MRD-guided postoperative monitoring and adaptive treatment for resectable NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective single-arm trial enrolling about 100 adults with stage IB-IIIA NSCLC who have received neoadjuvant immunotherapy with platinum-based chemotherapy and are undergoing radical surgery. Patients will have dynamic ctDNA MRD testing and pathological response assessment at several pre- and post-operative timepoints to decide on personalized follow-up and adjuvant therapy. The goal is to see if adjusting treatment based on MRD and pathology can improve 2-year recurrence-free survival after surgery. Adjuvant therapy will be added if there is no pathological complete response or if ctDNA remains detectable after neoadjuvant therapy or surgery. The study is led by Peking University People's Hospital and is conducted at that site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written informed consent.
2. Male or female, aged ≥ 18 and \< 85 years.
3. Radical resection performed, pathologic stage IB-IIIA (8th TNM) non-small-cell lung cancer.
4. Tumor tissue and blood samples obtainable at all protocol-specified time-points.
5. No pure ground-glass nodule on imaging.
6. Completed standard neoadjuvant immunotherapy combined with platinum-based chemotherapy.

Exclusion Criteria:

1. Postoperative pathology shows other than NSCLC, including but not limited to benign lesions, small-cell carcinoma, metastasis, or indeterminate/inadequate histology.
2. Insufficient or poor-quality blood or tissue samples.
3. Pure ground-glass nodule on imaging.
4. History of any malignancy within the past 5 years.
5. Contraindication to surgery preventing radical resection.
6. Non-radical (R2) resection.
7. Pathologic stage IIIB-N3, IIIC, or IV on paraffin sections.
8. Refusal or withdrawal of informed consent.
9. Any condition deemed unsuitable by the investigator (e.g., perioperative blood transfusion, severe psychiatric disorder precluding follow-up).

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Kezhong Chen
• Email: mdkzchen@163.com
• Phone: +86-010-88325983

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.