Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05963867

A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer

Led by Boehringer Ingelheim · Updated on 2026-05-08

12

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Weight of at least 60 kg
  • Signed written informed consent according to guidelines before any study procedures
  • Have advanced small cell lung cancer or neuroendocrine cancer with no successful standard treatment
  • Have failed previous conventional treatments including at least one line of platinum-based chemotherapy
  • Prior therapy with anti PD-1 or PD-L1 allowed
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have at least one measurable tumor lesion outside the central nervous system
  • Patients with brain metastases are eligible if radiotherapy or surgery was completed at least 2 weeks before treatment, are off steroids for at least 7 days, and are off or stable on anti-epileptic drugs
Not Eligible

You will not qualify if you...

  • Previous or other cancers within last 2 years except certain effectively treated skin or cervical cancers or other cured malignancies
  • Major injury, surgery, or bone fracture within 28 days before starting treatment or planned surgery
  • Known leptomeningeal disease or spinal cord compression from metastases
  • Use of anticoagulant treatment that cannot be safely stopped if needed
  • Active infection requiring treatment or significant intervention
  • COVID-19 infection within 2 weeks before study entry or suspected infection or close contact within 1 week
  • Laboratory evidence of hepatitis B or C infection
  • Known HIV infection
  • Additional exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC Locatie VUMC

Amsterdam, Netherlands, 1081HV

Actively Recruiting

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Research Team

B

Boehringer Ingelheim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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