Not Yet RecruitingNot Applicable

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

Italy107 participantsStarted 2025-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Disease-control Rate (DCR)

Timeframe: 24 months

Trial details

NCT IDNCT07051928

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07

Contact for this trial

Emilio Bria, Prof.

0630155202 ext +39 emilio.bria@policlinicogemelli.it

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