Comparison of the Effect of Surgical Resection Based on Lesion Extent Before and After Neoadjuvant Therapy in Patients With Stage II-IIIB Non-Small Cell Lung Cancer: A Single-Center, Real-World, Open-Label Study

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Invitation-only

Conditions: Surgery; Carcinoma, Non-Small-Cell Lung; Neoadjuvant Immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT07373899

NCC5959

Details and patient eligibility

About

This study intends to conduct a prospective, non-interventional study to compare the survival benefits of different surgical resection patterns for patients with non-small cell lung cancer who have achieved partial response (PR) after immunotherapy induction. The study plans to enroll patients suitable for surgery as assessed by radiomics evaluation and multidisciplinary team (MDT) discussion, and will assign them to the modified surgery group and the conventional surgery group based on patient preference. The resection scope in the modified surgery group is more limited compared to conventional surgery, aiming to maximize preservation of pulmonary function while ensuring oncological safety. This study will systematically evaluate the impact of different resection scopes on patient prognosis after neoadjuvant immunotherapy, providing clinical evidence for exploring individualized surgical strategies for non-small cell lung cancer in the era of immunotherapy.

Enrollment: 354 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed non-small cell lung cancer (NSCLC)
• Achieved resectability after neoadjuvant immunotherapy with or without chemotherapy
• Initially required pneumonectomy or combined lobectomy based on tumor size and extent, but became suitable for minimally invasive resection after neoadjuvant treatment
• Age ≥ 18 years
• ECOG performance status score of 0-1
• Complete imaging, pathological, and follow-up data available

Exclusion criteria

• Disease progression (PD) after neoadjuvant therapy
• Still required pneumonectomy or combined lobectomy after neoadjuvant therapy, with no reduction in the planned surgical extent
• Intraoperative findings indicating that R0 resection was not feasible
• Severe cardiopulmonary dysfunction or other complications that made the patient unable to tolerate surgery

Trial design

354 participants in 2 patient groups

Conventional Surgery Group

Description:

Perform a pneumonectomy or composite lobectomy within the originally planned scope

Modified/Reduced Surgery Group

Description:

Under the premise of ensuring R0 resection, reduce the surgical scope, prefer composite lobectomy or lobectomy to maximize the preservation of pulmonary function.