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

July 4, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients age ≥ 18 years with ECOG Performance Status of 0 to 2 who have previously untreated metastatic non-oncogene addicted PD-L1-selected NSCLC (TPS ≥50%)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Emilio Bria, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

June 26, 2025

First Submitted That Met QC Criteria

June 26, 2025

First Posted (Actual)

July 4, 2025

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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