At a glance
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A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab Compared With Chemotherapy in Patients With Treatment Naïve Advanced or Recurrent (Stage IIIb Not Amenable for Multimodality Treatment) or Metastatic (Stage IV) Non-Small Cell Lung Cancer Who Are Deemed Unsuitable for Platinum-Containing Therapy
In Brief
A Phase 3 clinical trial evaluating Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Vinorelbine, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 453 participants across 91 sites in 24 countries.
Detailed Summary
This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for any platinum-doublet chemotherapy due to poor performance status (Eastern Cooperative Oncology Group \[ECOG\] performance status of 2-3).
Study Details
Timeline
Interventions
Atezolizumab will be administered via IV infusion once every three weeks (QW3).
Vinorelbine will be administered per relevant local guidelines and Summary of Product Characteristics (SmPC) management.
Gemcitabine will be administered per relevant local guidelines and SmPC management.