NSCLCNCT07612722
Sub-lobectomy vs Lobectomy in IIA-IIIB NSCLC After Neoadjuvant IO+Chemo
A study testing Sub-lobectomy and Lobectomy in people with NSCLC, run by Wen-zhao ZHONG at 1 site in China.
Trial summary
This study is a prospective, randomized controlled multicenter clinical trial. The study population consisted of non-small cell lung cancer（NSCLC） patients in stage IIA-IIIB (IASLC 9th edition) who received immunotherapy combined with platinum based dual drug chemotherapy before neoadjuvant therapy and were evaluated… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Sub-lobectomy and Lobectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 585 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2026to 31 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the research and sign an informed consent form;
- Age ≥ 18 years old,<75 years old, both male and female;
- The physical fitness status score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1;
- Expected survival period ≥ 12 months;
- Peripheral non-small cell lung cancer (NSCLC) confirmed by histology/pathology, with TNM staging of IIA~IIIB before neoadjuvant therapy (IASLC 9th edition), without known EGFR mutations/ALK rearrangements;
- No solid lesions involving different lung lobes;
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- No history of ipsilateral open chest surgery;
- Prior to enrollment, the patient has received 2-4 cycles of neoadjuvant therapy, which includes PD-1/PD-L1 inhibitors and platinum based dual drug chemotherapy;
- Having sufficient organ function
- According to the researcher's assessment, the cardiovascular and pulmonary function meets the criteria for accepting surgery; The forced expiratory volume in the first second (FEV1) of the lung function test should be at least 1.5 L or the diffusion volume of carbon monoxide (DLCO) in the lungs should be at least 40%; The researchers determined that there was no other impact on the heart and lung function impairment during the surgery;
- Based on preoperative CT diagnosis, the distance between the tumor and the bronchial opening is greater than 2cm;
- After evaluation by the evaluation committee, the lesion can be treated with sub lobe R0 resection after neoadjuvant therapy.
Who cannot join
- Expected intolerance to lobectomy;
- Received chest radiation therapy before starting surgical treatment;
- Have undergone allogeneic tissue/solid organ transplantation;
- Diagnosed with autoimmune disease or undergoing long-term systemic steroid therapy (prednisone or equivalent dosage exceeding 10 mg/day) or any other form of immunosuppressive therapy within 3 months prior to surgery;
- There is a history of interstitial lung disease (non infectious) that requires steroid treatment or currently has interstitial lung disease that requires steroid treatment;
- Viral infectious disease in screening period:
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- Positive for human immunodeficiency virus (HIV) serum reaction; Active hepatitis B: Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA quantitative detection>500 IU/mL or>2000 copies/mL; Active hepatitis C: Hepatitis C (HCV) antibody positive and HCV-RNA quantitative detection above the upper limit of normal;
- Hypertension participants with poor drug treatment control are defined as systolic blood pressure>150 mmHg or diastolic blood pressure>90 mmHg (it is allowed to adjust the treatment of hypertension drugs before the start of the study, but the average value of the latest three consecutive blood pressure records before enrollment in the study should be ≤ 150/90 mmHg) (each measurement should be at least 2 minutes apart);
- During screening, there are still active infections that require intravenous anti infective treatment;
- Other malignant tumors, excluding cured skin basal cell cancer, cervical or breast cancer in situ, superficial bladder cancer cancer, localized prostate cancer, etc., within 3 years before signing the informed consent; Participants with low-risk early prostate cancer (T1-T2a stage, Gleason score ≤ 6, PSA<10 ng/mL) who have received curative treatment or are under active monitoring with stable condition, regardless of whether they have received treatment, are allowed to be enrolled;
- There are situations that may interfere with the interpretation of research results or may affect participants' ability to complete the entire research process, or based on the judgment of the treatment researcher, participation in the research is not in the best interests of the participants;
- Pregnancy, lactation, or planned pregnancy; Positive blood pregnancy test within 7 days prior to the first study treatment;
- Participants have poor compliance and are unwilling or unable to follow the research protocol.
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, 1 recruiting
- Recruiting
Guangdong provincial people's hospital
Guangzhou, Guangdong, 510000
Wen-zhao Zhong, +8613609777314, 13609777314@163.com
Wen-zhao Zhong
About this study
Official title: Sub-lobectomy Versus Lobectomy in IIA-IIIB Non-small-cell Lung Cancer After Neoadjuvant Immunochemotherapy: a Multicentre, Open-label, Randomised, Controlled, Non-inferiority Trial
This study is a prospective, randomized controlled multicenter clinical trial. The study population consisted of non-small cell lung cancer（NSCLC） patients in stage IIA-IIIB (IASLC 9th edition) who received immunotherapy combined with platinum based dual drug chemotherapy before neoadjuvant therapy and were evaluated by the committee to be feasible for sub lobectomy R0 resection. After entering the study, they were randomly divided into a sub lobectomy group (study group) and a lobectomy group (control group). Follow up will be conducted after surgery.
The study includes screening/baseline period, perioperative period, and follow-up period.
Read more
Screening/Baseline Period: The screening period is 28 days prior to receiving surgery. After the patient signs the informed consent form (ICF), the inclusion and exclusion criteria are reviewed during the screening/baseline period to include patients who meet the inclusion and exclusion criteria, with specific reference to the inclusion and exclusion criteria. During the screening period of this study, if laboratory and imaging tests that do not meet the inclusion criteria are found during the first screening, patients are allowed to undergo re examination and re screening. When re screening, informed consent must be signed and a new participant screening number must be obtained through re registration.
Perioperative period: During the perioperative period, patients were randomized into a sub lobectomy group (study group) and a lobectomy group (control group). The research group used thin-layer CT imaging and 3D reconstruction to accurately plan the surgical resection range before surgery, and underwent subpulmonary lobectomy+hilar/mediastinal lymph node dissection; The control group patients underwent direct lobectomy and lymph node dissection of the pulmonary hilum/mediastinum.
Follow up period: The follow-up period includes a safety follow-up period and a survival follow-up period. Safety follow-up will be conducted 30 days (+5 days) after surgery or before receiving the first postoperative adjuvant therapy medication. Survival follow-up will be conducted every 3 months (± 14 days) in the first year after surgery and every 6 months (± 14 days) in the second year after surgery. Participants' chest CT scan results, survival status, follow-up anti-tumor treatment, and drug-related SAEs (including lung function tests at 6 months, 12 months, and 3 years after surgery) will be collected until the 3-year follow-up time/(participant death, loss to follow-up, voluntary withdrawal from clinical study, or end of study) (whichever occurs first). The research plan can be found in the research flowchart.
Main objective:
Evaluate the prognostic differences between sub lobectomy and lobectomy in NSCLC patients after neoadjuvant immunotherapy and chemotherapy;
Secondary objective:
- Evaluate the lung function preservation of NSCLC patients after neoadjuvant immunotherapy and chemotherapy with sub lobectomy compared to lobectomy; Evaluate the safety of sub lobectomy compared to lobectomy in NSCLC patients after neoadjuvant immunotherapy and chemotherapy, including postoperative complications, length of hospital stay, etc; Evaluate the postoperative quality of life of NSCLC patients after neoadjuvant immunotherapy and chemotherapy with sub lobectomy compared to lobectomy.
- Conditions
- NSCLC
- Being tested
- Sub-lobectomy, Lobectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-lobectomyProcedure or surgery
Subaulmonary lobectomy group: Subaulmonary lobectomy is performed, which is defined as the preservation of at least one intact lung segment or a lung segment with equivalent volume and good blood supply and ventilation of lung tissue after lobectomy; When the tumor approaches an undeveloped lung fissure or invades across lobes, the resection range of the affected lung should not exceed one lung segment. The separation of the plane between lung segments is achieved by the surgeon using cutting and suturing devices, energy instruments, or a combination of both. If the surgical margin is smaller than the maximum diameter of the tumor or less than 20 millimeters, or if the frozen pathology of the margin is positive, additional local resection must be performed until the margin is negative. If it is determined that at least one lung segment equivalent lung tissue cannot be preserved after additional resection, lobectomy will be performed to ensure curative resection (R0 resection).
LobectomyProcedure or surgery
Lobectomy group: perform lobectomy. It is prohibited to remove more than one lung lobe. Intraoperative frozen pathology or cytology examination must be performed before closing the chest to confirm that there is no tumor residue at the margin of the bronchial resection; If the frozen bronchial margin is positive during surgery, local resection of the residual bronchus must be performed until the margin is negative.
| Study group | Role | What they receive |
|---|---|---|
| Sub-lobectomy | Experimental | Sub-lobectomy+mediastinal hilar lymph node dissection Receives: Procedure: Sub-lobectomy |
| Lobectomy | Active comparator | Lobectomy+mediastinal hilar lymph node dissection Receives: Procedure: Lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3y-DFS
3-year disease-free survival rate
Measured: From enrollment to the end of treatment at 3 years
Secondary outcomes (2)
3y-OS
3-year overall survival rate
Measured: From enrollment to the end of treatment at 3 years
Lung function
Postoperative lung function indicators at 6, 12, and 36 months include changes in forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) compared to baseline levels
Measured: From enrollment to the end of treatment at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start18 May 2026 (estimated)
- Primary completion31 May 2034 (estimated)
- Study completion31 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Masking
- None (open label)
- Enrolment
- 585 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen-zhao ZHONG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wen-zhao ZHONG, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612722
- Sponsor's protocol ID
- KY2026-234-1
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 29 May 2026
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-lobectomy Versus Lobectomy in IIA-IIIB Non-small-cell Lung Cancer After Neoadjuvant Immunochemotherapy: a Multicentre, Open-label, Randomised, Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07612722
- Acronym / sponsor ID
- KY2026-234-1
- Conditions
- NSCLC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 585 participants (estimated)
- Lead sponsor
- Wen-zhao ZHONGUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 31 May 2034 (estimated)
- Study completion
- 31 May 2034 (estimated)
- First posted
- 29 May 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.
This study is a prospective, randomized controlled multicenter clinical trial. The study population consisted of non-small cell lung cancer（NSCLC） patients in stage IIA-IIIB (IASLC 9th edition) who received immunotherapy combined with platinum based dual drug chemotherapy before neoadjuvant therapy and were evaluated by the committee to be feasible for sub lobectomy R0 resection. After entering the study, they were randomly divided into a sub lobectomy group (study group) and a lobectomy group (control group). Follow up will be conducted after surgery.
The study includes screening/baseline period, perioperative period, and follow-up period.
Screening/Baseline Period: The screening period is 28 days prior to receiving surgery. After the patient signs the informed consent form (ICF), the inclusion and exclusion criteria are reviewed during the screening/baseline period to include patients who meet the inclusion and exclusion criteria, with specific reference to the inclusion and exclusion criteria. During the screening period of this study, if laboratory and imaging tests that do not meet the inclusion criteria are found during the first screening, patients are allowed to undergo re examination and re screening. When re screening, informed consent must be signed and a new participant screening number must be obtained through re registration.
Perioperative period: During the perioperative period, patients were randomized into a sub lobectomy group (study group) and a lobectomy group (control group). The research group used thin-layer CT imaging and 3D reconstruction to accurately plan the surgical resection range before surgery, and underwent subpulmonary lobectomy+hilar/mediastinal lymph node dissection; The control group patients underwent direct lobectomy and lymph node dissection of the pulmonary hilum/mediastinum.
Follow up period: The follow-up period includes a safety follow-up period and a survival follow-up period. Safety follow-up will be conducted 30 days (+5 days) after surgery or before receiving the first postoperative adjuvant therapy medication. Survival follow-up will be conducted every 3 months (± 14 days) in the first year after surgery and every 6 months (± 14 days) in the second year after surgery. Participants' chest CT scan results, survival status, follow-up anti-tumor treatment, and drug-related SAEs (including lung function tests at 6 months, 12 months, and 3 years after surgery) will be collected until the 3-year follow-up time/(participant death, loss to follow-up, voluntary withdrawal from clinical study, or end of study) (whichever occurs first). The research plan can be found in the research flowchart.
Main objective:
Evaluate the prognostic differences between sub lobectomy and lobectomy in NSCLC patients after neoadjuvant immunotherapy and chemotherapy;
Secondary objective:
- Evaluate the lung function preservation of NSCLC patients after neoadjuvant immunotherapy and chemotherapy with sub lobectomy compared to lobectomy; Evaluate the safety of sub lobectomy compared to lobectomy in NSCLC patients after neoadjuvant immunotherapy and chemotherapy, including postoperative complications, length of hospital stay, etc; Evaluate the postoperative quality of life of NSCLC patients after neoadjuvant immunotherapy and chemotherapy with sub lobectomy compared to lobectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub-lobectomy | Experimental | Procedure: Sub-lobectomySub-lobectomy+mediastinal hilar lymph node dissection |
| Lobectomy | Active comparator | Procedure: LobectomyLobectomy+mediastinal hilar lymph node dissection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily participate in the research and sign an informed consent form;
- Age ≥ 18 years old,<75 years old, both male and female;
- The physical fitness status score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1;
- Expected survival period ≥ 12 months;
- Peripheral non-small cell lung cancer (NSCLC) confirmed by histology/pathology, with TNM staging of IIA~IIIB before neoadjuvant therapy (IASLC 9th edition), without known EGFR mutations/ALK rearrangements;
Key exclusion criteria (13 listed)
- Expected intolerance to lobectomy;
- Received chest radiation therapy before starting surgical treatment;
- Have undergone allogeneic tissue/solid organ transplantation;
- Diagnosed with autoimmune disease or undergoing long-term systemic steroid therapy (prednisone or equivalent dosage exceeding 10 mg/day) or any other form of immunosuppressive therapy within 3 months prior to surgery;
- There is a history of interstitial lung disease (non infectious) that requires steroid treatment or currently has interstitial lung disease that requires steroid treatment;
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 |
|---|---|---|
| Sub-lobectomySubaulmonary lobectomy group: Subaulmonary lobectomy is performed, which is defined as the preservation of at least one intact lung segment or a lung segment with equivalent volume and good blood supply and ventilation of lung tissue after lobectomy; When the tumor approaches an undeveloped lung fissure or invades across lobes, the resection range of the affected lung should not exceed one lung segment. The separation of the plane between lung segments is achieved by the surgeon using cutting and suturing devices, energy instruments, or a combination of both. If the surgical margin is smaller than the maximum diameter of the tumor or less than 20 millimeters, or if the frozen pathology of the margin is positive, additional local resection must be performed until the margin is negative. If it is determined that at least one lung segment equivalent lung tissue cannot be preserved after additional resection, lobectomy will be performed to ensure curative resection (R0 resection). | Procedure or surgery | Sub-lobectomy |
| LobectomyLobectomy group: perform lobectomy. It is prohibited to remove more than one lung lobe. Intraoperative frozen pathology or cytology examination must be performed before closing the chest to confirm that there is no tumor residue at the margin of the bronchial resection; If the frozen bronchial margin is positive during surgery, local resection of the residual bronchus must be performed until the margin is negative. | Procedure or surgery | Lobectomy |
Primary outcome
3y-DFS
Time frame: From enrollment to the end of treatment at 3 years
3-year disease-free survival rate
2 secondary outcomes
3y-OS
Time frame: From enrollment to the end of treatment at 3 years
Lung function
Time frame: From enrollment to the end of treatment at 3 years
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 29 May 2026.
- 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 study testing Sub-lobectomy and Lobectomy in people with NSCLC, run by Wen-zhao ZHONG 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 12 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 29 May 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?
Contact Zihao Chen (+8616620072467, 502433827@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3y-DFS (time frame: From enrollment to the end of treatment at 3 years). 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 29 May 2026.