eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02767804
- Lead Sponsor
- Xcovery Holdings, Inc.
- Brief Summary
The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) 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.
- Detailed Description
To evaluate the efficacy and safety of X-396 (ensartinib) 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), to obtain additional pharmacokinetic (PK) data from sparse PK sampling, 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, and to obtain germline DNA samples for possible pharmacogenetic analysis in the event that outliers with respect to efficacy, tolerability/safety, or exposure are identified.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 290
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description X-396 (ensartinib) X-396 (ensartinib) Eligible patients with ALK+ NSCLC will receive oral X-396 (ensartinib) at 225mg QD with or without food until progression or unacceptable toxicity develops crizotinib crizotinib Eligible patients with ALK+ NSCLC will receive oral crizotinib at 250mg BID with or without food until progression or unacceptable toxicity develops
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 36 months as assessed by independent radiology review based on RECIST v. 1.1 criteria
- Secondary Outcome Measures
Name Time Method CNS response rate 36 months Based on IRR, time to CNS progression (based on IRR), objective response rate (based on IRR)
Overall survival (OS) 48 months Time in months from date of randomization to death due to any cause
ORR based on independent radiology review 36 months The proportion of patients in ITT who have an objective response (i.e., those who achieve a best response of CR or PR) per RECIST 1.1 criteria
Trial Locations
- Locations (69)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
University Cancer & Blood Center
🇺🇸Athens, Georgia, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Sanatorio Parque S.A.
🇦🇷Rosario, Argentina
Border Medical Oncology Research Unit
🇦🇺Albury, New South Wales, Australia
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Chris O Brien Lifehouse
🇦🇺Camperdown, Australia
Catholic University of Louvain (UCL) - Site Mont Godinne
🇧🇪Yvoir, Belgium
Instituto do Câncer do Estado de São Paulo
🇧🇷São Paulo, SP, Brazil
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