Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-23
Brief Title:
The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC
Status:
NOT_YET_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:
None
Brief Summary:
This study aimed to assess the value of dynamic ctDNA monitoring in guiding the development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC patients
Detailed Description:
This study aimed to prospectively enroll approximately 300 resectable stage II-IIIB T1-4N0-2M0 excluding T4 with invasion of vital structures and bulky or infiltrative N2 NSCLC patients with histologically confirmed EGFR 19del or L858R mutations Peripheral blood samples will be collected at baseline before neoadjuvant 3rd-generationEGFR TKI therapy and ctDNA levels will be quantitatively assessed For patients with positive baseline ctDNA peripheral blood will be collected again after 3 weeks of neoadjuvant TKI therapy to assess if ctDNA has turned negative and HRCT will be performed to evaluate the treatment efficiency simultaneously
In patients with positive baseline ctDNA for ctDNA-negative patients after 3 weeks of neoadjuvant TKI treatment radical resection surgery will be performed after continuing TKI treatment for 9-12 weeks Group A For ctDNA-positive patients after 3 weeks of neoadjuvant TKI treatment in combination with imaging changes in the lesions a multidisciplinary team MDT evaluation will be conducted After discussion between the attending physicians and the patient the subsequent treatment will either continue TKI treatment for 9-12 weeks Group B undergo 3 cycles of TKI plus chemotherapy Group C or undergo sequential neoadjuvant immunotherapy plus chemotherapy for 3 cycles Group D before radical resection surgeryThe study intends to evaluate the correlation between the rate of major pathological response MPR and ctDNA levels at 3 weeks after TKI treatment to compare the difference in pathological response between ctDNA-negative and ctDNA-positive groups after 3 weeks of neoadjuvant TKI treatment and to evaluate the guiding value of dynamic ctDNA monitoring during neoadjuvant therapy for optimizing subsequent treatments
In patients with positive baseline ctDNA for ctDNA-negative patients after 3 weeks of neoadjuvant TKI treatment radical resection surgery will be performed after continuing TKI treatment for 9-12 weeks Group A For ctDNA-positive patients after 3 weeks of neoadjuvant TKI treatment in combination with imaging changes in the lesions a multidisciplinary team MDT evaluation will be conducted After discussion between the attending physicians and the patient the subsequent treatment will either continue TKI treatment for 9-12 weeks Group B undergo 3 cycles of TKI plus chemotherapy Group C or undergo sequential neoadjuvant immunotherapy plus chemotherapy for 3 cycles Group D before radical resection surgeryThe study intends to evaluate the correlation between the rate of major pathological response MPR and ctDNA levels at 3 weeks after TKI treatment to compare the difference in pathological response between ctDNA-negative and ctDNA-positive groups after 3 weeks of neoadjuvant TKI treatment and to evaluate the guiding value of dynamic ctDNA monitoring during neoadjuvant therapy for optimizing subsequent treatments
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