Adaptive follow-up for early-stage NSCLC patients with no detectable MRD after surgery
A Prospective Multicenter Randomized Controlled Study of Adaptive Therapy in Resected Stage ⅠA2-Ⅱ NSCLC Patients With Undetectable MRD
This trial will test whether people with resected early-stage NSCLC who have two post-surgery ctDNA tests showing no detectable MRD can safely skip standard adjuvant therapy and be closely monitored instead.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06924710 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, randomized controlled trial enrolling patients with completely resected stage IA2–II non–small cell lung cancer who have two consecutive undetectable circulating tumor DNA (ctDNA) MRD tests after surgery (first at 3–7 days, second at 1 month). Eligible patients are randomized to receive conventional adjuvant therapy or an adaptive approach that omits immediate adjuvant treatment and relies on close MRD and imaging surveillance every 3 months for two years. Patients in the adaptive arm will start treatment if MRD becomes detectable or imaging demonstrates recurrence. The trial will compare recurrence and survival outcomes between the two groups to determine whether MRD-guided omission of adjuvant therapy is safe.
Who should consider this trial
Good fit: Ideal candidates are people with completely resected stage IA2–II NSCLC, ECOG performance status 0–1, anticipated survival ≥24 months, two consecutive undetectable post-surgery MRD (ctDNA) tests, and willingness to attend MRD monitoring every 3 months for two years.
Not a fit: Patients with detectable MRD after surgery, prior radiotherapy or chemotherapy, a recent other malignancy, or unstable systemic disease are unlikely to benefit from this MRD-guided omission approach.
Why it matters
Potential benefit: If successful, some patients could avoid adjuvant chemotherapy or radiation and their side effects without increasing the risk of cancer recurrence.
How similar studies have performed: Previous research shows ctDNA-based MRD predicts recurrence risk in NSCLC, but using MRD to safely omit adjuvant therapy is still relatively unproven and remains under active study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stage IA2-II non-small cell cancer patients who after complete resection. * Two-round MRD tests confirm landmark undetectable MRD * Expected survival ≥24 months * ECOG PS 0-1 * Willing to accept MRD monitoring every 3 months for a total of 2 years after surgery Exclusion Criteria: * Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy * Patients with a history of other malignancies in the past 5 years * Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.) or other conditions that investigators considered would limit the ability of the patient to participate in the study
Where this trial is running
Beijing, Beijing Municipality
- Peking University Cancer Hospital & Institute — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Shaohua Ma, M.D. — Peking University Cancer Hospital & Institute, Beijing 100142, China
- Study coordinator: Luyan Shen, Ph.D.
- Email: shenluyan@pku.edu.cn
- Phone: 86-1581140843
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.