Non-small Cell Lung CancerSGS2512NCT07564557
Septum-guided Segmentectomy for Deep Early-stage Lung Cancer (SGS2512)
A study testing Septum-guided Segmentectomy in people with Non-small Cell Lung Cancer and Early-stage Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of a specialized surgical technique called "Septum-guided Segmentectomy" for treating early-stage lung cancer located deep within the lung tissue.Standard surgery for lung cancer often involves removing an entire lung lobe (lobectomy), which can… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Early-stage Lung Cancer, Deep-seated Lung Nodules
- What is being tested?
- Septum-guided Segmentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Apr 2031
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Clinical stage IA (cT1a-bN0M0)
- tumor diameter ≤ 2 cm
- Pathological feature: Solid-dominant lesion (CTR > 0.5)
- Tumor location: Deep-seated within the lung parenchyma (inner 2/3), defined as the tumor center being located in the inner 2/3 region of the lung field on axial, coronal, and sagittal CT views
- ECOG Performance Status: 0-1
- Pulmonary function: FEV1 ≥ 60% predicted and DLCO SB ≥ 60% predicted
- Participants must be willing and able to provide written informed consent
Who cannot join
- Multiple pulmonary nodules or evidence of distant metastasis
- Intraoperative confirmation of lymph node metastasis (N1/N2) or pleural dissemination
- History of previous ipsilateral lung surgery
- History of other malignant tumors within the past 5 years
- Presence of severe cardiovascular or cerebrovascular diseases that preclude surgical tolerance
- Pregnancy or breastfeeding
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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Qing Wang, 18516349006, pillawang@163.com
Junfeng Geng, MD, +8618017321501, drgengjunfeng@163.com
About this study
Official title: Effectiveness and Safety of Septum-guided Segmentectomy in Solid-dominant, Deep-seated Early-stage Non-small Cell Lung Cancer (≤2 cm): A Single-center, Prospective, Single-arm Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of a specialized surgical technique called "Septum-guided Segmentectomy" for treating early-stage lung cancer located deep within the lung tissue.Standard surgery for lung cancer often involves removing an entire lung lobe (lobectomy), which can significantly reduce a patient's breathing capacity. For small tumors, removing only a segment of the lung (segmentectomy) can preserve more healthy tissue. However, for tumors located deep in the lung, traditional segmentectomy is technically challenging and risks leaving cancer cells behind.In this study, surgeons will use the natural anatomical boundaries-the intersegmental veins and their surrounding thin membranes (septa)-as a guide to precisely remove the target lung segment. This "septum-guided" approach aims to ensure the cancer is completely removed while maximizing the preservation of healthy lung function.Participants will be followed for 3 years after surgery to monitor for cancer recurrence and assess their long-term recovery.
Read the detailed description
This is a single-center, prospective, single-arm clinical trial (SGS2512) designed to validate the oncological safety and technical feasibility of septum-guided segmentectomy for deep-seated, solid-dominant early-stage non-small cell lung cancer (NSCLC).Background: While segmentectomy has been proven comparable to lobectomy for small peripheral NSCLC (≤2 cm), its application for deep-seated lesions (inner 2/3 of the lung) remains controversial. Traditional methods rely on fixed safety margins, which are often difficult to achieve in deep regions without sacrificing excessive lung tissue. This study utilizes the "intersegmental septum" as a natural barrier to define the resection boundary.Key Procedures:Surgical Technique: All procedures are performed via single-port VATS or Robot-assisted Thoracic Surgery (RATS). The core technique involves the identification and exposure of the intersegmental veins and the corresponding septa to guide the separation of the target segment.Intraoperative Second Registration: After surgery begins but before the segment is resected, a second check is performed. If frozen section pathology reveals lymph node metastasis or if the anatomical structure is unsuitable for segmentectomy, the procedure will be converted to a standard lobectomy to ensure patient safety.Follow-up: Patients will undergo regular chest CT scans, tumor marker tests, and pulmonary function tests at 1, 6, 12, 18, 24, 30, and 36 months postoperatively.Statistical Design:
The study uses an A'Hern single-stage design to evaluate the primary endpoint. With a null hypothesis (H0) of 3-year RFS ≤ 81% and an alternative hypothesis (H1) of 3-year RFS ≥ 91%, a total of 89 participants are planned for enrollment to ensure 80 evaluable cases. Data analysis will be performed using R software (version 4.0 or above).
- Conditions
- Non-small Cell Lung Cancer, Early-stage Lung Cancer, Deep-seated Lung Nodules, Solid-dominant Lung Cancer
- Being tested
- Septum-guided Segmentectomy
- Keywords
- Septum-guided Segmentectomy, Intersegmental Septum, VATS Segmentectomy, Precision Surgery, Lung-sparing Surgery, Anatomical Boundary, SGS2512
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septum-guided SegmentectomyProcedure or surgery
This procedure is performed via single-port VATS or Robot-assisted Thoracic Surgery (RATS). The core technique involves the precise identification of the intersegmental veins and their surrounding fibrous sheath (septum). These natural anatomical boundaries are utilized to guide the separation and resection of the target lung segment. Unlike traditional methods that rely on fixed safety margins, this approach focuses on anatomical planes to ensure oncological safety for deep-seated lesions. Systematic lymph node sampling or dissection of at least 3 hilar and 3 mediastinal groups is mandatory. An intraoperative second registration is conducted to confirm the nodal status and anatomical suitability before finalizing the resection.
| Study group | Role | What they receive |
|---|---|---|
| Septum-guided Segmentectomy | Experimental | Participants with solid-dominant, deep-seated early-stage NSCLC will undergo septum-guided segmentectomy. The core technique involves identifying and utilizing the intersegmental veins and their surrounding fibrous septa as the anatomical boundaries for precise resection. Systemic lymph node sampling or dissection (at least 3 hilar and 3 mediastinal groups) is mandatory for all patients. An intraoperative second registration will be performed to ensure the oncological appropriateness of the procedure before resection. Receives: Procedure: Septum-guided Segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Recurrence-Free Survival (RFS)
Percentage of participants who are alive and free of any recurrence (including local, regional, or distant recurrence) at 3 years after the surgery. Recurrence is defined from the date of surgery to the date of first evidence of recurrence by imaging (CT, PET-CT, or MRI) or biopsy.
Measured: 3 years post-operation
Secondary outcomes (6)
Operation time
The total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure.
Measured: During surgery (Day 0)
Intraoperative Blood Loss
The total volume of blood lost during the surgical procedure, estimated by measuring the volume of suctioned fluid and weighing the surgical sponges.
Measured: During surgery (Day 0)
Incidence of Postoperative Complications
The percentage of participants experiencing one or more postoperative complications. Complications will be categorized and graded according to the Clavien-Dindo classification system (focusing on Grade II or higher).
Measured: From surgery through 30 days post-operation
Technical Success of Septum-guided Segmentectomy
Assessment of the surgical quality, including the R0 resection rate (no microscopic tumor cells at the margin) and the intact exposure rate of intersegmental veins.
Measured: During surgery and up to the availability of the final pathology report (typically within 7 days post-operation)
Change in Pulmonary Function (FEV1)
Comparison of the Forced Expiratory Volume in 1 second (FEV1) between preoperative baseline and postoperative follow-ups to assess the preservation of lung function.
Measured: Pre-operation, 6 months, and 12 months post-operation
Local Recurrence Rate
Incidence of recurrence occurring at the surgical margin, the remaining ipsilateral lung lobe, or the ipsilateral intrathoracic lymph nodes.
Measured: Up to 3 years post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, prospective, single-arm study. All enrolled participants who pass the intraoperative second registration will receive septum-guided segmentectomy. There is no concurrent control group; historical data and JCOG0802 results will serve as benchmarks for oncological safety and effectiveness 。
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junfeng Geng, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564557
- Sponsor's protocol ID
- IS26028
- Acronym
- SGS2512
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal.
Publications
Tsubokawa N, Mimae T, Saeki A, Miyata Y, Kanno C, Kudo Y, Nagashima T, Ito H, Ikeda N, Okada M. Feasibility and comparative prognosis of segmentectomy versus lobectomy in centrally located small and solid dominant cN0 non-small cell lung cancer. J Thorac Cardiovasc Surg. 2025 Feb;169(2):427-435.e2. doi: 10.1016/j.jtcvs.2024.06.016. Epub 2024 Jul 3.
PubMed 38969057Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3.
PubMed 35461558
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Septum-guided Segmentectomy in Solid-dominant, Deep-seated Early-stage Non-small Cell Lung Cancer (≤2 cm): A Single-center, Prospective, Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07564557
- Acronym / sponsor ID
- SGS2512 / IS26028
- Conditions
- Non-small Cell Lung Cancer, Early-stage Lung Cancer, Deep-seated Lung Nodules, Solid-dominant Lung Cancer
- Keywords
- Septum-guided Segmentectomy, Intersegmental Septum, VATS Segmentectomy, Precision Surgery, Lung-sparing Surgery, Anatomical Boundary, SGS2512
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2031 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 4 May 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.
The purpose of this study is to evaluate the safety and effectiveness of a specialized surgical technique called "Septum-guided Segmentectomy" for treating early-stage lung cancer located deep within the lung tissue.Standard surgery for lung cancer often involves removing an entire lung lobe (lobectomy), which can significantly reduce a patient's breathing capacity. For small tumors, removing only a segment of the lung (segmentectomy) can preserve more healthy tissue. However, for tumors located deep in the lung, traditional segmentectomy is technically challenging and risks leaving cancer cells behind.In this study, surgeons will use the natural anatomical boundaries-the intersegmental veins and their surrounding thin membranes (septa)-as a guide to precisely remove the target lung segment. This "septum-guided" approach aims to ensure the cancer is completely removed while maximizing the preservation of healthy lung function.Participants will be followed for 3 years after surgery to monitor for cancer recurrence and assess their long-term recovery.
Detailed description
This is a single-center, prospective, single-arm clinical trial (SGS2512) designed to validate the oncological safety and technical feasibility of septum-guided segmentectomy for deep-seated, solid-dominant early-stage non-small cell lung cancer (NSCLC).Background: While segmentectomy has been proven comparable to lobectomy for small peripheral NSCLC (≤2 cm), its application for deep-seated lesions (inner 2/3 of the lung) remains controversial. Traditional methods rely on fixed safety margins, which are often difficult to achieve in deep regions without sacrificing excessive lung tissue. This study utilizes the "intersegmental septum" as a natural barrier to define the resection boundary.Key Procedures:Surgical Technique: All procedures are performed via single-port VATS or Robot-assisted Thoracic Surgery (RATS). The core technique involves the identification and exposure of the intersegmental veins and the corresponding septa to guide the separation of the target segment.Intraoperative Second Registration: After surgery begins but before the segment is resected, a second check is performed. If frozen section pathology reveals lymph node metastasis or if the anatomical structure is unsuitable for segmentectomy, the procedure will be converted to a standard lobectomy to ensure patient safety.Follow-up: Patients will undergo regular chest CT scans, tumor marker tests, and pulmonary function tests at 1, 6, 12, 18, 24, 30, and 36 months postoperatively.Statistical Design:
The study uses an A'Hern single-stage design to evaluate the primary endpoint. With a null hypothesis (H0) of 3-year RFS ≤ 81% and an alternative hypothesis (H1) of 3-year RFS ≥ 91%, a total of 89 participants are planned for enrollment to ensure 80 evaluable cases. Data analysis will be performed using R software (version 4.0 or above).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, prospective, single-arm study. All enrolled participants who pass the intraoperative second registration will receive septum-guided segmentectomy. There is no concurrent control group; historical data and JCOG0802 results will serve as benchmarks for oncological safety and effectiveness 。
| Arm | Type | Receives |
|---|---|---|
| Septum-guided Segmentectomy | Experimental | Procedure: Septum-guided SegmentectomyParticipants with solid-dominant, deep-seated early-stage NSCLC will undergo septum-guided segmentectomy. The core technique involves identifying and utilizing the intersegmental veins and their surrounding fibrous septa as the anatomical boundaries for precise resection. Systemic lymph node sampling or dissection (at least 3 hilar and 3 mediastinal groups) is mandatory for all patients. An intraoperative second registration will be performed to ensure the oncological appropriateness of the procedure before resection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-80 years
- Clinical stage IA (cT1a-bN0M0)
- tumor diameter ≤ 2 cm
- Pathological feature: Solid-dominant lesion (CTR > 0.5)
- Tumor location: Deep-seated within the lung parenchyma (inner 2/3), defined as the tumor center being located in the inner 2/3 region of the lung field on axial, coronal, and sagittal CT views
Key exclusion criteria (6 listed)
- Multiple pulmonary nodules or evidence of distant metastasis
- Intraoperative confirmation of lymph node metastasis (N1/N2) or pleural dissemination
- History of previous ipsilateral lung surgery
- History of other malignant tumors within the past 5 years
- Presence of severe cardiovascular or cerebrovascular diseases that preclude surgical tolerance
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 |
|---|---|---|
| Septum-guided SegmentectomyThis procedure is performed via single-port VATS or Robot-assisted Thoracic Surgery (RATS). The core technique involves the precise identification of the intersegmental veins and their surrounding fibrous sheath (septum). These natural anatomical boundaries are utilized to guide the separation and resection of the target lung segment. Unlike traditional methods that rely on fixed safety margins, this approach focuses on anatomical planes to ensure oncological safety for deep-seated lesions. Systematic lymph node sampling or dissection of at least 3 hilar and 3 mediastinal groups is mandatory. An intraoperative second registration is conducted to confirm the nodal status and anatomical suitability before finalizing the resection. | Procedure or surgery | Septum-guided Segmentectomy |
Primary outcome
3-year Recurrence-Free Survival (RFS)
Time frame: 3 years post-operation
Percentage of participants who are alive and free of any recurrence (including local, regional, or distant recurrence) at 3 years after the surgery. Recurrence is defined from the date of surgery to the date of first evidence of recurrence by imaging (CT, PET-CT, or MRI) or biopsy.
6 secondary outcomes
Operation time
Time frame: During surgery (Day 0)
Intraoperative Blood Loss
Time frame: During surgery (Day 0)
Incidence of Postoperative Complications
Time frame: From surgery through 30 days post-operation
Technical Success of Septum-guided Segmentectomy
Time frame: During surgery and up to the availability of the final pathology report (typically within 7 days post-operation)
Change in Pulmonary Function (FEV1)
Time frame: Pre-operation, 6 months, and 12 months post-operation
Local Recurrence Rate
Time frame: Up to 3 years post-operation
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 4 May 2026.
- Background: PubMed 38969057Tsubokawa N, Mimae T, Saeki A, Miyata Y, Kanno C, Kudo Y, Nagashima T, Ito H, Ikeda N, Okada M. Feasibility and comparative prognosis of segmentectomy versus lobectomy in centrally located small and solid dominant cN0 non-small cell lung cancer. J Thorac Cardiovasc Surg. 2025 Feb;169(2):427-435.e2. doi: 10.1016/j.jtcvs.2024.06.016. Epub 2024 Jul 3.
- Background: PubMed 35461558Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septum-guided Segmentectomy in people with Non-small Cell Lung Cancer and Early-stage Lung Cancer, run by Shanghai Chest Hospital 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 8 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 4 May 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?
Contact Junfeng Gen, MD (+8618017321501, drgengjunfeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Recurrence-Free Survival (RFS) (time frame: 3 years post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07564557, which also lists 2 linked publications.
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 4 May 2026.