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

StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 10 months later Feb 28, 2026 → Dec 31, 2026
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Record History

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  1. Primary completion pushed from Feb 28, 2026 to Dec 31, 2026 Show 7 more changesShow less
    • Enrollment increased: 100 → 300 participants
    • Study completion pushed from Jun 30, 2029 to Dec 31, 2029
    • Start date: Aug 7, 2024 to Nov 1, 2022
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 191 words
    • Study title expanded, about 5 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06907160
Lead Sponsor Yonsei University
Conditions
(from sponsor)		 Resectable Clinical Stage IB to III NSCLC
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov