A Phase III Study of MPDL3280A (Anti-PD-L1 Antibody) in Combination With Carboplatin + Nab-Paclitaxel in Patients With Non-Squamous Non-Small Cell Lung Cancer

Official Title

A Phase III Multicentre, Randomized, Open-Label Study Evaluating the Efficacy and Safety of 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 MPDL3280A in combination with carboplatin + Nab-paclitaxel compared with treatment with carboplatin + Nab-paclitaxel in chemotherapy-naive patients with Stage IV non-squamous non-small cell lung cancer (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)
Secondary Outcome:
  • Objective Response as determined by the Investigator using RECIST v1.1
  • Overall Survival
  • Duration of Response as determined by the Investigator using RECIST v1.1
  • PFS as determined by the Independent Review Facility using RECIST v1.1
  • Time to Deterioration (TTD) in patient-reported Lung Cancer Symptoms
  • Change from Baseline in patient-reported Lung Cancer Symptoms
  • Safety: Incidence of Adverse Events

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