Non-Small Cell Lung CancerSOLIDNCT07698990
Segmentectomy Versus Lobectomy for Deep Solid-Dominant Early-Stage NSCLC
A study testing Anatomic Segmentectomy and Anatomic Lobectomy in people with Non-Small Cell Lung Cancer and Stage IA Non-Small Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Stage IA Non-Small Cell Lung Cancer
- What is being tested?
- Anatomic Segmentectomy and Anatomic Lobectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2026to Jul 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years.
- Solitary pulmonary nodule with whole-tumor maximal diameter <=2 cm confirmed by preoperative thin-slice CT (<=1 mm) and 3D reconstruction.
- Solid-dominant nodule with consolidation-to-tumor ratio (CTR) >0.5, including pure-solid nodules.
- 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.
- 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.
- 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.
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- Cardiopulmonary function sufficient to tolerate both lobectomy and segmentectomy, with FEV1 and DLCO >=60% predicted.
- Written informed consent, including special disclosure that final pathology may be benign.
- Centralized imaging review confirmation by the lead-center technical committee before randomization.
Who cannot join
- Lesion located in the right middle lobe.
- Lesion located in the inner two-thirds but adjacent to the lung apex or base and judged suitable for wedge resection.
- 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.
- Prior ipsilateral lung surgery or another malignancy within 5 years.
- Severe cardiovascular or cerebrovascular disease or other comorbidity making lobectomy or conversion to lobectomy intolerable.
- Planned basal segmentectomy (S7-10); proper segmentectomy is permitted.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Qing Shanghai Chest Hospital, 18516349006, pillawang@163.com
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Anatomic Segmentectomy, Anatomic Lobectomy
- Keywords
- segmentectomy, lobectomy, deep pulmonary nodule, solid-dominant nodule, early-stage NSCLC, non-inferiority trial, overall survival, recurrence-free survival
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomic SegmentectomyProcedure or surgery
Anatomical resection of the involved pulmonary segment or segments with lymph-node dissection and surgical quality-control assessment.
Anatomic LobectomyProcedure or surgery
Anatomical resection of the involved pulmonary lobe with lymph-node dissection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Anatomic Segmentectomy |
| Lobectomy | Active comparator | Participants assigned to this arm will undergo standard anatomic pulmonary lobectomy with required systematic or lobe-specific lymph-node dissection. Receives: Procedure: Anatomic Lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years after randomization
Secondary outcomes (12)
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.
Measured: 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.
Measured: Up to 5 years after randomization
Distant Metastasis Rate
Proportion of participants with metastasis involving contralateral lung, pleura, N3 lymph nodes, or extrathoracic organs.
Measured: 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.
Measured: Baseline and 6, 12, and 36 months after surgery
Six-Minute Walk Distance
Change in 6-minute walk test distance.
Measured: Baseline and 6 and 12 months after surgery
FEV1 Change Rate
Change or loss rate in FEV1 (Forced Expiratory Volume in 1 second).
Measured: 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.
Measured: Perioperative period
Perioperative Complications
Postoperative adverse events graded by Clavien-Dindo, with emphasis on grade II or higher complications.
Measured: Through discharge or 30 days after surgery, whichever came first
30-Day Mortality
All-cause mortality within 30 days after surgery.
Measured: 30 days after surgery
DLCO Change Rate
Change or loss rate in DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide).
Measured: 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.
Measured: Baseline and 3, 6, 12, and 36 months after surgery
90-Day Mortality
All-cause mortality within 90 days after surgery.
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start21 Aug 2026 (estimated)
- Primary completionJul 2034 (estimated)
- Study completionJul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Li, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698990
- Sponsor's protocol ID
- SOLID-V1.9
- Acronym
- SOLID
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07698990
- Acronym / sponsor ID
- SOLID / SOLID-V1.9
- Keywords
- segmentectomy, lobectomy, deep pulmonary nodule, solid-dominant nodule, early-stage NSCLC, non-inferiority trial, overall survival, recurrence-free survival
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 21 Aug 2026 (estimated)
- Primary completion
- Jul 2034 (estimated)
- Study completion
- Jul 2034 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Segmentectomy | Experimental | Procedure: Anatomic SegmentectomyParticipants 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. |
| Lobectomy | Active comparator | Procedure: Anatomic LobectomyParticipants assigned to this arm will undergo standard anatomic pulmonary lobectomy with required systematic or lobe-specific lymph-node dissection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 80 years.
- Solitary pulmonary nodule with whole-tumor maximal diameter <=2 cm confirmed by preoperative thin-slice CT (<=1 mm) and 3D reconstruction.
- Solid-dominant nodule with consolidation-to-tumor ratio (CTR) >0.5, including pure-solid nodules.
- 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.
- 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.
Key exclusion criteria (6 listed)
- Lesion located in the right middle lobe.
- Lesion located in the inner two-thirds but adjacent to the lung apex or base and judged suitable for wedge resection.
- 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.
- Prior ipsilateral lung surgery or another malignancy within 5 years.
- Severe cardiovascular or cerebrovascular disease or other comorbidity making lobectomy or conversion to lobectomy intolerable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomic SegmentectomyAnatomical resection of the involved pulmonary segment or segments with lymph-node dissection and surgical quality-control assessment. | Procedure or surgery | Segmentectomy |
| Anatomic LobectomyAnatomical resection of the involved pulmonary lobe with lymph-node dissection. | Procedure or surgery | Lobectomy |
Primary outcome
Overall Survival
Time frame: 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.
12 secondary outcomes
Recurrence-Free Survival
Time frame: 5 years after randomization
Locoregional Recurrence Rate
Time frame: Up to 5 years after randomization
Distant Metastasis Rate
Time frame: Up to 5 years after randomization
Patient-Reported Quality of Life Score (EORTC QLQ-C30)
Time frame: Baseline and 6, 12, and 36 months after surgery
Six-Minute Walk Distance
Time frame: Baseline and 6 and 12 months after surgery
FEV1 Change Rate
Time frame: Baseline and 6 and 12 months after surgery
Surgical Quality Metrics
Time frame: Perioperative period
Perioperative Complications
Time frame: Through discharge or 30 days after surgery, whichever came first
30-Day Mortality
Time frame: 30 days after surgery
DLCO Change Rate
Time frame: Baseline and 6 and 12 months after surgery
Patient-Reported Lung Cancer Symptom Score (EORTC QLQ-LC13)
Time frame: Baseline and 3, 6, 12, and 36 months after surgery
90-Day Mortality
Time frame: 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomic Segmentectomy and Anatomic Lobectomy in people with Non-Small Cell Lung Cancer and Stage IA Non-Small Cell Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 5 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.