已完成 NCT04087473

ALK抑制剂耐药NSCLC的血浆分子图谱分析

非小细胞肺癌淋巴瘤不适用III 期IV 期ALK

研究人员计划通过血浆进行全面的分子图谱分析,主要目的是利用此分析形式指导后续治疗选择。本研究将有助于更深入了解亚洲肺癌治疗中ALK耐药的情况,并通过将继发突变与能提供最大覆盖范围的ALK抑制剂进行「配对」,最终带来持久的疗效,从而改善临床结局。

适应症:Non-small Cell Lung Cancer、ALK-Positive Lung Cancer

入组条件

纳入标准

  • 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

排除标准

  • 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

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。