NCT06907160Recruiting
Prospective Observational Study of Baseline Tumor Genomic Profiling and Circulating Tumor DNA in Neoadjuvant Chemoimmunotherapy for Stage IB-III Non-Small Cell Lung Cancer
A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy in Stage IB-III Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 4 Dec 2024
- Start date
- 1 Nov 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Yonsei University
- Diseases
- Lung cancer
- NCT number
- NCT06907160
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Nov 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Age
- Under 19 years of age
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.