Clinical trial NCT06907160: Exploratory Biomarker Analysis of Neoadjuvant Chemoimmunotherapy Followed by Pulmonary Resection in Stage II-III Non-Small Cell Lung Cancer
Official title: A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy in Stage II-III Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clinical Stage II to III Non-Small Cell Lung Cancer
Keywords: NSCLC
Neoadjuvant chemoimmunotherapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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 outcomes:
measure: 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.
timeFrame: Within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes:
measure: Progression-free survival
timeFrame: Defined as time from initiation of neoadjuvant therapy to first disease recurrence or death (whichever occurred first), assessed up to 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine
Study officials:
References: