A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib

A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator

本研究为一项单臂、开放标签、多中心II期临床试验。LDK378 750mg每日一次的给药方案将持续实施，直至患者出现不可耐受的毒性反应而无法继续治疗、经研究者或患者自主决定停止治疗、开始新的抗肿瘤治疗或死亡。若研究者判断患者存在临床获益证据，则即便经研究者评估符合实体瘤疗效评价标准（Response Evaluation Criteria in Solid Tumors, RECIST）定义的疾病进展（Progressive Disease, PD），仍可继续使用LDK378治疗。此类患者需按照既定评估计划继续开展肿瘤评估，直至LDK378治疗被永久终止。未出现疾病进展即停止研究药物治疗的患者，需继续接受肿瘤评估随访，直至经研究者评估确认出现疾病进展。