进行中(不再招募) NCT06564844

一项第三期、随机研究:于完全肿瘤切除后,对ctDNA阳性或具高风险病理特征之第一期腺癌NSCLC参与者,评估辅助Dato-DXd联合Rilvegostomig或Rilvegostomig单药治疗对比标准治疗

非小细胞肺癌Phase IIII 期EGFRALK

这是一项第三期、随机、开放标签、多中心、全球性研究,评估于完全手术切除(R0)后,对ctDNA阳性(由申办方指定的ctDNA检测确定)或具有至少一项高风险病理特征之第一期腺癌NSCLC参与者,辅助Dato-DXd联合rilvegostomig对比标准治疗(SoC)的疗效与安全性。

适应症:Non-small Cell Lung Cancer

入组条件

纳入标准

  • Histologically documented treatment-naive Stage I (T \< 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
  • Complete surgical resection (R0) of the primary NSCLC
  • Unequivocal no evidence of disease at post-surgical
  • Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)
  • ECOG of 0 or 1, life expectancy of \> 6 months and complete recovery after surgery
  • Adequate bone marrow reserve and organ function

排除标准

  • Sensitizing EGFR mutation and/or ALK alteration
  • History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Significant pulmonary function compromise
  • History of another primary malignancy within 3 years (with exceptions)
  • Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease
  • Active or prior documented autoimmune or inflammatory disorders (with exceptions)
  • Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled
  • History of active primary immunodeficiency
  • Clinically significant corneal disease

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。