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

Yonsei University

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06907160

4-2024-0434

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Neoadjuvant Immunotherapy

Description:

Establishment of a neoadjuvant ICI treatment cohort for resectable stage II-III lung cancer patients and acquisition of clinical-pathological-radiological data