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

NCT06950697 | Recruiting

• 1 other identifier: CYFH202212
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 5

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. 1.What is the real-world incidence of VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors?
2. 2.What are the risk factors and biomarkers for VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors?
3. 3.What is the impact of VTE/ATE on the prognosis of lung cancer patients receiving immune checkpoint inhibitors?

Conditions

Venous Thromboembolism; Arterial Thromboembolism; Lung Cancer; Immune Checkpoint Inhibitors (ICIs)

Outcome Measures

Primary Outcomes (1)

• Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism

  From the administration of the first dose of immune checkpoint inhibitors until death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, symptomatic and incidentally detected arterial thromboembolism and venous thromboembolism events that occur during this period are included.

  Begin on the date of the first ICI dose and end upon death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, whichever comes first, assessed up to 96 months.

Secondary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (4)

With immune checkpoint inhibitor-associated venous thromboembolism

Patients with immune checkpoint inhibitor-associated venous thromboembolism would be included in this group

Without immune checkpoint inhibitor-associated venous thromboembolism

Patients without immune checkpoint inhibitor-associated venous thromboembolism would be included in this group

With immune checkpoint inhibitor-associated arterial thromboembolism

Patients with immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group

Without immune checkpoint inhibitor-associated arterial thromboembolism

Patients without immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with histopathologically confirmed lung cancer who were treated with immune checkpoint inhibitors between January 1, 2019, and December 31, 2026.

You may qualify if:

• 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

You may not qualify if:

• Presence of two or more primary cancers
• Missing data for key variables
• Inability to comply with follow-up requirements
• Presence of VTE/ATE at the time of ICI initiation

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Capital Medical University: collaborator
• China-Japan Friendship Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The Fourth Hospital of Inner Mongolia Autonomous Region: collaborator

Study Sites (5)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

The Fourth Hospital of Inner Mongolia Autonomous Region

Hohhot, Inner Mongolia, China

RECRUITING

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing Luhe Hospital, Capital Medical University

Beijing, China

RECRUITING

China-japan Friendship Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Lung Neoplasms; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yuhui Zhang

CONTACT

86+13520108369; zhangyhcy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 30, 2025
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)