eligibility_summary
Eligible: adults with locally advanced/metastatic NEC (extrapulmonary, pulmonary LCNEC, unknown primary), mixed histology if NEC/small-cell ≥50%, ECOG 0–1, life exp ≥12 wks, measurable lesion, stable CNS mets (no RT ≤7 d, off steroids/anti-convulsants ≥7 d). Exclude: prior treatment in this trial, other trials ≤30 d, Merkel cell, medullary thyroid, or grade 3 NET, leptomeningeal disease, prior DLL3 TCE/cell therapy, extensive RT ≤2 wks, major surgery ≤28 d, other malignancy ≤5 yrs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06132113 (DAREON-7) tests BI 764532 (Obrixtamig) plus standard platinum–etoposide in first‑line DLL3‑positive advanced neuroendocrine carcinomas. BI 764532 is an immunotherapy: a DLL3×CD3 bispecific T‑cell engager antibody that binds DLL3 on tumor cells and CD3 on T cells to activate cytotoxic T‑cell killing. Chemotherapies: carboplatin or cisplatin (platinum DNA cross‑linking agents) and etoposide (topoisomerase II inhibitor causing DNA strand breaks). Targets/pathways: DLL3 (a Notch pathway ligand) on NEC cells, CD3/T‑cell activation to mediate immune cytotoxicity, DNA damage pathways via platinum cross‑links and topo II inhibition. The study escalates BI 764532 dose and explores combinations for tolerability and activity.