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

Conditions

• Non-small-cell Lung Cancer Patients

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Atezolizumab administered intravenously at 1200 mg every 3 weeks
• Bevacizumab — DRUG
  Bevacizumab intravenously at 15 mg/kg every 3 weeks

Study Details

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.

Key Dates

Start date

Mar 2, 2020

Status verified

Feb 2026

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

206 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atezolizumab
  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
• Experimental: Atezolizumab plus bevacizumab
  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

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 18 months ]