Partial versus full lobe removal after treatment for lung cancer
Compares partial and full lobe removal in lung cancer after immunochemotherapy.
Key facts
- Who runs it
- Wen-zhao ZHONG
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- Sub-lobectomy vs Lobectomy in IIA-IIIB NSCLC After Neoadjuvant IO+Chemo
- Status
- Recruiting
- People taking part
- 585 people, planned
- Started
- 18 May 2026
- Expected to end
- 31 May 2034
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Sub-lobectomy
- Lobectomy
- Record updated
- 29 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-small cell lung cancer, stage IIA-IIIB, who had 2-4 cycles of immunotherapy plus platinum chemotherapy before surgery and whose tumour can be removed with a smaller lung operation. They are randomly given either a smaller lung operation or removal of a whole lung lobe.
- Age
- 18 years or older and younger than 75 years
- Sex
- Men and women can join.
- Disease stage
- Peripheral non-small cell lung cancer (NSCLC) confirmed by tissue tests, stage IIA to IIIB before neoadjuvant therapy (IASLC 9th edition). No solid lesions in different lung lobes. The tumour is more than 2cm (0.8 in) from the bronchial opening. A review committee must find the tumour can be fully removed with a smaller (sub-lobar) operation.
- Earlier treatment
- Must have had 2-4 cycles of neoadjuvant therapy with a PD-1/PD-L1 inhibitor plus platinum-based two-drug chemotherapy. Cannot have had chest radiation, or open chest surgery on the same side.
- Biomarker or test result
- No known EGFR mutation or ALK rearrangement.
Main reasons for not taking part
- Not expected to tolerate removal of a whole lung lobe
- Chest radiation before surgery
- Organ or tissue transplant from another person
- Autoimmune disease, long-term steroids above 10 mg/day, or other immunosuppressive treatment within 3 months before surgery
- Positive HIV test, or active hepatitis B or C
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- 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
- 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 take part
- 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
- 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
- Pregnancy, lactation, or planned pregnancy; Positive blood pregnancy test within 7 days prior to the first study treatment
- There is a history of interstitial lung disease (non infectious) that requires steroid treatment or currently has interstitial lung disease that requires steroid treatment
- 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
- Viral infectious disease in screening period:; 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
- Expected intolerance to lobectomy
- 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
- Participants have poor compliance and are unwilling or unable to follow the research protocol
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Guangdong Provincial People's HospitalGuangzhou, ChinaContact: Wen-zhao ZhongTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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:
1. 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.
The 2 groups in the trial
- Sub-lobectomyTreatment being tested
Sub-lobectomy+mediastinal hilar lymph node dissection
- LobectomyExisting treatment, for comparison
Lobectomy+mediastinal hilar lymph node dissection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Partial versus full lobe removal after treatment for lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07612722, who can take part
- Record updated
- 29 May 2026