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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

403

Study ID:

NCT02763579

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 113 Locations for this study

See Locations Near You

Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers Florida, 33901, United States
Florida Hospital
Orlando Florida, 32804, United States
Florida Cancer Specialists.
Saint Petersburg Florida, 33705, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta Georgia, 30060, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
Cancer Treatment Centers of America - Midwestern Regional Medical Center
Zion Illinois, 60099, United States
Louisville Oncology
Louisville Kentucky, 40202, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Weinberg CA Inst Franklin Sq
Baltimore Maryland, 21237, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas Nevada, 89169, United States
The Valley Hospital
Paramus New Jersey, 07652, United States
Broome Oncology - Binghamton
Binghamton New York, 13905, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville Tennessee, 37203, United States
Vanderbilt Medical Center
Nashville Tennessee, 37232, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Blue Ridge Cancer Care
Roanoke Virginia, 24014, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States
University of Wisconsin
Madison Wisconsin, 53705, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
The Prince Charles Hospital; Oncology Dept.
Chermside Queensland, 4032, Australia
Royal Melbourne Hospital; Hematology and Medical Oncology
Parkville Victoria, 3052, Australia
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten
Linz , 4020, Austria
Salzburger Landeskliniken; Universitätsklinik für Pneumologie/ Lungenheilkunde
Salzburg , 5020, Austria
SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung
Wien , 1140, Austria
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
Wien , 1210, Austria
Santa Casa de Misericordia de Salvador
Salvador BA, 40050, Brazil
Hospital Bruno Born
Lajeado RS, 95900, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre RS, 90035, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
Recoleta , 84203, Chile
OrlandiOncología
Santiago , 75007, Chile
Beijing Cancer Hospital
Beijing , 10014, China
Jilin Cancer Hospital
Changchun , 13201, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou , 51012, China
Harbin Medical University Cancer Hospital
Harbin , 15008, China
Jiangsu Cancer Hospital
Nanjing City , 21110, China
Fudan University Shanghai Cancer Center
Shanghai City , 20012, China
Zhongshan Hospital Fudan University
Shanghai , 20003, China
Zhejiang Cancer Hospital
Zhejiang , 31002, China
Henan Cancer Hospital
Zhengzhou , 45000, China
Fakultni nemocnice Olomouc
Olomouc , 775 2, Czechia
Thomayerova nemocnice
Praha 4 - Krc , 140 5, Czechia
Fakultni nemocnice Na Bulovce
Praha 8 , 180 8, Czechia
Institut Bergonie; Oncologie
Bordeaux , 33076, France
Centre Francois Baclesse; Oncologie
Caen , 14076, France
Hopital Calmette; Pneumologie Oncologie Ouest
Lille , 59037, France
Hôpital Nord - AP-HM Marseille#
Marseille , 13915, France
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
Gauting , 82131, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf , 22927, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
Halle , 06120, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg , 69126, Germany
Fachklinik für Lungenerkrankungen
Immenhausen , 34376, Germany
Sotiria Chest Hospital of Athens
Athens , 11527, Greece
Agioi Anargyroi; 3Rd Dept. of Medical Oncology
Athens , 145 6, Greece
University Hospital of Patras Medical Oncology
Patras , 265 0, Greece
Semmelweis Egyetem, AOK, Pulmonologiai Klinika
Budapest , 1083, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest , 1121, Hungary
Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
Debrecen , 4032, Hungary
Tudogyogyintezet Torokbalint
Torokbalint , 2045, Hungary
A.O. Universitaria Di Parma
Parma Emilia-Romagna, 43100, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Roma Lazio, 00128, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano Lombardia, 20133, Italy
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
Milano Lombardia, 20141, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
San Giovanni Rotondo Puglia, 71013, Italy
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
Pisa Toscana, 56124, Italy
Kyushu University Hospital; Respiratory
Fukuoka , 812-8, Japan
National Hospital Organization Himeji Medical Center
Hyogo , 670-8, Japan
Kanagawa Cancer Center;Thoracic Oncology
Kanagawa , 241-8, Japan
University Hospital Kyoto Prefectural University of Medicine, Pulmonary Medicine
Kyoto , 602-8, Japan
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi , 980-0, Japan
Kurashiki Central Hospital; Respiratory Medicine
Okayama , 710-8, Japan
Kindai University Hospital; Medical Oncology
Osaka , 589-8, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine
Osaka , 591-8, Japan
Saitama Cancer Center; Thoracic Oncology
Satima , 362-0, Japan
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka , 411-8, Japan
Tokyo Metropolitan Komagome Hospital; Thoracic Oncology and Respiratory Medicine
Tokyo , 113-8, Japan
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo , 135-8, Japan
Wakayama Medical University Hospital; Respiratory Medicine and Medical Oncology
Wakayama , 641-8, Japan
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Health Pharma Professional Research
Cdmx Mexico CITY (federal District), 03100, Mexico
Medical University of Gdansk
Gdansk , 80-95, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz , 93-51, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc
Olsztyn , 10-35, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock , 05-40, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan , 60-56, Poland
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology
Warszawa , 02-78, Poland
Moscow City Oncology Hospital #62
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow , 10522, Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin
Moscow , 11547, Russian Federation
City Clinical Hospital No. 1
Novosibirsk , 63004, Russian Federation
City Clinical Onc.
Saint-Petersburg , 19825, Russian Federation
Scientific Research Oncology Institute named after N.N. Petrov; Oncology
St. Petersburg , 19775, Russian Federation
Clinical Center of Serbia
Belgrade , 11000, Serbia
Clinical Center Nis; Clinic for pulmonary diseases
Nis , 18 00, Serbia
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga , 29010, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
Zaragoza , 50009, Spain
National Taiwan Uni Hospital; Internal Medicine
Taipei , 100, Taiwan
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
Taipei , 112, Taiwan
Chang Gung Medical Foundation - Linkou; Chest Dept
Taoyuan , 333, Taiwan
Royal Devon & Exeter Hospital; Oncology Centre
Exeter , EX2 5, United Kingdom
Barts and the London NHS Trust.
London , EC1A , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London , SE1 9, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester , M2O 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

403

Study ID:

NCT02763579

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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