A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) 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) (IMpower150)

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 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 v1.1) for Tumour Cell (TC) 2/3 or Tumour-Infiltrating Immune Cell (IC) 2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • PFS as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • PFS as Determined by the Investigator Using RECIST v1.1 for Intent-to-Treat (ITT) Population (Arm A vs Arm C, Arm B vs Arm C)
  • Overall Survival (OS) for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • OS for ITT Population (Arm A vs Arm C, Arm B vs Arm C)
Secondary Outcome:
  • Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • DOR as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • DOR as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • Time to Response (TTR) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • TTR as Determined by the Investigator Using ECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • TTR as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • Time in Response (TIR) as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • TIR as Determined by the Investigator Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • TIR as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • Percentage of Participants Who are Alive at Year 1 and 2
  • Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score for ITT Population
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-C30 Score for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-C30 Score for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score for ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-LC13 Score for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-LC13 Score for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale for ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the SILC Scale for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the SILC Scale for TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • PFS as Determined by the Investigator using RECIST v1.1 for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm B)
  • PFS as Determined by the Investigator Using RECIST v1.1 for TC2/3 or IC2/3 Population (Arm A vs Arm B)
  • PFS as Determined by the Investigator Using RECIST v1.1 for ITT Population (Arm A vs Arm B)
  • OS for TC1/2/3 or IC1/2/3 Population (Arm A vs Arm B)
  • OS for ITT Population (Arm A vs Arm B)
  • 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
  • Percentage of Participants With Adverse Events
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

View this trial on ClinicalTrials.gov

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Resources

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