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

7. juli 2026 opdateret af: 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, Phase III, 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200030
        • Shanghai Chest Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Anatomic Segmentectomy
Anatomical resection of the involved pulmonary segment or segments with lymph-node dissection and surgical quality-control assessment.
Aktiv komparator: Lobectomy
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 lobe with lymph-node dissection.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recurrence-Free Survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 30 days after surgery
All-cause mortality within 30 days after surgery.
30 days after surgery
DLCO Change Rate
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 90 days after surgery
All-cause mortality within 90 days after surgery.
90 days after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Chest Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2034

Studieafslutning (Anslået)

1. juli 2034

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SOLID-V1.9

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