Segmentectomy Versus Lobectomy for Deep Solid-Dominant Early-Stage NSCLC
NCT07698990 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200
Last updated 2026-07-13
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.
Conditions
- Non-Small Cell Lung Cancer
- Stage IA Non-Small Cell Lung Cancer
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.
Sponsors & Collaborators
-
Shanghai Chest Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2034-07-31
- Completion
- 2034-07-31
Countries
- China
Study Locations
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