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Study of subcutaneous nivolumab with ipilimumab and chemotherapy in previously untreated patients with metastatic or recurrent non-small cell lung cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating Non-small cell lung cancer (NSCLC) that has spread to other parts of the body or has come back after previous treatment. The study will test a combination of different medications: nivolumab (given as an injection under the skin), ipilimumab (given through a vein), and chemotherapy drugs including pemetrexed, cisplatin, carboplatin, and paclitaxel.

The main purpose of this research is to understand how the body processes nivolumab when it is given under the skin in two different doses, along with ipilimumab and chemotherapy. The study will look at how the medications work together and how they are processed by the body.

During the study, participants will receive nivolumab as an injection under the skin, while ipilimumab and chemotherapy medications will be given through a vein. The treatment will continue for up to 24 months. Throughout the study, doctors will monitor how participants respond to the treatment and check for any side effects that may occur.

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 cycle

    You will receive a combination of medications through different methods:

    - Nivolumab given as an injection under the skin

    - Ipilimumab given through an intravenous (IV) line

    - Chemotherapy medications (pemetrexed, cisplatin/carboplatin, paclitaxel) given through an IV line

    During this first cycle, blood samples will be taken to measure how the medications are processed by your body

  2. Step 2

    Continued treatment cycles

    Treatment will continue in cycles

    Blood tests will be performed before each new treatment cycle

    Your response to treatment will be monitored through CT or MRI scans

  3. Step 3

    Seventh treatment cycle

    Additional blood samples will be taken before receiving the next dose

    These samples will measure the amount of nivolumab remaining in your body

  4. Step 4

    Monitoring period

    Your health will be monitored for any side effects throughout the treatment

    The monitoring will continue for 100 days after the end of treatment

    Doctors will check for:

    - General side effects

    - Serious health issues related to treatment

    - Immune system reactions

    - Development of antibodies to the medications

  5. Step 5

    Study completion

    The study is expected to continue until October 2028

    Your participation will end after completing the 100-day monitoring period following your last treatment

Who can join the trial?

8 criteria

  • Must be at least 18 years old at the time of signing the consent form
  • Must have confirmed stage IV or recurrent non-small cell lung cancer (cancer that has spread to other parts of the body or has come back)
  • Must not have received any previous systemic treatment (medication that travels through the bloodstream) for advanced or spreading cancer
  • If you had previous treatment combining chemotherapy and radiation for locally advanced cancer, it must have been completed at least 6 months before joining the study
  • If you had chemotherapy for early-stage lung cancer, it must have been completed at least 6 months before joining the study
  • Must have good physical function ability (able to carry out light daily activities) with an ECOG Performance Status of 0 or 1
  • Must have tumors that can be measured by CT scan or MRI according to specific measurement criteria (RECIST 1.1), with imaging done within 28 days before starting the study
  • Both men and women can participate in the study

Who cannot join the trial?

14 criteria

  • People below 18 years of age
  • Pregnant or breastfeeding women
  • People with known active or untreated brain metastases (cancer that has spread to the brain)
  • Patients with active autoimmune disease (when body's immune system attacks healthy cells)
  • People who have received other cancer treatments within 4 weeks before starting this study
  • Patients with serious heart conditions or uncontrolled high blood pressure
  • People with active infections requiring treatment
  • Patients who have had organ transplants
  • People currently participating in other clinical trials
  • Individuals with known allergies to the study medications
  • Patients with severe liver or kidney problems
  • People with conditions that might interfere with study procedures or evaluation
  • Patients taking medications that could interact with the study drugs
  • People unable to follow study instructions or attend scheduled visits
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Investigated drugs

Nivolumab is a medication used to treat certain types of cancer. It works by helping your immune system fight cancer cells. In this trial, it is given as an injection under the skin (subcutaneously). Ipilimumab is another cancer treatment that helps activate your immune system to fight cancer cells. In this trial, it is administered through an intravenous (IV) infusion, which means it goes directly into your bloodstream through a vein. This trial also includes chemotherapy treatment, which uses medications to kill cancer cells or stop them from growing. The specific chemotherapy drugs used in this trial are not specified in the source data. These medications are being tested in combination to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) or has come back (recurrent), and hasn't been treated before.

What is already known about the treatment

  • Nivolumab

    A monoclonal antibody medication administered subcutaneously (under the skin) that works as an immunotherapy agent for treating non-small cell lung cancer (NSCLC). It belongs to the class of PD-1 inhibitors that help the immune system fight cancer cells by blocking proteins that prevent T-cells from attacking the cancer. The medication is typically used in combination with other cancer treatments, including chemotherapy and ipilimumab, to enhance therapeutic outcomes in metastatic or recurrent NSCLC patients.

  • Ipilimumab

    An intravenously administered immunotherapy medication that works by targeting CTLA-4, a protein that helps regulate immune system responses. It belongs to the class of immune checkpoint inhibitors and is used in combination with nivolumab and chemotherapy for treating advanced non-small cell lung cancer. The medication works by helping to activate and multiply T-cells, enhancing the body's natural ability to fight cancer cells through immune system stimulation.

Investigated diseases

Non-small cell lung cancer (NSCLC) - A type of lung cancer that develops in the cells lining the airways of the lungs. It begins when healthy cells in the lung change and grow out of control, forming a mass called a tumor. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease usually starts in the flat cells that line the airways (squamous cells) or in the cells that produce mucus (adenocarcinoma). As the cancer grows, it can spread to nearby lymph nodes and other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520108-25-00Protocol codeCA209-1533Estimated enrolment76 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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