Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923945
Status:
RECRUITING
Last Update Posted:
2021-09-02
First Post:
2021-05-30
Brief Title:
Savolitinib for Treating Locally Advanced or Metastatic Non-small Cell Lung Cancer NSCLC Patients
Sponsor:
Hutchison Medipharma Limited
Organization:
Hutchmed
Study Overview
Official Title:
A Multi-center Open-label Phase IIIb Confirmatory Clinical Trial to Evaluate the Efficacy Safety and Tolerability of Savolitinib in Treating Locally Advanced or Metastatic NSCLC Patients With MET Exon 14mutations
Status:
RECRUITING
Status Verified Date:
2021-08
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:
Treating Non-small Cell Lung Cancer NSCLC Patients with MET exon 14mutations with Savolitinib
Detailed Description:
This is a single-arm multi-cohort multi-center open-label phase IIIb clinical study The objective is to evaluate the efficacy and safety of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations The study involves a Screening Period a Treatment Period and a Follow-up Period It is planned that about 40 study sites will enroll 163 advanced or metastatic NSCLC patients with MET exon 14 mutations
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