Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

Official Title

A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

Summary:

This is a Phase III, global, multicentre, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.

Trial Description

Primary Outcome:

  • DFS, Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray in in Stage IB-IIIA (Intent-to-Treat [ITT]) Population
  • DFS, Assessed Using CT/MRI/X-Ray in Stage II-IIIA and PD-L1-Selected Subpopulation
Secondary Outcome:
  • Overall Survival (OS)
  • Percentage of Participants Who are Disease-Free at Year 3, Assessed Using CT/MRI/X-Ray
  • Percentage of Participants Who are Disease-Free at Year 5, Assessed Using CT/MRI/X-Ray
  • Percentage of Participants with Adverse Events
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
  • Maximum Plasma Concentration (Cmax) of Atezolizumab
  • Minimum Serum Concentration (Cmin) at Steady-State of Atezolizumab

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