Efficacy of Torque Teno Virus as a Biomarker for Predicting Treatment Response of Immune Checkpoint Inhibitor Therapy and Postoperative Outcome in NSCLC Patients

Recruiting

• Conditions: NSCLC (Non-small Cell Lung Cancer)

• Registration Number: NCT06967532
• Lead Sponsor: Medical University of Vienna

Brief Summary

First discovered in 1997 the torque teno virus (TTV) can be found in the vast majority of the human population throughout their lifetime. The TTV levels correlate with infectious diseases and organ rejection and are therefore currently being investigated as a tool to optimize the management of patients after solid organ transplantation (SOT). While TTV levels are already tested to guide immunosuppressive therapy its significance for oncologic patients is unclear. In recent years immune checkpoint inhibitors (ICIs) are increasingly implemented in multimodal therapy approaches for patients with non-small-cell lung cancer (NSCLC). Since ICI and TTV levels depend on T-cell function, the TTV load may be a relevant biomarker for the treatment response as well as complication risk after ICI therapy. Current standard imaging using PERCIST and RECIST criteria is prone to misinterpretation of treatment response of ICI therapy due to pseudoprogression and nodal immune flaring. This study aims to prospectively analyze TTV levels in NSCLC patients before, during and after neoadjuvant chemo-immunotherapy and correlate inter- and intraindividual changes in TTV levels with response rates observed on PET/CT restaging and histopathological response rates as well as postoperative outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-06
• Status Verified: 2025-05
• Study First Submitted: 2025-05-03
• Study First Submitted QC: 2025-05-03
• Last Update Submitted: 2025-05-03
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Histologically or cytologically verified NSCLC stage II-IV (OMD) according to UICC TNM8 edition considered operable in curative intent after neoadjuvant systemic therapy containing immune checkpoint inhibition by local multidisciplinary tumor board (MDT) decision.

ECOG < or = 1 Staging with PET/CT and cMRI/CCT Written informed consent

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histopathological response to neoadjuvant chemo-immunotherapy	2 years

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria