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NCT Number: NCT07051928

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

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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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location contact

Emilio Bria, Prof.

CONTACT

[email protected]

0630155202 ext +39

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

c-FLIP expression on MDSC

Diagnostic Test

Longitudinal c-FLIP expression on circulating MDSC

Primary outcomes

  1. Disease-control Rate (DCR)

    Time frame: 24 months

    Disease-control rate at 12 weeks based on basal c-FLIP expression on MDSC

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 24 months

    Median Progression-free Survival among subgroups defined according to c-FLIP expression in M-MDSC at baseline

  2. Overall Survival (OS)

    Time frame: 24 months

    Median overall survival among subgroups defined according to c-FLIP expression in M-MDSC at baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Emilio Bria, Prof.

CONTACT

[email protected]

0630155202 ext +39

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: FLIP-IMMUNO

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jul 4, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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