Sub-lobectomy vs. Lobectomy after neoadjuvant IO and chemo in NSCLC
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
Run by Guangdong Provincial People's Hospital · NCT07612722 · Data updated 2026-11-12
This trial tests if performing a sub-lobectomy instead of a full lobectomy after initial immunotherapy plus platinum chemotherapy can still safely remove NSCLC tumors in eligible patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 585 (estimated) |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 18, 2026 |
| Main results expected | May 31, 2034 |
| Study ends | May 31, 2034 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT07612722 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with NSCLC (IIA–IIIB) who have received neoadjuvant IO+chemo, are candidates for sub-lobar resection with R0 intent, and meet fitness criteria for surgery.
✕Probably not a fit
Patients who do not achieve adequate disease control with the pretreatment strategy or who are not suitable for sub-lobar resection may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, multicenter trial in NSCLC patients with stage IIA–IIIB who have already received immunotherapy plus platinum-based chemotherapy before surgery and are deemed feasible for sub-lobar resection with clear margins. After screening and enrollment, participants are randomized to undergo either sub-lobectomy or lobectomy, followed by perioperative care and long-term follow-up. The study includes a defined screening/baseline period, the surgical perioperative phase, and subsequent follow-up to assess outcomes. Primary considerations include oncologic adequacy of resection (R0) and postoperative outcomes, with safety and efficacy evaluated through standardized assessments.
Why it matters
Potential benefit: If successful, patients may benefit from a less extensive surgery without compromising cancer control.
How similar studies have gone: Prior approaches in selected NSCLC patients have explored sub-lobar resections after neoadjuvant therapy, with mixed results; this study contributes prospective randomized data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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: 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.
Where it's running
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Guangdong provincial people's hospital
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Zihao Chen
- Email: 502433827@qq.com
- Phone: +8616620072467
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.