Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

neoadjuvant immunotherapy: Patients 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Technical Dissection Difficulty (TDD) Rate — During the radical surgery (Day 0 of surgery)
  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) — From the date of radical surgery to the date of disease recurrence, progression, death, or last follow-up, up to 5 years.
  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.

Trial sites (4)

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