Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

The purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of VTE (venous thromboembolism) and ATE (arterial thromboembolism) associated with immune checkpoint inhibitors (ICIs) therapy. The primary questions it aims to address are: 1. What is the real-world incidence of VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors? 2. What are the risk factors and biomarkers for VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors? 3. What is the impact of VTE/ATE on the prognosis of lung cancer patients receiving immune checkpoint inhibitors? Researchers will compare the characteristics and biomarkers of patients with and without ICI-associated VTE/ATE to identify novel specific biomarkers for thrombotic events. Furthermore, they will construct a risk assessment model for thrombotic events to provide guidance for precision prevention and treatment in clinical practice.

NCT Number	NCT06950697
Lead Sponsor	Beijing Chao Yang Hospital Collaborators: Capital Medical University, China-Japan Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, The Fourth Hospital of Inner Mongolia Autonomous Region
Conditions	Lung Cancer, Venous Thromboembolism, Arterial Thromboembolism, Immune Checkpoint Inhibitors (ICIs)
Enrollment	2,400 participants
Start Date	2019-01-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-30