Non-Small Cell Lung CancerNCT07801430
Station 4L Lymph Node Dissection Versus No Dissection in Clinical Stage I Solid Nodule-Type Invasive NSCLC
A study testing Station 4L Lymph Node Dissection in people with Non-Small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
This multicenter, prospective, randomized clinical trial will enroll adults aged 18 to 75 years with resectable clinical stage I (T1-T2aN0M0) invasive non-small cell lung cancer presenting as a single solid nodule (consolidation-to-tumor ratio 1.0) in the left lung. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Station 4L Lymph Node Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 15 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Xuhui, 200000
Yang Zhang, MD, 86-18717722753, 16301050173@fudan.edu.cn
About this study
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
This multicenter, prospective, randomized clinical trial will enroll adults aged 18 to 75 years with resectable clinical stage I (T1-T2aN0M0) invasive non-small cell lung cancer presenting as a single solid nodule (consolidation-to-tumor ratio 1.0) in the left lung. After intraoperative frozen-section confirmation of invasive non-small cell lung cancer and completion of standard lung resection and systematic mediastinal lymph node dissection, participants will be randomly assigned 1:1 either to undergo station 4L lymph node dissection or to omit station 4L dissection. The primary hypothesis is that omitting station 4L dissection is noninferior to performing it with respect to 3-year disease-free survival. Secondary outcomes include 3-year overall survival, perioperative complications, 90-day mortality, and station 4L nodal metastasis.
Read the detailed description
Station 4L lymph nodes are located in a technically challenging area near the aortic arch, left pulmonary artery, thoracic duct, and left recurrent laryngeal nerve. Dissection may improve nodal staging but may also increase operative complexity and complications. This study will evaluate whether station 4L dissection can be omitted without compromising long-term outcomes in patients with early-stage left-sided invasive non-small cell lung cancer.
Eligible participants will undergo complete resection by segmentectomy or lobectomy and systematic mediastinal lymph node dissection. After intraoperative frozen-section confirmation of invasive non-small cell lung cancer, participants will be randomized in a 1:1 ratio to station 4L lymph node dissection or no station 4L dissection. Randomization is stratified by tumor lobe. The planned enrollment is 384 participants, including 258 with left upper lobe tumors and 126 with left lower lobe tumors.
Participants will be followed every 6 months for 3 years after surgery. The primary comparison is 3-year disease-free survival. Secondary assessments include 3-year overall survival, surgery-related complications within 30 days, all-cause mortality within 90 days, and the frequency of station 4L nodal metastasis among participants assigned to station 4L dissection.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Station 4L Lymph Node Dissection
- Keywords
- Left Lower Paratracheal Lymph Node Dissection, Mediastinal Lymph Node Dissection, Solid Pulmonary Nodule, Noninferiority Trial
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Station 4L Lymph Node DissectionProcedure or surgery
During complete lung resection and systematic mediastinal lymph node dissection, all lymphatic and fatty tissue in the station 4L region is surgically removed and submitted for pathological examination. Other mediastinal stations are dissected according to the study protocol in both arms.
| Study group | Role | What they receive |
|---|---|---|
| Station 4L Lymph Node Dissection | Experimental | Participants undergo complete lung resection and systematic mediastinal lymph node dissection, including surgical dissection of station 4L lymph nodes. Receives: Procedure: Station 4L Lymph Node Dissection |
| No Station 4L Lymph Node Dissection | No intervention | Participants undergo complete lung resection and systematic mediastinal lymph node dissection, but station 4L lymph nodes are not surgically removed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Year Disease-Free Survival
Proportion of participants alive without disease recurrence. A disease-free survival event is the first documented recurrence of non-small cell lung cancer or death from any cause.
Measured: From enrollment to 3 years
Secondary outcomes (4)
3-Year Overall Survival
Proportion of participants alive 3 years after enrollment. Death from any cause is counted as an event.
Measured: From enrollment to 3 years
30-Day Surgery-Related Complication Rate
Proportion of participants with at least one surgery-related complication, graded according to Common Terminology Criteria for Adverse Events version 3.0.
Measured: From surgery through postoperative day 30
90-Day All-Cause Mortality
Proportion of participants who die from any cause within 90 days after surgery.
Measured: From surgery through postoperative day 90
Station 4L Lymph Node Metastasis Rate
Among participants assigned to station 4L lymph node dissection, the proportion with pathologically confirmed metastasis in resected station 4L lymph nodes.
Measured: At postoperative pathological assessment, up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start15 Dec 2025
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
- Investigators
- Haiquan Chen, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801430
- Sponsor's protocol ID
- ECTOP-1034
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07801430
- Acronym / sponsor ID
- ECTOP-1034
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Left Lower Paratracheal Lymph Node Dissection, Mediastinal Lymph Node Dissection, Solid Pulmonary Nodule, Noninferiority Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, prospective, randomized clinical trial will enroll adults aged 18 to 75 years with resectable clinical stage I (T1-T2aN0M0) invasive non-small cell lung cancer presenting as a single solid nodule (consolidation-to-tumor ratio 1.0) in the left lung. After intraoperative frozen-section confirmation of invasive non-small cell lung cancer and completion of standard lung resection and systematic mediastinal lymph node dissection, participants will be randomly assigned 1:1 either to undergo station 4L lymph node dissection or to omit station 4L dissection. The primary hypothesis is that omitting station 4L dissection is noninferior to performing it with respect to 3-year disease-free survival. Secondary outcomes include 3-year overall survival, perioperative complications, 90-day mortality, and station 4L nodal metastasis.
Detailed description
Station 4L lymph nodes are located in a technically challenging area near the aortic arch, left pulmonary artery, thoracic duct, and left recurrent laryngeal nerve. Dissection may improve nodal staging but may also increase operative complexity and complications. This study will evaluate whether station 4L dissection can be omitted without compromising long-term outcomes in patients with early-stage left-sided invasive non-small cell lung cancer.
Eligible participants will undergo complete resection by segmentectomy or lobectomy and systematic mediastinal lymph node dissection. After intraoperative frozen-section confirmation of invasive non-small cell lung cancer, participants will be randomized in a 1:1 ratio to station 4L lymph node dissection or no station 4L dissection. Randomization is stratified by tumor lobe. The planned enrollment is 384 participants, including 258 with left upper lobe tumors and 126 with left lower lobe tumors.
Participants will be followed every 6 months for 3 years after surgery. The primary comparison is 3-year disease-free survival. Secondary assessments include 3-year overall survival, surgery-related complications within 30 days, all-cause mortality within 90 days, and the frequency of station 4L nodal metastasis among participants assigned to station 4L dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Station 4L Lymph Node Dissection | Experimental | Procedure: Station 4L Lymph Node DissectionParticipants undergo complete lung resection and systematic mediastinal lymph node dissection, including surgical dissection of station 4L lymph nodes. |
| No Station 4L Lymph Node Dissection | No intervention | –Participants undergo complete lung resection and systematic mediastinal lymph node dissection, but station 4L lymph nodes are not surgically removed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Station 4L Lymph Node DissectionDuring complete lung resection and systematic mediastinal lymph node dissection, all lymphatic and fatty tissue in the station 4L region is surgically removed and submitted for pathological examination. Other mediastinal stations are dissected according to the study protocol in both arms. | Procedure or surgery | Station 4L Lymph Node Dissection |
Primary outcome
3-Year Disease-Free Survival
Time frame: From enrollment to 3 years
Proportion of participants alive without disease recurrence. A disease-free survival event is the first documented recurrence of non-small cell lung cancer or death from any cause.
4 secondary outcomes
3-Year Overall Survival
Time frame: From enrollment to 3 years
30-Day Surgery-Related Complication Rate
Time frame: From surgery through postoperative day 30
90-Day All-Cause Mortality
Time frame: From surgery through postoperative day 90
Station 4L Lymph Node Metastasis Rate
Time frame: At postoperative pathological assessment, up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haiquan Chen principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Station 4L Lymph Node Dissection in people with Non-Small Cell Lung Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year Disease-Free Survival (time frame: From enrollment to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.