Clinical trial · Observational
Study of Atezolizumab in Advanced Non-oncogene-addicted NSCLC With PD-L1 ≥50%, Including Longitudinal c-FLIP Assessment in Monocytic MDSCs.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| c-FLIP expression on MDSC | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-control Rate (DCR)
- timeFrame
- 24 months
- description
- Disease-control rate at 12 weeks based on basal c-FLIP expression on MDSC
Secondary outcomes (2)
- measure
- Progression-free survival (PFS)
- timeFrame
- 24 months
- description
- Median Progression-free Survival among subgroups defined according to c-FLIP expression in M-MDSC at baseline
- measure
- Overall Survival (OS)
- timeFrame
- 24 months
- description
- Median overall survival among subgroups defined according to c-FLIP expression in M-MDSC at baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDRiley 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