Exploratory Biomarker Analysis of Neoadjuvant Chemoimmunotherapy Followed by Pulmonary Resection in Stage II-III Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Clinical Stage II to III Non-Small Cell Lung Cancer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy in Stage II-III Non-small Cell Lung Cancer
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University C — Seoul
Identifiers
NCT: NCT06907160 · 4-2024-0434