LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.
Status:
Completed
Trial end date:
2018-05-24
Target enrollment:
Participant gender:
Summary
This was a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and
safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged
stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd
continued until the patient experienced disease progression as determined by the investigator
according to RECIST 1.1, unacceptable toxicity that precluded further treatment, pregnancy,
start of a new anticancer therapy, discontinued treatment at the discretion of the patient or
investigator, lost to follow-up, death, or study was terminated by Sponsor.