Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348927
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-30
Brief Title:
Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC
Sponsor:
Hunan Province Tumor Hospital
Organization:
Hunan Province Tumor Hospital
Study Overview
Official Title:
A Phase II Single-Arm Study Evaluating the 1st Line Efficacy and Safety of Sunvozertinib Plus Anlotinib in EGFR-Sensitive Mutations Combined With Co-Mutations Locally Advanced or Metastatic Non-Small Cell Lung Cancer NSCLC WUKONG-32
Status:
RECRUITING
Status Verified Date:
2024-09
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:
WUKONG-32
Brief Summary:
This is a phase II open-label single-arm single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer
Condition or disease Interventiontreatment Phase Non-Small Cell Lung Cancer Drug sunvozertinib Drug anlotinib Phase 2
Condition or disease Interventiontreatment Phase Non-Small Cell Lung Cancer Drug sunvozertinib Drug anlotinib Phase 2
Detailed Description:
This is a Phase II open-label single-arm single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with locally advanced or metastatic primary non-small cell lung cancer with EGFR-sensitive mutations combined with co-mutations Approximately 52 NSCLC patients with EGFR-sensitive mutations 19del L858R and T790M and co-mutations were enrolled and treated with sunvozertinib 300 mg once daily in combination with anlotinib 8 mg once daily for 2 weeks followed by a 1-week interruption until the patients experienced disease progression intolerable toxicity or met the criteria for discontinuation of the trial drug The primary endpoint was investigator-assessed PFS and secondary endpoints included ORR DCR OS and safety The study is expected to commence recruitment in mainland China in about April 2024 It is expected that the trial will end in April 2027
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