癌研連線CancerLink
进行中（不再招募） NCT05048797

一项研究，探讨 trastuzumab deruxtecan 作为带 HER2 突变的不可切除、局部晚期/转移性非小细胞肺癌第一线治疗选择的疗效及安全性

非小细胞肺癌Phase IIIIII 期IV 期EGFRALKHER2

DESTINY-Lung04 将探讨 trastuzumab deruxtecan（T-DXd）对比标准治疗（SoC）作为带 HER2 外显子 19 或 20 突变的非小细胞肺癌（NSCLC）第一线治疗的疗效及安全性

适应症：Locally Advanced or Metastatic Non-Small Cell Lung Cancer

入组条件

纳入标准

  • 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

排除标准

  • 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

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。