An interventional study of Anatomic Segmentectomy and Anatomic Lobectomy in Non-Small Cell Lung Cancer and Stage IA Non-Small Cell Lung Cancer, sponsored by Shanghai Chest Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment
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.
Segmentectomy has been established as an accepted treatment option for selected small peripheral NSCLC, but high-level randomized evidence is limited for tumors located in the inner two-thirds of the lung parenchyma. Deep, solid-dominant nodules may have higher oncologic risk, more complex anatomy, and greater difficulty achieving conventional linear surgical margins.
This trial evaluates whether standardized anatomic segmentectomy, including surgical quality control and lymph-node dissection requirements, is non-inferior to lobectomy for overall survival in patients with deeply located, solid-dominant, clinical stage IA NSCLC \<=2 cm. The trial incorporates centralized pre-randomization imaging review, mandatory recording of margin and surgical quality metrics, systematic or lobe-specific lymph-node dissection, independent endpoint adjudication, and DSMB safety and quality oversight.
Participants randomized to the segmentectomy arm will undergo anatomic segmentectomy when feasible. Conversion to lobectomy is required for intraoperative frozen-section N1/N2 nodal metastasis and may occur for inadequate margins, anatomic difficulty, or safety concerns. Participants randomized to the lobectomy arm will undergo standard anatomic lobectomy. Intraoperative findings and final pathology do not change the original randomized assignment for the primary intention-to-treat analysis.
Exclusion Criteria:
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
Participants assigned to this arm will undergo standard anatomic pulmonary lobectomy with required systematic or lobe-specific lymph-node dissection.
Procedure: Anatomic Lobectomy
Anatomical resection of the involved pulmonary segment or segments with lymph-node dissection and surgical quality-control assessment.
Anatomical resection of the involved pulmonary lobe with lymph-node dissection.
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.
Time frame: 5 years after randomization
Recurrence-Free Survival
Recurrence-free survival is defined as the time from randomization to first recurrence, distant metastasis, second primary lung cancer, or death from any cause. Event-free participants will be censored at the last event-free follow-up. RFS will be formally tested only if OS non-inferiority is established.
Time frame: 5 years after randomization
Locoregional Recurrence Rate
Proportion of participants with recurrence at the surgical margin, ipsilateral remaining lung, or ipsilateral hilar/mediastinal lymph nodes.
Time frame: Up to 5 years after randomization
Distant Metastasis Rate
Proportion of participants with metastasis involving contralateral lung, pleura, N3 lymph nodes, or extrathoracic organs.
Time frame: Up to 5 years after randomization
Patient-Reported Quality of Life Score (EORTC QLQ-C30)
Patient-reported quality of life measured using EORTC QLQ-C30, with attention to dyspnea, chest pain, and cough.
Time frame: Baseline and 6, 12, and 36 months after surgery
Six-Minute Walk Distance
Change in 6-minute walk test distance.
Time frame: Baseline and 6 and 12 months after surgery
FEV1 Change Rate
Change or loss rate in FEV1 (Forced Expiratory Volume in 1 second).
Time frame: Baseline and 6 and 12 months after surgery
Surgical Quality Metrics
Surgical grade distribution, margin distance, R0 resection rate, lymph-node dissection station and count compliance, and conversion rate from segmentectomy to lobectomy.
Time frame: Perioperative period
Perioperative Complications
Postoperative adverse events graded by Clavien-Dindo, with emphasis on grade II or higher complications.
Time frame: Through discharge or 30 days after surgery, whichever came first
30-Day Mortality
All-cause mortality within 30 days after surgery.
Time frame: 30 days after surgery
DLCO Change Rate
Change or loss rate in DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide).
Time frame: Baseline and 6 and 12 months after surgery
Patient-Reported Lung Cancer Symptom Score (EORTC QLQ-LC13)
Patient-reported lung cancer-specific symptoms measured using EORTC QLQ-LC13, with attention to dyspnea, chest pain, and cough.
Time frame: Baseline and 3, 6, 12, and 36 months after surgery
90-Day Mortality
All-cause mortality within 90 days after surgery.
Time frame: 90 days after surgery
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Shanghai Chest Hospital