進行中(不再收案) NCT02542293

Durvalumab 聯合 Tremelimumab 對比標準治療作為轉移性非小細胞肺癌(NSCLC)第一線治療的研究(NEPTUNE)

非小細胞肺癌淋巴瘤肉瘤Phase IIIIII 期IV 期EGFRALKPD-L1TMB

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。