A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:April 16, 2015
End Date:December 28, 2019

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A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

This randomized Phase III, multicenter, open-label study designed to evaluate the safety and
efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in
combination with carboplatin+nab-paclitaxel compared with treatment with
carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous
NSCLC. Participants will be randomized in a 2:1 ratio to Arm A
(Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).


Inclusion Criteria:

- Eastern Cooperative Oncology Group performance status of 0 or 1

- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC

- Participants with no prior treatment for Stage IV non-squamous NSCLC

- Previously obtained archival tumor tissue or tissue obtained from fresh biopsy at
screening

- Measurable disease, as defined by RECIST v1.1

- Adequate hematologic and end organ function

Exclusion Criteria:

Cancer-Specific Exclusions:

- Active or untreated central nervous system metastases

- Malignancies other than NSCLC within 5 years prior to randomization, with the
exception of those with a negligible risk of metastasis or death treated with expected
curative outcome

General Medical Exclusions:

- Pregnant or lactating women

- History of autoimmune disease

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography scan. History of radiation pneumonitis in the radiation
field (fibrosis) is permitted

- Positive test for human immunodeficiency virus

- Active hepatitis B or hepatitis C

- Severe infection within 4 weeks prior to randomization

- Significant cardiovascular disease

- Illness or condition that interferes with the participant's capacity to understand,
follow and/or comply with study procedures

Exclusion Criteria Related to Medications:

- Prior treatment with cluster of differentiation 137 agonists or immune checkpoint
blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
We found this trial at
73
sites
11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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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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3320 Old Jefferson Road
Athens, Georgia 30607
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Battle Creek, MI
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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10 Avenue Hippocrate
Bruxelles, 1200
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Carrollton, Georgia 30117
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200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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979 E 3rd St # A540
Chattanooga, Tennessee 37403
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Chattanooga, Tennessee 37404
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5454 Wisconsin Avenue
Chevy Chase, Maryland 20815
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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1192 East Newport Center Drive
Deerfield Beach, Florida 33442
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800 West Magnolia Avenue
Denton, Texas 76210
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8 Duke University Medical Center Greenspace
Durham, North Carolina 27710
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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208 Mill Road
Fairhaven, Massachusetts 02719
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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Gilbert, Arizona 85234
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Greenville, South Carolina 29605
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2055 Hospital Drive
Hamilton, Ohio 45103
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Harrisburg, Pennsylvania 17043
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Hattiesburg, Mississippi 39401
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Hazard, Kentucky 41701
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2406 Century Place Southeast
Hickory, North Carolina 28602
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321 North Kuakini Street
Honolulu, Hawaii 96817
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Joliet, IL
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Lake Success, New York 11042
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Lawrenceville, Georgia 30046
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16 Hayden Avenue
Lexington, Kentucky 02421
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Lincoln, Nebraska 68510
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4301 West Markham Street
Little Rock, Arkansas 72205
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Louisville, Kentucky 40207
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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195 Little Albany Street
New Brunswick, New Jersey 08901
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New Orleans, Louisiana 70121
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Newnan, Georgia 30265
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Oakland, California 94611
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Peoria, Illinois 61656
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Quincy, Illinois 62301
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Rochester, Minnesota 55905
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Rogers, Arkansas 72758
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Roseville, California 95661
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2025 Morse Avenue
Sacramento, California 95825
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1900 Centracare Circle
Saint Cloud, Minnesota 56303
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1201 5th Avenue North
Saint Petersburg, Florida 33705
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Salisbury, North Carolina 28144
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San Francisco, California 94115
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San Jose, California 95119
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2500 Merced Street
San Leandro, California 94577
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Santa Clara, California 95051
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Sioux City, Iowa 51101
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South San Francisco, California 94080
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Tallahassee, Florida 32308
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Thomasville, Georgia 31792
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Vallejo, California 94589
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