Trials / Completed
CompletedNCT03191786
A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 453 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody | Atezolizumab will be administered via IV infusion once every three weeks (QW3). |
| DRUG | Vinorelbine | Vinorelbine will be administered per relevant local guidelines and Summary of Product Characteristics (SmPC) management. |
| DRUG | Gemcitabine | Gemcitabine will be administered per relevant local guidelines and SmPC management. |
Timeline
- Start date
- 2017-09-11
- Primary completion
- 2022-04-30
- Completion
- 2023-10-25
- First posted
- 2017-06-19
- Last updated
- 2024-10-23
- Results posted
- 2023-05-17
Locations
91 sites across 24 countries: Argentina, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Denmark, Germany, India, Ireland, Italy, Kazakhstan, Luxembourg, Mexico, Poland, Portugal, Romania, Slovakia, Spain, Switzerland, United Kingdom, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03191786. Inclusion in this directory is not an endorsement.