Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05341583
Status:
RECRUITING
Last Update Posted:
2023-07-14
First Post:
2022-04-18
Brief Title:
Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase ALK Positive Non-small Cell Lung Cancer
Sponsor:
Betta Pharmaceuticals Co Ltd
Organization:
Betta Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase Ⅲ Double-blind Randomized Placebo-Controlled Study to Assess the Efficacy and Safety of Ensartinib Versus Placebo as Adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase ALK-Positive Stage IB- IIIB Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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 double-blind randomized placebo-controlled multicenter Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy
Detailed Description:
This is a double-blind randomized placebo-controlled multicenter Phase III study the primary endpoint is disease-free survival Participants in the experimental arm will receive Ensatinib at 225 mg orally once a day taken with or without food for 2 years Participants in the control arm will receive placebo at 225 mg orally once a day taken with or without food for 2 years Treatments will continue until disease recurrence meeting one of treatment discontinuation criteria eg patient decision adverse event pregnancy or achieving a maximum treatment duration of 2 years whichever occurs earlier At the time of treatment discontinuation participants will enter a survival follow-up until death withdrawal of consent or study closure whichever occurs earlier
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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