A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:March 11, 2014
End Date:January 9, 2019

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A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy

This 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 docetaxel in participants with locally advanced or metastatic non-small cell lung cancer
(NSCLC) after failure with platinum-containing chemotherapy. Participants will be randomized
1:1 to receive either docetaxel or atezolizumab. Treatment may continue 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:

- Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) 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 or combined modality (e.g., chemoradiation) regimen with curative intent

- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

- Known active or untreated central nervous system (CNS) metastases

- 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 computed tomography (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 cluster of differentiation 137 (CD137) agonists,
anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1
(anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
We found this trial at
63
sites
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...
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1045 North 30th Street
Billings, Montana 59101
406-255-8470
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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24 Sturtevant St
Orlando, Florida 32806
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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,...
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Atlanta, Georgia 30341
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6204 Balcones Drive
Austin, Texas 78731
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Bakersfield, California 93309
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1351 Kimberly Rd
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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Buffalo, New York 14263
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3 Crossing Boulevard
Clifton Park, New York 12065
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Columbus, Ohio 43213
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1020 Hipólito Irigoyen
Córdoba, 5800
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4100 John R Street
Detroit, Michigan 48201
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235 North Belle Mead Avenue
East Setauket, New York 11733
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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...
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Farmington, New Mexico 87401
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140 Park Avenue
Florham Park, New Jersey 07932
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2151 North Harbor Boulevard
Fullerton, California 92835
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Grand Junction, Colorado 81501
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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...
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Hayward, California 94545
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Houston, Texas 77030
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
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La Jolla, California 92037
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
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2045 Franklin Street
Lone Tree, Colorado 80205
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Long Beach, California 90813
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Los Angeles, California 90095
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Miami, Florida 33145
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910 East 26th Street
Minneapolis, Minnesota 55404
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Missoula, Montana 59802
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Oakland, California 94611
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515 North 162nd Avenue
Omaha, Nebraska 68130
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1 Valley Health Plaza
Paramus, New Jersey 07652
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Park Ridge, Illinois 60068
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Peoria, Illinois 61656
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Quincy, Illinois 62301
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Redondo Beach, California 90277
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Roanoke, Virginia 24014
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Roseville, California 95678
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4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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Sacramento, California 95825
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1-99 Garden Street
San Francisco, California 94115
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275 Hospital Parkway
San Jose, California 95119
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San Luis Obispo, California 93401
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San Marcos, California 92078
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710 Lawrence Expressway
Santa Clara, California 95051
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Santa Maria, California 93454
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Scarborough, Maine 04074
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1200 El Camino Real
South San Francisco, California 94080
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Tacoma, Washington 98405
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910 East Houston Street
Tyler, Texas 75702
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Vallejo, California 94589
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Vancouver, Washington 98684
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Walla Walla, Washington 99362
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1425 South Main Street
Walnut Creek, California 94596
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