A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
NCT ID: NCT02763579
Last Updated: 2023-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
503 participants
INTERVENTIONAL
2016-06-07
2022-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Atezolizumab + Carboplatin + Etoposide
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab intravenous infusion was administered at a dose of 1200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
Carboplatin
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
Etoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
Placebo + Carboplatin + Etoposide
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Carboplatin
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
Etoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
Placebo
Placebo intravenous infusion was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
Interventions
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Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab intravenous infusion was administered at a dose of 1200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
Carboplatin
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
Etoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
Placebo
Placebo intravenous infusion was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers, Florida, United States
Florida Hospital
Orlando, Florida, United States
Florida Cancer Specialists.
St. Petersburg, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
Cancer Treatment Centers of America - Midwestern Regional Medical Center
Zion, Illinois, United States
Louisville Oncology
Louisville, Kentucky, United States
New England Cancer Specialists
Scarborough, Maine, United States
Weinberg CA Inst Franklin Sq
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, United States
The Valley Hospital
Paramus, New Jersey, United States
Broome Oncology - Binghamton
Binghamton, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville, Tennessee, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
The Prince Charles Hospital; Oncology Dept.
Chermside, Queensland, Australia
Royal Melbourne Hospital; Hematology and Medical Oncology
Parkville, Victoria, Australia
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten
Linz, , Austria
Salzburger Landeskliniken; Universitätsklinik für Pneumologie/ Lungenheilkunde
Salzburg, , Austria
Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
Vienna, , Austria
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
Vienna, , Austria
Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Bradford Hill Centro de Investigaciones Clinicas
Recoleta, , Chile
OrlandiOncología
Santiago, , Chile
Beijing Cancer Hospital
Beijing, , China
Jilin Cancer Hospital
Changchun, , China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Jiangsu Cancer Hospital
Nanjing, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Zhejiang Cancer Hospital
Zhejiang, , China
Henan Cancer Hospital
Zhengzhou, , China
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Na Bulovce
Prague, , Czechia
Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Institut Bergonie; Oncologie
Bordeaux, , France
Centre Francois Baclesse; Oncologie
Caen, , France
Hopital Calmette; Pneumologie Oncologie Ouest
Lille, , France
Hôpital Nord - AP-HM Marseille#
Marseille, , France
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
Gauting, , Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, , Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
Halle, , Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, , Germany
Fachklinik für Lungenerkrankungen
Immenhausen, , Germany
Sotiria Chest Hospital of Athens
Athens, , Greece
Agioi Anargyroi; 3Rd Dept. of Medical Oncology
Athens, , Greece
University Hospital of Patras Medical Oncology
Pátrai, , Greece
Semmelweis Egyetem, AOK, Pulmonologiai Klinika
Budapest, , Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, , Hungary
Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika
Debrecen, , Hungary
Tudogyogyintezet Torokbalint
Törökbálint, , Hungary
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
San Giovanni Rotondo, Apulia, Italy
A.O. Universitaria Di Parma
Parma, Emilia-Romagna, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
Pisa, Tuscany, Italy
Kyushu University Hospital; Respiratory
Fukuoka, , Japan
National Hospital Organization Himeji Medical Center
Hyōgo, , Japan
Kanagawa Cancer Center;Thoracic Oncology
Kanagawa, , Japan
University Hospital Kyoto Prefectural University of Medicine,?Pulmonary Medicine
Kyoto, , Japan
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi, , Japan
Kurashiki Central Hospital; Respiratory Medicine
Okayama, , Japan
Kindai University Hospital; Medical Oncology
Osaka, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine
Osaka, , Japan
Saitama Cancer Center; Thoracic Oncology
Satima, , Japan
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka, , Japan
Tokyo Metropolitan Komagome Hospital; Thoracic Oncology and Respiratory Medicine
Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo, , Japan
Wakayama Medical University Hospital; Respiratory Medicine and Medical Oncology
Wakayama, , Japan
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
Medical University of Gdansk
Gdansk, , Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, , Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc
Olsztyn, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, , Poland
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology
Warsaw, , Poland
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, Russia
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow, Moscow Oblast, Russia
Russian Oncology Research Center n.a. N.N. Blokhin
Moscow, Moscow Oblast, Russia
Scientific Research Oncology Institute named after N.N. Petrov; Oncology
Saint Petersburg, Sankt-Peterburg, Russia
City Clinical Onc.
Saint Petersburg, Sankt-Peterburg, Russia
City Clinical Hospital No. 1
Novosibirsk, , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Center Nis; Clinic for pulmonary diseases
Niš, , Serbia
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Sant Andreu de la Barca, Barcelona, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, , Spain
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
Zaragoza, , Spain
National Taiwan Uni Hospital; Internal Medicine
Taipei, , Taiwan
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Chest Dept
Taoyuan District, , Taiwan
Royal Devon & Exeter Hospital; Oncology Centre
Exeter, , United Kingdom
Barts and the London NHS Trust.
London, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, , United Kingdom
Countries
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References
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Bernabe R, Liu SV, Sanchez-Gastaldo A, Alonso Garcia M. Long-Term Survival and Stable Disease in a Patient with Extensive-Stage Small-Cell Lung Cancer after Treatment with Carboplatin, Etoposide and Atezolizumab. Oncol Ther. 2024 Mar;12(1):175-182. doi: 10.1007/s40487-023-00257-0. Epub 2024 Jan 27.
Liu SV, Mok TSK, Nabet BY, Mansfield AS, De Boer R, Losonczy G, Sugawara S, Dziadziuszko R, Krzakowski M, Smolin A, Hochmair MJ, Garassino MC, Gay CM, Heymach JV, Byers LA, Lam S, Cardona A, Morris S, Adler L, Shames DS, Reck M. Clinical and molecular characterization of long-term survivors with extensive-stage small cell lung cancer treated with first-line atezolizumab plus carboplatin and etoposide. Lung Cancer. 2023 Dec;186:107418. doi: 10.1016/j.lungcan.2023.107418. Epub 2023 Oct 31.
Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, Garassino MC, De Castro Carpeno J, Califano R, Nishio M, Orlandi F, Alatorre-Alexander J, Leal T, Cheng Y, Lee JS, Lam S, McCleland M, Deng Y, Phan S, Horn L. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39(6):619-630. doi: 10.1200/JCO.20.01055. Epub 2021 Jan 13.
Mansfield AS, Kazarnowicz A, Karaseva N, Sanchez A, De Boer R, Andric Z, Reck M, Atagi S, Lee JS, Garassino M, Liu SV, Horn L, Wen X, Quach C, Yu W, Kabbinavar F, Lam S, Morris S, Califano R. Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial. Ann Oncol. 2020 Feb;31(2):310-317. doi: 10.1016/j.annonc.2019.10.021. Epub 2019 Dec 9.
Nishio M, Sugawara S, Atagi S, Akamatsu H, Sakai H, Okamoto I, Takayama K, Hayashi H, Nakagawa Y, Kawakami T. Subgroup Analysis of Japanese Patients in a Phase III Study of Atezolizumab in Extensive-stage Small-cell Lung Cancer (IMpower133). Clin Lung Cancer. 2019 Nov;20(6):469-476.e1. doi: 10.1016/j.cllc.2019.07.005. Epub 2019 Jul 31.
Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-004861-97
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO30081
Identifier Type: -
Identifier Source: org_study_id
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