Advanced non-small-cell lung cancer MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864
Conditions
Sponsors
FONDAZIONE RICERCA TRASLAZIONALE (FORT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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 0-1. 6) Life expectancy > 3 months 7) Age =18 years. 8) Measurable disease, as defined by RECIST v1.1. 9) 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 103 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 103
Exclusion criteria
Exclusion criteria: 1. No tumor tissue available. 2. PD-L1 expression 2 weeks prior to randomization 41. Prophylactic anticoagulation fo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To evaluate response rate (RR), progression free survival (PFS) and safety profile of the combination versus the single agent. To evaluate whether the combination of atezolizumab and bevacizumab improves overall survival (OS) over single agent atezolizumab according to presence of bone and/or hepatic metastases, considering their potential predictive value.;Primary end point(s): Overall Survival (OS) rate at 18 months in patients treated with atezolizumab alone versus atezolizumab-bevacizumab combination;Timepoint(s) of evaluation of this end point: Overall survival (OS) will be calculated from the date of randomization to the date of death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response rate (complete + partial responses); Progression-free survival; Overall survival according to presence of bone and/ or hepatic metastases;Timepoint(s) of evaluation of this end point: Tumor assessment will be performed every 6 weeks during treatment and every 3 months after PD or until initiation of new systemic anti-cancer therapy, whichever occurs first, and at end of treatment; Tumor assessment will be performed every 6 weeks during treatment and every 3 months after PD or until initiation of new systemic anti-cancer therapy, whichever occurs first, and at end of treatment.; Overall survival (OS) will be calculated from the date of randomization to the date of death due to any cause. | — |
Countries
Italy
Contacts
Public ContactCRO
Clinical Research Technology
Outcome results
None listed