A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Official Title

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

Summary:

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
  • Overall Survival (OS)
Secondary Outcome:
  • PFS as Determined by the Independent Review Facility (IRF) Using RECIST v1.1
  • Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1
  • Percentage of Participants Who are Alive at Years 1 and 2
  • Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
  • Percentage of Participants With Adverse Events
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
  • Maximum Observed Serum Concentration (Cmax) of Atezolizumab
  • Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion
  • Plasma Concentrations for Carboplatin
  • Plasma Concentrations for Paclitaxel
  • Cmax of Bevacizumab
  • Cmin of Bevacizumab

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society