Ignite Creation Date:
2024-05-06 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05351320
Status:
RECRUITING
Last Update Posted:
2022-04-28
First Post:
2022-04-24
Brief Title:
WX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC
Sponsor:
Jinming Yu
Organization:
Shandong Cancer Hospital and Institute
Study Overview
Official Title:
A Phase II Study of WX-0593 Combined With Concurrent Chemoradiotherapy in the Treatment of Unresectable Locally Advanced Non-small Cell Lung Cancer NSCLC With Activating Mutation of ALK or ROS1
Status:
RECRUITING
Status Verified Date:
2022-04
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:
The aim of this trial is to evaluate the safety of WX-0593 combined with concurrent chemoradiotherapy in unresectable locally advanced non-small cell lung cancer NSCLC with activating mutation of ALK or ROS1 This trial consists of two parts In Part 1 approximately 8 patients will be included and receive WX-0593 maintenance until disease progression or unacceptable toxicity In Part 2 approximately 32 patients will be included and receive WX-0593 monotherapy for 1-2 cycles and subsequently with concurrent chemoradiation followed by WX-0593 maintenance until disease progression or unacceptable toxicity
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