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 |
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).
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
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
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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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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8901 Rockville Pike
Bethesda, Maryland 20889
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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Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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University of Illinois at Chicago A major research university in the heart of one of...
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The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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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
Deerfield Beach, Florida 33442
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8 Duke University Medical Center Greenspace
Durham, North Carolina 27710
Durham, North Carolina 27710
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Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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2406 Century Place Southeast
Hickory, North Carolina 28602
Hickory, North Carolina 28602
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1515 Holcombe Blvd
Houston, Texas 77030
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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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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University of Louisville The University of Louisville is a state supported research university located in...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Florida Hospital Florida Hospital is one of the country
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2025 Morse Avenue
Sacramento, California 95825
Sacramento, California 95825
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Saint Petersburg, Florida 33705
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