Sub-lobectomy vs Lobectomy in IIA-IIIB NSCLC After Neoadjuvant IO+Chemo

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 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:

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.

Conditions

• NSCLC

Interventions

PROCEDURE

Sub-lobectomy

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).

PROCEDURE

Lobectomy

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.

Sponsors & Collaborators

• Wen-zhao ZHONG

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-18

Primary Completion

2034-05-31

Completion

2034-05-31

Countries

• China

Study Locations