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Segmentectomy Versus Lobectomy for Deep Solid-Dominant Early-Stage NSCLC (SOLID)

2026년 8월 24일 업데이트: Zhigang Li, Shanghai Chest Hospital

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

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

1200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 중국
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200030
        • Shanghai Chest Hospital
        • 연락하다:
          • Qing Shanghai Chest Hospital
          • 전화번호: 18516349006
          • 이메일: pillawang@163.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Segmentectomy
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.
절차: Anatomic Segmentectomy
Anatomical resection of the involved pulmonary segment or segments with lymph-node dissection and surgical quality-control assessment.
활성 비교기: Lobectomy
Participants assigned to this arm will undergo standard anatomic pulmonary lobectomy with required systematic or lobe-specific lymph-node dissection.
절차: Anatomic Lobectomy
Anatomical resection of the involved pulmonary lobe with lymph-node dissection.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall Survival
기간: 5 years after randomization
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

2차 결과 측정

결과 측정
측정값 설명
기간
Recurrence-Free Survival
기간: 5 years after randomization
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
Locoregional Recurrence Rate
기간: Up to 5 years after randomization
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
기간: Up to 5 years after randomization
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)
기간: Baseline and 6, 12, and 36 months after surgery
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
기간: Baseline and 6 and 12 months after surgery
Change in 6-minute walk test distance.
Baseline and 6 and 12 months after surgery
FEV1 Change Rate
기간: Baseline and 6 and 12 months after surgery
Change or loss rate in FEV1 (Forced Expiratory Volume in 1 second).
Baseline and 6 and 12 months after surgery
Surgical Quality Metrics
기간: Perioperative period
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
기간: Through discharge or 30 days after surgery, whichever came first
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
기간: 30 days after surgery
All-cause mortality within 30 days after surgery.
30 days after surgery
DLCO Change Rate
기간: Baseline and 6 and 12 months after surgery
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)
기간: Baseline and 3, 6, 12, and 36 months after surgery
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
기간: 90 days after surgery
All-cause mortality within 90 days after surgery.
90 days after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Shanghai Chest Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 21일

기본 완료 (추정된)

2034년 7월 1일

연구 완료 (추정된)

2034년 7월 1일

연구 등록 날짜

최초 제출

2026년 6월 18일

QC 기준을 충족하는 최초 제출

2026년 7월 7일

처음 게시됨 (실제)

2026년 7월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 24일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SOLID-V1.9

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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