A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:June 11, 2015
End Date:February 15, 2023

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

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab
(MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel
compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants
with Stage IV squamous NSCLC.


Inclusion Criteria:

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

- Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC

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

- Measurable disease as defined by RECIST v1.1

- Adequate hematologic and end organ function

Exclusion Criteria:

- Active or untreated central nervous system (CNS) metastasis

- 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

- 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 (CT) scan, History of radiation pneumonitis in the radiation
field (fibrosis) is permitted

- Positive test for Human Immunodeficiency Virus (HIV)

- Active hepatitis B or hepatitis C

- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1
therapeutic antibody

- Severe infection within 4 weeks prior to randomization

- Significant history of cardiovascular disease
We found this trial at
85
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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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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Fort Wayne, IN
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2500 Campus Rd
Honolulu, Hawaii 96822
(808) 956-8111
Univ of Hawaii Honolulu Community College is an integral part of the University of Hawai?i,...
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Miami, Florida 33136
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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Ann Arbor, Michigan 48106
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3320 Old Jefferson Road
Athens, Georgia 30607
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Bend, Oregon 97701
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2500 Northeast Neff Road
Bend, Oregon 97701
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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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701 Ostrum Street
Bethlehem, Pennsylvania 18015
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1351 Kimberly Rd
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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1180 Avenida Crámer
Buenos Aires, C1426
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Carrollton, Georgia 30117
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Chandler, Arizona 85224
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Chattanooga, Tennessee 37404
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Cherry Hill, New Jersey
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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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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Danbury, Connecticut 06810
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800 West Magnolia Avenue
Denton, Texas 76210
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Denver, Colorado 80218
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Detroit, Michigan 48201
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1001 East Superior Street
Duluth, Minnesota 55805
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1717 13th St
Everett, Washington 98201
(425) 297-5500
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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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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206 Mill Road
Fairhaven, Massachusetts 02719
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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8116 Good Luck Road
Gettysburg, Pennsylvania 17325
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2055 Hospital Drive
Hamilton, Ohio 45103
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Harrisburg, Pennsylvania 17043
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Hazard, Kentucky
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Kansas City, Missouri 64111
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Knoxville, Tennessee 37920
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Lake Success, New York 11042
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450 Lakeville Rd
Lake Success, New York 11040
(516) 734-8900
Monter Cancer Center The Monter Cancer Center is a unique facility dedicated to providing state-of-the-art...
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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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4301 West Markham Street
Little Rock, Arkansas 72205
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Longview, Texas 75601
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Louisville, Kentucky 40207
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Macon, Georgia 31201
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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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1 Medical Center Drive
Morgantown, West Virginia 26506
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New Orleans, Louisiana 70121
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Newnan, Georgia 30265
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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...
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Oakland, California 94611
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3401 PGA Boulevard
Palm Beach Gardens, Florida 33410
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1 Valley Health Plaza
Paramus, New Jersey 07652
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Park Ridge, Illinois 60068
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Pittsburgh, Pennsylvania 15212
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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Quincy, Illinois 62301
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Richmond, Virginia 23235
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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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1201 5th Avenue North
Saint Petersburg, Florida 33705
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Salisbury, North Carolina 28144
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San Diego, California 92120
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2500 Merced Street
San Leandro, California 94577
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Santa Clara, California 95051
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Scarborough, Maine 04074
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9055 East Del Camino Drive
Scottsdale, Arizona 85258
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Sewell, New Jersey 08080
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Tallahassee, Florida 32308
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3404 West Sylvania Avenue
Toledo, Ohio 43623
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