LDK378 in Crizotinib na�ve Adult Patients With ALK-activated Non-small Cell Lung Cancer

A single-arm, open-label, two-stage multicenter, phase II study. Patients will be pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd will continue until the patient experiences unacceptable toxicity that precludes further treatment, discontinues treatment at the discretion of the investigator or patient, starts a new anticancer therapy and/or dies. LDK378 may be continued beyond RECIST defined PD as assessed by the investigator, if in the judgment of the investigator, there is evidence of clinical benefit. Patients who discontinue the study medication in the absence of progression will continue 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 NSCLC will be screened for eligibility. Patients must have received no prior crizotinib, and must be chemotherapy-naïve or have been pretreated with cytotoxic chemotherapy (up to three prior lines)


Study Type: Interventional
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
Enrollment: 126
Study Start Date: August 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental: LDK378 (Oral LDK378 750 mg once daily)