RecruitingNCT06926179

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

Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer: A Multicenter Real-World Study

Sponsor

Peking University Cancer Hospital & Institute

Enrollment

500 participants

Start Date

Dec 1, 2024

Study Type

OBSERVATIONAL

Conditions

Radiotherapy Lung Cancer (NSCLC)Neoadjuvant Immunotherapy Lung Surgery

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

Min Age: 18 Years

Inclusion Criteria4

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.

Exclusion Criteria4

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.

Interventions

DRUGneoadjuvant 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.