Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
Location status: Recruiting
Recruiting
NCT Number: NCT06907160
Exploratory Biomarker Analysis of Neoadjuvant Chemoimmunotherapy Followed by Pulmonary Resection in Stage II-III Non-Small Cell Lung Cancer
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
Recruiting
Interested in participating?
Request InfoKey information
Age range
19 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
- Construction of a neoadjuvant chemoimmuntherapy cohort of resectable stage 2-3 lung cancer patients and acquisition of clinical-pathological-radiological data.
- Plasma from individual patient will be collected at preneoadjuvant and postneoadjuvant stages and ctDNA analysis will be performed.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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.
Time frame: 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 outcomes
-
Progression-free survival
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Yonsei University
Other
Registry information
Official study title
A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy in Stage II-III Non-small Cell Lung Cancer
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2029
- First posted
- Apr 2, 2025
- Registry last updated
- Apr 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.