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Comparing two surgical approaches for lung cancer treatment

Lobectomy-First Versus Lymphadenectomy-First Surgical Approach on Long-Term Survival in Operable Non-Small Cell Lung Cancer Patients: A Prospective, Multi-Center, Randomized Study

Not applicable Interventional Sun Yat-sen University · NCT06577792

This study is testing which order of lung cancer surgery works better for patients with early-stage non-small cell lung cancer: removing lymph nodes first or removing a lobe of the lung first.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment620 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorSun Yat-sen University Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations26 sites (Beijing, Beijing Municipality and 25 other locations)
Trial IDNCT06577792 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of two surgical sequences for patients with operable non-small cell lung cancer (NSCLC): performing lymphadenectomy first versus lobectomy first. It aims to determine which approach leads to better short-term and long-term outcomes for patients diagnosed with stage I-II NSCLC. The study is a multi-center randomized controlled trial, enrolling patients to provide high-level evidence on the optimal surgical sequence. The trial will assess various clinical outcomes to guide surgical practices in treating NSCLC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a clinical diagnosis of stage I-II non-small cell lung cancer who can tolerate lobectomy.

Not a fit: Patients with advanced-stage lung cancer or those unable to undergo lobectomy due to health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients undergoing surgery for non-small cell lung cancer.

How similar studies have performed: While there is limited high-level evidence on this specific comparison, similar studies have explored surgical techniques in lung cancer with varying results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age from 18 to 80 years old;
2. The first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types;
3. Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor \<= 5 cm and short diameter of mediastinal lymph node \<= 1cm in thin layer computed tomography (CT);
4. The patient's physical condition is able to tolerate lobectomy: (1) Goldman index 0-1; (2) Predicted forced expiratory volume in 1s (FEV1) \>= 40% and diffusing capacity of the lung for carbon monoxide (DLCO) \>= 40%; (3) Total bilirubin \<= 1.5 upper limit of normal; (4) Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) \<= 2.5 upper limit of normal; (5) Creatinine \<= 1.25 upper limit of normal and creatinine clearance rate (CCr) \>= 60 ml/min;
5. Performance status of Eastern Cooperative Oncology Group (ECOG) = 0-1;
6. All relevant examinations were completed within 28 days before the operation;
7. Patients who understand this study and have signed an approved Informed Consent.

Exclusion Criteria:

1. Patients who have undergone anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) before surgery;
2. Patients with previous medical history of other malignant tumors or combined with second primary cancer at the time of enrollment;
3. Patients who meet all of the following criteria are eligible for sublobar resection (segment/wedge resection): (1) Ground glass opacity (GGO) with a solid component \<= 50%; (2) The largest diameter of nodule is \<= 2 cm; (3) The nodule is located in the outer third of the lung field;
4. Patients with preoperative diagnosis of pure GGO;
5. Patients with previous medical history of unilateral thoracotomy;
6. Women who are pregnant or breastfeeding;
7. Patients with active bacterial or fungal infection that is difficult to control;
8. Patients with serious psychosis;
9. Patients with a history of severe heart disease, heart failure, myocardial infarction or angina pectoris in the past 6 months.

Where this trial is running

Beijing, Beijing Municipality and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non Small Cell Lung CancerNon-small cell lung cancerLobectomyLymphadenectomy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.