A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower130)

Official Title

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

Summary:

This randomized Phase III, multicentre, open-label study is designed to evaluate the safety and efficacy of atezolizumab in combination with carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 2:1 ratio to Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin) or Arm B (Nab-Paclitaxel + Carboplatin).

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 Intent-to-Treat (ITT) Population
  • PFS as Determined by the Investigator Using RECIST v1.1 for PD-L1-Selected Population
  • Overall Survival (OS) for ITT Population
  • OS for PD-L1-Selected Population
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
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using RECIST v1.1 for PD-L1-Selected Population
  • Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 for ITT Population
  • DOR as Determined by the Investigator Using RECIST v1.1 for PD-L1-Selected Population
  • Time to Response (TTR) as Determined by the Investigator Using RECIST v1.1 for ITT Population
  • TTR as Determined by the Investigator Using RECIST v1.1 for PD-L1-Selected Population
  • Time in Response (TIR) as Determined by the Investigator Using RECIST v1.1 for ITT Population
  • TIR as Determined by the Investigator Using RECIST v1.1 for PD-L1-Selected Population
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for ITT Population
  • PFS as Determined by the Independent Review Facility Using RECIST v1.1 for PD-L1-Selected Population
  • 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 PD-L1-Selected Population
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) for ITT Population
  • TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC QLQ-LC13 for PD-L1-Selected Population
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale for ITT Population
  • Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the SILC Scale for PD-L1-Selected Population
  • 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 of Carboplatin
  • Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel
  • Cmax of Atezolizumab in Arm B Participants Who Received Atezolizumab During Maintenance Phase
  • Cmin of Atezolizumab Prior to Infusion in Arm B Participants Who Received Atezolizumab During Maintenance Phase

View this trial on ClinicalTrials.gov

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Resources

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