LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
Status:
Completed
Trial end date:
2018-01-22
Target enrollment:
Participant gender:
Summary
A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened
for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient
experienced unacceptable toxicity that precluded further treatment, discontinued treatment at
the discretion of the investigator or patient, started a new anticancer therapy and/or died.
LDK378 was 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.
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. Male and
female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were
screened for eligibility. Patients had to have received no prior crizotinib, and had to be
chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).