Available IPD datapackage for study 'Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer Patients Previously Treated With Platinum-Based Chemotherapy and Crizotinib'

This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).

本项随机阳性对照多中心Ⅲ期开放标签临床试验，旨在对比评估阿来替尼（alectinib）与化疗对既往接受过化疗与克唑替尼（crizotinib）治疗的ALK阳性晚期非小细胞肺癌（NSCLC）患者的疗效，其疗效以研究者评估的无进展生存期（PFS）作为衡量指标；同时本研究还将对比两组患者中基线存在可测量中枢神经系统（CNS）转移灶者的中枢神经系统客观缓解率（C-ORR），该指标由独立评审委员会（IRC）评估。