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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Carcinoma, Non-Small-Cell Lung, Neoadjuvant Immunotherapy, Surgery. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Disease-free survival [Time frame: Evaluate over a period of up to five years]
Secondary outcome measures (3)
- Overall Survival (OS) [Time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 5 years.]
- Pathological Complete Response(pCR) [Time frame: up to 1 month after surgery]
- Incidence of perioperative complications [Time frame: up to 1 month after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07373899 · NCC5959