Clinical trial NCT06950697: Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
Official title: Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Venous Thromboembolism
Arterial Thromboembolism
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Capital Medical University
name: China-Japan Friendship Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: The Fourth Hospital of Inner Mongolia Autonomous Region
First posted: 2025-04-30
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism
timeFrame: 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.
Secondary outcomes:
measure: Progression-free survival
timeFrame: 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.
measure: Overall survival
timeFrame: 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.
measure: Objective response rate
timeFrame: From the date of the first dose of immune checkpoint inhibitors until the best efficacy is achieved, assessed up to 96 months.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Hohhot City
country: China
facility: The Fourth Hospital of Inner Mongolia Autonomous Region
state: Inner Mongolia Autonomous Region
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
city: Beijing
country: China
facility: China-japan Friendship Hospital
Study officials:
References: