How gene changes relate to clotting risk in advanced or metastatic non-small-cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter prospective observational study enrolling 500 patients with locally advanced or metastatic NSCLC at 15 Italian oncology centers, with equal groups of oncogene‑addicted and wild‑type tumors. Blood samples will be collected before starting a new anticancer treatment and again at 3 and 6 months to measure plasma tissue factor, thrombin generation, IL‑6, von Willebrand factor, ADAMTS‑13 activity, PAI‑1, and soluble P‑selectin. The study will compare these biomarker levels across oncogene profiles and disease stages and correlate them with clinically overt venous thromboembolism events. Analyses will also examine how anticancer treatments and combined clinical/genomic/biomarker models relate to VTE risk and patient survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • 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

Exclusion Criteria:

* • 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's running

• Emily Oliovecchio
  Perugia, Perugia, Italy Recruiting

Study contacts

• Principal investigator: Melina Verso — Univesity of Perugia
• Study coordinator: Melina Verso, Professor
• Email: melina.verso@unipg.it
• Phone: 0039+0755782326

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.