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NCT Number: NCT06950697

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.

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Key information

Conditions

Lung Cancer Arterial Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Immune Checkpoint Inhibitors (ICIs) Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Primary outcomes

  1. Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism

    Time frame: 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.

    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.

Secondary outcomes

  1. Progression-free survival

    Time frame: 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.

  2. Overall survival

    Time frame: 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."

  3. Objective response rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuhui Zhang

CONTACT

[email protected]

86+13520108369

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Collaborators

  • Capital Medical University
  • China-Japan Friendship Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • The Fourth Hospital of Inner Mongolia Autonomous Region

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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