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Study Comparing BMS-986489 with Chemotherapy to Atezolizumab with Chemotherapy for First-Line Treatment in Patients with Extensive-Stage 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 clinical trial is focused on studying a type of lung cancer known as Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The study aims to compare two different treatment combinations to see which one helps patients live longer. One group of participants will receive a combination of BMS-986489 (a fixed dose combination of BMS-986012 and nivolumab) along with chemotherapy drugs carboplatin and etoposide. The other group will receive atezolizumab with the same chemotherapy drugs.

The purpose of this study is to determine if the combination of BMS-986489 with chemotherapy is more effective than atezolizumab with chemotherapy in treating ES-SCLC. Participants will be randomly assigned to one of the two treatment groups. The study will monitor how long participants live after starting the treatment, as well as other factors like how long it takes for symptoms to worsen, the safety of the treatments, and how well the tumors respond to the treatments.

Throughout the study, participants will receive their treatments through an intravenous (IV) infusion, which means the medicine will be given directly into a vein. The study will continue until the estimated end date in 2031, with the goal of providing valuable information on the effectiveness and safety of these treatment combinations for people with ES-SCLC.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm the diagnosis of extensive-stage small cell lung cancer (ES-SCLC).

    Eligibility is determined based on the ability to perform normal activities with little or no help, as assessed by the ECOG performance scale.

    At least one tumor must be measurable using imaging techniques like a CT scan or MRI, excluding the brain and nervous system.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups.

    One group receives BMS-986489 (a combination of BMS-986012 and nivolumab) with chemotherapy.

    The other group receives atezolizumab with chemotherapy.

  3. Step 3

    Treatment administration

    Treatment is administered intravenously as a solution for injection.

    The chemotherapy regimen includes carboplatin and etoposide.

    The specific dosage and frequency of administration are determined by the study protocol and medical team.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for overall survival, which is the primary endpoint of the study.

    Secondary endpoints include the time for disease-related symptoms to worsen, safety (including side effects), tumor response, duration of response, and progression-free survival.

    Regular follow-up visits are scheduled to assess these outcomes and ensure participant safety.

  5. Step 5

    Study completion

    The study is estimated to end on August 31, 2031.

    Participants will continue to be monitored until the study's conclusion to gather comprehensive data on the treatment's effectiveness and safety.

Who can join the trial?

4 criteria

  • Must have a diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). This is a type of lung cancer that has spread widely in the body.
  • Must be healthy enough to do normal activities with little or no help. This is based on the ECOG performance scale, which is a way to measure how well a person can perform daily activities.
  • Must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI. These are types of scans that create detailed pictures of the inside of the body. The tumor must be located in a place other than the brain and nervous system.
  • Both men and women can participate in the study.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than Extensive-Stage Small Cell Lung Cancer (ES-SCLC) cannot participate. This is a specific type of lung cancer that has spread widely in the body.
  • Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not eligible for the specific treatment plan being tested in the study cannot participate.
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Investigated drugs

  • BMS-986489

    This is a combination of two medications, BMS-986012 and Nivolumab, used together as a fixed dose. It is being tested to see if it can help people with extensive-stage small cell lung cancer live longer when used with chemotherapy.

  • Carboplatin

    This is a chemotherapy medication that is used to treat various types of cancer, including lung cancer. It works by stopping the growth of cancer cells.

  • Etoposide

    This is another chemotherapy medication used to treat lung cancer. It works by interfering with the DNA of cancer cells, preventing them from dividing and growing.

  • Atezolizumab

    This is an immunotherapy medication that helps the immune system recognize and attack cancer cells. It is used in combination with chemotherapy to treat extensive-stage small cell lung cancer.

What is already known about the treatment

BMS-986489 – This medication is administered as an intravenous infusion, typically in a clinical setting. It is currently being studied in clinical trials for its effectiveness in treating extensive-stage small cell lung cancer (ES-SCLC). The main therapeutic indication is to serve as a first-line treatment for this type of cancer. BMS-986489 works by combining two agents, BMS-986012 and Nivolumab, which together aim to enhance the immune system's ability to target and destroy cancer cells. It falls under the pharmacological classification of immunotherapy, specifically as a combination of a monoclonal antibody and an immune checkpoint inhibitor.

Investigated diseases

Extensive-Stage Small Cell Lung Cancer (ES-SCLC) – This is a type of lung cancer characterized by the rapid growth and spread of cancer cells in the lungs and potentially to other parts of the body. It is called "extensive-stage" because the cancer has spread beyond the lung to other areas, such as the opposite lung, lymph nodes, or distant organs. The disease progresses quickly, often leading to symptoms like coughing, chest pain, and difficulty breathing. As the cancer advances, it may cause additional symptoms related to the areas it has spread to, such as bone pain or neurological issues. The aggressive nature of this cancer means it can change rapidly, requiring close monitoring.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515740-23-00Protocol codeCA245-0001Estimated enrolment530 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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