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

Recruiting

• Conditions: Lung Cancer; Venous Thromboembolism; Arterial Thromboembolism

• Registration Number: NCT06950697
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2025-03
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-27
• Last Update Submitted: 2025-04-27
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

• Age ≥18 years
• Histopathologically confirmed lung cancer diagnosis at enrollment
• Received at least one dose of a China-approved lung cancer immune checkpoint inhibitor
• Signed informed consent form

Exclusion Criteria

• Excluded based on inclusion criteria
• Cannot comply with follow-up requirements

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism	From the date of the administration of the first dose of immune checkpoint inhibitors until three months after the completion of therapy or the initiation of other anti-tumor therapies, whichever comes first, assessed up to 96 months.	From the administration of the first dose of immune checkpoint inhibitors until three months after the completion of immune checkpoint inhibitor therapy, or until the initiation of other anti-tumor therapies following immune checkpoint inhibitor therapy, symptomatic and incidentally detected arterial thromboembolism and venous thromboembolism events that occur during this period are included.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	From the date of the administration of the first dose of immune checkpoint inhibitors until the date of disease progression, death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months.	Progression-Free Survival refers to the time from the start of immune checkpoint inhibitor therapy until the disease progresses or the patient dies, whichever occurs first.
Overall survival	From the date of the administration of the first dose of immune checkpoint inhibitors until the date of death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months.	Overall survival refers to the time from the start of immune checkpoint inhibitor therapy until the patient dies or the cutoff date, whichever occurs first."
Objective response rate	From the date of the first dose of immune checkpoint inhibitors until the best efficacy is achieved, assessed up to 96 months.	Objective Response Rate (ORR) refers to the proportion of patients who experience a confirmed reduction in tumor size or complete disappearance of the tumor, as assessed by standard criteria such as RECIST (Response Evaluation Criteria in Solid Tumors). It includes both complete responses (CR) and partial responses (PR) and is typically reported as a percentage of the total treated population.

Trial Locations

Locations (5)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

The Fourth Hospital of Inner Mongolia Autonomous Region; 🇨🇳 Hohhot City, Inner Mongolia Autonomous Region, China

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, China

Beijing Luhe Hospital, Capital Medical University; 🇨🇳 Beijing, China

China-japan Friendship Hospital; 🇨🇳 Beijing, China