Lung Cancer Clinical Trial
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]
Summary
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.
Eligibility Criteria
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
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There are 233 Locations for this study
Chandler Arizona, 85224, United States
Springdale Arkansas, 72762, United States
Bellflower California, , United States
Oakland California, 94611, United States
Sacramento California, 95825, United States
San Leandro California, 94577, United States
Santa Clara California, 95051, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Denver Colorado, 80218, United States
Danbury Connecticut, 06810, United States
Fort Lauderdale Florida, 33308, United States
Fort Myers Florida, 33916, United States
Palm Beach Gardens Florida, 33410, United States
Port Saint Lucie Florida, 34952, United States
Saint Petersburg Florida, 33705, United States
Athens Georgia, 30607, United States
Carrollton Georgia, 30117, United States
Macon Georgia, 31201, United States
Newnan Georgia, 30265, United States
Chicago Illinois, 60637, United States
Joliet Illinois, 60435, United States
Quincy Illinois, 62301, United States
Fort Wayne Indiana, 46845, United States
Bettendorf Iowa, 52722, United States
Sioux City Iowa, 51101, United States
Lexington Kentucky, 02421, United States
Louisville Kentucky, 40202, United States
New Orleans Louisiana, 70121, United States
Scarborough Maine, 04074, United States
Fairhaven Massachusetts, 02719, United States
Ann Arbor Michigan, 48106, United States
Detroit Michigan, 48201, United States
Duluth Minnesota, 55805, United States
Tupelo Mississippi, 38801, United States
Billings Montana, 59102, United States
Paramus New Jersey, 07652, United States
Sewell New Jersey, 08080, United States
Westbury New York, 11590, United States
Salisbury North Carolina, , United States
Cincinnati Ohio, 45203, United States
Columbus Ohio, 43219, United States
Hamilton Ohio, 45103, United States
Portland Oregon, 97239, United States
Bethlehem Pennsylvania, 18015, United States
Gettysburg Pennsylvania, 17325, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Chattanooga Tennessee, 37404, United States
Knoxville Tennessee, 37920, United States
Denton Texas, 76210, United States
Longview Texas, 75601, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Roanoke Virginia, 24014, United States
Everett Washington, 98201, United States
Spokane Washington, 99208, United States
Buenos Aires , C1125, Argentina
Cordoba , X5000, Argentina
La Rioja , F5300, Argentina
Pergamino , B2700, Argentina
Santa Rosa , L6304, Argentina
Viedma , R8500, Argentina
Camperdown New South Wales, 2050, Australia
Waratah New South Wales, 2298, Australia
Chermside Queensland, 4032, Australia
Townsville Queensland, 4810, Australia
Woolloongabba Queensland, 4102, Australia
Adelaide South Australia, 5000, Australia
Heidelberg Victoria, 3084, Australia
Malvern Victoria, 3144, Australia
St Albans Victoria, 3021, Australia
Nedlands Western Australia, 6009, Australia
Salzburg , 5020, Austria
Bruxelles , 1200, Belgium
Liège , 4000, Belgium
Namur , 5000, Belgium
Ronse , 9600, Belgium
Wilrijk , 2610, Belgium
Belo Horizonte MG, 30130, Brazil
Londrina PR, 86 01, Brazil
Natal RN, 59040, Brazil
Caxias do Sul RS, 95070, Brazil
Lajeado RS, 95900, Brazil
Porto Alegre RS, 90035, Brazil
Porto Alegre RS, 90470, Brazil
Barretos SP, 14784, Brazil
Sao Jose do Rio Preto SP, 15090, Brazil
Sao Paulo SP, 01525, Brazil
Plovdiv , 4000, Bulgaria
Sofia , 1303, Bulgaria
Barrie Ontario, L4M 6, Canada
Etobicoke Ontario, M9V 1, Canada
Oshawa Ontario, L1J 2, Canada
Laval Quebec, H7M 3, Canada
Montreal Quebec, H4J 1, Canada
St. Jerome Quebec, J7Z 5, Canada
Santiago , 75000, Chile
Temuco , 48104, Chile
Grenoble , 38043, France
Le Mans , 72000, France
Lyon , 69008, France
Montpellier , 34070, France
Orleans , 45067, France
Pierre Benite , 69495, France
Rennes , 35033, France
Saint Pierre , 97448, France
Saint Quentin , 2100, France
Toulon Cedex 9 , 83800, France
Berlin , 12203, Germany
Bielefeld , 33611, Germany
Bochum , 44791, Germany
Dresden , 01307, Germany
Frankfurt am Main , 60487, Germany
Gerlingen , 70839, Germany
Großhansdorf , 22927, Germany
Halle , 06120, Germany
Hamburg , 20246, Germany
Hamburg , 21075, Germany
Hemer , 58675, Germany
Homburg , 66421, Germany
Immenhausen , 34376, Germany
Koln , 51109, Germany
Minden , 32429, Germany
München , 81925, Germany
Regensburg , 93049, Germany
Regensburg , 93053, Germany
Rheine , 48431, Germany
Villingen-Schwenningen , 78052, Germany
Beer Sheva , 84101, Israel
Jerusalem , 91120, Israel
Kfar-Saba , 44281, Israel
Petach Tiqwa , 49414, Israel
Ramat Gan , 52621, Israel
Rambam , 35254, Israel
Tel Aviv , 64239, Israel
Avellino Campania, 83100, Italy
Napoli Campania, 80131, Italy
Napoli Campania, 80131, Italy
Napoli Campania, 80131, Italy
Roma Lazio, 00152, Italy
Genova Liguria, 16147, Italy
Pavia Lombardia, 27100, Italy
Bari Puglia, 70124, Italy
Catania Sicilia, 95123, Italy
Livorno Toscana, 57124, Italy
Pisa Toscana, 56100, Italy
Perugia Umbria, 06122, Italy
Aichi , 464-8, Japan
Aichi , 466-8, Japan
Chiba , 277-8, Japan
Ehime , 791-0, Japan
Fukuoka , 810-8, Japan
Fukuoka , 812-8, Japan
Hyogo , 650-0, Japan
Hyogo , 670-8, Japan
Hyogo , 673-8, Japan
Ibaraki , 309-1, Japan
Kanagawa , 241-8, Japan
Kyoto , 606-8, Japan
Miyagi , 980-0, Japan
Niigata , 951-8, Japan
Okayama , 700-8, Japan
Osaka , 541-8, Japan
Osaka , 545-8, Japan
Osaka , 573-1, Japan
Osaka , 583-8, Japan
Sakai-shi , 591-8, Japan
Satima , 362-0, Japan
Shizuoka , 411-8, Japan
Tokyo , 104-0, Japan
Tokyo , 160-0, Japan
Riga , LV-10, Latvia
RÄ«ga , LV-10, Latvia
Vilnius , 08660, Lithuania
Monterrey , 64020, Mexico
Queretaro , 76090, Mexico
Amsterdam , 1007 , Netherlands
Amsterdam , 1066 , Netherlands
EDE , 6716 , Netherlands
Eindhoven , 5623 , Netherlands
Nieuwegein , 3435 , Netherlands
Arequipa , 04001, Peru
Lima , Lima , Peru
Trujillo , 12345, Peru
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
Saint-Petersburg , 19702, Russian Federation
Volgograd , 40013, Russian Federation
Singapore , 11907, Singapore
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
A Coruña LA Coruña, 15006, Spain
Las Palmas de Gran Canaria LAS Palmas, 35016, Spain
Seville Sevilla, 41014, Spain
S. Cristobal De La Laguna Tenerife, 38320, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Cordoba , 14008, 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
Valencia , 46014, Spain
Zaragoza , 50009, Spain
Changhua , 500, Taiwan
Kaohsiung City , 807, Taiwan
Liuying Township , 736, Taiwan
Putzu , 613, Taiwan
Taichung , 40447, Taiwan
Taipei City , 10041, Taiwan
Taipei , 104, Taiwan
Dnipropetrovsk Katerynoslav Governorate, 49102, Ukraine
Uzhhorod Katerynoslav Governorate, 88000, Ukraine
Zaporizhzhia Katerynoslav Governorate, 69040, Ukraine
Kharkiv Kharkiv Governorate, 61070, Ukraine
Vinnytsia KIEV Governorate, 21029, Ukraine
Lviv Volhynian Governorate, 79031, Ukraine
Chernivtsi , 58013, Ukraine
Kharkiv , 61024, Ukraine
Kryvyi Rih , 50048, Ukraine
Poltava , 36011, Ukraine
Sumy , 40005, Ukraine
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