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

Lung cancer is the leading cause of cancer-related deaths in both China and the world. In recent years, neoadjuvant immunotherapy has achieved breakthrough advancements in the treatment of non-small cell lung cancer (NSCLC). Evidence from multiple Phase III randomized controlled trials (RCTs), such as CheckMate 816, KEYNOTE-671, and AEGEAN, has demonstrated clear benefits of this therapy in improving survival. However, these studies exhibited several limitations: first, stringent selection criteria resulting in limited heterogeneity among participants challenge the generalizability of their conclusions; Second, some studies and clinical observations have preliminarily suggested that neoadjuvant immunotherapy may increase technical surgical difficulty; however, large-sample, real-world data on its perioperative safety remain limited; third, clinical practice involves numerous borderline resectable and unresectable cases, leading to highly complex treatment decisions (such as timing of surgical intervention after conversion therapy, radiotherapy strategies, etc.), with none of the existing guidelines reach clear consensus.

This study employs a multicenter real-world design, establishing a retrospective cohort covering from neoadjuvant/induction therapy period to the surveillance period. It evaluates the safety, efficacy, and survival outcomes of neoadjuvant/induction immunotherapy across diverse treatment strategies including both surgery and radiotherapy, providing real-world evidence to inform clinical decision-making.

• Postoperative Complications Incidence (Clavien- Dindo ≥ III) [Срок оценки: Within 30 days after surgery]
• Treatment-Related Adverse Events (TRAEs) Incidence (CTCAE Grade ≥ 3) [Срок оценки: From the start of neoadjuvant or induction therapy to 90 days after the initiation of definitive local treatment (surgery or radiotherapy).]
• Immune-Related Adverse Events (irAEs) Incidence [Срок оценки: From the start of neoadjuvant or induction therapy to 90 days after the initiation of definitive local treatment (surgery or radiotherapy).]
• Progression-Free Survival (PFS) [Срок оценки: From the start of neoadjuvant immunotherapy to the date of disease progression, death, or last follow-up, up to 5 years.]
• Overall Survival (OS) [Срок оценки: From the date of treatment initiation to death from any cause or last follow-up, up to 5 years]
• Conversion Rate to Thoracotomy [Срок оценки: During the radical surgery (Day 0)]
• Operative Time (minutes) [Срок оценки: During the radical surgery (Day 0)]
• pathologic Complete Response (pCR) Rate [Срок оценки: At the time of postoperative pathological assessment]
• Major Pathologic Response (MPR) Rate [Срок оценки: At the time of postoperative pathological assessment]
• Number of Dissected Lymph Nodes (N1, N2) [Срок оценки: During radical surgery (Day 0)]
• Number of Dissected Lymph Node Stations (N1, N2) [Срок оценки: During radical surgery (Day 0)]
• Reduction Rate of Surgical Resection Extent [Срок оценки: During the radical surgery (Day 0 of surgery)]