Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
Completed
Xcovery Holding Company, LLC
Phase 1/Phase 2
2012-06-01
This is the first human study to use X-396 (ensartinib), a drug being developed for treatment
of advanced cancers. The initial purpose of the study is to determine the largest amount of
X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended
Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor
activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide
early information on how the body handles the drug (pharmacokinetics) and on the efficacy of
X-396.
eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Active, not recruiting
Xcovery Holding Company, LLC
Phase 3
2016-06-01
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.
Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer
Completed
Cancer Research Institute, New York City
Phase 1/Phase 2
2017-05-10
This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with
ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed
cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive)
non-small cell lung cancer (NSCLC). Primary study objectives were to determine the
recommended combination dose (RCD) and safety and tolerability of the combination. Further
objectives were to evaluate the clinical efficacy and biologic activity of the combination.
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