Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300424
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-03
Brief Title:
Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Neoadjuvant Almonertinib Followed by Adebrelimab-based Chemo-immunotherapy in II-IIIB EGFR-mutant Non-small Cell Lung Cancer a Single Arm Phase II Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
NEOVADE
Brief Summary:
Phase II single-arm open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery adjuvant treatment was upon investigators decisions
Detailed Description:
This study plans to include 32 eligible II-IIIB non small cell lung cancer NSCLC patients will receive 6 weeks of almonertinib and to avoid overlap of interstitial lung disease ILD and immune-related pneumonitis 2 weeks of washout period was designed before 3 cycles of adebrelimab doublet platinum-based chemotherapy is administered Dynamic blood samples before during or after neoadjuvant treatment will be obtained for exploratory analysis Patients with local disease and resectable or potentially resectable NSCLC will receive anatomic resection Patients who progress upon neoadjuvant treatment and further assessed as unresectable disease will be scheduled for local radiation or other potential subsequent treatment regarding multidisciplinary discussion After completion of local treatment surgery or radiation patients will undergo optional adjuvant treatment including epidermal growth factor receptor tyrosine kinase inhibitor EGFR-TKI or immunotherapy upon investigators consideration or CT surveillance Patients will be follow-up within 5 years after surgery The primary endpoint of this study is major pathological response MPR defined as no more than 10 residual tumor found in primary lung cancer as per International Association for the Study of Lung Cancer IASLC criteria
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