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 聯合治療對比鉑類標準治療化療,用於表皮生長因子受體(EGFR)及間變性淋巴瘤激酶(ALK)野生型晚期或轉移性 NSCLC 患者第一線治療的療效與安全性。
適應症:Non Small Cell Lung Carcinoma 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
- 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
排除條件
- 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)
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。