eligibility_summary
Adults (≥18) with metastatic, measurable SCCB or other high‑grade urinary‑tract neuroendocrine tumors (mixed histology, excludes prostate). Cohort 1: prior/ineligible for ICI, Cohort 2: ICI‑naive eligible. Prior/refused/ineligible platinum/etoposide. ECOG ≤2, adequate organs, stable CNS mets, controlled HIV/HBV/HCV, contraception. Exclude: recent therapy (<14d), prior lurbinectedin, drug allergy, active CNS mets, cohort 2 autoimmunity, prior transplant, live vaccine (<30d), pregnancy, severe illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: Lurbinectedin (IV chemotherapeutic, DNA-binding transcription inhibitor) given alone or with Avelumab (IV immunotherapy, anti–PD-L1 monoclonal antibody). Mechanisms: Lurbinectedin binds guanine residues in GC‑rich promoter regions, prevents transcription factor binding, suppresses oncogenic transcription, and induces tumor-cell apoptosis. Avelumab blocks PD‑L1, disrupting the PD‑1/PD‑L1 checkpoint to restore cytotoxic T‑cell antitumor activity. Targets: Tumor cell transcriptional machinery/oncogenic transcription programs in small cell and other high‑grade neuroendocrine carcinomas, PD‑L1 checkpoint pathway on tumor and immune cells, reactivating T‑cell–mediated killing.