Atezolizumab Versus Atezolizumab Plus Bevacizumab as First Line in NSCLC Patients (BEAT)

NCT03896074 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: FoRT 05- BEAT
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 33

Brief Summary

phase II controlled randomized study comparing atezolizumab as single agent to the combination of atezolizumab and bevacizumab in patients with chemonaive metastatic NSCLC with PD-L1 expression. All NSCLC patients with tumor tissue available for biomarker assessment and candidate for first-line therapy are considered eligible for the study. After evaluation of all inclusion and exclusion criteria and after informed consent signature all eligible patients will be randomized to atezolizumab (Arm A) or to the combination of atezolizumab and bevacizumab (Arm B). Disease assessment will be performed every 6 weeks.

Conditions

Non-small-cell Lung Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall Survival (OS) rate at 18 months in patients treated with atezolizumab alone versus atezolizumab-bevacizumab combination

  18 months

Secondary Outcomes (3)

• Response rate (complete + partial responses)

  Up to 24 months

• Progression-free survival

  Up to 24 months

• Overall survival according to presence of bone and/ or hepatic metastases

  Up to 24 months

Study Arms (2)

Atezolizumab

EXPERIMENTAL

Patients allocated to Arm A will be treated with atezolizumab administered intravenously at 1200 mg every 3 weeks given until disease progression, toxicity or patient refusal

Drug: Atezolizumab

Atezolizumab plus bevacizumab

EXPERIMENTAL

Patients in the Arm B will receive atezolizumab administered intravenously at 1200 mg every 3 weeks plus bevacizumab intravenously at 15 mg/kg every 3 weeks given until disease progression, toxicity or patient refusal

Drug: Atezolizumab; Drug: Bevacizumab

Interventions

Atezolizumab DRUG

Atezolizumab administered intravenously at 1200 mg every 3 weeks

Atezolizumab; Atezolizumab plus bevacizumab

Bevacizumab DRUG

Bevacizumab intravenously at 15 mg/kg every 3 weeks

Atezolizumab plus bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of stage IV non-squamous NSCLC with no evidence of EGFR sensitizing mutations or ALK or ROS1 rearrangements.
• Availability of tumor tissue.
• Evidence of PD-L1 expression evaluated with immunohistochemistry (≥1%).
• 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.
• ECOG performance status 0-1.
• Life expectancy \> 3 months
• Age ≥18 years.
• Measurable disease, as defined by RECIST v1.1.
• Adequate hematologic and organ function, defined by the following laboratory results obtained within 28 days prior to randomization:
• ANC ≥ 1500 cells/μL without granulocyte colony-stimulating factor support
• Platelet count ≥ 100,000/μL without transfusion
• Hemoglobin ≥ 9.0 g/dL Patients may be transfused to meet this criterion
• 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.

You may not qualify if:

• No tumor tissue available.
• PD-L1 expression \< 1 % 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.
• Previous chemotherapy. Adjuvant or neoadjuvant chemotherapy is considered a line of therapy if completed less than 6 months before evidence of disease relapse.
• 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; asymptomatic brain metastases are accepted if no steroid therapy is required and if pretreated.
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \> 2 weeks prior to randomization.
• Leptomeningeal disease.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.
• Uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or Ca \> 12 mg/dL or corrected serum calcium \>ULN). Patients who are receiving denosumab prior to randomization must be willing and eligible to receive a bisphosphonate instead while on study.
• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS\> 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

Sponsors & Collaborators

• Fondazione Ricerca Traslazionale: lead

Study Sites (33)

Ospedale Degli Infermi Di Biella

Ponderano, BI, 13875, Italy

Location

Asst Di Lecco

Lecco, CM, 23900, Italy

Location

A.O.U. Policlinico - Vittorio Emanuele- Presidio Ospedaliero Gaspare Rodolico

Catania, CT, 95125, Italy

Location

Ospedale Della Misericordia

Grosseto, GR, 58100, Italy

Location

Presidio Ospedaliero Unico Av3 - Ospedale Generale Provinciale - Macerata

Macerata, MC, 62100, Italy

Location

Fondazione IRCCS - San Gerardo del Tintori

Monza, MILANO, 20900, Italy

Location

Azienda Ospedaliero-Universitaria Di Modena

Modena, MO, 41124, Italy

Location

AZIENDA USL DI PIACENZA-Ospedale Guglielmo da Saliceto

Piacenza, PC, 29121, Italy

Location

C.R.O.B. - I.R.C.C.S.

Rionero in Vulture, PZ, 85028, Italy

Location

AUSL della Romagna

Ravenna, RA, 48121, Italy

Location

OSPEDALE SAN PAOLO - ASL Roma 4

Civitavecchia, RM, 00053, Italy

Location

Fondazione PTV - POLICLINICO TOR VERGATA

Roma, RM, 00133, Italy

Location

Azienda Ospedaliera S.Giovanni Addolorata

Roma, RM, 00184, Italy

Location

Azienda Ospedaliera San Camillo-Forlanini

Roma, Roma, 00152, Italy

Location

P.O. Umberto I

Syracuse, SR, 96100, Italy

Location

Ospedale S.G. Moscati

Statte, TA, 74010, Italy

Location

AUSL di Teramo - Ospedale "Giuseppe Mazzini"

Teramo, TE, 64100, Italy

Location

AOU Ospedali Riuniti "Umberto I- G.M.Lancisi-G.Salesi"

Ancona, 60020, Italy

Location

IRCCS Oncologico Istituto Tumori "Giovanni Paolo II"

Bari, 70124, Italy

Location

P.O. Antonio Perrino

Brindisi, 72100, Italy

Location

A.O. Per l' emergenza Cannizzaro

Catania, 95126, Italy

Location

Irccs S.R.L. Irst

Meldola, 47014, Italy

Location

AO Papardo

Messina, 98158, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliera Dei Colli V.Monaldi

Naples, 80131, Italy

Location

Istituto Nazionale Tumori di Napoli IRCCS Pascale

Naples, 80131, Italy

Location

Ospedale Sacro Cuore- Don Calabria

Negrar, 37024, Italy

Location

AOU S. Luigi Orbassano

Orbassano, 10043, Italy

Location

IRCCS ISTITUTO Oncologico Veneto

Padua, 35128, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42100, Italy

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

ASST Sette Laghi

Varese, 21100, Italy

Location

AUOI di Verona- Borgo Trento

Verona, 37126, Italy

Location

MeSH Terms

Interventions

atezolizumab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 29, 2019
• Study Start: March 2, 2020
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

IT (33)