已完成 NCT03194893

Alectinib 用于间变性淋巴瘤激酶(ALK)阳性或转染期间重排(RET)阳性癌症患者的延伸研究

非小细胞肺癌淋巴瘤Phase IIIALKRET

本研究旨在为既往曾入组任何由 Roche 赞助的 alectinib 研究、且在母试验结束时仍从 alectinib 或 crizotinib 获得持续临床获益的 ALK 或 RET 阳性癌症参与者,继续提供 alectinib 或 crizotinib(如适用)治疗。

适应症:Neoplasms

入组条件

纳入标准

  • Participants enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible
  • Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form (eCRF)
  • For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the last dose of study drug
  • For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the last dose of study drug.

排除标准

  • Evidence of lack of clinical benefit in parent trial during the screening phase of this rollover study
  • Permanent discontinuation of alectinib or crizotinib for any reason during the parent study or before first dose of study drug in the rollover study
  • Evidence of an adverse event for which the parent protocol stipulates permanent discontinuation
  • Pregnant or breastfeeding women
  • Ongoing serious adverse event that has not resolved to baseline level or Grade ≤1 prior to first dose of study treatment in the rollover study
  • Treatment interruption for more than 21 days due to an adverse event since the last administration of alectinib or crizotinib in the parent trial. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator
  • Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib
  • Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; these conditions should be discussed with the participant before trial entry

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。