Study of Atezolizumab in Advanced Non-oncogene-addicted NSCLC With PD-L1 ≥50%, Including Longitudinal c-FLIP Assessment in Monocytic MDSCs.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: c-FLIP expression on MDSC.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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 test c-FLIP expression on MDSC
Longitudinal c-FLIP expression on circulating MDSC
Primary outcome measures
- Disease-control Rate (DCR) [Time frame: 24 months]
Secondary outcome measures (2)
- Progression-free survival (PFS) [Time frame: 24 months]
- Overall Survival (OS) [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
Publications
- 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 24309938
Identifiers
NCT: NCT07051928 · 7742