Adaptive follow-up for early-stage NSCLC patients with no detectable MRD after surgery

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, 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• YSCH-01 Nebulized Therapy for Lung Metastases in NSCLC and Advanced Solid Tumors

  A first-in-human, early-phase study tests a nebulized therapy called YSCH-01 to see if it is safe and shows any signs of benefit for adults with NSCLC or other cancers that have spread to the lungs.

  Recruiting Early Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing · NCT07793500

• NXP900 with Lorlatinib in ALK-positive NSCLC

  This study tests whether adding NXP900 to lorlatinib helps people with ALK-positive non-small cell lung cancer who have already received prior therapy.

  Recruiting Phase 1 Nuvectis Pharma, Inc. · Fairfax, Virginia · NCT07784959

• First-line treatment with pembrolizumab, pemetrexed, and platinum with or without zoldonrasib for metastatic non-squamous NSCLC

  This trial tests whether adding zoldonrasib to standard pembrolizumab and platinum chemotherapy helps people with untreated metastatic non-squamous NSCLC that has a RAS G12D mutation.

  Recruiting at 4 sites Phase 3 Revolution Medicines, Inc. · Anchorage, Alaska and 3 other locations · NCT07777822

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.