Spots Global Cancer Trial Database for A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Official Title: LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Study ID: NCT04194944
Conditions
Study Description
Brief Summary: The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centro de Oncología e Investigación de Buenos Aires, Berazategui, Buenos Aires, Argentina
Fundacion CENIT para la Investigacion en Neurociencias, Caba, Buenos Aires, Argentina
Clinica Viedma, Viedma, Río Negro, Argentina
Alexander Fleming, Ciudad de Buenos Aires, , Argentina
Clínica El Castaño, San Juan, , Argentina
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Monash Health, Clayton, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
St Vincent's Hospital, Melbourne, Victoria, Australia
Peninsula Oncology Centre, Frankston, , Australia
UZ Brussel, Brussels, Bruxelles-Capitale, Région De, Belgium
AZ Nikolaas, Sint Niklaas, Oost-Vlaanderen, Belgium
UZ Leuven, Leuven, Vlaams-Brabant, Belgium
AZ Delta, Roeselare, West Flanders, Belgium
UZ Gent Hospital, Gent, , Belgium
AZ Sint-Maarten, Campus Leopoldstraat 2, Mechelen, , Belgium
CHU UCL Namur/Site Sainte Elisabeth, Namur, , Belgium
Núcleo de Oncologia da Bahia, Salvador, Bahia, Brazil
Hospital de Cancer de Londrina, Londrina, Paraná, Brazil
Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil
Grupo COI - Clínicas Oncológicas Integradas, Rio de Janeiro, RJ, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos, Barretos, Sao Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR), Sao Paulo, SP, Brazil
Instituto Nacional de Câncer - INCA, Rio de Janeiro, , Brazil
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA, Rio de Janeiro, , Brazil
Hospital Sírio Libanês, Sao Paolo, , Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo, Sao Paulo, , Brazil
Hospital Sírio Libanês, São Paulo, , Brazil
Cross Cancer Institute, Edmonton, Alberta, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Beijing Cancer hospital, Beijing, Beijing, China
First affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China
The First Affiated Hospital Of Guangzhou Medical Collage, Guangzhou, Guangzhou, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Wuhan Union Hospital, Wuhan, Hubei, China
Hunan Provincial People's Hospital, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Changzhou No.2 People's Hospital, Changzhou, Jiangsu, China
Jilin Cancer Hospital, Changchun, Jilin, China
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Cheng Du, Sichuan, China
Xinjiang Medical University Cancer Hospital - Urumqi, Urumqi, Xinjiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
First Affiliated Hosp of College of Med, Zhejiang University, Hangzhou, , China
Shanghai Chest Hospital, Shanghai, , China
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Nemocnice AGEL Ostrava - Vitkovice a.s., Ostrava - Vitkovice, , Czechia
Fakultni nemocnice Bulovka, Praha 8, , Czechia
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone, Marseille, Bouches-du-Rhône, France
Institut Régional du Cancer Montpellier, Montpellier Cedex 5, Hérault, France
Chu Grenoble Alpes, La Tronche, Isère, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne, Clermont-Ferrand, Puy-de-Dôme, France
Centre Leon Berard, Lyon, Rhône-Alpes, France
Hopitaux Universitaires Paris Centre-Hopital Cochin, Paris, , France
Thoraxklinik-Heidelberg gGmbH, Heidelberg, Baden-Württemberg, Germany
Asklepios Fachkliniken München-Gauting, Gauting, Bayern, Germany
Klinikverbund Kempten-Oberallgäu, Immenstadt, Bayern, Germany
Franziskus-Hospital Harderberg, Georgsmarienhütte, Niedersachsen, Germany
Universitätsmedizin Göttingen, Göttingen, Niedersachsen, Germany
University Hospital of Cologne, Köln, Nordrhein-Westfalen, Germany
LungenClinic Grosshansdorf, Grosshansdorf, Schleswig-Holstein, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin, Berlin, , Germany
Sotiria Thoracic Diseases Hospital of Athens, Athens, Attikí, Greece
University General Hospital of Heraklion, Heraklion, Krítí, Greece
European Interbalkan Medical Center, Thessaloniki, Thessaloníki, Greece
G. Papanikolaou General Hospital, Thessaloniki, Thessaloníki, Greece
Hong Kong United Oncology Centre, Jordan, Kowloon, Hong Kong
Prince of Wales Hospital, Shatin, , Hong Kong
Soroka Medical Center, Beer-Sheva, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Rambam Health Care Campus, Haifa, Ḥeifā, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy
Ospedale Santa Maria delle Croci, Ravenna, Emilia-Romagna, Italy
Cro-Irccs, Aviano, Friuli-Venezia Giulia, Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, Lazio, Italy
Fondazione Policlinico Universitario Agostino Gemelli, Roma, Lazio, Italy
Ospedale San Gerardo-ASST Monza, Monza, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda, Milan, Milano, Italy
Humanitas, Rozzano, Milano, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga, Orbassano, Torino, Italy
Azienda Ospedaliera San Giuseppe Moscati, Avellino, , Italy
IRCCS - AOU di Bologna, Bologna, , Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, , Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Kanagawa cancer center, Yokohama, Kanagawa, Japan
Kindai University Hospital- Osakasayama Campus, Osaka Sayama-shi, Osaka, Japan
Tominaga Hospital, Nagaizumi, Shizuoka, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Japanese Foundation for Cancer Research, Koto, Tokyo, Japan
Tottori University Hospital, Yonago, Tottori, Japan
Okayama University Hospital, Okayama, , Japan
Osaka International Cancer Institute, Osaka, , Japan
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center, Incheon, Korea, Korea, Republic of
Asan Medical Center, Seoul, Korea, Korea, Republic of
Gyeongsang National University Hospital, Jin-ju-si, Kyǒngsangnam-do, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul, Korea, Korea, Republic of
Boramae Medical Center, Dongjak-gu, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Konyang University Hospital, Daejon, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Health Pharma Professional Research S.A. de C.V:, Mexico City, Federal District, Mexico
Actualidad Basada en la Investigación del Cáncer, Guadalajara, Jalisco, Mexico
Oncologico Potosino, S.C., San Luis Potosí, , Mexico
Ziekenhuis St. Jansdal, Harderwijk, Gelderland, Netherlands
Jeroen Bosch ziekenhuis, Den Bosch, Noord-Brabant, Netherlands
Erasmus Medisch Centrum, Rotterdam, Zuid-Holland, Netherlands
Amsterdam UMC, locatie VUmc, Amsterdam, , Netherlands
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Warszawa, , Poland
Institutul Oncologic, Bucharest, București, Romania
Gral Medical Diagnostic Center, Bucuresti, București, Romania
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei, Constanta, Constanța, Romania
Cabinet Medical Oncomed, Timișoara, Timiș, Romania
Spitalul Universitar de Urgență București, Bucuresti, , Romania
Institutul Oncologic, Cluj-Napoca, , Romania
Spitalul Județean Sfântul Ioan cel Nou Suceava, Suceava, , Romania
GBUZ Republican Clinical Oncological Dispensary, Ufa, Baškortostan, Respublika, Russian Federation
Kaluga Regional Clinical Oncology Center, Kaluga, Kalužskaja Oblast, Russian Federation
Murmansk Regional Clinical Hospital P.A. Bayandina, Murmansk, Murmanskaya Oblast', Russian Federation
Samara Regional Clinical Oncology Center, Samara, Samarskaya Oblast', Russian Federation
Scientific research institution of oncology named after N.N. Petrov, Saint Petersburg, Sankt-Peterburg, Russian Federation
Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (oncological) named afte -T, St. Petersburg, Sankt-Peterburg, Russian Federation
Arkhangelsk Clinical Oncological Dispensary, Arkhangelsk, , Russian Federation
Republican Clinical Oncology Dispensary, Kazan, , Russian Federation
First Moscow State Medical University I.M. Sechenov, Moscow, , Russian Federation
Hadassah Medical, Moscow, , Russian Federation
Tan Tock Seng Hospital, Singapore, , Singapore
Hospital Fundacion Son Llatzer, Palma de Mallorca, Baleares, Spain
Institut Català d'Oncologia (ICO) - Badalona, Badalona, Barcelona [Barcelona], Spain
CHUS - Hospital Clinico Universitario, Santiago de Compostela, Galicia [Galicia], Spain
Hospital Insular de Gran Canaria, Las palmas de gran canaria, Las Palmas, Spain
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain
Clinica Universitaria De Navarra, Pamplona, Navarra, Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Parc de Salut Mar - Hospital del Mar, Barcelona, , Spain
Hospital Universitari Dexeus, Barcelona, , Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Complejo Hospitalario de Jaén, Jaén, , Spain
Clinica Universidad de Navarra, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Regional Universitario, Malaga, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Changhua Christian Hospital, Changhua County, Changhua, Taiwan
Buddhist Dalin Tzu Chi General Hospital, Dalin Town, Chiayi, Taiwan
Chang Gung Memorial Hospital - Linkou, Guei Shan Township, Taoyuan County, Taiwan
E-Da hospital, Kaohsiung, , Taiwan
Chang Gung Memorial Hospital at Kaohsiung, Kaohsiung, , Taiwan
Tri-Service General Hospital, Neihu Taipei, , Taiwan
Taipei Medical University Shuang Ho Hospital, New Taipei, , Taiwan
Chung Shan Medical University Hospital, Taichung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
Chi Mei Hospital - Liouying Branch, Tainan City, , Taiwan
National Cheng-Kung Uni. Hosp., Tainan, , Taiwan
National Taiwan University Hospital, Taipei City, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Ege Universitesi Hastanesi, Bornova, İzmir, Turkey
Baskent University Dr. Turgut Noyan Research and Training Center, Adana, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi, Ankara, , Turkey
Hacettepe University Faculty of Medicine, Ankara, , Turkey
Memorial Antalya Hastanesi, Antalya, , Turkey
Dicle Üniversitesi, Diyarbakir, , Turkey
Trakya University, Edirne, , Turkey
Istanbul Medeniyet University, Istanbul, , Turkey
zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi, Izmir, , Turkey
Izmir Medical Park Hospital, Izmir, , Turkey
Inonu Universitesi Turgut Ozal Tıp Merkezi, Malatya, , Turkey
Acıbadem Maslak Hastanesi, Sarıyer, , Turkey
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Medical University", Dnipro, Dnipropetrovska Oblast, Ukraine
CNPE "Regional Center of Oncology", Kharkiv, Kharkivska Oblast, Ukraine
Odessa Regional Oncology Center, Odesa, Odeska Oblast, Ukraine
Sumy regional clinical oncological dispensary, Sumy, Sumska Oblast, Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council", Vinnytsia, Vinnytska Oblast, Ukraine
Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council, Lutsk, Volynska Oblast, Ukraine
"Oncolife" LLC, Zaporizhya, Zaporizka Oblast, Ukraine
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center", Chernivtsi, , Ukraine
Medical Center "Mriya Med-Service", LLC, Kryvyi Rig, , Ukraine
Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City Counci -T, Kyiv, , Ukraine
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council, Odesa, , Ukraine
City Hospital, Nottingham University Hospitals, Nottingham, Nottinghamshire, United Kingdom
Contact Details
Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR
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