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Less may be more: smaller lung surgery tested against standard removal
NCT ID NCT07169903
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study compares two types of surgery for people with a specific kind of lung cancer (adenocarcinoma) that is 2-3 cm in size and has a low-to-intermediate grade. One surgery removes just the part of the lung with the tumor (segmentectomy), while the other removes an entire lobe (lobectomy). The goal is to see if the smaller surgery works just as well at preventing the cancer from coming back, while possibly helping patients keep more lung function. About 587 participants will be followed for 5 years after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surgery (segmentectomy or lobectomy)
- What this could lead to
- If successful, this could show that a less extensive surgery (segmentectomy) is as effective as a larger one (lobectomy) for certain lung cancers, potentially preserving more lung function and improving recovery.
- What could go wrong
- This is a Phase 3 trial, but results are years away. The benefit may be small or not apply to all patients. Surgery always carries risks like infection or complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 587 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
1. 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). 4\. Good lung function (FEV1 \> 1.5 L or FEV1% ≥ 60%), tolerable for both segmentectomy and lobectomy. 5\. 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. 7\. No history of ipsilateral thoracotomy; video-thoracoscopic examination meets the criteria. 8\. 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. 9\. 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: 1. Active bacterial or fungal infection (confirmed by imaging diagnosis or bacteriological examination with fever \>38°C). 2. 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). 3. 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). 4. Patients with concomitant other malignant tumors or hematological diseases. 5. Pregnant, planning to become pregnant, or lactating female patients (diagnosed with early pregnancy when urine HCG \>2500 IU/L). 6. Any form of antitumor therapy before tumor resection, including interventional chemotherapy embolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy. 7. Patients who participated in other tumor-related clinical trials within the past three months. 8. Preoperative CT suggests ground-glass predominant nodules (CTR \< 0.5). 9. Patients with positive lymph nodes indicated by preoperative imaging or lymph node puncture (clinical N stage = 1 or 2). 10. Patients with tumors near the hilum who cannot undergo segmentectomy. 11. Patients deemed unsuitable for enrollment by the investigator. 2. 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). 2\. 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: 1. Patients with IASLC grade 3 (≥20% pathological high-grade subtypes) indicated by intraoperative frozen section. 2. Patients confirmed with in situ carcinoma or microinvasive adenocarcinoma by intraoperative frozen section. 3. Patients with preoperative findings of distant metastasis or pleural/ascitic effusion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
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