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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698990 on ClinicalTrials.gov