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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-31

Study Completion Date

2029-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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c-FLIP expression on MDSC

Longitudinal c-FLIP expression on circulating MDSC

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No