NCT01846416

A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]

A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression. Eligible participants will be categorized in to three groups as follows: 1. Participants with no prior chemotherapy for advanced disease; 2. Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants); 3. Participants who are 2L+ and previously treated for brain metastases.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody	Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression.

Timeline

• Start date: 2013-05-30
• Primary completion: 2015-01-07
• Completion: 2017-12-18
• First posted: 2013-05-03
• Last updated: 2019-01-08
• Results posted: 2016-12-16

Locations

31 sites across 5 countries: United States, Belgium, France, Netherlands, United Kingdom