This multicenter retrospective real-world study aims to evaluate the safety, efficacy and survival outcomes of neoadjuvant/induction immunotherapy in patients with non-small cell lung cancer (NSCLC). The study covers diverse treatment pathways, including surgery, definitive radiotherapy, and non-surgical strategies. It addresses gaps in existing trials by establishing a comprehensive cohort spanning neoadjuvant/induction therapy, perioperative management, and follow-up, providing real-world evidence to support treatment decisions in both operable and inoperable cases.
Histologically confirmed non-small cell lung cancer (NSCLC), regardless of the presence of EGFR or ALK sensitive driver gene mutations;
Clinical staging of IA-IIIC according to the AJCC 8th Edition before neoadjuvant treatment;
Received at least one cycle of neoadjuvant immunotherapy (with or without chemotherapy);
Assessed as resectable or potentially resectable by surgical experts prior to treatment.
Confirmed M1 disease;
History of previous lung malignancy or other metastatic malignant tumors;
Participation in other randomized controlled trials involving neoadjuvant treatment;
Significant missing clinical data.
This study will include real-world patients diagnosed with stage IA-IIIC non-small cell lung cancer (NSCLC) who received at least one cycle of neoadjuvant immunotherapy (with or without chemotherapy). According to surgical evaluation, patients eligible for inclusion were assessed as either resectable or potentially resectable before treatment. Subsequent treatment following the neoadjuvant therapy may include surgical resection, radiotherapy, or non-localized therapy.
Cohort
Retrospective
neoadjuvant immunotherapy
DrugPatients in the cohort received neoadjuvant immune checkpoint inhibitors (ICIs), including PD-1/PD-L1 inhibitors, as part of routine clinical care. The specific regimens included monotherapy or combination with chemotherapy. The agents used may include nivolumab, camrelizumab, sintilimab, atezolizumab, or others. This is a retrospective observational study. All interventions (neoadjuvant immunotherapy ± chemotherapy, surgery, or other treatments) were determined by treating physicians as part of standard care. The study aims to evaluate perioperative and survival outcomes across different treatment paths in real-world clinical settings.
Technical Dissection Difficulty (TDD) Rate
Defined as the intraoperative presence of fibrosis and/or tight adhesion between lymph nodes and surrounding structures around the hilar and fissure. TDD is considered present if either fibrosis or significant adhesion is noted, potentially increasing surgical complexity. Surgical difficulty is assessed based on operative reports and predefined intraoperative criteria, as documented by the operating surgeon.
Disease-Free Survival (DFS)
Defined as the time from the date of radical surgery to the first occurrence of disease recurrence, progression, or death from any cause. Patients without an event will be censored at the date of the last follow-up. Disease status is determined through radiological, pathological, or clinical assessment as documented during follow-up.
Postoperative Complications Incidence (Clavien- Dindo ≥ III)
Defined as the proportion of patients experiencing postoperative complications graded as Clavien-Dindo classification grade III or higher within 30 days after radical surgery. Complication data are collected from postoperative records, discharge summaries, and follow-up documentation.
Treatment-Related Adverse Events (TRAEs) Incidence (CTCAE Grade ≥ 3)
The incidence of treatment-related adverse events (TRAEs) graded ≥3 according to the Common Terminology Criteria for Adverse Events (CTCAE), v5.0, occurring during the neoadjuvant/induction phase and within 90 days following the initiation of definitive local therapy (surgery or radiotherapy). TRAEs are assessed based on clinical presentation, laboratory findings, imaging results, and physician judgment, with causality reviewed by the research team.
Immune-Related Adverse Events (irAEs) Incidence
Defined as the incidence of immune-related adverse events (irAEs) occurring from the start of neoadjuvant immunotherapy until 90 days after radical surgery or the initiation of definitive radiotherapy, whichever applies. irAEs are adverse events potentially attributable to immune checkpoint inhibitors and may involve organs such as the lung, liver, skin, or endocrine system. Events are graded according to CTCAE v5.0, and diagnosis is based on clinical presentation, laboratory/imaging findings, and expert clinical judgment.
Progression-Free Survival (PFS)
Defined as the time from the initiation of neoadjuvant immunotherapy to the first documented disease progression or death from any cause, whichever occurs first. Disease progression includes local recurrence, regional relapse, distant metastasis, or any clinically or radiologically confirmed progression. Patients without an event will be censored at the date of the last follow-up.
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