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 |
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).
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
sites
1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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4502 Medical Drive
San Antonio, Texas 78284
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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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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2500 Northeast Neff Road
Bend, Oregon 97701
Bend, Oregon 97701
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1351 Kimberly Rd
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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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
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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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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14546 Old Saint Augustine Road
Jacksonville, Florida 32258
Jacksonville, Florida 32258
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1 Medical Center Drive
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
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Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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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
Saint Louis Park, Minnesota 55426
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VA San Diego Healthcare System The VA San Diego Healthcare System (VASDHS) provides high quality...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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