Spots Global Cancer Trial Database for A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
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Trial Identification
Brief Title: A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-Tigit Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Study ID: NCT04256421
Conditions
Study Description
Brief Summary: This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (\</= upper limit of normal \[ULN\] vs. \> ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase: * Arm A: Tiragolumab plus atezolizumab plus CE * Arm B: Placebo plus atezolizumab plus CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rocky Mountain Cancer Centers - Lone Tree, Lone Tree, Colorado, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center), Washington, District of Columbia, United States
Florida Cancer Specialists; SCRI; Florida Cancer Specialists - Sarasota (Golf St), Fort Myers, Florida, United States
SCRI Florida Cancer Specialists North; Research Office North Region., Saint Petersburg, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta, Marietta, Georgia, United States
Illinois Cancer Care, Peoria, Illinois, United States
New England Cancer Specialists, Scarborough, Maine, United States
Weinberg Cancer Institution at Franklin Square, Baltimore, Maryland, United States
Minnesota Oncology Hematology, Saint Paul, Minnesota, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Broome Oncology - Binghamton, Binghamton, New York, United States
Mount Sinai - PRIME; Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga, Tennessee, United States
SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Texas Oncology Cancer Center, Austin, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Blue Ridge Cancer Care, Roanoke, Virginia, United States
University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Nepean Hospital; Nepean Cancer Care Centre, Kingswood, New South Wales, Australia
Sunshine Coast University Hospital; The Adem Crosby Centre, Birtinya, Queensland, Australia
Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit, Elizabeth Vale, South Australia, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie, Innsbruck, , Austria
Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten, Wien, , Austria
Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie, Wien, , Austria
AZ St Maarten Campus Leopoldstr, Mechelen, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
AZ Delta (Campus Rumbeke), Roeselare, , Belgium
Vitaz, Sint Niklaas, , Belgium
Hospital Sao Rafael - HSR, Salvador, BA, Brazil
Oncocentro Serviços Médicos e Hospitalares Ltda, Fortaleza, CE, Brazil
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia, Passo Fundo, RS, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Clínica de Oncologia Reichow, Blumenau, SC, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Fakultni nemocnice Olomouc; Pneumologicka klinika, Olomouc, , Czechia
Vitkovicka Nemocnice Bma, A.S.; Plicni Oddeleni, Ostrava, , Czechia
Thomayerova nemocnice; Pneumologicka klinika 1.LF UK TN, Praha 4 - Krc, , Czechia
Helios Klinikum Emil von Behring GmbH, Berlin, , Germany
Asklepios Klinik Gauting; Onkologisches Studienzentrum, Gauting, , Germany
LungenClinic Großhansdorf GmbH; Klinische Forschung, Großhansdorf, , Germany
Asklepios Klinik Harburg, Hamburg, , Germany
Fachklinik für Lungenerkrankungen, Immenhausen, , Germany
Universitätsklinikum Schleswig-Holstein; Campus Lübeck, Lübeck, , Germany
General Hospital "G.Papanikolaou"; Pulmonogy Clinic, Asvestochori, , Greece
Uoa Sotiria Hospital; Oncology, Athens, , Greece
Metropolitan General Hospital, Cholargos, , Greece
Univ General Hosp Heraklion; Medical Oncology, Heraklion, , Greece
Orszagos Koranyi TBC es Pulmonologiai Intezet, Budapest, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int., Szolnok, , Hungary
Tudogyogyintezet Torokbalint, Torokbalint, , Hungary
AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico, Napoli, Campania, Italy
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia, Ravenna, Emilia-Romagna, Italy
IRCCS Istituto Clinico Humanitas; Oncologia, Rozzano (MI), Lombardia, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga, Orbassano, Piemonte, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica, Bari, Puglia, Italy
Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica, Catania, Sicilia, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica, Siena, Toscana, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padova, Veneto, Italy
National Cancer Center Hospital East, Chiba, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Kindai University Hospital, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai-shi, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Wakayama Medical University Hospital, Wakayama, , Japan
Chungbuk National University Hospital, Cheongju si, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Samsung Changwon Hospital, Gyeongsangnam-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St Mary's Hospital, Seoul, , Korea, Republic of
Ulsan University Hosiptal, Ulsan, , Korea, Republic of
Maastricht University Medical Center, Maastricht, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Auckland City Hospital; Clinical Oncology, Auckland, , New Zealand
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny, Brzozów, , Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdansk, , Poland
Krakowski Szpital Specjalistyczny im sw.Jana Pawla II, Krakow, , Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii, Olsztyn, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii, Otwock, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu, Poznan, , Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers, Warszawa, , Poland
Principal Military Clinical Hospital n.a. N.N. Burdenko, Moscow, Moskovskaja Oblast, Russian Federation
BLOKHIN CANCER RESEARCH CENTER; CLINICAL ONCOLOGY; Clinical pharmacology and chemotheraphy, Moscow, Moskovskaja Oblast, Russian Federation
Scientific Research Institute n.a. N.N. Petrov, Saint Petersburg, Sankt Petersburg, Russian Federation
Clinical Center of Serbia; Clinic for Pulmonary Diseases, Belgrade, , Serbia
Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology, Belgrade, , Serbia
Institute for Pulmonary Diseases of Vojvodina; Clinic for Pulmonary Oncology, Sremska Kamenica, , Serbia
National University Hospital; National University Cancer Institute, Singapore (NCIS), Singapore, , Singapore
National Cancer Centre; Medical Oncology, Singapore, , Singapore
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Hospital Clinic Barcelona; Servicio de oncologia, Barcelona, , Spain
Fundacion Jimenez Diaz; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia, Zaragoza, , Spain
CHUV; Departement d'Oncologie, Lausanne, , Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie, Zürich, , Switzerland
National Cheng-Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
Chang-Gung Medical Foundation, Linkou Branch, Taoyuan, , Taiwan
National Taiwan University Hospital; Oncology, Zhongzheng Dist., , Taiwan
Adana Baskent University Hospital; Medical Oncology, Adana, , Turkey
Ankara University Medical Faculty; Medikal Onkoloji, Ankara, , Turkey
Gazi University Medical Faculty, Ankara, , Turkey
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani, Istanbul, , Turkey
Medipol University Medical Faculty; Oncology Department, Istanbul, , Turkey
?zmir Medical Park; Onkoloji, Izmir, , Turkey
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital, Edinburgh, , United Kingdom
Guys and St Thomas Hospital, London, , United Kingdom
Christie Foundation Trust, Manchester, , United Kingdom
Royal Marsden Hospital (Sutton), Sutton, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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