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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Lobectomy | Active Comparator | Participants assigned to this arm will undergo standard anatomic pulmonary lobectomy with required systematic or lobe-specific lymph-node dissection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anatomic Segmentectomy | Procedure | Anatomical resection of the involved pulmonary segment or segments with lymph-node dissection and surgical quality-control assessment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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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.
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| Anatomic Lobectomy | Procedure | Anatomical resection of the involved pulmonary lobe with lymph-node dissection. |
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| Locoregional Recurrence Rate | Proportion of participants with recurrence at the surgical margin, ipsilateral remaining lung, or ipsilateral hilar/mediastinal lymph nodes. | Up to 5 years after randomization |
| Distant Metastasis Rate | Proportion of participants with metastasis involving contralateral lung, pleura, N3 lymph nodes, or extrathoracic organs. | 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. | Baseline and 6, 12, and 36 months after surgery |
| Six-Minute Walk Distance | Change in 6-minute walk test distance. | Baseline and 6 and 12 months after surgery |
| FEV1 Change Rate | Change or loss rate in FEV1 (Forced Expiratory Volume in 1 second). | 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. | Perioperative period |
| Perioperative Complications | Postoperative adverse events graded by Clavien-Dindo, with emphasis on grade II or higher complications. | Through discharge or 30 days after surgery, whichever came first |
| 30-Day Mortality | All-cause mortality within 30 days after surgery. | 30 days after surgery |
| DLCO Change Rate | Change or loss rate in DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide). | 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. | Baseline and 3, 6, 12, and 36 months after surgery |
| 90-Day Mortality | All-cause mortality within 90 days after surgery. | 90 days after surgery |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |