NCT07698990Not yet recruiting
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 · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1200 (estimated)
- First submitted
- 18 Jun 2026
- Start date
- 21 Aug 2026
- Primary completion date
- 31 Jul 2034
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07698990
What you commit to
- Study type: Interventional
- Planned participants: 1200
- From 21 Aug 2026 to the primary completion date, 31 Jul 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Severe cardiovascular or cerebrovascular disease or other comorbidity making lobectomy or conversion to lobectomy intolerable.
Other
- Lesion located in the right middle lobe.
- Planned basal segmentectomy (S7-10); proper segmentectomy is permitted.
Who the study is looking for
- Age 18 to 80 years.
- Solitary pulmonary nodule with whole-tumor maximal 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.