DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy
18 Years and older, Male and Female
1438-0011 (primary)
NCI-2026-05224
2025-523869-22
2025-523869-22-00
U1111-1328-6623
Summary
This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The
purpose of this study is to find out if a study medicine called obrixtamig plus standard
chemotherapy (carboplatin and etoposide) improves survival when compared to standard
chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule
that may help the immune system fight cancer. Another purpose of the study is to test a
medical device being developed to measure levels of the tumour marker delta-like ligand 3
(DLL3).
Participants are put into 2 groups randomly, which means by chance. One group (treatment
arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to
3 years. The other group (control arm) receives standard chemotherapy without obrixtamig
for about 4 months. All treatments are given as infusions into a vein.
During the study, participants in both groups visit the study site regularly.
Participants in the treatment arm stay overnight at the study site following the first 2
obrixtamig treatments. The doctors regularly check participants' health and take note of
any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The
results are compared between the 2 groups to see whether the treatment works.
Eligibility
- Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 >20% or mitotic rate mitotic rate with number of mitoses >20 per 2 mm2, regardless of primary site (including site of unknown origin)
- Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue
- No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease
- Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg/m2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg/m2) prior to randomisation
- Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)
- Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Male or female participants =18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.
Treatment Sites in Georgia
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