Effects of Genomic Profiles on Thromboembolic Risk in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer

Recruiting now

Conditions studied: Venous Thromboembolism (VTE), NSCLC (Advanced Non-small Cell Lung Cancer)

In brief

Multicenter, prospective observational study (15 Oncologic Centers, in Italy). The purpose of the study is to assess the thromboembolic potential in patients with oncogene-addicted and wild-type NSCLC. The primary aim of this project is to evaluate the association between oncogene mutations and levels of plasma parameters of the activated coagulation cascade as the plasma levels of TF, thrombin generation, IL 6, vWF, ADAMTS-13 activity, PAI-1, and soluble P-selectin in NSCLC patients. A total of 500 NSCLC patients with a diagnosis (cytologically or histologically confirmed) of locally advanced or metastatic disease will be enrolled in the study, with a ratio of 1:1 for oncogene addicted or wild-type group. The oncogene-addicted group (Group A): patients with at least one oncogene mutation (i.e., patients expressing EGFR mutations, KRAS mutation, ALK or ROS1 rearrangements); the wild type group (Group B): patients without oncogene mutations, categorized in 2 subgroups according to expression of PD1/PD-L1 mutation or not. Patients will be followed up prospectively for 6 months or until death, VTE event, loss to follow-up, or voluntary consent withdrawal. This study will evaluate the effects of EGFR, KRAS mutations and ALK/ROS 1 and PD-1/PD-L1 rearrangements on the expression of TF and thrombin generation or the interaction between inflammation and endothelial or platelet and cancer cells, in patients with NSCLC. The study will also evaluate the potential correlation between VTE events and the expression of oncogene mutations in patients with NSCLC. The results of this study could generate the hypothesis of including the genetic profile as variable for a risk-stratification tools and decision-making algorithms in NSCLC patients.

Key facts

Study ID

NCT07288632

Run by

University Of Perugia

People needed

500

Starts

2024-02-09

Expected to finish

2026-02-28

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • Patients aged 18 years or older,
• Cytological or histological confirmation of NSCLC,
• Locally advanced or metastatic disease (Stage III-IV),
• Patients starting a new anticancer treatment for locally advanced/metastatic disease (first or further line of treatment),
• Testing for oncogenic (EGFR, KRAS, ALK, ROS1 and PD-1/PD-L1) profile performed,
• Written informed consent

You may not qualify if…

• • Patients received surgery or radiotherapy for lung cancer within the past 3 months before recruitment or chemotherapy within the past 1 months before recruitment,
• Patients with a history of VTE after cancer diagnosis or evidence of VTE events at enrollment
• Continuative use of anticoagulant drugs for any indication (atrial fibrillation or previous VTE)
• ECOG performance profile 3 or 4
• Life expectancy of less than 3 months

Where it is running

• Emily Oliovecchio — Perugia, Perugia, Italy (enrolling)

Full record on ClinicalTrials.gov

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