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 |
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.
(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
sites
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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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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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Univ of Hawaii Honolulu Community College is an integral part of the University of Hawai?i,...
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
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2500 Northeast Neff Road
Bend, Oregon 97701
Bend, Oregon 97701
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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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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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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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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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206 Mill Road
Fairhaven, Massachusetts 02719
Fairhaven, Massachusetts 02719
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Monter Cancer Center The Monter Cancer Center is a unique facility dedicated to providing state-of-the-art...
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Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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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
Morgantown, West Virginia 26506
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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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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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