A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

Official Title

A Phase III, Open-Label, Multicentre, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

Summary:

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

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) in the Tumour Gene Expression (tGE) Population (Arm A vs Arm C, Arm B vs Arm C)
  • PFS as Determined by the Investigator Using RECIST v1.1 in the Intent-to-Treat (ITT) Population (Arm A vs Arm C, Arm B vs Arm C)
  • Overall Survival (OS) in the ITT Population (Arm A vs Arm C, Arm B vs Arm C)
Secondary Outcome:
  • OS in the tGE Population (Arm A vs Arm C, Arm B vs Arm C)
  • PFS as Determined by the Investigator Using RECIST v1.1 in the 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 in the TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • OS in the TC2/3 or IC2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • OS in the TC1/2/3 or IC1/2/3 Population (Arm A vs Arm C, Arm B vs Arm C)
  • Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the tGE Population (Arm A vs Arm C, Arm B vs Arm C)
  • Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • Duration of Response as Determined by the Investigator Using RECIST v1.1 in the tGE Population (Arm A vs Arm C, Arm B vs Arm C)
  • Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • Percentage of Participants Alive at 1 and 2 Years in the tGE Population (Arm A vs Arm C, Arm B vs Arm C)
  • Percentage of Participants Alive at 1 and 2 Years in the ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • Time to Deterioration(TTD) in Patient-reported Lung Cancer Symptoms Using European Organisation for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core (QLQ-C30) Subscales in the tGE Population (Arm A vs Arm C, Arm B vs Arm C)
  • TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • TTD in Patient-reported Lung Cancer Symptoms Using EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Subscales in the tGE Population (Arm A vs Arm C, Arm B vs Arm C)
  • TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT 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 Symptom Severity Score in the tGE 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 Symptom Severity Score in the ITT Population (Arm A vs Arm C, Arm B vs Arm C)
  • PFS as Determined by the Investigator Using RECIST v1.1 in the TC2/3 or IC2/3 Population (Arm A vs Arm B)
  • PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population (Arm A vs Arm B)
  • OS in the TC2/3 or IC2/3 Population (Arm A vs Arm B)
  • OS in the TC1/2/3 or IC1/2/3 Population (Arm A vs Arm B)
  • Percentage of Participants With Adverse Events
  • Percentage of Participants with Anti-therapeutic Antibody (ATA) Response to Atezolizumab
  • Maximum Observed Serum Atezolizumab Concentration (Cmax)
  • Minimum Observed Serum Atezolizumab Concentration (Cmin)
  • Plasma Concentrations for Paclitaxel
  • Plasma Concentrations for Nab-Paclitaxel
  • Plasma Concentrations for Carboplatin

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