已完成 NCT04087473

ALK抑制劑耐藥NSCLC的血漿分子圖譜分析

非小細胞肺癌淋巴瘤不適用III 期IV 期ALK

研究人員計劃透過血漿進行全面的分子圖譜分析,主要目的是利用此分析形式指導後續治療選擇。本研究將有助於更深入了解亞洲肺癌治療中ALK耐藥的情況,並透過將繼發突變與能提供最大覆蓋範圍的ALK抑制劑進行「配對」,最終帶來持久的療效,從而改善臨床結局。

適應症:Non-small Cell Lung Cancer、ALK-Positive Lung Cancer

收案條件

納入條件

  • Patients with advanced ALK fusion oncogene positive lung adenocarcinoma that have progressed after 1-2 ALK inhibitors, with at least one prior line of 2nd generation ALKi (i.e. Ceritinib, Alectinib, Brigatinib or Ensartinib)
  • The availability of sufficient plasma
  • Age ≥ 21 years
  • WHO performance status ≤ 2
  • Life expectancy of ≥ 21 weeks
  • Patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment):
  • Adequate bone marrow function as shown by: ANC ≥ 1.0x10\^9/L, Platelets ≥ 75x10\^9/L, Hb ≥ 7.5 g/dL
  • Alanine aminotransferase (ALT) and aspirate aminotransferase (AST) normal range (or ≤ 3.0xULN if liver metastases are present)
  • Willing to provide signed informed consent
  • Patients whom do not fulfill the above criteria may be discussed on a case-by-case basis within the study team, for potential enrolment

排除條件

  • Received more than 2 prior ALK inhibitors (ALKi)
  • Symptomatic or uncontrolled brain metastases requiring concurrent treatment inclusive but not limited to surgery and radiation. Stable/ tailing doses of corticosteroids is permitted

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。