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Phase II Study of BI 764532 Added to Platinum Chemotherapy in Adults with Advanced Large‑Cell Neuroendocrine Lung Cancer

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What is this trial about?

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

The study focuses on adults with large-cell neuroendocrine carcinoma of the lung, a rare type of lung cancer that has spread locally or to other parts of the body and cannot be cured with surgery. The usual first‑line treatment for this disease is a chemotherapy regimen that contains a platinum drug, which works by damaging the DNA of cancer cells. In this trial, the standard chemotherapy is combined with a new medication called obrixtamig, which is designed to help the body’s own T‑cells recognize and attack the cancer.

The main goal of the trial is to see whether adding obrixtamig to the standard chemotherapy can improve overall survival, meaning the length of time patients live after starting treatment.

Participants will receive the regular platinum‑based chemotherapy according to usual schedules and will also receive an intravenous infusion of obrixtamig during the same treatment cycles. After the treatment period, patients will be monitored for several months to track their health status and any side effects, with regular visits to assess how well the cancer is controlled and to record survival outcomes.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessments

    After joining the study you will sign an informed consent form that explains the trial.

    The study team will collect basic health information, perform physical examinations, and obtain laboratory tests and imaging to confirm eligibility.

  2. Step 2

    Start of treatment

    Treatment begins with the standard-of-care platinum-based chemotherapy that is normally used for this type of lung cancer.

    At the same time you will receive bi 764532, a bispecific t‑cell engager, administered by intravenous infusion.

  3. Step 3

    Study drug infusion schedule

    The infusion of bi 764532 is given according to the study protocol; the exact dose, frequency, and length of each infusion are determined by the investigators and will be followed throughout the treatment period.

  4. Step 4

    Regular monitoring visits

    You will attend scheduled clinic visits where blood samples are taken and imaging studies are performed to check how the cancer is responding and to monitor safety.

    Any side effects are evaluated and managed according to standard medical practice.

  5. Step 5

    Continuation of therapy

    Treatment continues for multiple cycles as long as the cancer does not progress and side effects remain acceptable.

    The number of cycles and total duration are defined by the study protocol.

  6. Step 6

    End‑of‑treatment assessment

    When treatment is stopped, a final set of examinations is performed to document the overall response of the disease.

    The results are used to evaluate the primary outcome of the trial, which is overall survival.

  7. Step 7

    Post‑treatment follow‑up

    After completing therapy you will be followed for a period of time during which survival and any late effects are recorded.

    Follow‑up visits may include routine health checks and occasional imaging, as specified by the study schedule.

Who can join the trial?

6 criteria

  • You must sign a written consent form and be able to understand and agree to join the study.
  • You must have a lung cancer called large‑cell neuroendocrine carcinoma (LCNEC) that has been confirmed by a tissue test (called histology) and a lab test that looks for specific proteins (immunohistochemistry). If your tumor contains more than one type of cancer, at least half of it must be LCNEC.
  • The cancer must be locally advanced or have spread to other parts of the body (metastatic) and there must be no chance for a cure with surgery or radiation.
  • You must have already received exactly one cycle (one round) of standard chemotherapy that includes the drugs platinum and etoposide, with or without a medicine that helps the immune system fight cancer (called an immune checkpoint inhibitor). You cannot have had any other whole‑body (systemic) cancer treatment before.
  • Your cancer must be measurable, meaning doctors can see and measure it on scans using the standard criteria called RECIST version 1.1.
  • You must be an adult (usually 18 years or older) and can be male or female.

Who cannot join the trial?

4 criteria

  • You cannot join if you have symptomatic brain metastases – meaning cancer that has spread to the brain and is causing symptoms.
  • You cannot join if you have leptomeningeal disease – cancer cells that are present in the thin membranes covering the brain and spinal cord.
  • You cannot join if you have already received any systemic treatment (medicines that travel throughout the whole body) for metastatic disease, unless it was only one cycle of the standard chemotherapy described in the study’s inclusion rules.
  • You cannot join if you have previously been treated with obrixtamig or any anti‑DLL3 drug, including special experimental medicines called T‑cell engagers or antibody‑drug conjugates.
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Investigated drugs

  • obrixtamig

    (code name BI 764532) is a special type of medicine called a bispecific T‑cell engager. It is designed to attach to a protein called DLL3 on the cancer cells and to CD3 on the body’s T‑cells (a kind of immune cell). By linking the T‑cells to the cancer cells, it helps the immune system find and destroy the tumor. The drug is given through an intravenous (IV) infusion.

  • platinum‑based chemotherapy

    is the standard treatment used for advanced large‑cell neuroendocrine carcinoma of the lung. It includes chemotherapy drugs that contain a platinum compound (such as cisplatin or carboplatin). These drugs work by damaging the DNA inside cancer cells, which stops the cells from growing and leads them to die. This therapy is given as part of the usual first‑line treatment for this type of lung cancer.

What is already known about the treatment

BI 764532 - This medication is given as an intravenous infusion of a clear solution. It is currently an investigational drug being studied in early clinical trials and has not yet received marketing approval. It is designed for adult patients with advanced large‑cell neuroendocrine carcinoma of the lung who cannot receive curative treatment. The drug works by attaching to a protein called DLL3 on cancer cells and to CD3 on immune T‑cells, pulling the immune cells close to the tumor so they can destroy it. It belongs to the class of bispecific T‑cell engagers, a type of targeted immunotherapy.

Investigated diseases

large-cell neuroendocrine carcinoma of the lung - It is a rare type of lung cancer that arises from neuroendocrine cells and is composed of large malignant cells. The tumor often forms a sizable mass within the lung and can involve nearby lymph nodes. As it grows, it may invade surrounding lung tissue and chest structures. Over time, cancer cells can spread through the bloodstream or lymphatic system to distant organs such as the liver, brain, or bones. The disease can progress from a locally advanced stage to widespread metastasis.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524345-28-00Protocol codeTUD-ALPIN2-089Estimated enrolment75 patientsSponsorTechnische Universitaet Dresden

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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).