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.

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung; Surgery; Neoadjuvant Immunotherapy

• Study Type: Observational
• Enrollment (Estimated): 354

Contacts and Locations

• Study Contact: Name: S Gao, MD; Phone Number: 13801185056; Email: gaoshugeng@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All the patients were those admitted to the Thoracic Surgery Department of the Cancer Hospital of Chinese Academy of Medical Sciences.

Description

Inclusion Criteria:

• Histologically confirmed NSCLC; ② Achieved resectable criteria after neoadjuvant immunotherapy (± chemotherapy); ③ Originally required total lung resection or combined lobectomy based on the size and extent of the lesion, but after neoadjuvant treatment, the condition was suitable for minimally invasive resection; ④ Age ≥ 18 years; ⑤ ECOG score 0-1; ⑥ Complete imaging, pathological and follow-up data.

Exclusion Criteria:

• ① Disease progression (PD) after neoadjuvant therapy; ② Those who still require total lung resection or combined lobectomy and whose scope cannot be reduced; ③ During the operation, it is found that R0 resection is impossible; ④ Severe cardiopulmonary dysfunction or other complications make them intolerant to surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Conventional Surgery Group; Perform a pneumonectomy or composite lobectomy within the originally planned scope
Modified/Reduced Surgery Group; Under the premise of ensuring R0 resection, reduce the surgical scope, prefer composite lobectomy or lobectomy to maximize the preservation of pulmonary function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	It refers to the period from the beginning of the study until the recurrence of the disease or any cause of death.	Evaluate over a period of up to five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response(pCR)	After evaluating the removed tumor tissue and the regional lymph nodes, no residual tumor cells were found.	up to 1 month after surgery
Overall Survival (OS)	OS is defined as the time from surgery time until death from any cause.	From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 5 years.
Incidence of perioperative complications	The perioperative period refers to a certain period before, during and after the surgery. Postoperative pulmonary complications refer to various respiratory system complications that occur in patients after the surgery.	up to 1 month after surgery

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: NCC5959

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No