Exploring biomarkers in lung cancer treatment before surgery
A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy in Stage II-III Non-small Cell Lung Cancer
This study is testing if blood and tissue samples can help doctors figure out which patients with lung cancer will benefit from treatment before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06907160 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze tissue and blood-based biomarkers in patients with clinical stage II-III non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemoimmunotherapy followed by surgery. It will involve collecting clinical, pathological, and radiological data from a cohort of patients, along with plasma samples taken before and after the neoadjuvant treatment. The goal is to identify non-responders to immunotherapy at diagnosis and to predict pathological complete response using non-invasive blood tests.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old with histologically confirmed clinical stage II-III NSCLC and no driver mutations.
Not a fit: Patients under 19 years of age, those with serious medical conditions affecting compliance, or pregnant women may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for lung cancer patients, improving outcomes by identifying effective therapies early.
How similar studies have performed: Other studies have shown promise in using biomarkers for predicting treatment responses in lung cancer, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Tae Hee Hong
- Email: thhongcs@yuhs.ac
- Phone: (82)10-3487-6255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.