Selective lymph node removal for small non-small cell lung cancer
Official title: Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm: a Prospective, Single-arm, Multi-center, Phase Ⅱ Trial
Run by Fudan University · NCT06634979 · Data updated 2026-11-12
This study is testing a new surgery method that aims to safely remove fewer lymph nodes in patients with small non-small cell lung cancer to see if it leads to better recovery and fewer complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 684 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | May 1, 2026 |
| Study ends | May 1, 2029 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT06634979 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with surgically resectable cT1N0M0 invasive NSCLC and specific tumor characteristics.
✕Probably not a fit
Patients with lung cancer that does not meet the specific CTR and size criteria or those requiring complete surgical resection may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the safety and efficacy of a selective lymph node dissection strategy for patients with invasive non-small cell lung cancer (NSCLC) that have a central tumor ratio (CTR) between 0.5 and 1 and a diameter of 2 cm or less. The approach aims to minimize trauma by avoiding unnecessary lymph node removal based on tumor location and characteristics. The study builds on previous findings that certain tumor types and locations are less likely to metastasize, allowing for a more tailored surgical approach. By validating this selective strategy, the study seeks to improve patient outcomes while reducing surgical complications.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive surgeries and improved recovery for patients with early-stage lung cancer.
How similar studies have gone: Previous studies have indicated the feasibility of selective lymph node dissection in similar patient populations, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Volunteer to participate in a clinical study and be willing to follow and have the ability to complete all trial procedures; * Age 18-80 years at time of signing informed consent (including threshold); * ECOG score 0 or 1; * No previous surgery for lung cancer; * Intraoperative or postoperative pathologically confirmed non-small cell lung cancer; * Single pulmonary nodule with mixed ground glass on CT, or multiple pulmonary nodules but the main lesion is the above nodules; * The proportion of solid components of the nodule is between 0.5 and 1, and the total size of the nodule is less than or equal to 2 cm; * Patients with clinical stage T1N0M0 surgically resectable; * Primary treatment without radiotherapy or chemotherapy. Exclusion Criteria: * T1N0M0 with a clinical stage other than 0.5 \< CTR \< 1 and a diameter of ≤ 2 cm; * Inability to perform complete surgical resection; * cytology or histopathology confirms that it is a lung malignant tumor other than non-small cell lung cancer; * Previous surgery for lung cancer; * Patients who have received radiotherapy or chemotherapy for non-primary treatment.
Where it's running
-
Fudan University Shanghai Cancer Center
Shanghai, China Recruiting
Study contacts
- Principal investigator: Haiquan Chen — Fudan University
- Study coordinator: Penghao Deng
- Email: 18301050196@fudan.edu.cn
- Phone: +86-13278979834
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.