Clinical trial · Interventional
Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| septum-guided anatomical segmentectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- septum-guided segmentectomy
- description
- 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.
- interventionNames
- Procedure: septum-guided anatomical segmentectomy
Primary outcomes (1)
- measure
- 3-Year Recurrence-Free Survival
- timeFrame
- Up to 3 years after surgery
- description
- 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.
Secondary outcomes (20)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
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