Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Relatlimab and Nivolumab with Chemotherapy for Patients with Stage IV or Recurrent Non-Small Cell Lung Cancer

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 , which is a type of lung cancer. The study involves two main treatments: and , both of which are given through an intravenous infusion, meaning they are delivered directly into the bloodstream. These treatments are being tested in combination with various chemotherapy drugs, including , , , , and . The purpose of the study is to compare the effectiveness of Relatlimab plus Nivolumab with chemotherapy against Nivolumab with chemotherapy in patients with advanced or recurrent NSCLC.

Participants in the study will receive either the combination of Relatlimab and Nivolumab with chemotherapy or Nivolumab with chemotherapy. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment each participant is receiving. This helps ensure that the results are not biased. The study will take place over a period of time, with regular monitoring to assess the safety and effectiveness of the treatments. Participants will be closely observed for any side effects or changes in their condition.

The study aims to provide valuable information on how these treatments work together and their potential benefits for people with stage IV or recurrent NSCLC. By participating, individuals contribute to research that may improve future treatment options for this type of lung cancer. The trial will help determine if the combination of Relatlimab and Nivolumab with chemotherapy offers a better outcome compared to the current standard treatment of Nivolumab with chemotherapy.

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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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 7 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

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.