癌研連線CancerLink
進行中（不再收案） NCT05048797

一項研究，探討 trastuzumab deruxtecan 作為帶 HER2 突變的不可切除、局部晚期/轉移性非小細胞肺癌第一線治療選擇的療效及安全性

非小細胞肺癌Phase IIIIII 期IV 期EGFRALKHER2

DESTINY-Lung04 將探討 trastuzumab deruxtecan（T-DXd）對比標準治療（SoC）作為帶 HER2 外顯子 19 或 20 突變的非小細胞肺癌（NSCLC）第一線治療的療效及安全性

適應症：Locally Advanced or Metastatic Non-Small Cell Lung Cancer

收案條件

納入條件

  • Participants at least 18 years of age
  • Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease
  • Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA
  • Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • Measurable disease assessed by Investigator based on RECIST 1.1
  • Protocol-defined adequate organ function including cardiac, renal, hepatic function
  • ECOG 0-1
  • Having tumour tissue available for central testing

排除條件

  • Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy)
  • Any untreated brain metastases, including asymptomatic or clinically inactive brain metastases
  • Active autoimmune or inflammatory disorders
  • Medical history of myocardial infarction within 6 months prior to randomization
  • History of non-infectious pneumonitis/ILD, current or suspected ILD
  • Lung-specific intercurrent clinical significant severe illness
  • Contraindication to platinum-based doublet chemotherapy or pembrolizumab

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。