Tests how BI 764532 reaches tumours in lung and neuroendocrine cancers
Studies how the drug BI 764532 spreads to tumours in adults with advanced cancer.
Plain-language title generated from the registry record
Registry title: A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer
Key facts
- Where
- Amsterdam, NetherlandsSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced small-cell lung cancer or another neuroendocrine cancer, whose earlier treatment did not work or for whom no standard treatment exists.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Advanced cancer that failed conventional treatment, or with no proven treatment left. At least one measurable tumour outside the brain and spinal cord (CNS). Performance status (ECOG) of 0-1. Brain metastases are allowed if treated at least 2 weeks before and steroids stopped at least 7 days before.
- Earlier treatment
- Must have had at least one line of platinum-based chemotherapy. Earlier anti-PD-1 or PD-L1 treatment is allowed.
Main reasons for not taking part
- Another cancer within the last 2 years (a few effectively treated types are allowed)
- Known HIV infection
- Hepatitis B or hepatitis C infection shown by tests
- Active infection that needs treatment, or recent SARS-CoV-2 infection
- Known leptomeningeal disease or spinal cord compression from metastases
Read by machine on 12 November 2026.
Where in Netherlands
- Amsterdam UMC Locatie VUMCAmsterdam, NetherlandsContact: Boehringer IngelheimTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT05963867
- Record updated
- 14 October 2026
- Original description
This study is open to adults with small cell lung cancer and other neuroendocrine cancers. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out how a medicine called BI 764532 gets distributed in the body and in tumours.Read full original descriptionShow less
An Open-label Phase 1 PET Imaging Trial to Investigate [89Zr]Zr-BI 764532 Biodistribution and Tumour Uptake in Patients With Small-cell Lung Carcinoma or Neuroendocrine Carcinoma
This study is open to adults with small cell lung cancer and other neuroendocrine cancers. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out how a medicine called BI 764532 gets distributed in the body and in tumours.
Participants get BI 764532 when starting treatment. In the first weeks, doctors check how BI 764532 is taken up in tumours by means of an imaging method. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
Inclusion: Age ≥18 years; Weight ≥ 60kg; Signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses; Patient who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy. Previous therapy with anti Programmed Cell Death Protein 1 (PD-1) or Programmed Cell Death Ligand 1 (PD-L1) are allowed; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; At least one evaluable lesion outside of Central Nervous System (CNS) as defined per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1; Subjects with brain metastases are eligible provided they meet the following criteria:; radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532,; patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant CNS disease; Further inclusion criteria apply.
Exclusion: Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:; effectively treated non-melanoma skin cancers; effectively treated carcinoma in situ of the cervix; effectively treated ductal carcinoma in situ; other effectively treated malignancy that is considered cured by local treatment; Major injuries and/or surgery or bone fracture within 28 days of first dose BI 764532, or planned surgical procedures; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 2 weeks prior to study entry (confirmed via polymerase chain reaction (PCR) test or other applicable test as per local requirements) or suspected SARS-CoV-2 infection as per physician assessment, or close contact (within 1 week) with an individual with confirmed SARS-CoV-2 infection; Known leptomeningeal disease or spinal cord compression due to metastatic disease; Active infection that requires medical therapy or other clinically significant intervention; Known human immunodeficiency virus (HIV) infection. Further exclusion criteria apply; Any of the following known laboratory evidence of hepatitis virus infection:; Positive results of hepatitis B surface (HBs) antigen; Presence of hepatitis B core (HBc) antibody together with hepatitis B virus DNA (HBV-DNA); Presence of hepatitis C ribonucleic acid (RNA); Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed.