Clinical trial · Interventional
Segmentectomy Versus Lobectomy for Deep Solid-Dominant Early-Stage NSCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Stage IA Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anatomic Lobectomy | Procedure | — | UNRESOLVED |
| Anatomic Segmentectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Segmentectomy
- description
- 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.
- interventionNames
- Procedure: Anatomic Segmentectomy
- type
- ACTIVE_COMPARATOR
- label
- Lobectomy
- description
- Participants assigned to this arm will undergo standard anatomic pulmonary lobectomy with required systematic or lobe-specific lymph-node dissection.
- interventionNames
- Procedure: Anatomic Lobectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 to 80 years. 2. Solitary pulmonary nodule with whole-tumor maximal diameter \<=2 cm confirmed by preoperative thin-slice CT (\<=1 mm) and 3D reconstruction. 3. Solid-dominant nodule with consolidation-to-tumor ratio (CTR) \>0.5, including pure-solid nodules. 4. 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. 5. 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. 6. 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. 7. Cardiopulmonary function sufficient to tolerate both lobectomy and segmentectomy, with FEV1 and DLCO \>=60% predicted. 8. Written informed consent, including special disclosure that final pathology may be benign. 9. Centralized imaging review confirmation by the lead-center technical committee before randomization. Exclusion Criteria: 1. Lesion located in the right middle lobe. 2. Lesion located in the inner two-thirds but adjacent to the lung apex or base and judged suitable for wedge resection. 3. 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. 4. Prior ipsilateral lung surgery or another malignancy within 5 years. 5. Severe cardiovascular or cerebrovascular disease or other comorbidity making lobectomy or conversion to lobectomy intolerable. 6. Planned basal segmentectomy (S7-10); proper segmentectomy is permitted.
References
Publications (0)
Data not yet available