癌研連線CancerLink
招募中 NCT07379476

局部消融治疗应用于EGFR突变非小细胞肺癌寡残留转移

非小细胞肺癌宫颈癌／妇科肿瘤黑色素瘤Phase IIIV 期EGFR

这是一项开放标签、多中心、随机第二期临床试验。患有IV期（AJCC第9版）非小细胞肺癌（NSCLC），带有EGFR外显子19缺失或外显子21 L858R突变，在接受第一线osimertinib治疗3至6个月后，具有少于或等于3个适合局部消融治疗（LAT）的活跃寡残留癌症部位（由医生判定）的患者，符合纳入条件。

适应症：Lung Cancer (NSCLC)

入组条件

纳入标准

  • years of age or older and able to understand and give written informed consent
  • Pathologically proven non-small cell lung cancer
  • Positive for EGFR exon 19 deletion or EGFR exon 21 L858R mutation (either by tissue or plasma testing)
  • Stage IV disease
  • Receive first line osimertinib monotherapy for stage IV disease
  • Undergo a PET-CT scan after 12-24 weeks of initiation of osimertinib treatment, with no evidence of disease progression, and less than or equal to 3 active disease sites (including primary tumour) amenable to local ablative therapy, as determined by investigator
  • At least one brain imaging (CT Brain or MRI Brain with contrast, preferably MRI Brain), either at time of diagnosis or while on osimertinib treatment but before randomization, to document CNS status for stratification. Patients with asymptomatic CNS metastases are eligible. For patients with brain metastases diagnosed at baseline, follow up brain imaging is recommended before randomization.
  • Patients with history of palliative radiotherapy are eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate haematological values: haemoglobin ≥9.0g/dL, absolute neutreophil count ≥1.0 x 109/L, platelet count ≥100 x 109/L
  • Adequate hepatic function: bilirubin ≤1.5 x ULN, AST/ALT ≤2.5 x ULN
  • Adequate renal function: creatinine clearance ≥30ml/min, according to the formula of Cockcroft-Gault equation
  • Willing and able to comply with the requirements and restrictions in this protocol

排除标准

  • Previous or concomitant malignancy within 5 years prior registration with the exception of adequately treated localized non-melanoma skin cancer or cervical cancer in situ.
  • Mixed SCLC and NSCLC histology
  • Positive pregnancy test
  • Contraindication to radiotherapy
  • Any serious underlying medical, psychiatric, psychological, familial condition that in the judgement of the investigator, that may interfere with planned staging, treatment and follow up, affect patient compliance, or place the patient at high risk from treatment related complications

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。