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Study of Relatlimab and Nivolumab with Chemotherapy for Patients with Stage IV 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 trial involves adults with advanced Non-small Cell Lung Cancer, meaning the cancer has spread beyond the lungs or has returned after earlier treatment. The study is testing whether adding the immune‑targeting drug relatlimab to the already approved immunotherapy drug nivolumab and standard chemotherapy can improve how well the disease is controlled.

Participants are randomly assigned to receive either the two‑drug combination plus chemotherapy or the standard immunotherapy drug plus chemotherapy. The chemotherapy may include drugs such as cisplatin, carboplatin, paclitaxel, paclitaxel albumin-bound or pemetrexed disodium. Treatments are given by intravenous infusion, usually once every three weeks, for several cycles, followed by regular check‑ups to monitor health and any side effects.

The main goal is to determine whether the addition of relatlimab leads to a higher response rate and acceptable safety compared with the standard regimen. Throughout the study, doctors will watch for any serious side effects that might require stopping the medication, and will track how the cancer responds over time.

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 treatment begins with the administration of nivolumab and relatlimab through an intravenous infusion. The dosage of relatlimab is either 360 mg or 720 mg, depending on the specific group assignment.

    This phase also includes chemotherapy, which may involve drugs such as cisplatin, pemetrexed disodium, paclitaxel, carboplatin, or paclitaxel albumin-bound. These medications are administered via intravenous infusion as well.

  2. Step 2

    Monitoring and assessment

    Regular monitoring is conducted to evaluate the body's response to the treatment. This includes imaging tests like computed tomography (CT) or magnetic resonance imaging (MRI) to measure the size of the tumor.

    The assessment follows the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, which helps in determining the effectiveness of the treatment.

  3. Step 3

    Continuation or adjustment of treatment

    Based on the initial response and any side effects experienced, the treatment plan may be continued or adjusted. This decision is made to optimize the effectiveness of the therapy while minimizing adverse effects.

    The primary goal is to evaluate the occurrence of treatment-related adverse events (TRAEs) that might lead to discontinuation within the first 12 weeks.

  4. Step 4

    Ongoing evaluation

    Throughout the trial, ongoing evaluations are conducted to monitor the overall response rate (ORR) and progression-free survival (PFS) using the RECIST criteria.

    These evaluations help in understanding the long-term benefits and risks associated with the treatment regimen.

  5. Step 5

    Completion of trial

    The trial is estimated to conclude by July 2025. At the end of the trial, a comprehensive analysis of the data collected will be performed to determine the overall efficacy and safety of the treatment combinations.

Who can join the trial?

8 criteria

  • Participants must be males or females who are 18 years or older.
  • Participants must have non-small cell lung cancer (NSCLC) that is metastatic (spread to other parts of the body) or has come back after treatment for locally advanced disease. The cancer can be of squamous or non-squamous type.
  • The disease must be measurable using imaging tests like CT scans or MRI. These tests should be done within 28 days before joining the study.
  • Participants should not have received any systemic anti-cancer treatment as the main therapy for advanced or metastatic disease.
  • Participants must have an ECOG performance status of 1 or less. This is a scale that measures how well a person can perform daily activities.
  • Participants should have a life expectancy of at least 3 months at the time of the first dose.
  • A tissue sample from a previous biopsy or surgery must be available. This sample should be sent to a central laboratory for testing.
  • Participants must have results from a PD-L1 immunohistochemistry (IHC) test from a central laboratory during the screening period before joining the study. This test checks for a specific protein in the cancer cells.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer other than Non-Small Cell Lung Cancer cannot participate. This type of cancer affects the lungs and is not the same as other lung cancers.
  • Patients who have not been diagnosed with Stage IV or recurrent Non-Small Cell Lung Cancer are excluded. Stage IV means the cancer has spread to other parts of the body, and recurrent means it has come back after treatment.
  • Patients who are not able to safely receive the study medications, such as nivolumab or relatlimab, are not eligible. These are specific drugs used in the study.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or attend the required visits are excluded. This means they need to be able to come to appointments and follow instructions.
  • Patients who are part of a vulnerable population that the study cannot safely include are not eligible. This means people who might be at higher risk for complications.
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Investigated drugs

  • Relatlimab

    is an experimental medication being studied for its potential to help the immune system fight cancer. It is being tested in combination with other treatments to see if it can improve outcomes for patients with advanced or recurrent non-small cell lung cancer.

  • Nivolumab

    is a medication that helps the immune system attack cancer cells. It is used in this study to see if it can be more effective when combined with other treatments for patients with advanced or recurrent non-small cell lung cancer.

  • Chemotherapy

    is a type of cancer treatment that uses drugs to kill cancer cells. In this study, it is used in combination with other medications to see if it can improve treatment outcomes for patients with advanced or recurrent non-small cell lung cancer.

What is already known about the treatment

  • Relatlimab

    Relatlimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer. It is often used in combination with other medications, such as nivolumab, to enhance its therapeutic effects. Relatlimab works by targeting and inhibiting specific proteins on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps to boost the body's natural defenses against cancer.

  • Nivolumab

    Nivolumab is given through an intravenous infusion and is widely recognized in medical literature as a treatment for various types of cancer, including non-small cell lung cancer. It is used to help the immune system fight cancer by blocking a protein that prevents immune cells from attacking cancer cells. Nivolumab is also classified as an immune checkpoint inhibitor, and it is often used in combination with other drugs to improve treatment outcomes.

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 type 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. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. Early stages may not show significant symptoms, making it challenging to detect without medical screening.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508372-10-00Protocol codeCA224-104Estimated enrolment463 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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