A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"
This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti−PD-L1 Antibody) Compared With Docetaxel in Patients With Non−Small Cell Lung Cancer After Platinum Failure
Enrollment: 287
Actual Study Start Date: August 6, 2013
Estimated Study Completion Date: January 1, 2018
Primary Completion Date: November 19, 2015 (Final data collection date for primary outcome measure)
Arms:
- Active Comparator: Docetaxel
- Experimental: Atezolizumab
Category | Value |
---|---|
Date last updated at source | 2017-08-28 |
Study type(s) | Interventional |
Expected enrolment | 287 |
Study start date | 2013-08-06 |
Estimated primary completion date | 2015-11-19 |