Lung Cancer Clinical Trial
A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy
Summary
This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Eligibility Criteria
Inclusion Criteria:
Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent
Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
Known active or untreated central nervous system (CNS) metastases
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
History of autoimmune disease
History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Active hepatitis B or hepatitis C
Prior treatment with docetaxel
Prior treatment with cluster of differentiation 137 (CD137) agonists, anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1 (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
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There are 204 Locations for this study
Bakersfield California, 93309, United States
Burbank California, 91505, United States
Fullerton California, 92835, United States
Hayward California, 94545, United States
La Jolla California, 92037, United States
Long Beach California, 90813, United States
Los Angeles California, 90095, United States
Northridge California, 91328, United States
Oakland California, 94611, United States
Redondo Beach California, 90277, United States
Roseville California, 95661, United States
Sacramento California, 95814, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
San Jose California, 95119, United States
San Luis Obispo California, 93401, United States
San Marcos California, 92069, United States
Santa Clara California, 95051, United States
Santa Maria California, 93454, United States
South San Francisco California, 94080, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Grand Junction Colorado, 81501, United States
Lone Tree Colorado, , United States
Jacksonville Florida, 32256, United States
Miami Florida, 33145, United States
Orlando Florida, 32806, United States
Atlanta Georgia, 30341, United States
Harvey Illinois, 60426, United States
Peoria Illinois, 61615, United States
Quincy Illinois, 62301, United States
Bettendorf Iowa, 52722, United States
Scarborough Maine, 04074, United States
Detroit Michigan, 48201, United States
Minneapolis Minnesota, 55404, United States
Minneapolis Minnesota, 55455, United States
Billings Montana, 59101, United States
Missoula Montana, 59802, United States
Omaha Nebraska, 68130, United States
Henderson Nevada, 89014, United States
Las Vegas Nevada, 89169, United States
Florham Park New Jersey, 07932, United States
Paramus New Jersey, 07652, United States
Farmington New Mexico, 87401, United States
Buffalo New York, 14263, United States
Clifton Park New York, 12065, United States
Columbus Ohio, 43219, United States
Tulsa Oklahoma, 74133, United States
Eugene Oregon, 97401, United States
Providence Rhode Island, 02903, United States
Austin Texas, 78731, United States
Houston Texas, 77030, United States
Tyler Texas, 75702, United States
Fairfax Virginia, 22031, United States
Norfolk Virginia, 23502, United States
Roanoke Virginia, 24014, United States
Tacoma Washington, 98405, United States
Vancouver Washington, 98684, United States
Milwaukee Wisconsin, 53215, United States
Córdoba , , Argentina
Provincia De Buenos Aires , B1884, Argentina
Rosario , S2000, Argentina
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
Vöcklabruck , 4840, Austria
Porto Alegre RS, 90035, Brazil
Edmonton Alberta, T6G 1, Canada
Windsor Ontario, N8W 2, Canada
Laval Quebec, H7M 3, Canada
Montreal Quebec, H3T 1, Canada
Recoleta , 84203, Chile
Temuco , 48104, Chile
Vina Del Mar , 25205, Chile
Helsinki , 00290, Finland
Oulu , 90029, Finland
Tampere , 33520, Finland
Avignon , 84918, France
Besancon , 25030, France
Bordeaux , 33077, France
Caen , 14076, France
Creteil , 94010, France
Grenoble , 38043, France
Le Mans , 72000, France
Lille , 59020, France
Marseille , 13915, France
Mulhouse , 68070, France
Paris , 75014, France
Paris , 75475, France
Paris , 75674, France
Paris , 75970, France
Pierre Benite , 69495, France
Pringy , 74374, France
Rennes , 35033, France
Strasbourg , 67065, France
Suresnes , 92151, France
Toulon , 83041, France
Toulouse , 31059, France
Berlin , 14165, Germany
Frankfurt , 60488, Germany
Gauting , 82131, Germany
Halle , 06120, Germany
Heidelberg , 69126, Germany
Hemer , 58675, Germany
Immenhausen , 34376, Germany
Köln , 51109, Germany
Regensburg , 93053, Germany
Athens , 115 2, Greece
Patras , 265 0, Greece
Thermi Thessalonikis , 570 0, Greece
Guatemala City , 01015, Guatemala
Budapest , 1083, Hungary
Pecs , 7624, Hungary
Torokbalint , 2045, Hungary
Avellino Campania, 83100, Italy
Napoli Campania, 80131, Italy
Parma Emilia-Romagna, 43100, Italy
Aviano Friuli-Venezia Giulia, 33081, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Roma Lazio, 00168, Italy
Genova Liguria, 16132, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20141, Italy
Monza Lombardia, 20900, Italy
Bari Puglia, 70124, Italy
Catania Sicilia, 95100, Italy
Lucca Toscana, 55100, Italy
Pisa Toscana, 56124, Italy
Padova Veneto, 35128, Italy
Verona Veneto, 37134, Italy
Aichi , 464-8, Japan
Chiba , 277-8, Japan
Ehime , 791-0, Japan
Fukuoka , 811-1, Japan
Hyogo , 650-0, Japan
Hyogo , 673-8, Japan
Miyagi , 981-1, Japan
Okayama , 700-8, Japan
Osaka , 589-8, Japan
Osaka , 591-8, Japan
Saitama , 362-0, Japan
Shizuoka , 411-8, Japan
Tokyo , 104-0, Japan
Tokyo , 135-8, Japan
Tokyo , 160-0, Japan
Yamaguchi , 755-0, Japan
Gyeonggi-do , 410-7, Korea, Republic of
Gyeonggi-do , 463-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 137-8, Korea, Republic of
'S Hertogenbosch , 5223 , Netherlands
Eindhoven , 5623 , Netherlands
Nieuwegein , 3435 , Netherlands
Auckland , 1023, New Zealand
Dunedin , , New Zealand
Hamilton , 3240, New Zealand
Oslo , 0310, Norway
Panama , 0832, Panama
Gdansk , 80-95, Poland
Lodz , 93-51, Poland
Otwock , 05-40, Poland
Poznan , 60-69, Poland
Warszawa , 02-78, Poland
Coimbra , 3041-, Portugal
Lisboa , 1796-, Portugal
Porto , 4200-, Portugal
Moscow , 10522, Russian Federation
Saint-Petersburg , 19825, Russian Federation
Samara , 44303, Russian Federation
Belgrade , 11000, Serbia
Sremska Kamenica , 21204, Serbia
Las Palmas de Gran Canaria LAS Palmas, 35016, Spain
Majadahonda Madrid, 28222, Spain
La Coruña , 15006, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Zaragoza , 50009, Spain
Goeteborg , 41345, Sweden
Linköping , 581 8, Sweden
Stockholm , 171 7, Sweden
Baden , 5404, Switzerland
Geneve , 1211, Switzerland
Luzern , 6004, Switzerland
Taichung , 40447, Taiwan
Taipei , 100, Taiwan
Taipei , 112, Taiwan
Taoyuan , 333, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Istanbul , 34300, Turkey
Izmir , 35110, Turkey
Dnipropetrovsk , 43102, Ukraine
Kharkiv , 61070, Ukraine
Uzhgorod , 88000, Ukraine
Grimsby , DN33 , United Kingdom
London , NW1 -, United Kingdom
London , NW3 2, United Kingdom
London , SE1 9, United Kingdom
London , SW17 , United Kingdom
London , W6 8R, United Kingdom
Manchester , M20 4, United Kingdom
Sutton in Ashfield , NG17 , United Kingdom
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