BI 764532
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Technische Universitaet Dresden, Boehringer Ingelheim
Conditions
Extra-pulmonary neuroendocrine carcinomaGliomaLarge cell neuroendocrine carcinomaMale and female adult patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung not eligible for curative treatmentNeuroendocrine NeoplasmsSmall Cell Lung CancerSmall Cell Lung Carcinoma (SCLC)advanced or metastatic extrapulmonary neuroendocrine carcinoma
Phase 1
A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3
RecruitingNCT05916313
Start: 2024-01-30End: 2027-09-30Target: 20Updated: 2026-08-11
A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer
RecruitingNCT05963867
Start: 2024-08-06End: 2026-12-25Target: 12Updated: 2026-08-21
DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy
Active, not recruitingNCT05990738
Start: 2024-02-14End: 2027-04-30Updated: 2026-08-04
DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer
Active, not recruitingNCT06077500
Start: 2024-02-14End: 2027-04-01Updated: 2026-09-04
DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers
Active, not recruitingNCT06132113
Start: 2024-01-22End: 2027-12-31Updated: 2026-09-04
Phase 2
DAREON™-5: An open-label, multi-center Phase II dose selection trial of intravenous BI 764532, a DLL3-targeting T cell engager, in patients with relapsed/refractory extensive-stage small cell lung cancer and in patients with other relapsed/refractory neuroendocrine carcinomas
RecruitingCTIS2023-504247-13-00
Start: 2023-10-17Target: 100Updated: 2025-12-29
A Phase II, single-arm trial on the addition of the DLL3xCD3 bispecific T-cell engager obrixtamig (BI 764532) to standard-of-care platinum-based first-line treatment of advanced large-cell neuroendocrine carcinoma of the lung (ALPINE 2)
Not yet recruitingCTIS2025-524345-28-00
Target: 75Updated: 2026-08-31
Phase 3
DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.
Not yet recruitingCTIS2025-520565-51-00
Target: 105Updated: 2026-05-13
A Phase III, multi-center, open-label, randomised, controlled trial of intravenous obrixtamig in combination with carboplatin and etoposide vs. carboplatin and etoposide as first-line therapy in DLL3-positive patients with unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas.
Not yet recruitingCTIS2025-523869-22-00
Target: 86Updated: 2026-05-14