Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on BI 764532 for Patients with Relapsed or Refractory Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

Verified siteInvestigationalNo 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

This clinical trial is focused on studying the effects of a treatment called BI 764532 in patients with certain types of cancer. The cancers being studied include Small Cell Lung Cancer and other types of neuroendocrine carcinomas, which are cancers that can occur in different parts of the body and involve cells that release hormones into the blood. The treatment, BI 764532, is a special type of medication known as a T cell engager, which is designed to help the body's immune system target and fight cancer cells more effectively.

The purpose of this study is to evaluate the safety and effectiveness of different doses of BI 764532 in patients whose cancer has returned or continued to grow after previous treatments. Participants in the study will receive the medication through an intravenous infusion, which means it will be given directly into a vein. The study will monitor how well the treatment works and any side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, participants will have regular check-ups and assessments to track their response to the treatment. The study aims to find the most effective dose of BI 764532 that can help manage these types of cancers while ensuring the safety of the participants. The trial will provide valuable information that could lead to new treatment options for patients with these challenging cancers.

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

    Joining the study

    Upon joining the study, the patient will receive a detailed explanation of the trial, including its purpose and procedures. The patient must provide written informed consent to participate.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the type of cancer, previous treatments, and overall health status. The patient must have measurable lesions and adequate organ function.

  3. Step 3

    Treatment administration

    The patient will receive the medication BI 764532 through an intravenous infusion. The dosage and frequency will be determined based on the specific needs of the patient and the trial's protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, the patient will be monitored for any changes in their condition. This includes regular assessments of tumor response and any side effects experienced. The patient's response to the treatment will be evaluated using specific criteria.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, the patient will undergo a final assessment to determine the overall effectiveness of the treatment and any lasting effects.

  6. Step 6

    Post-trial follow-up

    After the trial, the patient may be asked to participate in follow-up visits to monitor long-term outcomes and gather additional data on the treatment's effects.

Who can join the trial?

11 criteria

  • Participants must be male or female and at least 18 years old. In some countries, they must be at the legal age of consent if it is higher than 18 years.
  • Participants need to sign a written informed consent form before joining the trial. This form shows they understand the trial and agree to participate.
  • Participants must have a confirmed diagnosis of one of the following types of cancer:
    • Small Cell Lung Cancer (SCLC)
    • Extra-pulmonary neuroendocrine carcinoma (epNEC), excluding certain types like Merkel cell carcinoma (MCC), medullary thyroid carcinoma (MTC), and neuroendocrine prostate cancer (NEPC)
    • Large cell neuroendocrine carcinoma (LCNEC) of the lung
    • Participants should have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. This score measures how well they can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
    • Participants must have measurable tumors as defined by specific guidelines within 21 days before the first dose of the trial medication.
    • Participants need to provide a sample of their tumor tissue from a previous biopsy.
    • Participants must have organs that are functioning well enough, as specified in the trial protocol.
    • Any side effects from previous cancer treatments should have improved to a mild level (Grade 1) before starting the trial treatment. Some exceptions are allowed for hair loss, nerve damage, tiredness, and hormone-related issues if they are at a moderate level (Grade 2) and menstrual issues of any severity.
    • Women who can have children and men who can father children must agree to use highly effective birth control methods that have a failure rate of less than 1% per year when used correctly. Details about these methods and how long to use them are provided in the trial information.

Who cannot join the trial?

4 criteria

  • Patients who have not experienced progression or recurrence of their cancer after at least two previous treatments, including one treatment with a platinum-based drug, cannot participate.
  • Patients with types of cancer not specified in the study, such as Merkel cell carcinoma (MCC), medullary thyroid carcinoma (MTC), or neuroendocrine prostate cancer (NEPC), are excluded.
  • Patients who have not had their cancer confirmed through specific medical tests called histology or cytology are not eligible.
  • Patients who have not experienced progression or recurrence after at least one treatment with a platinum-based drug are excluded.
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.

RecruitingNot 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 medication being tested in this clinical trial. It is designed to target a specific protein called DLL3, which is found on certain cancer cells. The medication works by engaging T cells, a type of immune cell, to attack and destroy these cancer cells. This trial is focused on patients with small cell lung cancer or other neuroendocrine carcinomas that have returned or worsened after previous treatments. The goal is to determine how safe and effective this medication is for these patients.

What is already known about the treatment

BI 764532 – This medication is administered intravenously and is currently being studied in a Phase II clinical trial. It is designed for patients with relapsed or refractory extensive-stage small cell lung cancer and other neuroendocrine carcinomas. The main therapeutic indications include small cell lung cancer, extra-pulmonary neuroendocrine carcinoma, and large cell neuroendocrine carcinoma. BI 764532 works by targeting DLL3, a protein found on the surface of certain cancer cells, and engaging T cells to attack these cancer cells. It is classified as a T cell engager, a type of immunotherapy that helps the immune system recognize and destroy cancer cells.

Investigated diseases

  • Small Cell Lung Cancer

    This is a fast-growing type of lung cancer that primarily originates in the bronchi, the main airways of the lungs. It is characterized by small cells that multiply quickly and form large tumors. The disease often spreads rapidly to other parts of the body, including the lymph nodes, liver, bones, and brain. Due to its aggressive nature, it is usually diagnosed at an advanced stage. The progression involves the rapid growth of cancerous cells, leading to significant health challenges.

  • Extra-pulmonary Neuroendocrine Carcinoma

    This is a rare type of cancer that arises from neuroendocrine cells located outside the lungs. These cells have traits of both nerve and hormone-producing cells and can be found in various organs. The disease can develop in areas such as the gastrointestinal tract, pancreas, or skin. It is known for its aggressive behavior and potential to spread to other parts of the body. The progression involves the rapid multiplication of abnormal cells, which can lead to the formation of tumors in different organs.

  • Large Cell Neuroendocrine Carcinoma

    This is a type of lung cancer that is part of the neuroendocrine tumor family. It is characterized by large, abnormal cells that grow and divide quickly. The disease often presents with symptoms similar to other lung cancers, such as coughing and difficulty breathing. It is known for its aggressive nature and tendency to spread to other parts of the body. The progression involves the rapid growth of cancerous cells, which can lead to significant health issues.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504247-13-00Protocol code1438-0005Estimated enrolment242 patientsSponsorBoehringer Ingelheim International GmbH

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.