Exploratory Biomarker Analysis of Neoadjuvant Chemoimmunotherapy Followed by Pulmonary Resection in Stage II-III Non-Small Cell Lung Cancer

Recruiting

• Conditions: Clinical Stage II to III Non-Small Cell Lung Cancer

• Registration Number: NCT06907160
• Lead Sponsor: Yonsei University

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

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.

Study Timeline

• Study Start: 2024-08-07
• Study First Submitted: 2024-12-04
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-02-28
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Histologically proven clinical stage II-III lung cancer patients
• No driver mutations (EGFR mutation and ALK alteration)
• Whole body performance (ECOG) 0-1
• Those over 19 years of age
• Subject who submitted Informed consent form

Exclusion Criteria

• Under 19 years of age
• If there is a history of causing infection or other serious medical problems that impair the patient's function and make it difficult to comply with the study protocol.
• Patients for whom the investigator determines that the patient should not participate in the clinical trial because the patient is judged to be unable to comply with the clinical trial procedures and requirements (a person lacking medical capacity)
• Other patients (pregnant women, etc.) determined by the clinical trial director to be unsuitable for this clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic response after surgery, assessed according to IASLC pathologic response criteria, including major pathologic response and pathologic complete response in resected specimens following neoadjuvant CIT.	Within the first 30 days (plus or minus 3 days) after surgery	Pathologic response after surgery will be assessed according to the IASLC pathologic response criteria in resected tumor specimens following neoadjuvant CIT.; Pathologic Complete Response (pCR): No residual viable tumor cells (0% viable tumor).; Major Pathologic Response (MPR): ≤10% residual viable tumor cells. Evaluation Method: Pathologic response will be determined by histopathological examination of the resected tumor tissue, with tumor regression grading based on hematoxylin and eosin (H\&E) staining.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Defined as time from initiation of neoadjuvant therapy to first disease recurrence or death (whichever occurred first), assessed up to 36 months	Defined as time from initiation of neoadjuvant therapy to first disease recurrence or death (whichever occurred first), assessed up to 36 months.; Recurrence was defined as a diagnosis of metastatic disease, new locoregional disease, or any additional treatments for NSCLC after a 90-day treatment-free interval (to indicate the end of primary treatment and serve as a proxy for disease-free state postsurgery) starting right after initial surgery.

Trial Locations

Locations (1)

Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of