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。