Monitoring minimal residual disease in patients with stage III non-small cell lung cancer

A Study Evaluating MRD Biomarker in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer

This study is testing if tracking tiny amounts of cancer DNA in the blood can help predict the chances of recurrence in patients with stage III non-small cell lung cancer who are eligible for surgery.

Quick facts

• Study type: Observational
• Enrollment: 65 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06081777 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the significance of monitoring minimal residual disease (MRD) in patients with potentially resectable stage III non-small cell lung cancer (NSCLC) who do not have EGFR or ALK mutations. A total of 65 patients will be enrolled, and their peripheral blood samples will be collected at various stages, including after neoadjuvant therapy, surgery, and during follow-up. The study will utilize high-throughput sequencing to analyze ctDNA and evaluate the risk of cancer recurrence over a follow-up period of two years. The goal is to explore the potential of MRD biomarkers in predicting patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with stage III non-small cell lung cancer who are eligible for surgery and do not have EGFR or ALK mutations.

Not a fit: Patients with other malignant tumors or those unable to comply with the study's follow-up requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the ability to predict cancer recurrence in patients with stage III NSCLC, leading to better management and treatment strategies.

How similar studies have performed: Other studies have shown promise in using ctDNA monitoring for cancer recurrence prediction, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Capable of giving signed informed consent, age ≥ 18 and ≤ 80.
2. patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities.
3. No driving gene EGFR/ALK mutation.
4. PS = 0-1.
5. the treatment process cooperated with the provision of clinicopathological and imaging data needed in the research process, followed up and collected the blood of the clinical efficacy evaluation nodes, and agreed to use the test data for follow-up research and product development.

Exclusion Criteria:

1. patients suffering from other malignant tumors.
2. patients change the treatment regimen before receiving the specified treatment or before the disease progresses.
3. Patients could not cooperate with the study for follow-up according to the defined clinical follow-up period;
4. Patients were unable to accept or provide imaging and other designated therapeutic evaluation means.

Where this trial is running

Beijing

• Yuyan Wang — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Yuyan Wang, doctorate — Peking University Cancer Hospital & Institute
• Study coordinator: Yuyan Wang

Conditions NSCLC; MRD, potentially resectable NSCLC, stage III