Clinical Trials Search
Clinical Trial 18677
Interventions:Crizotinib; X-396 (Ensartinib); Xalkori (Crizotinib)
Study Type: Treatment
Phase of Study: Phase III
- Alberto Chiappori
XALT3: Phase 3 Randomized Study Comparing X-396 to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients
The primary purpose of this study is to evaluate the efficacy and safety of ensartinib (X-396) ) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.
Primary: *To evaluate the efficacy and safety of X-396 vs. crizotinib in patients with ALK-positive NSCLC that have received up to 1 prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI). Secondary: *To obtain additional pharmacokinetic (PK) data on X-396 from sparse PK sampling from patients at selected sites. Exploratory: *To compare the quality of life (QoL) in patients receiving X-396 vs. crizotinib. *To evaluate the status of exploratory biomarkers and correlate with clinical outcome. *To obtain germline DNA samples for possible pharmacogenetic analysis in the event that outliers with respect to efficacy, tolerability/safety, or exposure are identified.