Clinical Research Directory

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

Sponsor: Yonsei University

Summary

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 be collected at several time points, including before and during neoadjuvant treatment, before surgery, and during follow-up after surgery. Treatment will not be changed by this study. Researchers will compare these test results with the response observed in the surgical specimen and with long-term outcomes such as cancer recurrence.

Official title: A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy in Stage IB-III Non-Small Cell Lung Cancer

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