Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102928
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-22
Brief Title:
A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation
Sponsor:
Kunming Medical University
Organization:
Kunming Medical University
Study Overview
Official Title:
A Prospective Multicenter Single-arm Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced Non-small Cell Lung Cancer With EGFR 21L858R Mutation
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 study is a prospective multicenter single arm clinical study Thirty subjects who will have been diagnosed with locally advanced or metastatic non-small cell lung cancer with EGFR 21L858R mutation detected in lung cancer tissue or peripheral blood will be recruited and treated with anlotinib and aumolertinib The efficacy will be evaluated according to the Solid Tumor Efficacy Evaluation Standard RECIST 11 and evaluated every 6 to 8 weeks The survival status and adverse reactions of the subjects will be recorded The study will be terminated when the subjects experience disease progression or intolerable drug toxicity or the subjects withdraw their informed consent The main purpose of the study is to observe the efficacy and safety of the combined treatment regimen in such subjects The primary endpoint of the study is median progression free survival mPFS The secondary study endpoints are objective response rate ORR disease control rate DCR median overall survival time mOS and safety
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