Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05777278
Status:
RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-02-21
Brief Title:
Savolitinib Plus Docetaxel as 2L in EGFRALKROS1MET ex14m-wildtype NSCLC With MET Overexpression
Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Organization:
The First Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
A Prospective Study of Savolitinib Plus Docetaxel in Pretreated EGFRALKROS1MET ex14m-wildtype Advanced NSCLC Patients With MET Overexpression FirstMET
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 pilot single-arm single-center study exploring the efficacy and safety of savolitinib plus docetaxel as second-line therapy in patients with MET overexpressed EGFRALKROS1MET ex14m-wildtype advanced NSCLC
Participants will receive treatment of docetaxel 60 mgm2 ivgtt q3w in combination with savolitinib 300mg or 200mg according to safety run-in recommendation po BID after informed consent signed Treatment will continue until either objective disease progression unacceptable toxicity occurs consent is withdrawn other discontinuation criterion is met or study completion
Participants will receive treatment of docetaxel 60 mgm2 ivgtt q3w in combination with savolitinib 300mg or 200mg according to safety run-in recommendation po BID after informed consent signed Treatment will continue until either objective disease progression unacceptable toxicity occurs consent is withdrawn other discontinuation criterion is met or study completion
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?:
False
Is an FDA AA801 Violation?:
None