LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib
Status:
Completed
Trial end date:
2016-03-29
Target enrollment:
Participant gender:
Summary
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