癌研連線CancerLink
招募中 NCT07472517

DAREON ® -Lung-1 ：一项针对晚期小细胞肺癌患者的研究，比较Obrixtamig Plus Atezolizumab、Carboplatin和依托泊苷治疗与标准化学免疫疗法的比较

肺癌Phase IIIIII 期IV 期

本研究对患有晚期小细胞肺癌（ SCLC ）的成年人开放。本研究的目的是了解一种名为obrixtamig加标准治疗（阿特珠单抗、卡铂和依托泊苷）的研究药物与单独的标准治疗相比是否能改善生存期。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：Small Cell Lung Cancer (SCLC)、Extensive-stage Small Cell Lung Cancer (ES-SCLC)

入组条件

纳入标准

  • Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)
  • Patients without any previous systemic anti-cancer treatment for ES-SCLC. Patients who received previous systemic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC.
  • 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 and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation.
  • Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:
  • Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation
  • Untreated brain metastases that do not require treatment and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy

排除标准

  • Presence of leptomeningeal disease and/or carcinomatous meningitis
  • Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)
  • Radiotherapy of any anatomical site within 7 days prior to randomisation
  • Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline. Patients with alopecia, any grade, CTCAE ≤Grade 2, asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE Grade ≤2 peripheral neuropathy, and/or CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment may be eligible. Note: Patients who developed toxicity from the cycle of standard therapy received prior to randomisation are eligible if adequate organ function is ensured as described
  • Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so.

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。