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

NCT07698990 | Not Yet Recruiting DMC

• 1 other identifier: SOLID-V1.9
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

segmentectomy; lobectomy; deep pulmonary nodule; solid-dominant nodule; early-stage NSCLC; non-inferiority trial; overall survival; recurrence-free survival

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival is defined as the time from randomization to death from any cause. The primary analysis will compare segmentectomy with lobectomy using the intention-to-treat set and a non-inferiority hazard-ratio margin of 1.54.

  5 years after randomization

Secondary Outcomes (12)

• Recurrence-Free Survival

  5 years after randomization

• Locoregional Recurrence Rate

  Up to 5 years after randomization

• Distant Metastasis Rate

  Up to 5 years after randomization

• Patient-Reported Quality of Life Score (EORTC QLQ-C30)

  Baseline and 6, 12, and 36 months after surgery

• Six-Minute Walk Distance

  Baseline and 6 and 12 months after surgery

Study Arms (2)

Segmentectomy

EXPERIMENTAL

Participants assigned to this arm will undergo anatomic pulmonary segmentectomy. Combined segmentectomy or proper segmentectomy is permitted; basal segmentectomy (S7-10) is prohibited. Segmentectomy must include anatomic treatment of the segmental hilar artery, vein, and bronchus, margin assessment, and required lymph-node dissection. Conversion to lobectomy is permitted or required according to protocol-defined clinical and safety criteria.

Procedure: Anatomic Segmentectomy

Lobectomy

ACTIVE COMPARATOR

Participants assigned to this arm will undergo standard anatomic pulmonary lobectomy with required systematic or lobe-specific lymph-node dissection.

Procedure: Anatomic Lobectomy

Interventions

Anatomic Segmentectomy PROCEDURE

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

Segmentectomy

Anatomic Lobectomy PROCEDURE

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

Lobectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years.
• Solitary pulmonary nodule with maximum diameter \<=2 cm confirmed by preoperative thin-slice CT (\<=1 mm) and 3D reconstruction.
• Solid-dominant nodule with consolidation-to-tumor ratio (CTR) \>0.5, including pure-solid nodules.
• Deeply located lesion, defined as the lesion center located in the inner two-thirds of the lung field on axial, coronal, and sagittal MPR images.
• Clinically definite suspected primary NSCLC after complete preoperative work-up and MDT discussion, with estimated malignancy probability \>=95%. Preoperative pathologic confirmation is not mandatory, but preoperative or intraoperative pathology should be obtained when technically safe and feasible.
• Complete staging with thin-slice contrast-enhanced chest CT, whole-body PET-CT, brain contrast-enhanced MRI or CT, and serum tumor markers as appropriate; clinical stage IA (cT1a-bN0M0) without regional nodal or distant metastasis.
• Cardiopulmonary function sufficient to tolerate both lobectomy and segmentectomy, with FEV1 and DLCO \>=60% predicted.
• Written informed consent, including special disclosure that final pathology may be benign.
• Centralized imaging review confirmation by the lead-center technical committee before randomization.

You may not qualify if:

• Lesion located in the right middle lobe.
• Lesion located in the inner two-thirds but adjacent to the lung apex or base and judged suitable for wedge resection.
• Two or more lesions requiring anatomic resection. One secondary lesion requiring only non-anatomic wedge resection is allowed; two main lesions in the same segment are excluded.
• Prior ipsilateral lung surgery or another malignancy within 5 years.
• Severe cardiovascular or cerebrovascular disease or other comorbidity making lobectomy or conversion to lobectomy intolerable.
• Planned basal segmentectomy (S7-10); proper segmentectomy is permitted.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Eligible participants will be randomized before induction of anesthesia in a 1:1 ratio to anatomic segmentectomy or anatomic lobectomy. Randomization is stratified by center, sex, age (\<65 vs \>=65 years), and clinicopathologic type (CTR 0.5 to \<1.0 vs CTR=1.0). All randomized participants will be analyzed according to the intention-to-treat principle.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): July 1, 2034
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

CN (1)