Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06082635
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-10-08
Brief Title:
TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer NSCLC
Sponsor:
Shenzhen TargetRx Inc
Organization:
Shenzhen TargetRx Inc
Study Overview
Official Title:
A Multi-centered Randomized Open-label Phase III Study to Evaluate the Efficacy and Safety of TGRX-326 Comparing With Crizotinib in Patients of Advanced ALK-positive or Metastatic Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
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 multi-center randomized open-label Phase III clinical trial which compares the safety and efficacy of TGRX-326 with crizotinib in patients with ALK-positive advanced or metastatic NSCLC
Detailed Description:
This Phase III study aims to evaluate the safety profile and efficacy profile in patients with ALK-positive advanced or metastatic NSCLC and to compare the efficacy and safety of TGRX-326 with that of crizotinib The primary purpose of this study is to evaluate and compare the efficacy profile of TGRX-326 with crizotinib with progression-free survival PFS as evaluated by independent review committee IRC as end point Secondary objectives include comparing efficacy profile of other endpoints and safety profiles of the investigational drug with crizotinib Exploratory objective includes the evaluation of population pharmacokinetic PK profile of TGRX-326 and efficacy of TGRX-326 in ALK-positive advanced NSCLC patients determined as progressive disease after crizotinib treatment
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