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

N/ANot Yet RecruitingNCT07698990

Shanghai Chest Hospital1,200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 to 80 years. 2. Solitary pulmonary nodule with maximum 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes