Exploring biomarkers for neoadjuvant immunotherapy in lung cancer
A Biomarker Study for Predicting the Response of Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer Based on Circulating Tumor DNA and Homologous Recombination Deficiency Analysis
This study is trying to find out if certain biological markers in patients with advanced lung cancer can help predict how well a new immunotherapy treatment will work before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Geneplus-Beijing Co. Ltd. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05965557 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify predictive biomarkers for the efficacy of neoadjuvant immunotherapy in patients with non-small cell lung cancer (NSCLC) who are stage II-IIIB and driver-negative. It will prospectively collect data from patients scheduled for neoadjuvant immunotherapy and surgical resection, focusing on homologous recombination deficiency (HRD) as a potential biomarker. Additionally, blood samples will be analyzed for circulating tumor DNA (ctDNA) to assess its correlation with treatment efficacy and patient prognosis. The goal is to validate the predictive value of these biomarkers in a larger cohort.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with stage II-IIIB non-small cell lung cancer who are EGFR and ALK negative.
Not a fit: Patients with a history of other malignancies within the past 5 years or those with autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with lung cancer.
How similar studies have performed: While the approach of using HRD and ctDNA as predictive markers is promising, it requires validation in larger cohorts, indicating that this area is still under exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stage II-IIIB NSCLC * EGFR/ALK negative * The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up Exclusion Criteria: * A history of other malignancies within the past 5 years * Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy
Where this trial is running
Shanghai
- Shanghai Chest Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Shun Lu, PhD
- Email: shunlu@sjtu.edu.cn
- Phone: +86 18017321551
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.