A Study of ALK Inhibitor, Ensartinib, and Anti-PD-L1, Durvalumab, in Subjects With ALK-rearranged Non-small Cell Lung Cancer
This is an open-label, multicenter, single-arm study to evaluate the safety and preliminary efficacy of a targeted therapy for NSCLC in combination with a checkpoint inhibitor:
- Ensartinib (X-396), an anaplastic lymphoma kinase (ALK) Inhibitor and
- Durvalumab (MEDI4736), an anti-programmed cell death ligand 1 (PD-L1) antibody.
|Non-small Cell Lung Cancer Carcinoma NSCLC||Drug: Ensartinib Drug: Durvalumab||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 1/2 Study of ALK Inhibitor, Ensartinib (X-396), and Anti-PD-L1, Durvalumab (MEDI4736), in Subjects With ALK-rearranged (ALK-positive) Non-small Cell Lung Cancer (NSCLC)|
- Number of Adverse Events [ Time Frame: up to 17 months ]Clinical laboratory tests, vital signs and weight measurements, physical exams, ECG, Eastern Cooperative Oncology Group (ECOG) performance status evaluation, imaging scans and any other medically indicated assessments, including subject interviews, will be performed to detect new abnormalities and deterioration of any preexisting conditions. The Investigator will evaluate any laboratory abnormalities for clinical significance, and clinically significant abnormalities will be recorded as adverse events. All treatment-emergent clinically significant abnormalities and deterioration from time of signing the informed consent to the end of study visit will be recorded in the Case Report Forms (CRFs) as adverse events and graded according to the CTCAE Version 4.03.
- Progression Free Survival Rate [ Time Frame: up to 24 weeks ]
- Response Rate [ Time Frame: up to 24 weeks ]
- Overall Best Response [ Time Frame: up to 48 weeks ]
- Disease Control Rate (DCR) [ Time Frame: up to 48 weeks ]
- Duration of Response (DoR) [ Time Frame: up to 48 weeks ]
- Progression Free Survival (PFS) [ Time Frame: up to 5 years ]
- Overall Survival [ Time Frame: up to 5 years ]
|Actual Study Start Date:||March 1, 2017|
|Estimated Study Completion Date:||December 2023|
|Estimated Primary Completion Date:||May 2019 (Final data collection date for primary outcome measure)|
Experimental: Esartinib monotherapy
There will be a run-in period where ensartinib will be given as monotherapy for 2 cycles.
Subjects who do not qualify for combination treatment may continue on monotherapy.
Other Name: X-396
Experimental: Combination Treatment
Subjects who qualify for combination treatment will receive ensartinib (X-396) by mouth daily and durvalumab (MEDI4736) intravenously every 4 weeks.
Other Name: X-396Drug: Durvalumab
Other Name: MEDI4736
Please refer to this study by its ClinicalTrials.gov identifier: NCT02898116
|Contact: Kristen Aufieroemail@example.com|
|United States, Florida|
|Research Facility||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|United States, New York|
|New York, New York, United States, 10016|
|Study Chair:||Leena Gandhi, MD, PhD||Laura & Isaac Perlmutter Cancer Center|