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

Plain Language Summary

Simplified for easier understanding

This observational study is collecting real-world data on patients with non-small cell lung cancer (NSCLC) who received pre-surgery (neoadjuvant) immunotherapy — with or without chemotherapy — to better understand treatment outcomes in routine clinical practice. **You may be eligible if...** - You have confirmed non-small cell lung cancer (any EGFR or ALK mutation status) - Your cancer was clinically staged IA–IIIC before neoadjuvant treatment - You received at least one cycle of pre-surgery immunotherapy - Your cancer was considered resectable (able to be removed by surgery) before treatment **You may NOT be eligible if...** - Your cancer had already spread to distant sites (M1 disease) - You have a history of a previous lung cancer or other metastatic cancer - You participated in another randomised controlled trial for neoadjuvant treatment - There are significant gaps in your clinical records Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.