drugset / Trial / NCT02898116
Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer
Phase 1/2
Completed
2 enrolled
Ludwig Institute for Cancer Research
Cancer Research Institute, New York City · collabMedImmune LLC · collabXcovery Holdings, Inc. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-05-10
- Primary completion
- 2017-08-04
- Completion
- 2017-08-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Ensartinib | Small molecule | 150 mg | Oral |
| Subject | Ensartinib | Small molecule | 200 mg | Oral |
| Subject | Ensartinib | Small molecule | 225 mg | Oral |