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Study Comparing Nivolumab and Relatlimab with Chemotherapy to Pembrolizumab with Chemotherapy for Advanced Non-Small Cell Lung Cancer Patients

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 clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC), specifically in its advanced stages, either stage IV or when it has returned after treatment. The study aims to compare two different treatment approaches to see which one helps patients live longer. One group of participants will receive a combination of two medications, nivolumab and relatlimab, along with chemotherapy. The other group will receive pembrolizumab with chemotherapy. These treatments are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The main goal of the study is to determine if the combination of nivolumab and relatlimab with chemotherapy is more effective in extending the lives of patients compared to pembrolizumab with chemotherapy. The study will also look at other factors, such as how long the cancer stays under control and the overall response to the treatments. Participants will be monitored for any side effects from the medications.

The study will take place over several years, with the estimated completion date in 2027. Participants will be randomly assigned to one of the two treatment groups and will receive their assigned treatment as part of the study. The results will help determine the best first-line treatment option for people with this type of lung cancer.

The research process

The trial runs in 6 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, participants will be assigned to one of two groups. Each group will receive a different combination of medications to treat non-small cell lung cancer (NSCLC).

  2. Step 2

    Treatment group assignment

    Participants will be randomly assigned to either Arm A or Arm B. This assignment determines the specific treatment regimen to be followed.

  3. Step 3

    Treatment in arm a

    Participants in Arm A will receive a combination of nivolumab and relatlimab along with chemotherapy. The chemotherapy may include drugs such as pemetrexed disodium, cisplatin, or carboplatin.

    All medications will be administered through an intravenous infusion, which means they will be given directly into a vein. The specific dosage and frequency will be determined by the study team.

  4. Step 4

    Treatment in arm b

    Participants in Arm B will receive pembrolizumab along with chemotherapy. The chemotherapy may include drugs such as pemetrexed disodium, cisplatin, or carboplatin.

    All medications will be administered through an intravenous infusion. The specific dosage and frequency will be determined by the study team.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, participants will undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects. This will include medical examinations, blood tests, and imaging scans such as CT or MRI.

    Participants will be required to attend scheduled visits as determined by the study team.

  6. Step 6

    End of study participation

    The study is expected to continue until May 2027. Participants will be informed about the end of their participation and any necessary follow-up care.

    The main goal of the study is to compare the overall survival of participants in Arm A and Arm B.

Who can join the trial?

7 criteria

  • Participants must be men or women who are 18 years or older.
  • They must have a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is either in stage IV or has come back after treatment.
  • This type of cancer must not have been treated with any other cancer drugs before.
  • The cancer cells must have a certain amount of a protein called PD-L1, which will be checked in a lab before the study starts.
  • The cancer must be visible on a CT or MRI scan, and these scans must be done within 32 days before receiving study treatment.
  • Participants should be generally healthy, with a score of 1 or less on a scale that measures how well they can do their daily activities.
  • They should also be expected to live for at least 3 months from the start of the study.

Who cannot join the trial?

3 criteria

  • Patients with a type of lung cancer that is not non-squamous (NSQ) Stage IV or Recurrent Non-small Cell Lung Cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.
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Investigated drugs

  • Nivolumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this study, it is used in combination with another medication to see if it can help people with a specific type of lung cancer live longer.

  • Relatlimab

    is another immune checkpoint inhibitor. It is used together with nivolumab in a fixed-dose combination. This means both medications are given together in a single treatment. The goal is to enhance the immune system's ability to fight cancer cells in people with lung cancer.

  • Pembrolizumab

    is also an immune checkpoint inhibitor. It helps the immune system target and destroy cancer cells. In this study, it is used alongside chemotherapy to see how well it works compared to the combination of nivolumab and relatlimab with chemotherapy.

What is already known about the treatment

  • Nivolumab + Relatlimab Fixed-dose Combination

    This medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials as a potential treatment for a type of lung cancer known as non-squamous, Stage IV or recurrent non-small cell lung cancer. The main goal of this combination is to help patients live longer by enhancing the body's immune response against cancer cells. Nivolumab and relatlimab work together by blocking certain proteins that usually help cancer cells hide from the immune system, allowing the immune system to better detect and attack the cancer. This combination is classified as an immunotherapy, which is a type of treatment that uses the body's own immune system to fight cancer.

  • Pembrolizumab

    This medication is also given through an intravenous infusion and is currently used in clinical trials as a treatment for non-squamous, Stage IV or recurrent non-small cell lung cancer. Pembrolizumab is designed to help the immune system recognize and destroy cancer cells by blocking a specific protein that prevents the immune system from attacking the cancer. This medication is part of a class of drugs known as immune checkpoint inhibitors, which are a type of immunotherapy aimed at boosting the body's natural defenses to fight cancer.

Investigated diseases

Non-squamous Stage IV or Recurrent Non-small Cell Lung Cancer – This type of lung cancer originates in the tissues of the lung, specifically in cells that are not squamous cells. It is classified as Stage IV when it has spread beyond the lungs to other parts of the body, such as the brain, bones, or liver. Recurrent non-small cell lung cancer refers to cancer that has returned after treatment. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with normal lung function. As it advances, it can cause symptoms like persistent cough, chest pain, and difficulty breathing. The spread to other organs can lead to additional symptoms depending on the affected area.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513682-40-01Protocol codeCA2241093Estimated enrolment1 000 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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