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Study of BMS-986012, carboplatin, etoposide and nivolumab combination as first treatment for 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 studies a combination treatment for Extensive-stage Small Cell Lung Cancer. The study tests a new treatment approach that combines several medications: BMS-986012 (an experimental antibody), carboplatin, etoposide, and nivolumab. The purpose is to evaluate how safe and effective this combination therapy is compared to standard treatment.

The study involves two different treatment approaches. One group of patients receives all four medications (BMS-986012, carboplatin, etoposide, and nivolumab) for the first part of treatment, followed by continued treatment with BMS-986012 and nivolumab. The other group receives only carboplatin, etoposide, and nivolumab initially, followed by nivolumab alone.

During the study, patients will undergo regular medical examinations and imaging tests such as computed tomography or magnetic resonance imaging to monitor how well the treatment is working. The researchers will track how the cancer responds to treatment and monitor any side effects that may occur. The study will also measure how long patients live without their cancer getting worse and their overall survival time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase - Induction therapy

    You will be randomly assigned to one of two treatment groups (Arm A or Arm B)

    The induction phase consists of 4 treatment cycles with the following medications:

    Arm A receives: carboplatin, etoposide, nivolumab, and BMS-986012 - all given as intravenous infusions

    Arm B receives: carboplatin, etoposide, and nivolumab - all given as intravenous infusions

  2. Step 2

    Maintenance treatment phase

    After completing the 4 cycles of induction therapy, you will continue with maintenance treatment:

    Arm A continues with: BMS-986012 and nivolumab infusions

    Arm B continues with: nivolumab infusions only

  3. Step 3

    Monitoring and evaluation

    Your condition will be monitored through regular imaging scans (CT or MRI)

    Healthcare providers will track any side effects or reactions to the treatment

    Treatment response will be evaluated using standardized criteria (RECIST v1.1)

    Blood tests will be performed to check your body's response to the medications

  4. Step 4

    Study duration

    The study continues from March 2021 to December 2026

    Your participation duration will depend on how your body responds to the treatment

    Regular assessments will determine if you should continue with the treatment

Who can join the trial?

6 criteria

  • Must be an adult aged 18 years or older
  • Must have a good physical condition, measured by ECOG performance status of 0 or 1 (meaning able to perform all or most daily activities without assistance)
  • Must have at least one tumor that can be measured using CT scan (detailed X-ray imaging) or MRI (magnetic imaging) according to specific measurement criteria called RECIST v1.1
  • Must have adequate blood cell counts and proper functioning of vital organs (such as liver and kidneys)
  • Must be willing and able to use effective birth control methods during the study if capable of having children
  • Both men and women may participate in the study

Who cannot join the trial?

12 criteria

  • History of previous treatments with anti-cancer therapy for extensive-stage small cell lung cancer
  • Active brain metastases (cancer spread to the brain) or spinal cord compression that is not fully treated
  • Other types of cancer within the last 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Serious heart conditions in the past 6 months, including heart attack, unstable angina, or heart failure
  • Active autoimmune disease that requires systemic treatment
  • History of organ transplantation
  • Previous severe allergic reactions to study medications or similar compounds
  • Pregnancy or breastfeeding
  • Any condition that, in the investigator's opinion, would interfere with the safety of the participant
  • Unable to give informed consent or follow study procedures
  • Current participation in another clinical trial
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Investigated drugs

  • BMS-986012

    is an investigational medication being studied for the treatment of small cell lung cancer. It is being tested in combination with other cancer medications as a first-line treatment.

  • Carboplatin

    is a chemotherapy medication commonly used to treat various types of cancer. It works by interfering with cancer cell growth and division.

  • Etoposide

    is another chemotherapy medication that works by blocking an enzyme needed for cancer cell growth. It is often used in combination with other cancer treatments.

  • Nivolumab

    is an immunotherapy medication that helps the body's immune system recognize and fight cancer cells. It works by blocking a protein that prevents T-cells (immune cells) from attacking cancer cells.

What is already known about the treatment

  • BMS-986012

    An investigational monoclonal antibody being studied in clinical trials for the treatment of extensive-stage small cell lung cancer. It is administered intravenously in combination with carboplatin, etoposide, and nivolumab as first-line therapy. The medication is currently in Phase II clinical trials to evaluate its safety, tolerability, and effectiveness in cancer treatment.

  • Carboplatin

    A platinum-based chemotherapy drug administered intravenously to treat various types of cancer, including small cell lung cancer. It works by interfering with DNA replication in cancer cells, preventing them from dividing and growing. This medication belongs to the alkylating agents class of chemotherapy drugs and is commonly used in combination therapy protocols.

  • Etoposide

    A chemotherapy medication given intravenously that works by blocking an enzyme necessary for cancer cell DNA repair. It belongs to the topoisomerase inhibitor class of drugs and is commonly used in combination with other medications to treat small cell lung cancer. The drug interferes with the cancer cells' ability to divide and multiply.

  • Nivolumab

    An immunotherapy drug administered through intravenous infusion that helps the immune system fight cancer cells. It works by blocking the PD-1 protein on immune cells, which allows them to better recognize and attack cancer cells. This medication belongs to the class of drugs known as checkpoint inhibitors and is used both in combination therapy and as maintenance treatment.

Investigated diseases

Small Cell Lung Cancer (Extensive Stage) - A fast-growing type of lung cancer that typically starts in the bronchi, the large airways in the center of the chest. It is characterized by small, round cancer cells that form into masses and spread quickly to other parts of the body. In extensive stage, the cancer has spread beyond one lung and nearby lymph nodes to other parts of the body. The disease often develops in people with a history of smoking and can cause symptoms such as persistent cough, chest pain, and difficulty breathing. Small cell lung cancer can spread rapidly to the lymph nodes, liver, bones, brain, and other organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510700-36-00Protocol codeCA001-050Estimated enrolment185 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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