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

NCT07288632 | Recruiting

• 1 other identifier: 20223ZYAJL
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Thromboembolism (VTE); NSCLC (Advanced Non-small Cell Lung Cancer)

Keywords

NSCLC; venous thromboembolism; genomic profile; activation of coagulation cascade

Outcome Measures

Primary Outcomes (1)

• Levels of plasma TF, thrombin generation, IL6, vWF, ADAMTS-13 activity, PAI-1and soluble P-selectin

  Levels of plasma TF, thrombin generation, IL6, vWF, ADAMTS-13 activity, PAI-1and soluble P-selectin in patients with NSCLC before the starting of the new line of anticancer therapy and after 3 and 6 months of anticancer treatment, across different patterns and association of oncogene mutations.

  From enrollment to the end of study period at 6 months

Study Arms (1)

patients with diagnosis of locally advanced or metastatic NSCLC

NSCLC patients will be enrolled in the study with a ratio 1:1 for oncogene addicted or wild type group. The oncogene-addicted group (Group A): patients with at least one oncogene mutation (ie. 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.

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

Patients with diagnosis (cytologically or histologically confirmed) of locally advanced or metastatic disease will be enrolled in the study with a ratio 1:1 for oncogene addicted or wild type group.

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

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Emily Oliovecchio

Perugia, Perugia, 06135, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

levels of plasma TF, thrombin generation, IL 6, vWF, ADAMTS-13 activity PAI-1 and soluble P-selectin

MeSH Terms

Conditions

Venous Thromboembolism; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Melina Verso

  Univesity of Perugia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melina Verso, Professor

CONTACT

0039+0755782326; melina.verso@unipg.it

Emily Oliovecchio, doctor

CONTACT

emily.oliovecchio@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: December 17, 2025
• Study Start: February 9, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)