Status:
COMPLETED
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"
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 afte...
Eligibility Criteria
Inclusion
- Adult participants, \>/= 18 years of age
- Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
- Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
- Measurable disease, as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion
- Known active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Active hepatitis B or hepatitis C
- Prior treatment with docetaxel
- Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Key Trial Info
Start Date :
August 6 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2018
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT01903993
Start Date
August 6 2013
End Date
September 6 2018
Last Update
October 2 2019
Active Locations (65)
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1
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States, 85704
2
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
3
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
4
Kaiser Permanente - San Marcos
San Marcos, California, United States, 92069