Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

24 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

1200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200030
        • Shanghai Chest Hospital
        • Contact:
          • Qing Shanghai Chest Hospital
          • Numéro de téléphone: 18516349006
          • E-mail: pillawang@163.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: Anatomic Segmentectomy
Anatomical resection of the involved pulmonary segment or segments with lymph-node dissection and surgical quality-control assessment.
Comparateur actif: Lobectomy
Participants assigned to this arm will undergo standard anatomic pulmonary lobectomy with required systematic or lobe-specific lymph-node dissection.
Procédure: Anatomic Lobectomy
Anatomical resection of the involved pulmonary lobe with lymph-node dissection.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall Survival
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Recurrence-Free Survival
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 30 days after surgery
All-cause mortality within 30 days after surgery.
30 days after surgery
DLCO Change Rate
Délai: 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)
Délai: 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
Délai: 90 days after surgery
All-cause mortality within 90 days after surgery.
90 days after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shanghai Chest Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

21 août 2026

Achèvement primaire (Estimé)

1 juillet 2034

Achèvement de l'étude (Estimé)

1 juillet 2034

Dates d'inscription aux études

Première soumission

18 juin 2026

Première soumission répondant aux critères de contrôle qualité

7 juillet 2026

Première publication (Réel)

13 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SOLID-V1.9

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner