癌研連線CancerLink
招募中 NCT07379476

局部消融治療應用於EGFR突變非小細胞肺癌寡殘留轉移

非小細胞肺癌子宮頸癌／婦癌黑色素瘤Phase IIIV 期EGFR

這是一項開放標籤、多中心、隨機第二期臨床試驗。患有IV期（AJCC第9版）非小細胞肺癌（NSCLC），帶有EGFR外顯子19缺失或外顯子21 L858R突變，在接受第一線osimertinib治療3至6個月後，具有少於或等於3個適合局部消融治療（LAT）的活躍寡殘留癌症部位（由醫生判定）的患者，符合納入條件。

適應症：Lung Cancer (NSCLC)

收案條件

納入條件

  • 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

排除條件

  • 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

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。