Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06282536
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-21
Brief Title:
Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC A Single Arm Exploratory Trial
Sponsor:
Shanghai Pulmonary Hospital Shanghai China
Organization:
Shanghai Pulmonary Hospital Shanghai China
Study Overview
Official Title:
Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive Non-Small Cell Lung Cancer A Single Arm Exploratory Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
Fusion of anaplastic lymphoma kinase ALK is an important driving gene for NSCLC with an incidence rate of 3-7 In patients with advanced ALK mutation NSCLC first-line use of ALK inhibitors significantly improves progression free survival The perioperative research on ALK positive NSCLC was relatively late and currently most studies mainly focus on early to mid stage ALK positive NSCLC patients The results of two Phase III clinical trials showed that second-generation ALK targeted drugs neoadjuvant andor adjuvant therapy for ALK positive NSCLC significantly prolonged DFS in patients including increased pathological response rate median response duration and prolonged OS For ALK positive advanced NSCLC patients who are resistant to second-generation ALK targeted drugs there is currently limited exploration and there is an urgent need for new exploratory clinical studiesThis trial aims to evaluate the effectiveness of Iruplinalkib neoadjuvant therapy for potentially resectable ALK positive non-small cell lung cancer
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