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

A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy 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

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Tae Hee Hong; Phone Number: (82)10-3487-6255; Email: thhongcs@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine
    • Contact: Tae Hee Hong; Phone Number: (82)10-3487-6255; Email: thhongcs@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients who visited the Severance Hospital Lung Cancer Center Outpatient Clinic (Thoracic Surgery and Hematology Oncology) where the research team is affiliated will be registered after reviewing whether they meet the above selection/exclusion criteria by a researcher assigned by the research director.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Neoadjuvant Immunotherapy; Establishment of a neoadjuvant ICI treatment cohort for resectable stage II-III lung cancer patients and acquisition of clinical-pathological-radiological data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Within the first 30 days (plus or minus 3 days) after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. 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.	Defined as time from initiation of neoadjuvant therapy to first disease recurrence or death (whichever occurred first), assessed up to 36 months

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: NSCLC; Neoadjuvant chemoimmunotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 4-2024-0434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No