NCT07169903

Segmentectomy vs Lobectomy for 2 - 3cm IASLC Grade 1-2 Lung Adenocarcinoma: A Multi-center RCT

Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma 2 - 3cm With IASLC Grade 1 - 2 by Intraoperative Frozen Sections: A Prospective and Multi - Center Randomized Controlled Trial Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 587 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter randomized controlled trial (RCT) designed to compare the efficacy of segmentectomy and lobectomy for invasive lung adenocarcinoma with a diameter of 2-3 cm and intraoperative frozen section-confirmed IASLC pathological new grade 1-2. The non-inferiority of segmentectomy is primarily evaluated by 5-year relapse-free survival (RFS) and overall survival (OS) after surgery, while secondary endpoints include pulmonary function preservation, perioperative complications, etc. With a planned enrollment of 587 patients over a 3-year recruitment period and a 5-year follow-up, this study aims to identify an optimized surgical approach.

Detailed description

Lung cancer is the most prevalent and lethal malignant tumor worldwide. Surgical resection remains the most effective treatment for early-stage lung cancer, with lobectomy historically serving as the standard procedure. Recent studies have demonstrated that segmentectomy can achieve comparable outcomes to lobectomy for tumors ≤2 cm and those with ground-glass opacity dominance (CTR ≤0.5). However, for invasive lung adenocarcinomas measuring 2-3 cm with solid predominance (CTR \>0.5), high-level evidence supporting segmentectomy as an alternative to lobectomy is lacking. The 2020 International Association for the Study of Lung Cancer (IASLC) proposed a new grading system for invasive adenocarcinoma, which stratifies prognosis based on histologic subtypes. Tumors with IASLC Grade 1-2 (≤20% high-grade components) have better outcomes, but their optimal surgical approach (segmentectomy vs. lobectomy) in solid-predominant lesions (2-3 cm) remains unproven. Intraoperative frozen section has shown high accuracy in diagnosing IASLC grades, enabling real-time surgical decision-making. The primary objective of this study is to evaluate whether segmentectomy is non-inferior to lobectomy in terms of 5-year relapse-free survival (RFS) and overall survival (OS) for patients with 2-3 cm lung adenocarcinomas confirmed as IASLC Grade 1-2 by intraoperative frozen section.

Conditions

• Lung Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Pulmonary segmentectomy	Segmentectomy is applied to lung adenocarcinomas with a diameter of 2-3 cm, in which intraoperative frozen pathology confirms a new pathological grade of 1-2.

Timeline

• Start date: 2025-10-01
• Primary completion: 2033-03-31
• Completion: 2033-12-31
• First posted: 2025-09-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: China