DAREON-5 Phase II Study Testing Different Doses of BI 764532 Infusion in Adults With Relapsed or Refractory Small Cell Lung Cancer and Other Neuroendocrine Cancers

What this Trial Is About

This research aims to find the right dose of BI 764532 obrixtamig, an antibody-like molecule that may help the immune system fight advanced small cell lung cancer and other neuroendocrine tumors. It includes adults whose cancer has not responded to previous treatments or for whom no standard treatment exists. The study is a multi-center, open-label Phase II trial sponsored by Boehringer Ingelheim. Participants receive BI 764532 as an infusion into a vein. The study has three parts Part 1 randomly assigns participants to one of two doses, while Parts 2 and 3 give all participants the same dose and focus on a specific tumor type called extrapulmonary neuroendocrine carcinoma. Treatment continues as long as participants tolerate it and benefit, with regular visits to the study site. The first visits include an overnight stay for safety monitoring. During the study, doctors monitor participants safety, side effects, and overall health through regular assessments. They measure tumor response and track treatment-emergent adverse events for up to 23 to 27 months, depending on the study part. Quality of life and survival outcomes are also recorded. The total number of visits depends on treatment response and tolerance, with ongoing evaluation until study completion.

DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers