癌研連線CancerLink
招募中 NCT07544654

DAREON ® -NEC-1 ：一项针对晚期肺外神经内分泌癌(epNEC)患者的研究，比较Obrixtamig加卡铂和依托泊苷治疗与标准化疗

前列腺癌甲状腺癌神经内分泌肿瘤Phase IIIIII 期IV 期PD-L1

本研究对患有晚期肺外神经内分泌癌的成年人开放。本研究的目的是找出与单独使用标准化疗（卡铂和依托泊苷）相比，一种名为obrixtamig加标准化疗（卡铂和依托泊苷）的研究药物是否能改善生存期。Obrixtamig是一种类似抗体的分子，可能有助于免疫系统对抗癌症。

适应症：Extrapulmonary Neuroendocrine Cancer (epNEC)

入组条件

纳入标准

  • 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

排除标准

  • Presence of leptomeningeal disease and/or carcinomatous meningitis
  • Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma
  • Patients with neuroendocrine prostate cancer
  • Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition
  • Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)
  • Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
  • Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。