癌研連線CancerLink
招募中 NCT07195695

Beamion LUNG-3 ：完全切除II-IIIB期NSCLC隐匿激活HER2 TKD突变患者的佐剂Zongertinib与标准治疗

非小细胞肺癌淋巴瘤神经内分泌肿瘤Phase IIIII 期III 期EGFRALKHER2

Beamion LUNG-3研究评估口服HER2靶向治疗药物zongertinib与完全切除II-IIIB期非小细胞肺癌（ NSCLC ）的成年人相比，能否改善肿瘤具有活化HER2酪氨酸激酶结构域（ TKD ）突变的标准辅助治疗结果。

适应症：Non-small Cell Lung Cancer

入组条件

纳入标准

  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  • Patients must be ≥18 years old or over the legal age of consent in their country
  • Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol
  • HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations
  • Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC
  • An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
  • Staging: Pretherapeutic classification not exceeding Stage IIIB
  • Performance status and organ function:
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

排除标准

  • Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
  • Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
  • Treatment with radiation therapy for primary NSCLC
  • Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))
  • Any investigational drug within 5 half-lives of the compound or any of its related material, if known
  • History or presence of
  • Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis
  • Active infectious disease requiring systemic therapy
  • Uncontrolled gastrointestinal disorders affecting drug intake/absorption
  • Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers

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。