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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07051928

Acronym

FLIP-IMMUNO

Enrollment

107

Registered

2025-07-04

Start date

2025-07-31

Completion date

2029-07-31

Last updated

2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Immunotherapy, Lung cancer, Atezolizumab

Brief 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.

Interventions

DIAGNOSTIC_TESTc-FLIP expression on MDSC

Longitudinal c-FLIP expression on circulating MDSC

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Disease-control Rate (DCR)	24 months	Disease-control rate at 12 weeks based on basal c-FLIP expression on MDSC

Secondary

Measure	Time frame	Description
Progression-free survival (PFS)	24 months	Median Progression-free Survival among subgroups defined according to c-FLIP expression in M-MDSC at baseline
Overall Survival (OS)	24 months	Median overall survival among subgroups defined according to c-FLIP expression in M-MDSC at baseline.

Countries

Italy

Contacts

Primary ContactEmilio Bria, Prof.

emilio.bria@policlinicogemelli.it0630155202 ext +39

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026