Spots Global Cancer Trial Database for A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
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Trial Identification
Brief Title: A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
Official Title: LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC
Study ID: NCT04819100
Conditions
Study Description
Brief Summary: The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Hematology/Oncology - Santa Monica, Los Angeles, California, United States
Stockton Hematology Oncology Group, Stockton, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States
GenesisCare, Aventura, Florida, United States
GenesisCare - Boca Raton, Boca Raton, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic in Rochester, Minnesota, Rochester, Minnesota, United States
USO - New York Oncology Hematology, P.C., Albany, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Sarah Cannon Research Institute SCRI, Nashville, Tennessee, United States
Tennessee Oncology Nashville, Nashville, Tennessee, United States
USO-Texas Oncology-Central/South Texas, Austin, Texas, United States
US Oncology, The Woodlands, Texas, United States
USO-New York Oncology Hematology, P.C, The Woodlands, Texas, United States
Border Medical Oncology, Albury, New South Wales, Australia
Sunshine Coast University Hospital, Birtinya, Queensland, Australia
Rockhampton Hospital, Rockhampton, Queensland, Australia
The Townsville Hospital, Townsville, Queensland, Australia
Ballarat Health Services, Ballarat Central, Victoria, Australia
Bendigo Health Care Group, Bendigo, Victoria, Australia
Goulburn Valley Health, Shepparton, Victoria, Australia
South West Healthcare, Warrnambool, Victoria, Australia
Landeskrankenhaus Feldkirch, Feldkirch, Vorarlberg, Austria
Klinik Floridsdorf, Wien, , Austria
Antwerp University Hospital, Edegem, Antwerpen, Belgium
Cliniques universitaires Saint-Luc, Brussels, Bruxelles-Capitale, Région De, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne, Yvoir, Namur, Belgium
Clinique Saint Pierre, Ottignies, Wallonne, Région, Belgium
AZ Delta vzw, Roeselare, West-Vlaanderen, Belgium
CHU UCL Namur/Site Sainte Elisabeth, Namur, , Belgium
Nucleo de Oncologia da Bahia, Salvador, Bahia, Brazil
Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul, Brasilia, Distrito Federal, Brazil
Centro Avançado de Tratamento Oncológico- CENANTRON, Belo Horizonte, Minas Gerais, Brazil
Centro Oncológico do Triângulo, Uberlândia, Minas Gerais, Brazil
Hospital de Câncer de Recife, Recife, Pernambuco, Brazil
Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital BP, Sao Paulo, São Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR), Sao Paulo, São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, Sao Paulo, São Paulo, Brazil
Grupo COI - Clínicas Oncológicas Integradas, Rio de Janeiro, , Brazil
Centro Paulista de Oncologia Clínica, São Paulo, , Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo, São Paulo, , Brazil
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Beijing Friendship Hospital, Beijing, Beijing, China
Beijing Cancer hospital, Haidian District, Beijing, China
Fujian Provincial Hospital, Fuzhou, Fujian, China
Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiangya Hospital, Central South University, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jilin Cancer Hospital, Changchun, Jilin, China
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army, Xi'an, Shaanxi, China
Jinan Central Hospital, Jinan, Shandong, China
Shanghai Chest Hospital, Shanghai, Shanghai, China
Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China
the Third People's Hospital of Chengdu, Chengdu, Sichuan, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
First Affiliated Hosp of College of Med, Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Masarykuv onkologicky ustav, Brno, Brno-město, Czechia
Nemocnice AGEL Ostrava - Vitkovice a.s, Ostrava, Ostrava Město, Czechia
Fakultni nemocnice Bulovka, Prague, Praha 8, Czechia
Odense Universitetshospital, Odense, Syddanmark, Denmark
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone, Marseille, Bouches-du-Rhône, France
CHU Charles Nicolle, Rouen, Haute-Normandie, France
Centre Chirurgical Marie Lannelongue, Le Plessis-Robinson, Hauts-de-Seine, France
Centre Leon Berard, Lyon CEDEX 08, Rhône-Alpes, France
Hospices Civils de Lyon - Hopital Louis Pradel, Lyon, Rhône, France
Hopitaux Universitaires Paris Centre-Hopital Cochin, Paris, , France
Thoraxklinik-Heidelberg gGmbH, Heidelberg, Baden-Württemberg, Germany
Klinik Löwenstein, Löwenstein, Baden-Württemberg, Germany
Asklepios Fachkliniken München-Gauting, Gauting, Bayern, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen, München, Bayern, Germany
Lungenfachklinik Immenhausen, Immenhausen, Hessen, Germany
Franziskus-Hospital Harderberg, Georgsmarienhütte, Niedersachsen, Germany
KRH, Klinikum Siloah, Hannover, Niedersachsen, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus, Münster, Nordrhein-Westfalen, Germany
LungenClinic Grosshansdorf, Grosshansdorf, Schleswig-Holstein, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin, Berlin, , Germany
Evangelische Lungenklinik Berlin, Berlin, , Germany
Asklepios Klinik Harburg, Hamburg, , Germany
University Hospital of Patras, Patras, Achaḯa, Greece
Agios Savvas Regional Cancer Hospital, Athens, Attikí, Greece
Errikos Dunant Hospital Center, Athens, Attikí, Greece
Sotiria Thoracic Diseases Hospital of Athens, Athens, Attikí, Greece
University General Hospital of Heraklion, Heraklion, Irakleío, Greece
European Interbalkan Medical Center, Thessaloniki, Thessaloníki, Greece
G. Papanikolaou General Hospital, Thessaloniki, Thessaloníki, Greece
Hong Kong United Oncology Centre, Hong Kong, , Hong Kong
Princess Margaret Hospital, Lai Chi Kok, , Hong Kong
Queen Elizabeth Hospital, Yau Ma Tei, , Hong Kong
Rajiv Gandhi Cancer Institute And Research Centre, New Delhi, Delhi, India
Regional Cancer Centre - Thiruvananthapuram, Thiruvananthapuram, Kerala, India
Tata Memorial Hospital, Mumbai, Maharashtra, India
Rashtrasant Tukdoji Regional Cancer Hospital, Nagpur, Maharashtra, India
HCG Manavata Cancer Centre, Nashik, Maharashtra, India
Sheba Medical Center, Ramat Gan, HaMerkaz, Israel
Hadassah Medical Center, Jerusalem, Yerushalayim, Israel
Rambam Health Care Campus, Haifa, Ḥeifā, Israel
ASST Grande Ospedale Metropolitano Niguarda, Milan, Milano, Italy
Humanitas, Rozzano, Milano, Italy
Azienda Ospedaliera Dei Colli, Naples, Napoli, Italy
Instituto Tumori Giovanni Paolo II, Bari, Puglia, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga, Orbassano, Torino, Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Himeji Medical Center, Himeji, Hyogo, Japan
Kanagawa cancer center, Yokohama, Kanagawa, Japan
Tominaga Hospital, Nagaizumi, Shizuoka, Japan
Japanese Foundation for Cancer Research, Koto, Tokyo, Japan
Tottori University Hospital, Yonago, Tottori, Japan
Hiroshima University Hospital, Hiroshima, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, , Japan
Chonnam National University Hwasun Hospital, Hwasun, Jeonranamdo, Korea, Republic of
National Cancer Center, Goyang-si, Kyǒnggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Kyǒnggi-do, Korea, Republic of
Pusan National University Hospital, Busan, Pusan-Kwangyǒkshi, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Asan Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Korea University Guro Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Kyungpook National University Chilgok Hospital, Deagu, Taegu-Kwangyǒkshi, Korea, Republic of
Actualidad Basada en la Investigación del Cáncer, Guadalajara, Jalisco, Mexico
Oncare Viaducto Napoles, Cdmx, México, Mexico
Avix Investigación Clinica, S.C., Monterrey, Nuevo León, Mexico
Hospital Universitario ""Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo León, Mexico
Ziekenhuis St. Jansdal, Harderwijk, Gelderland, Netherlands
Radboudumc, Nijmegen, Gelderland, Netherlands
Oslo Universitetssykehus Ullevål, Oslo, , Norway
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk, Pomorskie, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii, Poznan, Wielkopolskie, Poland
Pan American Center for Oncology Trials, Rio Piedras, , Puerto Rico
Institutul Oncologic, Cluj, , Romania
Arkhangelsk Clinical Oncological Dispensary, Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation
Hadassah Medical, Moscow, Moskva, Russian Federation
First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Sankt-Peterburg, Russian Federation
Scientific research institution of oncology named after N.N. Petrov, Sankt-Peterburg, , Russian Federation
Parkway Cancer Centre - Gleneagles Hospital, Singapore, Central Singapore, Singapore
Tan Tock Seng Hospital, Singapore, Central Singapore, Singapore
CHUS - Hospital Clinico Universitario, Santiago de Compostela, A Coruña [La Coruña], Spain
Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain
Hospital Universitario Puerta del Mar, Cádiz, Andalucía, Spain
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Institut Català d'Oncologia (ICO) - Badalona, Badalona, Barcelona [Barcelona], Spain
Parc de Salut Mar - Hospital del Mar, Barcelona, Barcelona [Barcelona], Spain
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals, L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain
Hospital de Mataró", Mataró, Barcelona [Barcelona], Spain
Complejo Asistencial Universitario de León - Hospital de León, León, Castilla Y León, Spain
Hospital Universitari Dexeusa, Barcelona, Catalunya [Cataluña], Spain
Hospital Clínic de Barcelona, Barcelona, Catalunya [Cataluña], Spain
Hospital Son Llàtzer, Palma, Illes Balears [Islas Baleares], Spain
Hospital Lucus Augusti, Lugo, Lugo [Lugo], Spain
Hospital Universitario Ramón y Cajal, Madrid, Madrid, Comunidad De, Spain
Hospital Universitario 12 de Octubre, Madrid, Madrid, Comunidad De, Spain
Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, Murcia, Región De, Spain
Complexo Hospitalario Universitario de Ourense, Ourense, Ourense [Orense], Spain
CHUVI- Hospital Alvaro Cunqueiro, Pontevedra, Pontevedra [Pontevedra], Spain
Hospital Universitario de Canarias, La Laguna, Santa Cruz De Tenerife, Spain
Hospital Universitari Sant Joan de Reus, Reus, Tarragona [Tarragona], Spain
Hospital General Universitario de Albacete, Albacete, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Regional Universitario, Málaga, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, València, , Spain
Sahlgrenska Universitetssjukhuset, Gothenburg, Västra Götalands Län [se-14], Sweden
Changhua Christian Hospital, Changhua County, Changhua, Taiwan
Chang Gung Memorial Hospital at Kaohsiung, Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Chung Shan Medical University Hospital, Taichung City, Taichung, Taiwan
Chi Mei Hospital - Liouying Branch, Tainan City, Tainan, Taiwan
National Taiwan University Cancer Center (NTUCC), Taipei City, Taipei, Taiwan
Taipei Veterans General Hospital, Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch, Taoyuan, , Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center, Adana, Diyarbakır, Turkey
Ege Universitesi Hastanesi, Bornova, İzmir, Turkey
Izmir Medical Park Hospital, Izmir, Karsiyaka, İzmir, Turkey
Adana City Hospital, Adana, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi, Ankara, , Turkey
Ankara Bilkent Şehir Hastanesi, Ankara, , Turkey
Memorial Antalya Hospital, Antalya, , Turkey
Uludag Universitesi, Bursa, , Turkey
Dicle Üniversitesi, Diyarbakir, , Turkey
Trakya University, Edirne, , Turkey
Medipol Mega Universite Hastanesi, Istanbul, , Turkey
Acıbadem Maslak Hastanesi, İstanbul, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul, , Turkey
Izmir Katip Celebi Universitesi Ataturk Egitim Ve Arastrma Hastanesi, Izmir, , Turkey
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma, Malatya, , Turkey
Sumy regional clinical oncological dispensary, Sumy, Sumska Oblast, Ukraine
Chelsea and Westminster Hospital NHS Foundation Trust, London, England, United Kingdom
Royal Brompton Hospital, London, Kensington And Chelsea, United Kingdom
University College London Hospital, London, London, City Of, United Kingdom
City Hospital, Nottingham University Hospitals, Nottingham, , United Kingdom
New Cross Hospital, Wolverhampton, , 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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