Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631989
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients with EGFRm Advanced Non-small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Multicenter Open Label Single-arm Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multicenter open label single-arm phase III clinical study of WSD0922-FU conducted in China including Part A dose escalation and expansion study and Part B dose extension To explore the safety tolerability pharmacokinetic characteristics and efficacy of WSD0922-FU in patients with non-small cell lung cancer NSCLC with C797S mutation after first-line third-generation EGFR-TKI resistance Osimertinib Almonertinib Furmonertinib Befotertinib
Detailed Description:
A multicenter open label single-arm phase III clinical study of WSD0922-FU conducted in China
To explore the safety tolerability pharmacokinetic characteristics and efficacy of WSD0922-FU in patients with non-small cell lung cancer NSCLC with C797S mutation after first-line third-generation EGFR-TKI resistance
To explore the safety tolerability pharmacokinetic characteristics and efficacy of WSD0922-FU in patients with non-small cell lung cancer NSCLC with C797S mutation after first-line third-generation EGFR-TKI resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None