A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab 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:3/7/2019
Start Date:March 31, 2015
End Date:December 22, 2019

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A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (an
engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with
carboplatin+paclitaxel with or without bevacizumab compared with treatment with
carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV
non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A
(Atezolizumab+Carboplatin+Paclitaxel), Arm B
(Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C
(Carboplatin+Paclitaxel+Bevacizumab).


Inclusion Criteria:

- Eastern Cooperative Oncology Group performance status 0 or 1

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

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

- Known PD-L1 status as determined by immunohistochemistry assay performed on previously
obtained archival tumor tissue or tissue obtained from a 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
77
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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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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3700 Johnson Street
Hollywood, Florida 33021
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Ann Arbor, Michigan 48106
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Atlanta, Georgia 30318
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Auburn, Washington 98002
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Bend, Oregon 97701
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2500 Northeast Neff Road
Bend, Oregon 97701
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Berkeley Heights, New Jersey 07922
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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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Boynton Beach, Florida 33426
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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578 Alvear
Buenos Aires, B1878FZL
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Chandler, Arizona 85224
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Charleston, South Carolina 29403
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Cherry Hill, New Jersey
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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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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Columbia, Maryland 21044
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Danbury, Connecticut 06810
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Denver, Colorado 80218
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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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1329 North Beaver Street
Flagstaff, Arizona 86001
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400 West 7th Street
Frederick, Maryland 21701
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Germantown, Tennessee 38138
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Greenbrae, California 94904
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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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888 South King Street
Honolulu, Hawaii 96813
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Houston, Texas 77030
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Jacksonville, Florida 32216
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14546 Old Saint Augustine Road
Jacksonville, Florida 32258
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Kansas City, Missouri 64111
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Knoxville, Tennessee 37920
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La Jolla, California 92037
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902 West Meeting Street
Lancaster, South Carolina 29720
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Lonetree, Colorado 80205
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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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Missoula, Montana 59802
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1 Medical Center Drive
Morgantown, West Virginia 26506
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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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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101 The City Drive South
Orange, California 92868
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1 Valley Health Plaza
Paramus, New Jersey 07652
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Park Ridge, Illinois 60068
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Pinehurst, North Carolina 28374
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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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50 Leroy Street
Potsdam, New York 13676
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Richmond, Virginia 23235
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Roanoke, Virginia 24014
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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3931 Louisiana Avenue South
Saint Louis Park, Minnesota 55426
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4647 Zion Avenue
San Diego, California 92120
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3350 La Jolla Village Dr
San Diego, California 92161
(858) 552-8585
VA San Diego Healthcare System The VA San Diego Healthcare System (VASDHS) provides high quality...
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Scarborough, Maine 04074
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9055 East Del Camino Drive
Scottsdale, Arizona 85258
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Sewell, New Jersey 08080
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Spokane, Washington 99208
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2055 South Fremont Avenue
Springfield, Missouri 65804
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3404 West Sylvania Avenue
Toledo, Ohio 43623
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721 Clinic Drive
Tyler, Texas 75701
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