Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer

NCT07780591 | Not Yet Recruiting DMC

• 1 other identifier: SGS2606
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Non-Small Cell Lung Cancer

Keywords

segmentectomy; clinical stage IA3; peripheral NSCLC

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 years after surgery

Secondary Outcomes (20)

• Change in Forced Expiratory Volume in 1 Second at 6 Months

  Baseline and 6 months after surgery

• Change in Forced Expiratory Volume in 1 Second at 12 Months

  Baseline and 12 months after surgery

• Change in Forced Vital Capacity at 6 Months

  Baseline and 6 months after surgery

• Change in Forced Vital Capacity at 12 Months

  Baseline and 12 months after surgery

• Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 6 Months

  Baseline and 6 months after surgery

Study Arms (1)

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.

Procedure: septum-guided anatomical segmentectomy

Interventions

septum-guided anatomical segmentectomy PROCEDURE

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.

septum-guided segmentectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able to understand the study and voluntarily sign written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2032
• Study Completion (Estimated): August 1, 2034
• Last Updated: August 21, 2026

Record last verified: 2026-08