Lung AdenocarcinomaPhase 3STAR012NCT07169903
Segmentectomy vs Lobectomy for 2 - 3cm IASLC Grade 1-2 Lung Adenocarcinoma: A Multi-center RCT
A Phase 3 study testing Pulmonary segmentectomy in people with Lung Adenocarcinoma, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
This study is a prospective, multicenter randomized controlled trial (RCT) designed to compare the efficacy of segmentectomy and lobectomy for invasive lung adenocarcinoma with a diameter of 2-3 cm and intraoperative frozen section-confirmed IASLC pathological new grade 1-2. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Pulmonary segmentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 587 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2033
- Phase
- Phase 3
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Initial Registration (1.1) Inclusion Criteria: 1. Aged 20 to 79 years, regardless of gender. 2. Preoperative CT or PET-CT suggests: ① Imaging diameter of 2-3 cm.
- Suspicion of non-small cell lung cancer (NSCLC).
- Solitary nodule or concomitant lesions with microinvasion or below.
- Primary tumor not located in the middle lobe.
- No suspected lymph node involvement. 3. Preoperative CT lung window (window level -700HU, window width 1500HU) indicates the nodule is predominantly solid, i.e., the consolidation-to-tumor ratio (CTR) is greater than 0.5 (CTR > 0.5).
- Good lung function (FEV1 > 1.5 L or FEV1% ≥ 60%), tolerable for both segmentectomy and lobectomy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 6. Voluntary participation with signed informed consent, able to comply with study visit plans and other protocol requirements.
- No history of ipsilateral thoracotomy; video-thoracoscopic examination meets the criteria.
- No history of chemotherapy or radiotherapy, including treatment for other cancers. Eligible if more than 5 years have passed since completion of perioperative adjuvant chemotherapy. Eligible if there is a history of or ongoing hormone therapy.
- All the following laboratory test results are eligible (all laboratory tests use the latest results within 28 days before initial registration; laboratory tests on the same day within 4 weeks before initial registration are allowed):
- White blood cell count ≥ 3000/mm³.
- Hemoglobin ≥ 8.0 g/dL (without blood transfusion within 28 days before initial registration).
- Platelet count ≥ 10×10⁴/mm³.
- AST ≤ 100 IU/L. ⑤ ALT ≤ 100 IU/L. ⑥ Total bilirubin ≤ 2.0 mg/dL. ⑦ Serum creatinine ≤ 1.5 mg/dL. 10. The patient has signed a written informed consent. (1.2) Exclusion Criteria:
- Active bacterial or fungal infection (confirmed by imaging diagnosis or bacteriological examination with fever >38°C).
- Multiple active cancers (synchronous or metachronous multiple primary cancers, excluding in situ carcinoma or intramucosal cancer lesions considered cured by local treatment; such lesions are not included in active multiple cancers).
- Patients with severe impairment of cardiac, hepatic, or renal function (cardiac function grade 3-4; ALT and/or AST more than 3 times the upper limit of normal; Cr exceeding the upper limit of normal).
- Patients with concomitant other malignant tumors or hematological diseases.
- Pregnant, planning to become pregnant, or lactating female patients (diagnosed with early pregnancy when urine HCG >2500 IU/L).
- Any form of antitumor therapy before tumor resection, including interventional chemotherapy embolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy.
- Patients who participated in other tumor-related clinical trials within the past three months.
- Preoperative CT suggests ground-glass predominant nodules (CTR < 0.5).
- Patients with positive lymph nodes indicated by preoperative imaging or lymph node puncture (clinical N stage = 1 or 2).
- Patients with tumors near the hilum who cannot undergo segmentectomy.
- Patients deemed unsuitable for enrollment by the investigator.
- Intraoperative Secondary Registration (2.1) Inclusion Criteria: 1. Intraoperative frozen section indicates invasive lung adenocarcinoma with International Association for the Study of Lung Cancer (IASLC) grade 1-2 (<20% pathological high-grade subtypes).
- Intraoperative frozen section shows negative surgical margins. 3. Intraoperative exploration reveals no severe adhesions or lymph node inflammatory changes (adhesions of pulmonary vessels or bronchi), confirming feasibility for both lobectomy and segmentectomy. (2.2) Exclusion Criteria:
- Patients with IASLC grade 3 (≥20% pathological high-grade subtypes) indicated by intraoperative frozen section.
- Patients confirmed with in situ carcinoma or microinvasive adenocarcinoma by intraoperative frozen section.
- Patients with preoperative findings of distant metastasis or pleural/ascitic effusion.
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 Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Chang Chen, PhD, MD, +8613816869003, chenthoracic@163.com
About this study
Official title: Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma 2 - 3cm With IASLC Grade 1 - 2 by Intraoperative Frozen Sections: A Prospective and Multi - Center Randomized Controlled Trial Study
This study is a prospective, multicenter randomized controlled trial (RCT) designed to compare the efficacy of segmentectomy and lobectomy for invasive lung adenocarcinoma with a diameter of 2-3 cm and intraoperative frozen section-confirmed IASLC pathological new grade 1-2. The non-inferiority of segmentectomy is primarily evaluated by 5-year relapse-free survival (RFS) and overall survival (OS) after surgery, while secondary endpoints include pulmonary function preservation, perioperative complications, etc. With a planned enrollment of 587 patients over a 3-year recruitment period and a 5-year follow-up, this study aims to identify an optimized surgical approach.
Read the detailed description
Lung cancer is the most prevalent and lethal malignant tumor worldwide. Surgical resection remains the most effective treatment for early-stage lung cancer, with lobectomy historically serving as the standard procedure. Recent studies have demonstrated that segmentectomy can achieve comparable outcomes to lobectomy for tumors ≤2 cm and those with ground-glass opacity dominance (CTR ≤0.5). However, for invasive lung adenocarcinomas measuring 2-3 cm with solid predominance (CTR >0.5), high-level evidence supporting segmentectomy as an alternative to lobectomy is lacking. The 2020 International Association for the Study of Lung Cancer (IASLC) proposed a new grading system for invasive adenocarcinoma, which stratifies prognosis based on histologic subtypes. Tumors with IASLC Grade 1-2 (≤20% high-grade components) have better outcomes, but their optimal surgical approach (segmentectomy vs. lobectomy) in solid-predominant lesions (2-3 cm) remains unproven. Intraoperative frozen section has shown high accuracy in diagnosing IASLC grades, enabling real-time surgical decision-making. The primary objective of this study is to evaluate whether segmentectomy is non-inferior to lobectomy in terms of 5-year relapse-free survival (RFS) and overall survival (OS) for patients with 2-3 cm lung adenocarcinomas confirmed as IASLC Grade 1-2 by intraoperative frozen section.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Pulmonary segmentectomy
- Keywords
- Segmentectomy, Lobectomy, Lung Adenocarcinoma, IASLC Grade, Randomized Controlled Trial
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary segmentectomyProcedure or surgery
Also called Segmentectomy
Segmentectomy is applied to lung adenocarcinomas with a diameter of 2-3 cm, in which intraoperative frozen pathology confirms a new pathological grade of 1-2.
| Study group | Role | What they receive |
|---|---|---|
| Lobectomy Group | No intervention | Lobectomy includes resection of the right upper or lower lobe, and the left upper or lower lobe. Resection of more than one pulmonary lobe does not meet the criteria. The surgical margin, that is, the distance between the cut end covered by the visceral pleura and the tumor edge, is evaluated macroscopically to confirm that the surgical margin is not less than the maximum diameter of the tumor or 20 mm. If there is no frozen pathological diagnosis or cytological examination, it is necessary to confirm that there is no tumor residue at the margin before closing the chest. If the resection margin is positive for residual tumor cells, further surgical resection beyond the planned procedure must be performed. |
| Segmentectomy group | Experimental | Segmentectomy involves resection of a pulmonary segment or a segment along with its adjacent segments. After segmentectomy, the surgical margin is examined macroscopically by evaluating the distance between the cut end covered by the visceral pleura and the tumor edge. If the surgical margin is smaller than the maximum diameter of the tumor or 20 mm, or if the margin is positive for residual tumor cells, the resection scope should be expanded. If the margin remains positive after expansion, segmentectomy should be converted to lobectomy. Receives: Procedure: Pulmonary segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of surgery to death from any cause. For surviving patients, survival time is censored at the last date when survival was confirmed; the study allows telephone confirmation of survival status, provided that medical records are available. For lost-to-follow-up patients, survival time is censored on the last date when survival was confirmed before the loss of follow-up. For patients diagnosed with non-malignant tumors, the date of surgery is used as the censorship point.
Measured: 5 years
Recurrence-Free Survival (RFS)
Recurrence-Free Survi refers to the time from the date of surgery to the diagnosis of recurrence or death from any cause, whichever occurs first. "Recurrence" includes both cases confirmed by imaging diagnosis and clinical exacerbation (symptomatic aggravation) not confirmed by imaging diagnosis. For the former, the day of imaging examination is regarded as the recurrence date, while for the latter, the day of diagnosing symptomatic deterioration is considered the recurrence date. An increase in tumor marker values alone is not considered an RFS event. When recurrence is confirmed based on the pathological results of a biopsy specimen, if the patient had already been clinically diagnosed with recurrence before, the endpoint is the date of clinical diagnosis; otherwise, it is the biopsy date. The occurrence of other primary cancers is not considered an endpoint, and RFS continues until other events are identified.
Measured: 5 years
Secondary outcomes (5)
Postoperative Respiratory Function
Patients underwent respiratory function tests (forced expiratory volume in 1 second) at 6 months and 12 months postoperatively to assess the differences between baseline respiratory function and that at 6 months and 12 months postoperatively.
Measured: 12 months
Hospitalization Duration
The hospitalization duration was calculated as the median number of days from the date of surgery.
Measured: 1 month
Chest Tube Placement Time
The chest tube placement time is calculated as the median number of days from the surgery date to chest tube removal. If the chest tube is placed after the patient's discharge, the placement time is calculated until the tube is removed. If the patient undergoes a second chest tube placement, the time after replacement is not included in the calculation.
Measured: 1 month
Surgical Time
The surgical time is calculated as the duration from incision to the end of the operation.
Measured: 1 day
Blood Loss
The blood loss is measured from the incision to the end of the operation and recorded in milliliters (mL).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Mar 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 587 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Affiliated Hospital of Nantong University, Huadong Hospital, Anhui Chest Hospital, Ningbo No. 1 Hospital, Ningbo No.2 Hospital, Center hospital of Nanyang, The Affiliated Hospital of Xuzhou Medical University, Huzhou Central Hospital, Anhui Provincial Hospital, Shandong Public Health Clinical Center
- Responsible party
- Principal investigator, Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169903
- Sponsor's protocol ID
- STAR012
- Acronym
- STAR012
- Status last verified
- Jul 2025
- First submitted
- 15 Jun 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma 2 - 3cm With IASLC Grade 1 - 2 by Intraoperative Frozen Sections: A Prospective and Multi - Center Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT07169903
- Acronym / sponsor ID
- STAR012 / STAR012
- Conditions
- Lung Adenocarcinoma
- Keywords
- Segmentectomy, Lobectomy, Lung Adenocarcinoma, IASLC Grade, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 587 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Affiliated Hospital of Nantong University, Huadong Hospital, Anhui Chest Hospital, Ningbo No. 1 Hospital, Ningbo No.2 Hospital, Center hospital of Nanyang, The Affiliated Hospital of Xuzhou Medical University, Huzhou Central Hospital, Anhui Provincial Hospital, Shandong Public Health Clinical Center
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Mar 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 12 Sep 2025 (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.
This study is a prospective, multicenter randomized controlled trial (RCT) designed to compare the efficacy of segmentectomy and lobectomy for invasive lung adenocarcinoma with a diameter of 2-3 cm and intraoperative frozen section-confirmed IASLC pathological new grade 1-2. The non-inferiority of segmentectomy is primarily evaluated by 5-year relapse-free survival (RFS) and overall survival (OS) after surgery, while secondary endpoints include pulmonary function preservation, perioperative complications, etc. With a planned enrollment of 587 patients over a 3-year recruitment period and a 5-year follow-up, this study aims to identify an optimized surgical approach.
Detailed description
Lung cancer is the most prevalent and lethal malignant tumor worldwide. Surgical resection remains the most effective treatment for early-stage lung cancer, with lobectomy historically serving as the standard procedure. Recent studies have demonstrated that segmentectomy can achieve comparable outcomes to lobectomy for tumors ≤2 cm and those with ground-glass opacity dominance (CTR ≤0.5). However, for invasive lung adenocarcinomas measuring 2-3 cm with solid predominance (CTR >0.5), high-level evidence supporting segmentectomy as an alternative to lobectomy is lacking. The 2020 International Association for the Study of Lung Cancer (IASLC) proposed a new grading system for invasive adenocarcinoma, which stratifies prognosis based on histologic subtypes. Tumors with IASLC Grade 1-2 (≤20% high-grade components) have better outcomes, but their optimal surgical approach (segmentectomy vs. lobectomy) in solid-predominant lesions (2-3 cm) remains unproven. Intraoperative frozen section has shown high accuracy in diagnosing IASLC grades, enabling real-time surgical decision-making. The primary objective of this study is to evaluate whether segmentectomy is non-inferior to lobectomy in terms of 5-year relapse-free survival (RFS) and overall survival (OS) for patients with 2-3 cm lung adenocarcinomas confirmed as IASLC Grade 1-2 by intraoperative frozen section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lobectomy Group | No intervention | –Lobectomy includes resection of the right upper or lower lobe, and the left upper or lower lobe. Resection of more than one pulmonary lobe does not meet the criteria. The surgical margin, that is, the distance between the cut end covered by the visceral pleura and the tumor edge, is evaluated macroscopically to confirm that the surgical margin is not less than the maximum diameter of the tumor or 20 mm. If there is no frozen pathological diagnosis or cytological examination, it is necessary to confirm that there is no tumor residue at the margin before closing the chest. If the resection margin is positive for residual tumor cells, further surgical resection beyond the planned procedure must be performed. |
| Segmentectomy group | Experimental | Procedure: Pulmonary segmentectomySegmentectomy involves resection of a pulmonary segment or a segment along with its adjacent segments. After segmentectomy, the surgical margin is examined macroscopically by evaluating the distance between the cut end covered by the visceral pleura and the tumor edge. If the surgical margin is smaller than the maximum diameter of the tumor or 20 mm, or if the margin is positive for residual tumor cells, the resection scope should be expanded. If the margin remains positive after expansion, segmentectomy should be converted to lobectomy. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Pulmonary segmentectomyAlso: SegmentectomySegmentectomy is applied to lung adenocarcinomas with a diameter of 2-3 cm, in which intraoperative frozen pathology confirms a new pathological grade of 1-2. | Procedure or surgery | Segmentectomy group |
Primary outcome
Overall Survival (OS)
Time frame: 5 years
Overall Survival (OS) is defined as the time from the date of surgery to death from any cause. For surviving patients, survival time is censored at the last date when survival was confirmed; the study allows telephone confirmation of survival status, provided that medical records are available. For lost-to-follow-up patients, survival time is censored on the last date when survival was confirmed before the loss of follow-up. For patients diagnosed with non-malignant tumors, the date of surgery is used as the censorship point.
Recurrence-Free Survival (RFS)
Time frame: 5 years
Recurrence-Free Survi refers to the time from the date of surgery to the diagnosis of recurrence or death from any cause, whichever occurs first. "Recurrence" includes both cases confirmed by imaging diagnosis and clinical exacerbation (symptomatic aggravation) not confirmed by imaging diagnosis. For the former, the day of imaging examination is regarded as the recurrence date, while for the latter, the day of diagnosing symptomatic deterioration is considered the recurrence date. An increase in tumor marker values alone is not considered an RFS event. When recurrence is confirmed based on the pathological results of a biopsy specimen, if the patient had already been clinically diagnosed with recurrence before, the endpoint is the date of clinical diagnosis; otherwise, it is the biopsy date. The occurrence of other primary cancers is not considered an endpoint, and RFS continues until other events are identified.
5 secondary outcomes
Postoperative Respiratory Function
Time frame: 12 months
Hospitalization Duration
Time frame: 1 month
Chest Tube Placement Time
Time frame: 1 month
Surgical Time
Time frame: 1 day
Blood Loss
Time frame: 1 day
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 12 Sep 2025.
- Individual participant dataSharing planned: No
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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 Phase 3 study testing Pulmonary segmentectomy in people with Lung Adenocarcinoma, run by Shanghai Pulmonary Hospital, Shanghai, China 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?
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 12 Sep 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Haojie Si, MD (+8613777120014, 2446135063@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 5 years). The study lists 2 primary outcomes in all. 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 12 Sep 2025.