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NCT07780591

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

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-08

Completion Date

2034-08

Last Updated

2026-08-21

Healthy Volunteers

Conditions

Non-Small Cell Lung Cancer

Interventions

PROCEDURE

septum-guided anatomical segmentectomy

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.