Lung Cancer Clinical Trial
A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
Summary
This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
No prior systemic treatment for ES-SCLC
Eastern Cooperative Oncology Group performance status of 0 or 1
Measurable disease, as defined by RECIST v1.1
Adequate hematologic and end organ function
Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
Exclusion Criteria:
Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
Malignancies other than SCLC 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 CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Positive test result for human immunodeficiency virus (HIV)
Active hepatitis B or hepatitis C
Severe infections at the time of randomization
Significant cardiovascular disease
Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibody
History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation.
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There are 113 Locations for this study
Fort Myers Florida, 33901, United States
Orlando Florida, 32804, United States
Saint Petersburg Florida, 33705, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60612, United States
Peoria Illinois, 61615, United States
Zion Illinois, 60099, United States
Louisville Kentucky, 40202, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21237, United States
Rochester Minnesota, 55905, United States
Las Vegas Nevada, 89169, United States
Paramus New Jersey, 07652, United States
Binghamton New York, 13905, United States
Charlotte North Carolina, 28204, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Fairfax Virginia, 22031, United States
Roanoke Virginia, 24014, United States
Tacoma Washington, 98405, United States
Madison Wisconsin, 53705, United States
Camperdown New South Wales, 2050, Australia
Chermside Queensland, 4032, Australia
Parkville Victoria, 3052, Australia
Linz , 4020, Austria
Salzburg , 5020, Austria
Wien , 1140, Austria
Wien , 1210, Austria
Salvador BA, 40050, Brazil
Lajeado RS, 95900, Brazil
Porto Alegre RS, 90035, Brazil
Sao Paulo SP, 01246, Brazil
Recoleta , 84203, Chile
Santiago , 75007, Chile
Beijing , 10014, China
Changchun , 13201, China
Guangzhou , 51012, China
Harbin , 15008, China
Nanjing City , 21110, China
Shanghai City , 20012, China
Shanghai , 20003, China
Zhejiang , 31002, China
Zhengzhou , 45000, China
Olomouc , 775 2, Czechia
Praha 4 - Krc , 140 5, Czechia
Praha 8 , 180 8, Czechia
Bordeaux , 33076, France
Caen , 14076, France
Lille , 59037, France
Marseille , 13915, France
Gauting , 82131, Germany
Großhansdorf , 22927, Germany
Halle , 06120, Germany
Heidelberg , 69126, Germany
Immenhausen , 34376, Germany
Athens , 11527, Greece
Athens , 145 6, Greece
Patras , 265 0, Greece
Budapest , 1083, Hungary
Budapest , 1121, Hungary
Debrecen , 4032, Hungary
Torokbalint , 2045, Hungary
Parma Emilia-Romagna, 43100, Italy
Roma Lazio, 00128, Italy
Milano Lombardia, 20133, Italy
Milano Lombardia, 20141, Italy
San Giovanni Rotondo Puglia, 71013, Italy
Pisa Toscana, 56124, Italy
Fukuoka , 812-8, Japan
Hyogo , 670-8, Japan
Kanagawa , 241-8, Japan
Kyoto , 602-8, Japan
Miyagi , 980-0, Japan
Okayama , 710-8, Japan
Osaka , 589-8, Japan
Osaka , 591-8, Japan
Satima , 362-0, Japan
Shizuoka , 411-8, Japan
Tokyo , 113-8, Japan
Tokyo , 135-8, Japan
Wakayama , 641-8, Japan
Seongnam-si , 13620, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Cdmx Mexico CITY (federal District), 03100, Mexico
Gdansk , 80-95, Poland
Lodz , 93-51, Poland
Olsztyn , 10-35, Poland
Otwock , 05-40, Poland
Poznan , 60-56, Poland
Warszawa , 02-78, Poland
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Moscow , 10522, Russian Federation
Moscow , 11547, Russian Federation
Novosibirsk , 63004, Russian Federation
Saint-Petersburg , 19825, Russian Federation
St. Petersburg , 19775, Russian Federation
Belgrade , 11000, Serbia
Nis , 18 00, Serbia
Barcelona , 08035, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Sevilla , 41013, Spain
Zaragoza , 50009, Spain
Taipei , 100, Taiwan
Taipei , 112, Taiwan
Taoyuan , 333, Taiwan
Exeter , EX2 5, United Kingdom
London , EC1A , United Kingdom
London , SE1 9, United Kingdom
Manchester , M2O 4, United Kingdom
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