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

NCT ID: NCT06907160

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-07

Study Completion Date

2029-06-30

Brief Summary

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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

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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.

Conditions

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Clinical Stage II to III Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neoadjuvant Immunotherapy

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Tae Hee Hong

Role: CONTACT

(82)10-3487-6255

Facility Contacts

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Tae Hee Hong

Role: primary

(82)10-3487-6255

Other Identifiers

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4-2024-0434

Identifier Type: -

Identifier Source: org_study_id

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