women who can have children must have a negative pregnancy test before starting the study medication. This test checks for a hormone called **human chorionic gonadotropin (HCG)**, which is present during pregnancy.
  • Women who can have children must agree to use birth control while taking the study medication and for 5 months after the last dose. This is to prevent pregnancy during the study.
  • Men who are sexually active with women who can have children must agree to use birth control while taking the study medication and for 7 months after the last dose. This is to prevent pregnancy during the study.
  • Both men and women can participate in the study.
  • The study includes people who are considered a vulnerable population, meaning they may need extra protection or care.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer other than Stage IV Non-Small Cell Lung Cancer (NSCLC) cannot participate. Stage IV means the cancer has spread to other parts of the body.
  • Patients who have not had their cancer confirmed by a test called a histological test cannot participate. This test checks the tissue under a microscope to confirm the type of cancer.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is not detailed here, but it is a requirement for the study.
  • Patients who are not male or female cannot participate, as the study includes both genders.
  • Patients who are considered part of a vulnerable population cannot participate. This term refers to groups who may need special protection, like children or those unable to give consent.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to help the immune system attack cancer cells. It works by blocking a protein that prevents the immune system from effectively targeting and destroying cancer cells.

  • Ipilimumab

    is another medication used in combination with nivolumab. It also helps the immune system fight cancer by blocking a different protein that can stop the immune system from working properly against cancer cells.

  • Chemotherapy

    is a standard cancer treatment that uses drugs to kill or stop the growth of cancer cells. In this trial, chemotherapy is used both alone and in combination with nivolumab and ipilimumab to treat patients with stage IV non-small cell lung cancer.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently approved and widely used in the treatment of various cancers, including advanced non-small cell lung cancer (NSCLC). The main therapeutic indication for nivolumab is to enhance the immune system's ability to fight cancer cells. It works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Nivolumab is classified as an immune checkpoint inhibitor.

  • Ipilimumab

    Ipilimumab is also administered through an intravenous infusion, usually in a healthcare facility. It is approved for use in treating certain types of cancer, including melanoma and, in combination with other drugs, advanced non-small cell lung cancer (NSCLC). The primary therapeutic use of ipilimumab is to stimulate the immune system to attack cancer cells. It functions by blocking CTLA-4, a protein on T-cells, thereby enhancing the immune response against cancer. Ipilimumab is categorized as an immune checkpoint inhibitor.

Investigated diseases

Stage IV Non-Small Cell Lung Cancer (NSCLC) – This is an advanced form of lung cancer where the disease has spread beyond the lungs to other parts of the body. It originates from the epithelial cells lining the lungs and is characterized by uncontrolled cell growth. As the disease progresses, it can invade nearby tissues and organs, leading to symptoms such as persistent cough, chest pain, and difficulty breathing. The spread of cancer cells, known as metastasis, often affects the brain, bones, liver, and adrenal glands. This stage of NSCLC is typically diagnosed through imaging tests and biopsy, revealing the extent of the disease. The progression of Stage IV NSCLC can vary, with some patients experiencing rapid advancement while others may have a slower disease course.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508757-75-00Protocol codeCA209-9LAEstimated enrolment840 patientsSponsorBristol Myers Squibb International Corporation

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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).