Study of Atezolizumab in Advanced Non-oncogene-addicted NSCLC With PD-L1 ≥50%, Including Longitudinal c-FLIP Assessment in Monocytic MDSCs.
FLIP-IMMUNO
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
1 other identifier
observational
107
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedFirst Posted
Study publicly available on registry
July 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
July 9, 2025
June 1, 2025
2 years
June 26, 2025
July 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-control Rate (DCR)
Disease-control rate at 12 weeks based on basal c-FLIP expression on MDSC
24 months
Secondary Outcomes (2)
Progression-free survival (PFS)
24 months
Overall Survival (OS)
24 months
Interventions
Longitudinal c-FLIP expression on circulating MDSC
Eligibility Criteria
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%)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy
Related Publications (1)
Riley JS, Hutchinson R, McArt DG, Crawford N, Holohan C, Paul I, Van Schaeybroeck S, Salto-Tellez M, Johnston PG, Fennell DA, Gately K, O'Byrne K, Cummins R, Kay E, Hamilton P, Stasik I, Longley DB. Prognostic and therapeutic relevance of FLIP and procaspase-8 overexpression in non-small cell lung cancer. Cell Death Dis. 2013 Dec 5;4(12):e951. doi: 10.1038/cddis.2013.481.
PMID: 24309938BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emilio Bria
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2025
First Posted
July 4, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2029
Last Updated
July 9, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share