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A Study of BI 764532, Atezolizumab, Carboplatin, and Etoposide in Patients With Extensive-Stage Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being done in small cell lung cancer, a fast-growing type of lung cancer that has already spread widely. The purpose of the study is to compare a new treatment, obrixtamig (also called BI 764532), given by vein, with the current treatment used first, which includes atezolizumab, carboplatin, and etoposide. Atezolizumab is a medicine that helps the body’s immune system attack cancer cells, carboplatin and etoposide are chemotherapy medicines, and obrixtamig is a new study medicine designed to help immune cells find and attack cancer cells.

In the study, people are randomly assigned to receive either the new treatment combination or the standard treatment combination. The medicines are given as intravenous infusion, which means they are delivered slowly through a vein. Treatment is given in cycles over time, with regular visits for infusions and checks by the study team. The study will look at how long people live and will also follow symptoms and side effects, including breathing problems, chest pain, cough, and treatment-related reactions such as CRS and ICANS. CRS, or cytokine release syndrome, is a strong immune reaction that can cause fever and other symptoms. ICANS, or immune effector cell-associated neurotoxicity syndrome, is a brain and nerve problem that can affect thinking, speech, or alertness.

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

    Starting the study treatment

    After you join the study, you are assigned by chance to one of the study treatment groups. The study compares two treatment approaches for small cell lung cancer.

    One group receives obrixtamig together with atezolizumab, carboplatin, and etoposide. The other group receives atezolizumab, carboplatin, and etoposide without obrixtamig.

  2. Step 2

    Study medicines given by infusion

    All study medicines are given as intravenous infusion, which means they are delivered through a vein.

    atezolizumab is given at a dose of 1200 mg by intravenous infusion.

    carboplatin is given at a dose of 750 mg by intravenous infusion.

    etoposide is given at a dose of 100 mg/m2 by intravenous infusion. mg/m2 means the dose is based on body surface area.

    tocilizumab is given at a dose of 2400 mg by intravenous infusion as a background medicine.

    obrixtamig is the study medicine being tested in one treatment group. The source data do not give a dose, frequency, or duration for obrixtamig.

  3. Step 3

    Treatment period

    You continue to receive the assigned study treatment during the treatment period. The source data do not give the exact number of treatment cycles, the exact schedule, or the total duration for the medicines.

    During this period, the study checks for treatment-emergent adverse events, which means health problems that start or get worse after treatment begins.

    The study also checks for CRS, which means cytokine release syndrome, a strong reaction caused by the immune system.

    The study also checks for ICANS, which means immune effector cell-associated neurotoxicity syndrome, a group of nervous system problems that can happen with immune treatments.

  4. Step 4

    Disease and symptom assessments

    Your cancer is assessed to see whether it gets smaller, stays the same, or gets worse. The study uses RECIST 1.1, which is a standard way to measure tumor changes on scans. This is done by the study doctor.

    The study measures overall survival, which means how long you live after random assignment to a treatment group.

    The study measures progression-free survival, which means the time from random assignment until the cancer gets worse or death occurs.

    The study measures overall response, which means the best tumor result seen during the study, such as a complete response or partial response. A complete response means no visible cancer on assessment, and a partial response means the cancer has shrunk but not disappeared.

    The study measures changes in breathing symptoms, chest pain, and cough using patient questionnaires. One assessment compares your symptoms from the start of the study to Week 19.

    The study also measures the time until symptoms get worse and stay worse, including breathlessness, chest pain, and cough.

  5. Step 5

    End of treatment follow-up

    The study records whether treatment is stopped, delayed, or reduced because of side effects.

    The source data do not give the exact follow-up schedule after treatment ends.

    The study continues to collect information on survival and cancer status until the study ends.

  6. Step 6

    Study time frame

    The planned recruitment period is from 2026-03-05 to 2029-03-22.

Who can join the trial?

14 criteria

  • The patient must have extensive-stage small cell lung cancer that has been confirmed by a tissue test under a microscope.
  • The patient must have completed 1 cycle of first-line treatment with platinum and etoposide, with or without anti-PD-1 or anti-PD-L1 treatment. These are immune-based cancer medicines that help the body’s immune system attack cancer cells. The treatment must have included at least the required doses of cisplatin, carboplatin, and etoposide listed in the study.
  • The patient must not have had any previous full-body cancer treatment for this cancer, except for the 1 completed treatment cycle mentioned above.
  • If the patient had full-body cancer treatment for limited-stage small cell lung cancer in the past, that treatment must have finished more than 6 months before the diagnosis of the current extensive-stage disease.
  • There must be enough stored tumor tissue available for central laboratory testing. FFPE means tissue that has been preserved in a special wax block for testing.
  • The stored tumor tissue must be available for testing of DLL3 and other biomarkers. A biomarker is a measurable sign in the tumor that helps guide research and treatment.
  • The central laboratory test result for the VENTANA DLL3 (SP347) RxDx test must be available before the patient is assigned to a study group.
  • If the patient has brain metastases that do not cause symptoms, they may still join if they meet one of these conditions: treatment for the brain metastases was completed at least 14 days before assignment and the patient is neurologically stable, or the brain metastases were not treated because they did not need treatment and the patient has been neurologically stable for at least 28 days before assignment.
  • The patient must be neurologically stable, meaning their brain and nerve-related symptoms are not getting worse.
  • The patient must not need glucocorticoids or therapeutic anti-convulsants before assignment, or must have stopped them for the required time. Glucocorticoids are steroid medicines, and anti-convulsants are medicines used to prevent seizures.
  • The patient must have an ECOG performance status of 0 or 1. This is a measure of how well a person can do daily activities; 0 means fully active, and 1 means able to do light work.
  • The patient must be able to continue the carboplatin + etoposide + atezolizumab treatment plan as the standard first-line treatment within 28 days after starting the first treatment cycle.
  • The patient must be able to receive the full study doses of atezolizumab 1200 mg, carboplatin AUC 5, and etoposide 80 to 100 mg/m2. AUC is a measure used to set the carboplatin dose.
  • Any other inclusion requirements in the study must also be met.

Who cannot join the trial?

10 criteria

  • People with leptomeningeal disease or carcinomatous meningitis cannot take part. These are cancer cells affecting the fluid and coverings around the brain and spinal cord.
  • People who have already had treatment that targets DLL3 cannot take part. This includes TcEs (special immune-based treatments that help the immune system attack cancer), cell therapies (treatments using modified cells), antibody-drug conjugates (antibodies linked to cancer drugs), and radiopharmaceuticals (radioactive medicines used to treat cancer).
  • People who had radiotherapy (treatment with radiation) to any part of the body within 14 days before randomization cannot take part.
  • People with side effects from earlier treatments that have not improved to Grade 1 or less cannot take part. Grade 1 means mild side effects. The only exceptions are hair loss, tiredness, no periods or menstrual changes, certain Grade 2 nerve problems, certain Grade 2 hormone gland problems that are controlled with replacement treatment, and side effects that are permanent but have stayed stable for at least 4 weeks, if the study doctor thinks it is appropriate.
  • People with an active autoimmune disease cannot take part. An autoimmune disease is when the immune system attacks the body’s own tissues.
  • People with a past autoimmune disease that needs systemic treatment cannot take part. Systemic treatment means medicine that affects the whole body, such as glucocorticoids (steroid medicines) or immunosuppressive drugs (medicines that weaken the immune system).
  • People with vitiligo, childhood asthma or allergies that have fully gone away, alopecia (hair loss), or a long-term skin condition that does not need systemic treatment are not excluded by this rule.
  • People with autoimmune-related hypothyroidism (an underactive thyroid caused by autoimmunity) may still be allowed if they are on a stable dose of thyroid replacement hormone.
  • People with controlled type 1 diabetes mellitus may still be allowed if they are on a stable insulin regimen.
  • Any other exclusion criteria listed in the study also apply.
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Investigated drugs

  • Carboplatin

    is a chemotherapy medicine given through a vein. In this trial, it is part of the standard treatment used to treat small cell lung cancer by helping to kill cancer cells or stop them from growing.

  • Tocilizumab

    is a medicine given through a vein that helps calm down the immune system. In this trial, it is used as background treatment to help lower the risk of strong immune reactions during treatment.

  • Atezolizumab

    is an immunotherapy medicine given through a vein. It helps the immune system recognize and attack cancer cells, and it is being used as part of the main treatment in this study.

  • BI 764532

    is an experimental treatment given through a vein. It is designed to help immune cells find and attack cancer cells that carry a target called DLL3, while also linking them to T cells so the immune system can better fight the cancer.

  • Etoposide

    is a chemotherapy medicine given through a vein. In this trial, it is used together with other cancer medicines to help stop cancer cells from multiplying and to treat extensive-stage small cell lung cancer.

What is already known about the treatment

  • Carboplatin

    Carboplatin is given as a liquid through a vein by intravenous infusion, usually in a hospital or clinic setting. It is a well-established cancer medicine that is widely used in medical practice and studied in the medical literature, especially for lung cancer and other solid tumors. It belongs to the platinum-based chemotherapy group and works by damaging the DNA of cancer cells, which stops them from growing and dividing.

  • Tocilizumab

    Tocilizumab is given by intravenous infusion and is used under medical supervision, usually in a clinic or hospital. It is an approved and well-studied medicine in medical literature, mainly used for inflammatory diseases, and it is also used in some cancer trial settings to help manage immune-related side effects. It is an immune-blocking medicine that targets a protein called interleukin-6 receptor, which helps reduce harmful inflammation in the body.

  • Atezolizumab

    Atezolizumab is given as an intravenous infusion in a hospital or clinic. It is an established and widely studied cancer medicine, especially in lung cancer, and it is also used in other cancers in medical practice and research. It is an immunotherapy medicine called a PD-L1 blocker, and it helps the immune system recognize and attack cancer cells by preventing the tumor from switching off immune cells.

  • BI 764532

    BI 764532 is given by intravenous infusion, which means it is delivered directly into a vein under close medical supervision. It is an experimental medicine and is still being studied in clinical trials, so its full place in medical practice is not yet known. It is a targeted cancer immunotherapy called a T-cell engager, designed to bind DLL3 on cancer cells and CD3 on T cells so the immune cells can attach to the tumor and destroy it.

  • Etoposide

    Etoposide is given as a liquid infusion into a vein, usually in repeated treatment cycles in a hospital or clinic. It is a well-known and long-used cancer medicine in medical literature, especially for small cell lung cancer and some other cancers. It belongs to the topoisomerase inhibitor group and works by blocking a cell enzyme needed to copy DNA, which leads to damage in rapidly growing cancer cells and stops them from multiplying.

Investigated diseases

small cell lung cancer - Small cell lung cancer is a fast-growing type of lung cancer that usually starts in the cells lining the airways. It often grows and spreads quickly to nearby lymph nodes and other parts of the body. The disease commonly causes tumors to enlarge over time and may later involve more than one area of the lungs or distant organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520565-51-00Protocol code1438-0012Estimated enrolment674 patientsSponsorBoehringer Ingelheim Espana S.A.

sourced from the EU Clinical Trials Register and site verification

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This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).