Lung Cancer Clinical Trial
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)
Summary
This randomized, open-label study evaluated 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 were 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).
Eligibility Criteria
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
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There are 231 Locations for this study
Chandler Arizona, 85224, United States
Flagstaff Arizona, 86001, United States
Bellflower California, , United States
Greenbrae California, 94904, United States
La Jolla California, 92037, United States
Orange California, 92868, United States
Denver Colorado, 80218, United States
Lonetree Colorado, 80124, United States
Danbury Connecticut, 06810, United States
New Haven Connecticut, 06520, United States
Fort Lauderdale Florida, 33308, United States
Jacksonville Florida, 32258, United States
Miami Beach Florida, 33140, United States
Port Saint Lucie Florida, 34952, United States
Atlanta Georgia, 30318, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Harvey Illinois, 60426, United States
Park Ridge Illinois, 60068, United States
Bettendorf Iowa, 52722, United States
Louisville Kentucky, 40202, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21202, United States
Bethesda Maryland, 20817, United States
Columbia Maryland, 21044, United States
Ann Arbor Michigan, 48106, United States
Duluth Minnesota, 55805, United States
Saint Louis Park Minnesota, 55426, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63131, United States
Billings Montana, 59102, United States
Missoula Montana, 59802, United States
Henderson Nevada, 89014, United States
Berkeley Heights New Jersey, 07922, United States
Paramus New Jersey, 07652, United States
Sewell New Jersey, 08080, United States
Bronx New York, 10467, United States
Brooklyn New York, 11219, United States
Pinehurst North Carolina, 28374, United States
Cincinnati Ohio, 45203, United States
Toledo Ohio, 43623, United States
Bend Oregon, 97701, United States
Bend Oregon, 97701, United States
Springfield Oregon, 97477, United States
Bethlehem Pennsylvania, 18015, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Germantown Tennessee, 38138, United States
Knoxville Tennessee, 37920, United States
Houston Texas, 77030, United States
Longview Texas, 75601, United States
San Antonio Texas, 78229, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23226, United States
Roanoke Virginia, 24014, United States
Auburn Washington, 98002, United States
Everett Washington, 98201, United States
Seattle Washington, 98101, United States
Spokane Washington, 99208, United States
Morgantown West Virginia, 26506, United States
Buenos Aires , 1019, Argentina
Buenos Aires , C1125, Argentina
Cordoba , X5000, Argentina
La Rioja , F5300, Argentina
Rosario , 2000, Argentina
Santa Rosa , 6300, Argentina
Viedma , R8500, Argentina
Camperdown New South Wales, 2050, Australia
Concord New South Wales, 2139, Australia
Sydney New South Wales, 2747, Australia
Chermside Queensland, 4032, Australia
Townsville Queensland, 4810, Australia
Woolloongabba Queensland, 4102, Australia
Adelaide South Australia, 5000, Australia
Kurralta Park South Australia, 5037, Australia
Hobart Tasmania, 7000, Australia
Launceston Tasmania, 7250, Australia
Frankston Victoria, 3199, Australia
Heidelberg Victoria, 3084, Australia
Malvern Victoria, 3144, Australia
Prahan Victoria, 3181, Australia
St Albans Victoria, 3021, Australia
Nedlands Western Australia, 6009, Australia
Salzburg , 5020, Austria
Wels , 4600, Austria
Liège , 4000, Belgium
Namur , 5000, Belgium
Uberaba MG, 38082, Brazil
Londrina PR, 86 01, Brazil
Natal RN, 59040, Brazil
Caxias do Sul RS, 95070, Brazil
Porto Alegre RS, 90470, Brazil
Barretos SP, 14784, Brazil
Ribeirão Preto SP, 14015, Brazil
Sao Jose do Rio Preto SP, 15090, Brazil
Sao Paulo SP, 01509, Brazil
Plovdiv , 4000, Bulgaria
Sofia , 1303, Bulgaria
Oshawa Ontario, L1J 2, Canada
Santiago , 0, Chile
Santiago , 75000, Chile
Temuco , 48104, Chile
Bordeaux , 33076, France
Grenoble , 38043, France
Le Mans , 72015, France
Marseille , 13008, France
Marseille , 13015, France
Paris , 75908, France
Pessac , 33600, France
Saint Denis Cedex , 97405, France
Saint Quentin , 2100, France
Toulon , 83000, France
Toulon , 83000, France
Toulouse , 31059, France
Augsburg , 86156, Germany
Berlin , 14165, Germany
Bielefeld , 33611, Germany
Bochum , 44791, Germany
Dresden , 01307, Germany
Frankfurt am Main , 60487, Germany
Großhansdorf , 22927, Germany
Halle , 06120, Germany
Hamburg , 21075, Germany
Hemer , 58675, Germany
Homburg , 66421, Germany
Koln , 51109, Germany
Loewenstein , 74245, Germany
München , 81925, Germany
Regensburg , 93049, Germany
Regensburg , 93053, Germany
Rheine , 48431, Germany
Napoli Campania, 80131, Italy
Roma Lazio, 00128, Italy
Roma Lazio, 00152, Italy
Roma Lazio, 00168, Italy
Genova Liguria, 16132, Italy
Genova Liguria, 16147, Italy
Novara Piemonte, 28100, Italy
Sassari Sardegna, 07100, Italy
Catania Sicilia, 95123, Italy
Lido Di Camaiore Toscana, 55043, Italy
Livorno Toscana, 57124, Italy
Ehime , 791-0, Japan
Fukuoka , 810-8, Japan
Fukuoka , 811-1, Japan
Fukuoka , 830-0, Japan
Kanagawa , 236-0, Japan
Kanagawa , 252-0, Japan
Kyoto , 606-8, Japan
Miyagi , 981-1, Japan
Niigata , 951-8, Japan
Osaka , 545-8, Japan
Osaka , 560-8, Japan
Tokyo , 105-8, Japan
Tokyo , 162-0, Japan
Tokyo , 181-8, Japan
Wakayama , 641-8, Japan
Riga , LV-10, Latvia
RÄ«ga , LV-10, Latvia
Vilnius , 08660, Lithuania
Monterrey , 64020, Mexico
Queretaro , 76090, Mexico
Toluca , 50080, Mexico
'S Hertogenbosch , 5223 , Netherlands
Amsterdam , 1081 , Netherlands
Breda , 4818 , Netherlands
EDE , 6716 , Netherlands
Hilversum , 1201 , Netherlands
Hoofddorp , 2134 , Netherlands
Maastricht , 6229 , Netherlands
Nieuwegein , 3435 , Netherlands
Rotterdam , 3015 , Netherlands
Rotterdam , 3079 , Netherlands
Utrecht , 3584 , Netherlands
Zutphen , 7207 , Netherlands
Arequipa , 04001, Peru
Arequipa , , Peru
Lima , Lima , Peru
Coimbra , 3000-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1796-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Porto , 4200, Portugal
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Moscow , 11547, Russian Federation
Omsk , 64401, Russian Federation
Pushkin , 19660, Russian Federation
Saint-Petersburg , 19702, Russian Federation
Singapore , 16961, Singapore
Bratislava , 813 6, Slovakia
Bratislava , 833 1, Slovakia
Poprad , 058 0, Slovakia
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Sabadell Barcelona, 8208, Spain
Santander Cantabria, 39008, Spain
Palma De Mallorca Islas Baleares, 07014, Spain
Las Palmas de Gran Canaria LAS Palmas, 35016, Spain
Ourense Orense, 32005, Spain
Xativa Valencia, 46800, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Cordoba , 14004, Spain
Lugo , 27003, Spain
Madrid , 28007, Spain
Madrid , 28014, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Valencia , 46010, Spain
Bruderholz , 4101, Switzerland
Luzern , 6000, Switzerland
St. Gallen , 9007, Switzerland
Changhua , 500, Taiwan
Kaohsiung City , 807, Taiwan
Liuying Township , 736, Taiwan
Putzu , 613, Taiwan
Tainan , 00704, Taiwan
Taipei City , 10041, Taiwan
Taipei , 112, Taiwan
Taipei , 11490, Taiwan
Taoyuan City , 333, Taiwan
Xitun Dist. , 40705, Taiwan
Chernivtsi Chernihiv Governorate, 58013, Ukraine
Dnipropetrovsk Katerynoslav Governorate, 49102, Ukraine
Uzhhorod Katerynoslav Governorate, 88000, Ukraine
Zaporizhzhia Katerynoslav Governorate, 69040, Ukraine
Kharkiv Kharkiv Governorate, 61070, Ukraine
Uzhhorod Kherson Governorate, 88014, Ukraine
Ivano-Frankivsk KIEV Governorate, 76018, Ukraine
Vinnytsia KIEV Governorate, 21029, Ukraine
Kharkiv , 61024, Ukraine
Kryvyi Rih , 50048, Ukraine
Kyiv , 03115, Ukraine
Poltava , 36011, Ukraine
Sumy , 40005, Ukraine
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