Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:56 AM
Study NCT ID:
NCT06907160
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Biomarker Analysis of Neoadjuvant Chemoimmunotherapy Followed by Pulmonary Resection in Stage II-III Non-Small Cell Lung Cancer
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy in Stage II-III Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2025-03
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:
1. To explore tissue-based biomarkers to select patients who do not respond to neoadjuvant immunotherapy (non-responders) at the point of diagnosis
2. To explore blood-based non-invasive biomarkers to predict pathological complete response (pCR) before surgery
2. To explore blood-based non-invasive biomarkers to predict pathological complete response (pCR) before surgery
Detailed Description:
1. Construction of a neoadjuvant chemoimmuntherapy cohort of resectable stage 2-3 lung cancer patients and acquisition of clinical-pathological-radiological data.
2. Plasma from individual patient will be collected at preneoadjuvant and postneoadjuvant stages and ctDNA analysis will be performed.
2. Plasma from individual patient will be collected at preneoadjuvant and postneoadjuvant stages and ctDNA analysis will be performed.
Study Oversight
Has Oversight DMC:
True
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?: