FoRT 05- BEAT Phase II randomized trial comparing atezolizumab versus atezolizumab plus bevacizumab as first-line treatment in PD-L1 high advanced non-small-cell lung cancer patients

Fondazione Ricerca Traslazionale32 sites in 1 country130 target enrollmentNovember 26, 2024

DrugsRO5541267 Tecentriq 1 200 mg concentrate for solution for infusion Avastin 25 mg/ml concentrate for solution for infusion.

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Fondazione Ricerca Traslazionale
Enrollment: 130
Locations: 32
Primary Endpoint: Overall Survival (OS) in patients treated with atezolizumab alone versus atezolizumab-bevacizumab combination
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess whether the combination of atezolizumab and bevacizumab improves overall survival (OS) over atezolizumab as single agent in untreated PD-L1 high metastatic NSCLC.

Registry

euclinicaltrials.eu

Start Date

November 26, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Fondazione Ricerca Traslazionale

Responsible Party

Principal Investigator

Federico Cappuzzo

Scientific

Fondazione Ricerca Traslazionale

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed diagnosis of stage IV non-squamous NSCLC with no evidence of EGFR sensitizing mutations or ALK or ROS1 rearrangements. 2) Availability of tumor tissue. 3) 3) Evidence of high levels of PD-L1 expression evaluated with immunohistochemistry (=50% by 22C3 or SP263 or TC/IC 3 scoring by SP 142) . 4) No previous chemotherapy. Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last dose of chemotherapy and/or radiotherapy. 5) ECOG performance status 0-
•Life expectancy > 3 months 7) Age =18 years. 8) Measurable disease, as defined by RECIST v1.
•Adequate hematologic and organ function, defined by the following laboratory results obtained within 28 days prior to randomization: o ANC = 1500 cells/µL without granulocyte colony-stimulating factor support o Platelet count = 100,000/µL without transfusion o Hemoglobin = 9.0 g/dL Patients may be transfused to meet this criterion o AST, ALT, and alkaline phosphatase = 2.5 × ULN, with the following exceptions: ¿ Patients with documented liver metastases: AST and/or ALT = 5 × ULN ¿ Patients with documented liver or bone metastases: alkaline phosphatase = 5 × ULN. o Serum bilirubin = 1.25 × ULN o Patients with known Gilbert disease who have serum bilirubin level = 3 mg/dL may be enrolled o Calculated creatinine clearance (CRCL) = 45 mL/min or calculated CRCL must be = 60 mL/min 10) Patient compliance to trial procedures. 11) Written informed consent.

Exclusion Criteria

•No tumor tissue available.
•PD-L1 expression < 50 % or PD-L1 expression unknown or not assessable
•Patient positive for EGFR mutations or ALK or ROS1 rearrangements.
•Patients with squamous histology or with specific contraindication to bevacizumab therapy.
•Previously treated with chemotherapy
•Concomitant radiotherapy or chemotherapy.
•Previous therapy with any checkpoint inhibitor.
•Pregnancy or lactating women who are pregnant, lactating, or intending to become pregnant during the study.
•Symptomatic brain metastases
•Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression