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NOT YET RECRUITING
NCT07698990
NA

Segmentectomy Versus Lobectomy for Deep Solid-Dominant Early-Stage NSCLC

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

Summary

SOLID is a multicenter, open-label, randomized, controlled, phase III non-inferiority trial comparing anatomic segmentectomy with lobectomy in patients with deeply located, solid-dominant, clinical stage IA non-small cell lung cancer (NSCLC) measuring \<=2 cm. Eligible participants will undergo centralized imaging review and will be randomized preoperatively in a 1:1 ratio before induction of anesthesia. The primary endpoint is 5-year overall survival. The key supportive secondary endpoint is 5-year recurrence-free survival. The study will enroll 1,200 participants and will use intention-to-treat analysis for the primary endpoint. An independent Data and Safety Monitoring Board and an independent Endpoint Adjudication Committee will oversee safety, surgical quality, data quality, and endpoint adjudication.

Official title: Comparison of Segmentectomy and Lobectomy for Deeply Located, Solid-Dominant Early-Stage Non-Small Cell Lung Cancer (<=2 cm): A Multicenter, Open-Label, Randomized, Controlled, Non-Inferiority Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2026-08-21

Completion Date

2034-07

Last Updated

2026-08-26

Healthy Volunteers

No

Interventions

PROCEDURE

Anatomic Segmentectomy

Anatomical resection of the involved pulmonary segment or segments with lymph-node dissection and surgical quality-control assessment.

PROCEDURE

Anatomic Lobectomy

Anatomical resection of the involved pulmonary lobe with lymph-node dissection.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China