Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05241028
Status:
RECRUITING
Last Update Posted:
2023-10-10
First Post:
2022-01-24
Brief Title:
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
Sponsor:
Hebei Medical University Fourth Hospital
Organization:
Hebei Medical University Fourth Hospital
Study Overview
Official Title:
Adjuvant Therapy of Ensatinib in Patients With Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer a Prospective Multi-center Single-arm Exploratory Study
Status:
RECRUITING
Status Verified Date:
2023-10
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 is a prospective multi-center single-arm phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer NSCLC with positive ALK-fusion Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity following complete tumour resection with or without adjuvant standard chemotherapy
Detailed Description:
None
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