Left-lung cancer: is removing station 4L lymph nodes necessary for early-stage tumors?
Official title: A Multicenter Prospective Randomized Controlled Trial of Station 4L Lymph Node Dissection Versus No Dissection in Clinical Stage I Solid Nodule-Type Invasive Non-Small Cell Lung Cancer
Run by Fudan University · NCT07801430 · Data updated 2026-11-12
In adults with a small, single solid tumor in the left lung, the study tests whether skipping station 4L lymph node dissection during surgery is as safe as doing it.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 384 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Xuhui) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | December 15, 2028 |
| Study ends | December 15, 2030 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07801430 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–75 with a single left-lung solid nodule (consolidation-to-tumor ratio 1.0) and resectable clinical stage I NSCLC (T1–T2aN0M0) planning lobectomy or segmentectomy with complete lymph node dissection.
✕Probably not a fit
Patients whose cancer behaves aggressively or has occult nodal disease may not benefit and could lose unnecessary procedures without gain.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized trial enrolls adults aged 18–75 with resectable clinical stage I left-lung NSCLC presenting as a single solid nodule. After confirming invasive cancer intraoperatively, participants are randomized to either perform station 4L lymph node dissection or omit it during standard lobectomy or segmentectomy with systematic mediastinal dissection. The primary goal is to see if omitting station 4L dissection is noninferior for 3-year disease-free survival, with secondary measures including 3-year overall survival and perioperative outcomes. The study also documents the rate of station 4L nodal metastasis among those assigned to dissection, and stratifies randomization by tumor lobe. Follow-up occurs every 6 months for 3 years.
Why it matters
Potential benefit: If successful, patients could avoid unnecessary lymph node dissection and related complications without compromising cancer control.
How similar studies have gone: Prior similar approaches have explored node-dissection necessity in early NSCLC, with mixed but informative results guiding decisions about extent of lymphadenectomy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 75 years. * A single solid pulmonary nodule (consolidation-to-tumor ratio of 1.0) located in the left lung. * Resectable clinical stage I (T1-T2aN0M0) non-small cell lung cancer, with a maximum tumor diameter of 4 cm or less, evaluated by positron emission tomography/computed tomography. * Planned complete lung resection by segmentectomy or lobectomy with systematic mediastinal lymph node dissection. * Intraoperative frozen-section pathological confirmation of invasive non-small cell lung cancer before randomization. * Able to provide written informed consent and willing to complete the protocol-specified follow-up. Exclusion Criteria: * Intraoperative or postoperative pathology indicates noninvasive non-small cell lung cancer. * Surgical procedure other than segmentectomy or lobectomy. * Incomplete tumor resection or residual tumor. * History of another malignant tumor. * History of previous lung surgery. * Previous radiotherapy or chemotherapy for the current lung cancer.
Where it's running
-
Fudan University Shanghai Cancer Center
Shanghai, Xuhui, China Recruiting
Study contacts
- Principal investigator: Haiquan Chen — Fudan University
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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.