Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT05503667
Status:
RECRUITING
Last Update Posted:
2022-08-17
First Post:
2022-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Furmonertinib Plus Bevacizumab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma
Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Organization:
Study Overview
Official Title:
Neoadjuvant Furmonertinib Plus Bevacizumab or Furmonertinib Monotherapy for Resectable and Potentially Resectable Stage III-IVA EGFR Mutation-Positive Lung Adenocarcinoma: A Randomized, Controlled, Open-label, Single-center Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2022-08
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:
To explore the efficacy and safety of neoadjuvant furmonertinib combined with bevacizumab in the treatment of resectable and potentially resectable stage III-IVA EGFR mutation-positive lung adenocarcinoma.
Detailed Description:
The best treatment for lung cancer is still radical resection, which is indicated for stage I-II and some stage III patients, but surgery is only suitable for 20-25% of NSCLC patients. Furmonertinib is a third-generation TKI drug. Compared with first and second-generation TKI drugs, it has good benefits in the Chinese population, patients with brain metastases, and patients with 19del/L858R mutation, with better and longer-lasting effects, and can significantly improve the progression-free survival of patients. Neoadjuvant therapy can shrink the tumor, increase the rate of complete surgical resection, remove micrometastases, and reduce the risk of recurrence. Cases of patients with locally advanced (IIIA-N2) NSCLC have been reported with neoadjuvant TKI therapy, and it has been found that neoadjuvant TKI therapy can downgrade or even complete tumor remission. However, for locally advanced potentially resectable, or EGFR mutation-positive NSCLC patients with single-organ metastasis, the efficacy of third-generation EGFR-TKI combined with VEFGR inhibitor combined with targeted therapy after induction and surgery is still unclear. Limited clinical research data suggest that this new treatment mode (induction therapy-surgery-adjuvant therapy) can significantly improve the progression-free survival of patients. However, the overall survival rate under the new treatment mode and the promotion of clinical work urgently need higher-level clinical evidence to support clinical decision-making.
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?: