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Clinical Trials in Italy / NCT07051928
Starting soon Observational

Study of Atezolizumab in Advanced Non-oncogene-addicted NSCLC With PD-L1 ≥50%, Including Longitudinal c-FLIP Assessment in Monocytic MDSCs.

NCT07051928 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2025-07
Last updated
2025-07-09

Condition(s) studied

Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

c-FLIP expression on MDSC

c-FLIP expression on MDSC: Longitudinal c-FLIP expression on circulating MDSC

Study summary

Prospective, observational, multi-site, single arm, exploratory pilot study, designed to prospectively assess the relationship between basal c-FLIP expression in M-MDSCs with clinical outcomes in patients treated with anti-PD-L1 monotherapy in a 1L mNSCLC setting, as well as evaluate changes in c-FLIP during treatment and correlate those changes with clinical outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years at time of signing Informed Consent Form * ECOG Performance Status of 0-2 * Advanced/metastatic NSCLC without prior treatment in the metastatic setting * Tumor PD-L1 expression with a TPS ≥ 50%, documented through local testing * Measurable disease per RECIST v1.1 * Adequate hematologic and end-organ function Exclusion Criteria: * Ineligibility to receive first line immunotherapy treatment * Patients with driver mutations amenable to molecular targeted therapies in I-line according to the indications of the AIFA

Primary outcome measure(s)

  • Disease-control Rate (DCR) — 24 months
    Disease-control rate at 12 weeks based on basal c-FLIP expression on MDSC

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07051928 on ClinicalTrials.gov ↗ ← All trials in Italy