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NCT07780591Not yet recruiting

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 · Last updated 21 Aug 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
11 Aug 2026
Start date
1 Aug 2026
Primary completion date
31 Aug 2032
Lead sponsor
Shanghai Chest Hospital
Diseases
Lung cancer
NCT number
NCT07780591

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 Aug 2026 to the primary completion date, 31 Aug 2032
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 illness

  • 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.
  • Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.

Other

  • 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.
  • Pregnant or breastfeeding women.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.