Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02898116
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2016-09-08
Brief Title:
Phase 12 Study of Ensartinib and Durvalumab in ALK-rearranged Non-small Cell Lung Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
A Phase 12 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
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a Phase 12 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
Detailed Description:
Prior to initiation of combination therapy with ensartinib plus durvalumab subjects were enrolled sequentially to receive ensartinib monotherapy orally once daily during a pre-immunotherapy Run-in Period for one to two 28-day cycles The purpose of the Run-in Period was to determine whether any safety signals might compromise combination therapy and to determine the effect of ALK inhibitor therapy on the immune tumor microenvironment For subjects with no dose-limiting toxicity DLT during the Run-in Period combination therapy was then initiated during a dose-finding phase using a standard 3 3 design until determination of the RCD which was defined as the highest dose level at which 1 of 6 subjects ie 33 experienced DLTs during the first 2 cycles of combination treatment
A fixed dose of durvalumab 1500 mg by intravenous IV infusion every 4 weeks was administered in all cohorts Ensartinib dosing started at 200 mg with subsequent cohorts receiving a reduced 150 mg or escalated 225 mg ensartinib dose depending upon observed toxicity The study was then designed to include an expansion phase in which the RCD cohort would be expanded to a total of 20 subjects
Subjects were monitored for safety including immune-related adverse events disease status using the Response Evaluation Criteria in Solid Tumors RECIST version 11 and immune-related RECIST and biologic activity peripheral blood assays and immunological changes in the tumor microenvironment for the duration of study participation
A fixed dose of durvalumab 1500 mg by intravenous IV infusion every 4 weeks was administered in all cohorts Ensartinib dosing started at 200 mg with subsequent cohorts receiving a reduced 150 mg or escalated 225 mg ensartinib dose depending upon observed toxicity The study was then designed to include an expansion phase in which the RCD cohort would be expanded to a total of 20 subjects
Subjects were monitored for safety including immune-related adverse events disease status using the Response Evaluation Criteria in Solid Tumors RECIST version 11 and immune-related RECIST and biologic activity peripheral blood assays and immunological changes in the tumor microenvironment for the duration of study participation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None