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Recruiting Observational

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

NCT06907160 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2024-08-07
Last updated
2025-04-02

Condition(s) studied

Clinical Stage II to III Non-Small Cell Lung Cancer

Study 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

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06907160 on ClinicalTrials.gov ↗ ← All trials in South Korea