Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruitingRare disease

Study of BI 764532 with drug combination in patients with extensive‑stage 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

The study focuses on people with advanced small cell lung carcinoma, a fast‑growing cancer that starts in the lungs and often spreads quickly. It tests a new combination of two experimental medicines, obrixtamig and pumitamig, given together with the usual chemotherapy drugs carboplatin and etoposide. The main purpose is to determine how safe the new combination is and how well it can be tolerated.

Participants receive the study medicines by intravenous infusion, meaning the drugs are slowly dripped into a vein through a small tube. The treatment is administered in several cycles, each lasting a few weeks, with regular doctor visits, blood tests, and imaging scans to monitor side effects and to see whether the tumor is shrinking, staying the same, or growing. The study follows each participant from the first dose until the treatment ends or the medication is stopped for safety reasons.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Medical Evaluation

    After joining the study, a comprehensive baseline assessment is performed. This includes a physical examination, blood laboratory tests, and imaging studies to confirm the extent of small cell lung carcinoma.

    The results of these assessments are used to determine eligibility for the study treatments.

  2. Step 2

    First Treatment Cycle

    On the first treatment day, the patient receives intravenous infusions of the study drugs:

    Obrixtamig (BI 764532) and Pumitamig (BNT327) as experimental agents, combined with the standard‑of‑care chemotherapy drugs carboplatin and etoposide. The background medication RoActemra (tocilizumab) may also be administered.

    All medications are given as a solution for infusion through a vein. The specific dose, frequency, and length of each infusion are defined by the study protocol and are administered by qualified medical staff.

    The first cycle marks the start of the combination therapy that will be repeated according to the protocol.

  3. Step 3

    Safety Monitoring During the Cycle

    During and after the infusion, the patient is monitored for vital signs, possible side effects, and any adverse reactions.

    Blood samples are taken at scheduled times to evaluate organ function and to detect early signs of toxicity.

  4. Step 4

    Imaging and Tumor Assessment

    After the first cycle, imaging studies (such as CT scans) are performed to assess the tumor’s response to treatment.

    These assessments follow the RECIST 1.1 criteria, which classify response as complete response, partial response, stable disease, or progression.

  5. Step 5

    Subsequent Treatment Cycles

    If the patient tolerates the therapy, additional cycles of the same intravenous infusions are given. Each cycle repeats the administration of obrixtamig, pumitamig, carboplatin, and etoposide (and RoActemra if required).

    The interval between cycles and the total number of cycles are specified by the study protocol and continue until disease progression, unacceptable toxicity, or completion of the planned treatment period.

  6. Step 6

    Ongoing Safety and Efficacy Evaluations

    Throughout the treatment period, regular clinic visits are scheduled to review side effects, perform laboratory tests, and repeat imaging to monitor tumor response.

    Any adverse event that requires dose adjustment or discontinuation is evaluated according to the study’s safety criteria.

  7. Step 7

    End of Treatment Assessment

    When treatment is stopped—either because the study protocol has been completed, the disease has progressed, or side effects are unmanageable—a final evaluation is performed.

    This includes a complete physical exam, laboratory tests, and imaging to document the overall outcome of the therapy.

  8. Step 8

    Post‑Treatment Follow‑Up

    After the last infusion, the patient continues with scheduled follow‑up visits to monitor long‑term safety and disease status.

    These visits may include blood tests and imaging at intervals defined by the study protocol, extending for several months after treatment ends.

Who can join the trial?

8 criteria

  • Sign a written informed consent form before any study procedures; this means you agree to take part after understanding what will happen.
  • Be at least 18 years old (or older than the legal age required in your country) at the time you sign the consent.
  • Be willing and able to follow the study schedule, attend all required visits, take the medication as directed, and follow any restrictions on other medicines or lifestyle habits.
  • Have a diagnosis of extensive‑stage small cell lung cancer (ES‑SCLC) that has been confirmed by looking at your tumor tissue or cells under a microscope.
  • Have already received systemic anti‑cancer treatment (such as chemotherapy) for ES‑SCLC.
  • Have at least one measurable lesion (a tumor that can be measured on scans) that is located outside of the brain or spinal cord, according to standard measurement rules called RECIST 1.1.
  • Have a previously collected tumor sample that can be used for testing (this requirement does not apply if you are in China).
  • Show that your major organs (like liver, kidneys, and blood‑forming organs) are working well enough, as determined by lab tests.

Who cannot join the trial?

9 criteria

  • Having a serious additional illness (such as a brain or nerve disorder, a mental health condition, an addiction problem, an active ulcer in the stomach, intestines or skin, or abnormal test results) that could make the study unsafe, make it hard to follow study rules, or affect the results.
  • Having small cell lung cancer that also contains another type of cancer tissue, or having other specific cancers such as Merkel cell carcinoma (a rare skin cancer), medullary thyroid carcinoma (a thyroid gland cancer), or neuroendocrine prostate cancer (a prostate cancer that behaves like a hormone‑related tumor).
  • Having cancer that has spread to the lining of the brain and spinal cord, known as leptomeningeal disease or carcinomatous meningitis.
  • Being allergic to the study drugs, any of their inactive ingredients (excipients), or having had a severe allergic reaction to similar medicines (such as monoclonal antibodies), or being judged at high risk for a serious allergic reaction (anaphylaxis).
  • Having previously experienced a severe immune‑related side effect (a serious Grade 3 or higher reaction) or a serious reaction during the infusion of a medication that caused you to stop treatment permanently.
  • Still having side effects from earlier cancer treatments that have not improved to a mild level (CTCAE Grade 1), except for hair loss, tiredness, menstrual changes, certain nerve problems, or hormone problems that are controlled, or side effects that are permanent but stable for at least four weeks.
  • Having received an organ or tissue transplant in the past (organ or tissue allograft).
  • Having a history of or current lung problems such as interstitial lung disease, pulmonary fibrosis (scarring of the lungs), organizing pneumonia (a type of lung inflammation), or any other condition that significantly reduces lung function.
  • Other reasons not listed here may also prevent participation in the study.
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 yet 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

  • BI 764532

    is an experimental drug that works like a bridge, connecting a type of immune cell (T‑cell) to cancer cells that have a protein called DLL3. By linking the T‑cell to the cancer cell, it helps the immune system recognize and attack the tumor. In this trial it is given through an IV infusion together with other treatments to see if it is safe and tolerable.

  • Carboplatin

    is a chemotherapy medicine that damages the DNA of rapidly growing cancer cells, helping to stop them from dividing. It is a standard part of treatment for small cell lung cancer and is given by IV infusion. In the study it is used as part of the usual care regimen to compare how patients do when the new drugs are added.

  • RoActemra

    (tocilizumab) is a medication that blocks a protein called interleukin‑6, which can cause inflammation. It is given intravenously and is included in the trial as background therapy, potentially helping to manage side effects or inflammation that may arise from the cancer or other treatments.

  • BNT327

    is a new investigational drug identified by its code name. It is supplied as a powder that is mixed and given by IV infusion. The trial is testing whether adding this agent to the standard chemotherapy is safe and how patients tolerate it.

  • Etoposide

    is another chemotherapy drug that interferes with the DNA of cancer cells, preventing them from multiplying. It is a common component of standard treatment for small cell lung cancer and is administered by IV infusion. In this study it is used together with carboplatin as the established care against which the new drugs are evaluated.

What is already known about the treatment

  • BI 764532

    This investigational drug is given by slow intravenous infusion of a clear solution. It is currently in early clinical testing and has orphan‑drug status for rare cancers. The molecule is a bispecific antibody that links T‑cells to tumor cells by binding CD3 on immune cells and DLL3 on cancer cells, helping the immune system attack the tumor. It belongs to the class of bispecific T‑cell engagers.

  • Carboplatin

    Carboplatin is administered as an intravenous infusion of a sterile solution. It is an approved chemotherapy drug that has been used for many years to treat lung, ovarian and other cancers. The drug works by forming cross‑links in DNA, which prevents cancer cells from dividing and leads to their death. It is classified as a platinum‑based alkylating‑like agent.

  • Tocilizumab

    Tocilizumab is delivered by intravenous infusion of a liquid solution. It is an approved medication used for autoimmune diseases such as rheumatoid arthritis and for managing severe inflammatory reactions. The drug is a monoclonal antibody that blocks the interleukin‑6 (IL‑6) receptor, reducing inflammation and immune over‑activity. It belongs to the class of biologic disease‑modifying anti‑rheumatic drugs.

  • BNT327

    BNT327 is supplied as a powder that is reconstituted to make an infusion solution for intravenous administration. It is an experimental compound currently being studied in early‑phase trials for cancer treatment. The exact way it works is still under investigation, but it is designed to target tumor‑related pathways and stimulate an anti‑cancer response. It is classified as an investigational biologic agent.

  • Etoposide

    Etoposide is given by intravenous infusion of a ready‑to‑use solution. It is a well‑established chemotherapy drug used for small cell lung cancer, testicular cancer and other solid tumors. The medication inhibits an enzyme called topoisomerase II, which stops cancer cells from properly copying their DNA and leads to cell death. It is classified as a topoisomerase II inhibitor, a type of cytotoxic chemotherapy.

Investigated diseases

Small cell lung carcinoma - Small cell lung carcinoma is a fast‑growing cancer that starts in the neuroendocrine cells of the lung, most often in people who smoke. It forms a dense tumor that can quickly invade nearby structures and spread through the bloodstream to lymph nodes, brain, liver, bone and other organs. Patients may notice a persistent cough, shortness of breath, weight loss or symptoms related to the sites where the cancer has spread. The disease typically progresses rapidly, with tumor size and spread increasing over weeks if not controlled.
Trial detailsLast updated 28 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-525459-99-00Protocol code1438-0035Estimated enrolment41 patientsSponsorBoehringer Ingelheim Espana S.A.

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.