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

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

A Prospective, Observational, Single Arm, Multi-site, Pilot Study of Atezolizumab in Non-oncogene Addicted Advanced Nsclc Patients With Pd-l1 Tps ≥ 50%, With Longitudinal Assessment of C-FLIP Expression of Monocytic Myeloid-derived Suppressor Cells

NCT07051928•Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Key Dates

Start Date

July 1, 2025

Primary Completion Date

July 1, 2027

Completion Date

July 1, 2029

Last Updated

July 9, 2025

Enrollment

107

ESTIMATED participants

Conditions

Non Small Cell Lung Cancer

Interventions

c-FLIP expression on MDSC

DIAGNOSTIC_TEST

Contacts

Emilio Bria, Prof.

CONTACT

0630155202 ext +39 emilio.bria@policlinicogemelli.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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