Spots Global Cancer Trial Database for A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
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Trial Identification
Brief Title: A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
Official Title: A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab
Study ID: NCT05091567
Conditions
Study Description
Brief Summary: Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Jewish Health, Denver, Colorado, United States
Florida Cancer Specialists - Fort Myers (Broadway), Fort Myers, Florida, United States
Florida Cancer Specialist, North Region, Saint Petersburg, Florida, United States
SCRI Florida Cancer Specialists PAN, Tallahassee, Florida, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Marietta, Georgia, United States
Illinois Cancer Care, Peoria, Illinois, United States
Hematology Oncology Clinic, Baton Rouge, Louisiana, United States
New England Cancer Specialists, Scarborough, Maine, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Cancer & Hematology Centers of Western Michigan; Spectrum Health Butterworth Research Pharmacy, Grand Rapids, Michigan, United States
Mercy Research - St. Louis, Saint Louis, Missouri, United States
Mercy Research SPRG, Springfield, Missouri, United States
Optum Health Care, Las Vegas, Nevada, United States
Clinical Research Alliance, Westbury, New York, United States
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc., Columbus, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Hollings Cancer Center, Charleston, South Carolina, United States
Greco-Hainesworth Centers for Research; ETN (East Tennessee), Chattanooga, Tennessee, United States
West Clinic, Germantown, Tennessee, United States
Tennessee Oncology; Sarah Cannon Research Institute, Nashville, Tennessee, United States
Michael E. DeBakey VA Medical Center, Houston, Texas, United States
Mays Cancer Center at UT Health San Antonio MD Anderson Cancer, San Antonio, Texas, United States
Institut Jules Bordet, Anderlecht, , Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
AZ St Maarten Campus Leopoldstr, Mechelen, , Belgium
CHU UCL Mont-Godinne, Mont-godinne, , Belgium
Vitaz, Sint Niklaas, , Belgium
Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie, Bad Berka, , Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie, Berlin, , Germany
Helios Klinikum Emil von Behring GmbH, Berlin, , Germany
Klinikum Chemnitz gGmbH, Chemnitz, , Germany
KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie, Essen, , Germany
Asklepios Klinik Gauting; Onkologisches Studienzentrum, Gauting, , Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH, Georgsmarienhütte, , Germany
LungenClinic Großhansdorf GmbH; Klinische Forschung, Großhansdorf, , Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II, Halle, , Germany
KRH Klinikum Siloah-Oststadt-Heidehaus, Hannover, , Germany
Fachklinik für Lungenerkrankungen, Immenhausen, , Germany
Universitätsklinikum Schleswig-Holstein; Campus Lübeck, Lübeck, , Germany
Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie, Regensburg, , Germany
Sotiria Thoracic Diseases Hospital of Athens; 3rd University Pathology Clinic, Athens, , Greece
ERRIKOS DYNAN HOSPITAL; 4th ONCOLOGY CLINIC, Athens, , Greece
University Hospital of Larissa;Department of Medical Oncology, Larissa, , Greece
Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki, , Greece
Diavalkaniko Hospital, Thessaloniki, , Greece
Orszagos Koranyi Pulmonologiai Intezet, Budapest, , Hungary
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet, Pécs, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int., Szolnok, , Hungary
Tudogyogyintezet Torokbalint, Torokbalint, , Hungary
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia, Ravenna, Emilia-Romagna, Italy
ASL 3 Genovese, Genova, Liguria, Italy
Irccs Ospedale San Raffaele;Oncologia Medica, Milano, Lombardia, Italy
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia, Milano, Lombardia, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck, Milano, Lombardia, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti, Torrette Di Ancona, Marche, Italy
Chungbuk National University Hospital, Cheongju si, , Korea, Republic of
Chilgok Kyungpook National University Medical Center, Daegu, , Korea, Republic of
Samsung Changwon Hospital, Gyeongsangnam-do, , Korea, Republic of
Gyeongsang National University Hospital, Gyeongsangnam-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Ulsan University Hosiptal, Ulsan, , Korea, Republic of
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Filios Alta Medicina, Monterrey, Nuevo LEON, Mexico
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii, Gdansk, , Poland
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? Onkologiczny, Kraków, , 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 Chorob Pluc, Otwock, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu; Oddzial Onkologii Klinicznej, Poznan, , Poland
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie; Klinika Nowotworow Pluca i Klatki Piersiowej, Warszawa, , Poland
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia, A Coruña, LA Coruña, Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia, Barcelona, , Spain
Hospital Universitario 12 de Octubre; 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
E-DA Hospital; Chest, Kaohsiung, , Taiwan
Taichung Veterans General Hospital; Dept of Internal Medicine, Taichung, , Taiwan
National Cheng Kung University Hospital; Oncology, Tainan, , Taiwan
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology, Taipei, , Taiwan
Adana Baskent University Hospital; Medical Oncology, Adana, , Turkey
Gülhane E?itim Ve Ara?t?rma Hastanesi, Ankara, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Liv Hospital Ankara; Medical Oncology, Ankara, , Turkey
Ankara City Hospital; Oncology, Ankara, , Turkey
Uludag Uni Hospital; Oncology, Bursa, , Turkey
Pamukkale University School Of Medicine; Oncology Department, Denizli, , Turkey
Dicle University Faculty of Medicine, Diyarbakir, , Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne, , Turkey
Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology, Istanbul, , Turkey
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology, Istanbul, , Turkey
?zmir Medical Park; Onkoloji, Izmir, , Turkey
Kocaeli University Faculty of Medicine; Medical oncology, Izmit, , Turkey
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology, Kadiköy, , Turkey
Medikal Park Samsun, Samsun, , Turkey
TC Necmettin Erbakan University Meram Medical Faculty Hospital, Selçuklu, , Turkey
Ac?badem Altunizade Hastanesi; Oncology, Üsküdar, , Turkey
Ysbyty Gwynedd Hospital, Bangor, , United Kingdom
Blackpool Victoria Hospital, Blackpool, , United Kingdom
Western General Hospital; Edinburgh Cancer Center, Edinburgh, , United Kingdom
Christie NHS Foundation Trust, GB Manchester, , United Kingdom
Castle Hill Hospital; The Queen's Centre for Oncology & Haematology, Hull, , United Kingdom
St James University Hospital, Leeds, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
University College London Hospital, London, , United Kingdom
Guy's Hospital; Oncology & Haematology Clinical Trials (OHCT) Unit. GI/Urology Research Office, London, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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