Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer
Status:
Completed
Trial end date:
2017-08-04
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborators:
Cancer Research Institute, New York City MedImmune LLC Xcovery Holding Company, LLC