OncoMatch/Clinical Trials/NCT05882058
DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
Is NCT05882058 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including BI 764532, dose 1 and BI 764532, dose 2 for small cell lung carcinoma.
Treatment: BI 764532, dose 1 · BI 764532, dose 2 — This study is open to adults with small cell lung cancer and other neuroendocrine tumours. 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 a suitable dose of BI 764532 that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. The study has 2 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2, all participants receive the same dose of BI 764532. Part 2 is open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma. All participants receive BI 764532 as an infusion into a vein when starting treatment. 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. The first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Neuroendocrine Tumor
Biomarker criteria
Required: DLL3 high expression (high)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — SCLC: at least two prior lines, including at least one platinum-based regimen; in countries where standard of care in first line therapy includes PD-L1 inhibitor treatment patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless unable to receive checkpoint inhibitor treatment. epNEC/LCNEC: at least one platinum-based regimen.
Patients must have progressed or recurred after standard of care therapy * SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen; in countries where standard of care in first line therapy includes PD-L1 inhibitor treatment patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment. * epNEC/LCNEC: after at least one platinum-based regimen.
Cannot have received: DLL3-targeting T cell engager or cell therapy
Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies.
Lab requirements
Blood counts
Adequate organ function as defined in the protocol.
Kidney function
Adequate organ function as defined in the protocol.
Liver function
Adequate organ function as defined in the protocol.
Adequate organ function as defined in the protocol.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Infirmary Cancer Care · Mobile, Alabama
- Mayo Clinic-Arizona · Phoenix, Arizona
- Valkyrie Clinical Trials · Los Angeles, California
- University of California San Francisco · San Francisco, California
- Mayo Clinic Cancer Center · Jacksonville, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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