Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05186506
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-01-11
First Post:
2021-12-29
Brief Title:
A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer
Sponsor:
Sichuan University
Organization:
Sichuan University
Study Overview
Official Title:
A Phase II Open-Label Randomized Study to Evaluate the Efficacy and Safety of Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-12
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 randomized active-controlled multicenter open-label Phase II study is designed to evaluate the efficacy and safety of ensatinib compared with Platinum-Based Chemotherapy as adjuvant treatment in ALK fusion positive II-IIIA stage non-small cell lung cancer after surgical resection
Detailed Description:
Participants in the experimental arm will receive Ensatinib at 225 mg orally once a day QD taken with food for 2 years Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles 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 At the time of disease recurrence 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