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Prospective Observational Study of Baseline Tumor Genomic Profiling and Circulating Tumor DNA in Neoadjuvant Chemoimmunotherapy for Stage IB-III Non-Small Cell Lung Cancer

Recruitingn/aAges 19 Years - anyAllYonsei University
NCT06907160 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to learn whether tests on tumor tissue and blood can predict how well patients with stage IB-III non-small cell lung cancer respond to chemotherapy combined with immunotherapy given before surgery (neoadjuvant chemoimmunotherapy). The main questions it aims to answer are: 1. Can tissue-based biomarkers, including genomic profiling of the tumor before treatment, identify at the time of diagnosis patients who are unlikely or likely to respond to neoadjuvant chemoimmunotherapy? 2. Can blood-based, non-invasive biomarkers, such as circulating tumor DNA, predict pathologic complete response (no remaining cancer cells in the surgical specimen) before surgery? Participants will receive neoadjuvant chemoimmunotherapy and surgery as part of their usual care. Tumor tissue obtained at diagnosis will be analyzed by genomic profiling, and blood samples will

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📋 Eligibility rules (as published)
Inclusion Criteria: * Histologically proven clinical stage IB-III non-small cell lung cancer * 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.
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What it tests

  • Not listed
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Where

1 site
Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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