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

NCT07373899 | Enrolling By Invitation

• 1 other identifier: NCC5959
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival (OS)

  From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 5 years.

• Pathological Complete Response(pCR)

  up to 1 month after surgery

• Incidence of perioperative complications

  up to 1 month after surgery

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Chaoyang, 250101, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 24, 2026

Record last verified: 2025-12

Locations

CN (1)