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Order of surgical steps may affect lung cancer survival

NCT ID NCT06577792

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests whether removing the lung tumor before the lymph nodes, or the lymph nodes before the tumor, leads to better long-term survival in people with early-stage non-small cell lung cancer. About 620 patients will be randomly assigned to one of the two sequences. The study tracks survival and complications over five years to determine the best approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surgical procedure comparing lobectomy-first versus lymphadenectomy-first
What this could lead to
If one sequence proves better, it could become the standard surgical approach for early-stage lung cancer, potentially improving long-term survival.
What could go wrong
This is a mid-stage trial with 620 participants, so results may not apply to all patients. The difference between sequences might be small or not statistically significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 620 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non small cell lung cancer

Contacts and locations

Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523059, China

  • First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510632, China

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032, China

  • First People's Hospital of Foshan

    Foshan, Guangdong, 528000, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001, China

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730013, China

  • Jiangsu Cancer Institute & Hospital

    Nanjing, Jiangsu, 210009, China

  • RenJi Hospital

    Shanghai, Shanghai Municipality, 200001, China

  • Shandong Provincial Hospital

    Jinan, Shandong, 250022, China

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 201209, China

  • Sichuan Cancer Hospital and Research Institute

    Chengdu, Sichuan, 610041, China

  • Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655, China

  • Suining Central Hospital

    Suining, Sichuan, 629099, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Tang-Du Hospital

    Xi'an, Shaanxi, 710032, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266075, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221132, China

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029, China

  • The General Hospital of Eastern Theater Command

    Nanjing, Jiangsu, 210016, China

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300222, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • West China Hospital

    Chengdu, Sichuan, 610041, China

  • Wuhan TongJi Hospital

    Wuhan, Hubei, 430014, China

  • Wuhan Union Hospital, China

    Wuhan, Hubei, 430090, China

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