Non-Small Cell Lung CancerSGS2606NCT07780591
Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer
A study testing septum-guided anatomical segmentectomy in people with Non-Small Cell Lung Cancer, run by Shanghai Chest Hospital.
Trial summary
This is a single-center, prospective, single-arm, open-label clinical trial evaluating the efficacy and safety of septum-guided segmentectomy in patients with 2-3 cm clinical stage IA3 peripheral non-small cell lung cancer (NSCLC) with a consolidation-to-tumor ratio (CTR) greater than 0.5 and up to 1.0. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- septum-guided anatomical segmentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 2034
- 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 to 80 years, male or female.
- Clinical stage IA3 non-small cell lung cancer according to the International Association for the Study of Lung Cancer 9th edition tumor, node, metastasis classification; clinical T1cN0M0; tumor maximum diameter >2 cm and <=3 cm on imaging evaluation.
- Consolidation-to-tumor ratio (CTR) >0.5 and <=1 on thin-section computed tomography.
- Peripheral tumor judged by the investigator to be amenable to curative segmentectomy or lobectomy, with an anticipated ability to achieve the protocol-specified surgical margin.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Preoperative pulmonary function adequate for surgery, with forced expiratory volume in 1 second >=60% predicted and single-breath diffusing capacity of the lung for carbon monoxide >=60% predicted, unless otherwise documented after multidisciplinary evaluation.
- Willing to undergo intraoperative lymph node frozen-section biopsy to confirm node-negative status and understands that a positive frozen-section result will lead to conversion to lobectomy as standard treatment and exclusion from the primary efficacy analysis.
- Able to understand the study and voluntarily sign written informed consent.
Who cannot join
- Intraoperative lymph node frozen-section biopsy confirms N1 or N2 metastasis, or preoperative endobronchial ultrasound-guided biopsy or mediastinoscopy confirms N1, N2, or N3 metastasis, pleural dissemination, or distant metastasis. Patients with positive intraoperative frozen-section results will be converted to lobectomy plus systematic lymph node dissection as standard treatment and recorded as screen failures.
- Multiple primary lung cancers or multiple pulmonary nodules requiring concurrent resection outside the protocol-defined scope that would affect assessment of the primary endpoint.
- Prior ipsilateral lobectomy or segmentectomy, or severe pleural adhesions making the study procedure unevaluable.
- Other active malignancy within 5 years, except cured low-risk tumors.
- Severe cardiac, cerebral, hepatic, renal, or other disease that would preclude general anesthesia or curative lung cancer surgery.
- Pregnant or breastfeeding women.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.
About this study
Official title: Efficacy and Safety of Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer: A Single-Center, Prospective, Single-Arm Clinical Trial
This is a single-center, prospective, single-arm, open-label clinical trial evaluating the efficacy and safety of septum-guided segmentectomy in patients with 2-3 cm clinical stage IA3 peripheral non-small cell lung cancer (NSCLC) with a consolidation-to-tumor ratio (CTR) greater than 0.5 and up to 1.0. All eligible participants will undergo planned septum-guided anatomical segmentectomy or combined segmentectomy after intraoperative frozen-section confirmation of node-negative (N0) lymph node status. The primary endpoint is 3-year recurrence-free survival (RFS).
Read the detailed description
Lobectomy has long been the standard surgical treatment for operable early-stage non-small cell lung cancer (NSCLC). Randomized studies such as Japan Clinical Oncology Group 0802/West Japan Oncology Group 4607L (JCOG0802/WJOG4607L) and Cancer and Leukemia Group B 140503 (CALGB 140503) have supported sublobar resection for selected early-stage peripheral NSCLC, but most evidence is concentrated in tumors measuring 2 cm or less. For patients with 2-3 cm, solid-predominant clinical stage IA3 peripheral NSCLC, prospective evidence on the oncologic safety and pulmonary function benefit of segmentectomy remains limited.
septum-guided segmentectomy uses the intersegmental vein and intersegmental septal membrane as anatomical landmarks to standardize the intersegmental plane and achieve reproducible anatomical resection while preserving lung function. This study uses a single-arm objective performance criterion design. The planned enrollment is 100 participants, allowing for approximately 15% unevaluable or lost-to-follow-up participants, with a target evaluable sample of 83.
Before proceeding with segmentectomy, intraoperative frozen-section biopsy of protocol-specified lymph node stations is required to confirm node-negative (N0) disease. A positive frozen-section result will lead to conversion to lobectomy plus systematic lymph node dissection as standard treatment, and the participant will be recorded as a screen failure for the primary efficacy analysis while contributing to safety follow-up as specified in the protocol.
Participants will be followed after surgery at 1, 6, 12, 18, 24, 30, and 36 months, and annually during years 4 and 5. The primary endpoint is 3-year recurrence-free survival (RFS). Secondary and safety outcomes include pulmonary function changes, perioperative outcomes, microscopically margin-negative (R0) resection, lymph node assessment, local recurrence, overall survival, disease-free survival, quality of life, and postoperative adjuvant therapy.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- septum-guided anatomical segmentectomy
- Keywords
- segmentectomy, clinical stage IA3, peripheral NSCLC
- 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.
septum-guided anatomical segmentectomyProcedure or surgery
septum-guided anatomical segmentectomy or combined segmentectomy performed for eligible peripheral clinical stage IA3 non-small cell lung cancer. The intersegmental vein and intersegmental septal membrane are used as anatomical landmarks to define the intersegmental plane. Intraoperative lymph node frozen-section biopsy must confirm node-negative (N0) status before segmentectomy proceeds; positive nodal disease leads to lobectomy plus systematic lymph node dissection as standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| septum-guided segmentectomy | Experimental | Participants with 2-3 cm clinical stage IA3 peripheral non-small cell lung cancer and consolidation-to-tumor ratio (CTR) >0.5 to <=1.0 will undergo planned septum-guided anatomical segmentectomy or combined segmentectomy after intraoperative frozen-section confirmation of node-negative (N0) lymph node status. Receives: Procedure: septum-guided anatomical segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Year Recurrence-Free Survival
Recurrence-free survival is defined as the time from surgery to the first imaging- or pathology-confirmed recurrence, metastasis, or death from any cause. The primary analysis will estimate the 3-year recurrence-free survival rate using the Kaplan-Meier method.
Measured: Up to 3 years after surgery
Secondary outcomes (20)
Change in Forced Expiratory Volume in 1 Second at 6 Months
Change in forced expiratory volume in 1 second (FEV1) from preoperative baseline to 6 months after surgery, reported as absolute and percent predicted values according to pulmonary function testing.
Measured: Baseline and 6 months after surgery
Change in Forced Expiratory Volume in 1 Second at 12 Months
Change in forced expiratory volume in 1 second (FEV1) from preoperative baseline to 12 months after surgery, reported as absolute and percent predicted values according to pulmonary function testing.
Measured: Baseline and 12 months after surgery
Change in Forced Vital Capacity at 6 Months
Change in forced vital capacity (FVC) from preoperative baseline to 6 months after surgery, reported as absolute and percent predicted values according to pulmonary function testing.
Measured: Baseline and 6 months after surgery
Change in Forced Vital Capacity at 12 Months
Change in forced vital capacity (FVC) from preoperative baseline to 12 months after surgery, reported as absolute and percent predicted values according to pulmonary function testing.
Measured: Baseline and 12 months after surgery
Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 6 Months
Change in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) from preoperative baseline to 6 months after surgery.
Measured: Baseline and 6 months after surgery
Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 12 Months
Change in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) from preoperative baseline to 12 months after surgery.
Measured: Baseline and 12 months after surgery
Operative Time
Operative time measured in minutes from surgical incision to closure, or according to the start and end times recorded in the operative or anesthesia record.
Measured: Intraoperative
Intraoperative Blood Loss
Estimated intraoperative blood loss measured in milliliters according to the operative or anesthesia record.
Measured: Intraoperative
Chest Tube Duration
Duration of postoperative chest tube placement measured in days from surgery to chest tube removal.
Measured: From surgery until chest tube removal, assessed up to 30 days
Postoperative Length of Stay
Length of postoperative hospital stay measured in days from surgery to discharge.
Measured: From surgery until hospital discharge, assessed up to 30 days
Postoperative Complications
Incidence and severity of postoperative complications within 30 days after surgery, graded according to the Clavien-Dindo classification.
Measured: Up to 30 days after surgery
Microscopically Margin-Negative Resection Rate
Proportion of participants with microscopically margin-negative resection based on the final pathology report.
Measured: Day of final pathology report, up to 30 days after surgery
Lymph Node Assessment Quality
Quality of lymph node assessment, including the number and stations of sampled or dissected lymph nodes as documented in the operative and pathology records.
Measured: Day of final pathology report, up to 30 days after surgery
Surgical Margin Distance
Distance from the tumor to the surgical resection margin, assessed from operative and final pathology findings.
Measured: Perioperative period and day of final pathology report, up to 30 days after surgery
Local Recurrence Rate
Proportion of participants with local recurrence, including recurrence at the surgical margin, ipsilateral thoracic cavity, or hilar or mediastinal lymph nodes.
Measured: Up to 5 years after surgery
Overall Survival
Overall survival is defined as the time from surgery to death from any cause.
Measured: Up to 5 years after surgery
Disease-Free Survival
Disease-free survival is defined as the time from surgery to recurrence, metastasis, or death from any cause.
Measured: Up to 5 years after surgery
Global Health Status and Quality of Life Score Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
The global health status and quality of life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 will be reported as one score. The score ranges from 0 to 100; higher scores indicate better global health status and quality of life.
Measured: Baseline, 6 months, 12 months, 36 months, and 60 months after surgery
Postoperative Adjuvant Therapy
Proportion of participants receiving postoperative adjuvant therapy and the type of adjuvant regimen administered during follow-up.
Measured: Up to 5 years after surgery
Lung Cancer Symptom Burden Summary Score Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13
Lung cancer symptom burden will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13. A prespecified summary score will be calculated as the mean of the available questionnaire symptom item or scale scores after linear transformation to a 0 to 100 scale; higher scores indicate worse lung cancer symptom burden.
Measured: Baseline, 6 months, 12 months, 36 months, and 60 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2032 (estimated)
- Study completionAug 2034 (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 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
- Single-arm objective performance criterion design. All eligible participants will receive septum-guided segmentectomy after confirmation of node-negative (N0) lymph node status by intraoperative frozen-section biopsy.
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT07780591
- Sponsor's protocol ID
- SGS2606
- Acronym
- SGS2606
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer: A Single-Center, Prospective, Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07780591
- Acronym / sponsor ID
- SGS2606 / SGS2606
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- segmentectomy, clinical stage IA3, peripheral NSCLC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2032 (estimated)
- Study completion
- Aug 2034 (estimated)
- First posted
- 21 Aug 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 is a single-center, prospective, single-arm, open-label clinical trial evaluating the efficacy and safety of septum-guided segmentectomy in patients with 2-3 cm clinical stage IA3 peripheral non-small cell lung cancer (NSCLC) with a consolidation-to-tumor ratio (CTR) greater than 0.5 and up to 1.0. All eligible participants will undergo planned septum-guided anatomical segmentectomy or combined segmentectomy after intraoperative frozen-section confirmation of node-negative (N0) lymph node status. The primary endpoint is 3-year recurrence-free survival (RFS).
Detailed description
Lobectomy has long been the standard surgical treatment for operable early-stage non-small cell lung cancer (NSCLC). Randomized studies such as Japan Clinical Oncology Group 0802/West Japan Oncology Group 4607L (JCOG0802/WJOG4607L) and Cancer and Leukemia Group B 140503 (CALGB 140503) have supported sublobar resection for selected early-stage peripheral NSCLC, but most evidence is concentrated in tumors measuring 2 cm or less. For patients with 2-3 cm, solid-predominant clinical stage IA3 peripheral NSCLC, prospective evidence on the oncologic safety and pulmonary function benefit of segmentectomy remains limited.
septum-guided segmentectomy uses the intersegmental vein and intersegmental septal membrane as anatomical landmarks to standardize the intersegmental plane and achieve reproducible anatomical resection while preserving lung function. This study uses a single-arm objective performance criterion design. The planned enrollment is 100 participants, allowing for approximately 15% unevaluable or lost-to-follow-up participants, with a target evaluable sample of 83.
Before proceeding with segmentectomy, intraoperative frozen-section biopsy of protocol-specified lymph node stations is required to confirm node-negative (N0) disease. A positive frozen-section result will lead to conversion to lobectomy plus systematic lymph node dissection as standard treatment, and the participant will be recorded as a screen failure for the primary efficacy analysis while contributing to safety follow-up as specified in the protocol.
Participants will be followed after surgery at 1, 6, 12, 18, 24, 30, and 36 months, and annually during years 4 and 5. The primary endpoint is 3-year recurrence-free survival (RFS). Secondary and safety outcomes include pulmonary function changes, perioperative outcomes, microscopically margin-negative (R0) resection, lymph node assessment, local recurrence, overall survival, disease-free survival, quality of life, and postoperative adjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm objective performance criterion design. All eligible participants will receive septum-guided segmentectomy after confirmation of node-negative (N0) lymph node status by intraoperative frozen-section biopsy.
| Arm | Type | Receives |
|---|---|---|
| septum-guided segmentectomy | Experimental | Procedure: septum-guided anatomical segmentectomyParticipants with 2-3 cm clinical stage IA3 peripheral non-small cell lung cancer and consolidation-to-tumor ratio (CTR) >0.5 to <=1.0 will undergo planned septum-guided anatomical segmentectomy or combined segmentectomy after intraoperative frozen-section confirmation of node-negative (N0) lymph node status. |
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 to 80 years, male or female.
- Clinical stage IA3 non-small cell lung cancer according to the International Association for the Study of Lung Cancer 9th edition tumor, node, metastasis classification; clinical T1cN0M0; tumor maximum diameter >2 cm and <=3 cm on imaging evaluation.
- Consolidation-to-tumor ratio (CTR) >0.5 and <=1 on thin-section computed tomography.
- Peripheral tumor judged by the investigator to be amenable to curative segmentectomy or lobectomy, with an anticipated ability to achieve the protocol-specified surgical margin.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Key exclusion criteria (7 listed)
- Intraoperative lymph node frozen-section biopsy confirms N1 or N2 metastasis, or preoperative endobronchial ultrasound-guided biopsy or mediastinoscopy confirms N1, N2, or N3 metastasis, pleural dissemination, or distant metastasis. Patients with positive intraoperative frozen-section results will be converted to lobectomy plus systematic lymph node dissection as standard treatment and recorded as screen failures.
- Multiple primary lung cancers or multiple pulmonary nodules requiring concurrent resection outside the protocol-defined scope that would affect assessment of the primary endpoint.
- Prior ipsilateral lobectomy or segmentectomy, or severe pleural adhesions making the study procedure unevaluable.
- Other active malignancy within 5 years, except cured low-risk tumors.
- Severe cardiac, cerebral, hepatic, renal, or other disease that would preclude general anesthesia or curative lung cancer 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 |
|---|---|---|
| septum-guided anatomical segmentectomyseptum-guided anatomical segmentectomy or combined segmentectomy performed for eligible peripheral clinical stage IA3 non-small cell lung cancer. The intersegmental vein and intersegmental septal membrane are used as anatomical landmarks to define the intersegmental plane. Intraoperative lymph node frozen-section biopsy must confirm node-negative (N0) status before segmentectomy proceeds; positive nodal disease leads to lobectomy plus systematic lymph node dissection as standard treatment. | Procedure or surgery | septum-guided segmentectomy |
Primary outcome
3-Year Recurrence-Free Survival
Time frame: Up to 3 years after surgery
Recurrence-free survival is defined as the time from surgery to the first imaging- or pathology-confirmed recurrence, metastasis, or death from any cause. The primary analysis will estimate the 3-year recurrence-free survival rate using the Kaplan-Meier method.
20 secondary outcomes
Change in Forced Expiratory Volume in 1 Second at 6 Months
Time frame: Baseline and 6 months after surgery
Change in Forced Expiratory Volume in 1 Second at 12 Months
Time frame: Baseline and 12 months after surgery
Change in Forced Vital Capacity at 6 Months
Time frame: Baseline and 6 months after surgery
Change in Forced Vital Capacity at 12 Months
Time frame: Baseline and 12 months after surgery
Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 6 Months
Time frame: Baseline and 6 months after surgery
Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 12 Months
Time frame: Baseline and 12 months after surgery
Operative Time
Time frame: Intraoperative
Intraoperative Blood Loss
Time frame: Intraoperative
Chest Tube Duration
Time frame: From surgery until chest tube removal, assessed up to 30 days
Postoperative Length of Stay
Time frame: From surgery until hospital discharge, assessed up to 30 days
Postoperative Complications
Time frame: Up to 30 days after surgery
Microscopically Margin-Negative Resection Rate
Time frame: Day of final pathology report, up to 30 days after surgery
Lymph Node Assessment Quality
Time frame: Day of final pathology report, up to 30 days after surgery
Surgical Margin Distance
Time frame: Perioperative period and day of final pathology report, up to 30 days after surgery
Local Recurrence Rate
Time frame: Up to 5 years after surgery
Overall Survival
Time frame: Up to 5 years after surgery
Disease-Free Survival
Time frame: Up to 5 years after surgery
Global Health Status and Quality of Life Score Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Time frame: Baseline, 6 months, 12 months, 36 months, and 60 months after surgery
Postoperative Adjuvant Therapy
Time frame: Up to 5 years after surgery
Lung Cancer Symptom Burden Summary Score Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13
Time frame: Baseline, 6 months, 12 months, 36 months, and 60 months 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 21 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing septum-guided anatomical segmentectomy in people with Non-Small Cell Lung Cancer, run by Shanghai Chest Hospital.
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 7 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year Recurrence-Free Survival (time frame: Up to 3 years after surgery). 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 21 Aug 2026.