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 + 标准治疗（SoC）化疗或 durvalumab 单药治疗 + SoC 化疗与单独 SoC 化疗相比，作为转移性非小细胞肺癌（NSCLC）患者第一线治疗的疗效和安全性，这些患者的肿瘤缺乏激活型表皮生长因子受体（EGFR）突变和间变性淋巴
适应症：Non Small Cell Lung Cancer 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.
- Histologically or cytologically documented Stage IV NSCLC.
- Confirmed tumor PD-L1 status prior to randomization.
- Patients must have tumors that lack activating EGFR mutations and ALK fusions.
- No prior chemotherapy or any other systemic therapy for metastatic NSCLC.
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines.
排除标准
- Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
- Active or prior documented autoimmune or inflammatory disorders.
- Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids.
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
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。