这是一项随机、开放标签、多中心、全球性第三期研究,旨在确定 durvalumab + tremelimumab 联合治疗对比铂类标准治疗化疗,用于表皮生长因子受体(EGFR)及间变性淋巴瘤激酶(ALK)野生型晚期或转移性 NSCLC 患者第一线治疗的疗效与安全性。
适应症:Non Small Cell Lung Carcinoma NSCLC
入组条件
纳入标准
- For inclusion in the study, patients should fulfill the following criteria:
- Aged at least 18 years
- Documented evidence of Stage IV NSCLC
- No activating EGFR mutation or ALK rearrangement
- No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
- World Health Organization (WHO) Performance Status of 0 or 1
- No Prior exposure to Immune Mediated Therapy (IMT), including, but not limited to, other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, excluding therapeutic anticancer vaccines
排除标准
- Mixed small cell lung cancer and NSCLC histology, sarcomatoid variant
- Brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment.
- Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's disease, ulcerative colitis)
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。