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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Non Small Cell Lung Cancer

Treatments: Diagnostic Test: c-FLIP expression on MDSC

Study type: Observational

Funder types: Other

Identifiers

NCT07051928

7742

Details and patient eligibility

About

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.

Enrollment: 107 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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