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"



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:August 6, 2013
End Date:August 31, 2018

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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

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/m^2) 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.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
30
sites
11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
1919
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Loma Linda, CA
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1045 North 30th Street
Billings, Montana 59101
406-255-8470
1345
mi
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Billings, MT
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433 Southwest 10th Street
Ocala, Florida 34471
746
mi
from 43215
Ocala, FL
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
619
mi
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Providence, RI
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Albany, New York 12206
514
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Albany, NY
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Atlanta, Georgia 30341
425
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Atlanta, GA
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Austin, Texas 78745
1065
mi
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Austin, TX
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169 Riverside Drive
Binghamton, New York 13905
397
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Binghamton, NY
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Detroit, Michigan 48201
164
mi
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Detroit, MI
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2055
mi
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Eugene, OR
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
316
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Fairfax, VA
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Fort Worth, Texas 76104
937
mi
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Fort Worth, TX
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
267
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Harvey, IL
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Hot Springs, Arkansas 71913
670
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Hot Springs, AR
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Knoxville, Tennessee 37909
282
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Knoxville, TN
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
1756
mi
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Las Vegas, NV
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49 Herestraat
Leuven, 3000
4063
mi
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Leuven,
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10103 RidgeGate Parkway
Lone Tree, Colorado 80124
1158
mi
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Lone Tree, CO
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
426
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Norfolk, VA
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Paramus, New Jersey 07450
475
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Paramus, NJ
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Peoria, Illinois 61656
356
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Peoria, IL
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Roanoke, Virginia 24014
253
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Roanoke, VA
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San Marcos, California 92078
1941
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San Marcos, CA
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Scarborough, Maine 04074
696
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Scarborough, ME
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1638
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Tucson, AZ
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Vallejo, California 94589
2091
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Vallejo, CA
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Vancouver, Washington 98684
2025
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Vancouver, WA
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Walla Walla, Washington 99362
1804
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Walla Walla, WA
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Wenatchee, Washington 98801
1912
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Wenatchee, WA
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Whittier, California 90603
1961
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Whittier, CA
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