這是一項隨機、開放標籤、多中心、全球性第三期研究,旨在確定 durvalumab + tremelimumab 聯合治療 + 標準治療(SoC)化療或 durvalumab 單藥治療 + SoC 化療與單獨 SoC 化療相比,作為轉移性非小細胞肺癌(NSCLC)患者第一線治療的療效和安全性,這些患者的腫瘤缺乏激活型表皮生長因子受體(EGFR)突變和間變性淋巴
適應症:Non Small Cell Lung Cancer NSCLC
收案條件
納入條件
- 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.
排除條件
- 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.
收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。