Клинические исследование Carcinoma, Non-Small-Cell Lung: Selpercatinib, Placebo

Спонсоры	Ведущий спонсор: Loxo Oncology, Inc. Коллаборационист: Eli Lilly and Company
Источник	Eli Lilly and Company
Краткое содержание	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.

Спонсоры

Ведущий спонсор: Loxo Oncology, Inc.

Коллаборационист: Eli Lilly and Company

Источник

Eli Lilly and Company

Краткое содержание

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.

Общий статус

Recruiting

Дата начала

2021-12-20

Дата завершения

2032-11-30

Дата первичного завершения

2028-08-31

Фаза

Phase 3

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Event-Free Survival (EFS)	Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)

Вторичный результат

Мера	Временное ограничение
EFS	Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Overall Survival (OS)	Randomization to death from any cause (estimated as up to 9 years)]
EFS	Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]
Time to Distant Disease Recurrence in the Central Nervous System (CNS)	Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Progression Free Survival on the Next Line of Treatment (PFS2)	Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)
Positive Predictive Value (PPV) of Local Lab Tests Compared to Central Lab Test to Detect Rearranged during Transfection (RET) Gene Fusion	Baseline
Mean Change from Baseline over Time in NSCLC Symptoms	Baseline to treatment discontinuation (estimated as up to 3 years)
Mean Change from Baseline over Time in Physical Function	Baseline to treatment discontinuation (estimated as up to 3 years)

Регистрация

170

Состояние	Carcinoma, Non-Small-Cell Lung
Вмешательство	Тип вмешательства: Drug Название вмешательства: Selpercatinib Описание: Administered orally. Этикетка Arm Group: Selpercatinib Тип вмешательства: Drug Название вмешательства: Placebo Описание: Administered orally. Этикетка Arm Group: Placebo
Приемлемость	Критерии: Inclusion Criteria: - Must have histologically confirmed Stage IB, II, or IIIA NSCLC. - Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR) or next generation sequencing (NGS). - Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC. -- Must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion. - Must have completely recovered from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy at the time of randomization. - Maximum time allowed between definitive therapy completion and randomization must be: - 10 weeks if no chemotherapy was administered - 26 weeks if adjuvant chemotherapy was administered - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - Adequate hematologic, hepatic, and renal function. - Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of the study and for at least 2 weeks after last dose of study drug. Exclusion Criteria: - Additional oncogenic drivers in NSCLC, if known. - Evidence of small cell lung cancer. - Clinical or radiologic evidence of disease recurrence or progression following definitive therapy. - Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids. - Clinically significant active cardiovascular disease or history of myocardial infarction within six months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than 470 milliseconds. - Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection. - Have known active hepatitis B or C. - Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. - Major surgery within 4 weeks prior to planned start of selpercatinib. - Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug. - Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed greater than or equal to two years previously and not currently active. - Pregnancy or lactation. - Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib). Пол: All Минимальный возраст: 18 Years Максимальный возраст: N/A Здоровые волонтеры: No

Состояние

Carcinoma, Non-Small-Cell Lung

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Selpercatinib

Описание: Administered orally.

Этикетка Arm Group: Selpercatinib

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Administered orally.

Этикетка Arm Group: Placebo

Приемлемость

Критерии:

Inclusion Criteria: - Must have histologically confirmed Stage IB, II, or IIIA NSCLC. - Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR) or next generation sequencing (NGS). - Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC. -- Must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion. - Must have completely recovered from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy at the time of randomization. - Maximum time allowed between definitive therapy completion and randomization must be: - 10 weeks if no chemotherapy was administered - 26 weeks if adjuvant chemotherapy was administered - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - Adequate hematologic, hepatic, and renal function. - Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of the study and for at least 2 weeks after last dose of study drug. Exclusion Criteria: - Additional oncogenic drivers in NSCLC, if known. - Evidence of small cell lung cancer. - Clinical or radiologic evidence of disease recurrence or progression following definitive therapy. - Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids. - Clinically significant active cardiovascular disease or history of myocardial infarction within six months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than 470 milliseconds. - Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection. - Have known active hepatitis B or C. - Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. - Major surgery within 4 weeks prior to planned start of selpercatinib. - Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug. - Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed greater than or equal to two years previously and not currently active. - Pregnancy or lactation. - Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

N/A

Здоровые волонтеры:

Общий Официальный

Фамилия	Роль	Присоединение
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)	Study Director	Eli Lilly and Company

Общий контакт

Фамилия: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Телефон: 1-317-615-4559

Расположение

Объект:	Положение дел:	Контакт:	Исследователь:
UCLA Hematology Oncology \| Santa Monica, California, 90404, United States	Not yet recruiting	310-633-8400	Jonathan W Goldman Principal Investigator
Stockton Hematology Oncology Medical Group \| Stockton, California, 95204, United States	Recruiting	209-466-2626	Chunhui Fang Principal Investigator
UCLA Medical Center \| Torrance, California, 90502, United States	Recruiting	310-306-8223	Mykola Onyshchenko Principal Investigator
GenesisCare \| Aventura, Florida, 33180, United States	Not yet recruiting	561-409-1767	Edgardo S Santos Principal Investigator
GenesisCare - Boca Raton \| Boca Raton, Florida, 33431, United States	Not yet recruiting	561-409-1767	Edgardo S Santos Principal Investigator
Florida Cancer Specialists \| Fort Myers, Florida, 33901, United States	Recruiting	239-938-0888	Lowell L Hart Principal Investigator
Mayo Clinic in Florida \| Jacksonville, Florida, 32224, United States	Not yet recruiting	904-953-2000	Yanyan Lou Principal Investigator
Florida Cancer Specialists \| Saint Petersburg, Florida, 33705, United States	Recruiting	727-216-1143	Maen A Hussein Principal Investigator
Beth Israel Deaconess Medical Center \| Boston, Massachusetts, 02215, United States	Not yet recruiting	617-667-9236	Daniel Costa Principal Investigator
Dana-Farber Cancer Institute \| Boston, Massachusetts, 02215, United States	Recruiting	617-632-6190	Jacob Sands Principal Investigator
Mayo Clinic \| Rochester, Minnesota, 55905, United States	Not yet recruiting	5072660911	K Robert Shen Principal Investigator
New York Oncology Hematology, P.C \| Clifton Park, New York, 12065, United States	Recruiting	518-262-6696	Makenzi C Evangelist Principal Investigator
Memorial Sloan Kettering Cancer Center \| New York, New York, 10021, United States	Recruiting	646-449-1772	Alexander Drilon Principal Investigator
Sarah Cannon Research Institute SCRI \| Nashville, Tennessee, 37203, United States	Not yet recruiting	615-329-7274	SMO Sarah Cannon Research Inst. Principal Investigator
Tennessee Oncology PLLC \| Nashville, Tennessee, 37203, United States	Recruiting	615-524-4525	Melissa L Johnson Principal Investigator
US Oncology \| The Woodlands, Texas, 77380, United States	Not yet recruiting	281-863-1000	SMO US Oncology Principal Investigator
University of Vermont Medical Center \| Burlington, Vermont, 05405, United States	Not yet recruiting	802-847-8400	Hibba Rehman Principal Investigator
Border Medical Oncology \| Albury, New South Wales, 2640, Australia	Recruiting	61260515300	Craig R Underhill Principal Investigator
Sunshine Coast University Hospital \| Birtinya, Queensland, 4575, Australia	Not yet recruiting	61752020000	Bryan Chan Principal Investigator
The Townsville Hospital \| Douglas, Queensland, 4814, Australia	Not yet recruiting	61744331671	Abhishek Joshi Principal Investigator
Rockhampton Hospital \| Rockhampton, Queensland, 4700, Australia	Not yet recruiting	61749206211	Sudhakar Vemula Principal Investigator
Ballarat Health Services \| Ballarat, Victoria, 3350, Australia	Recruiting	61353208529	Wasek Faisal Principal Investigator
Bendigo Health \| Bendigo, Victoria, 3550, Australia	Recruiting	61354548815	Sam Harris Principal Investigator
Goulburn Valley Health \| Shepparton, Victoria, 3630, Australia	Recruiting	61358323777	Javier Torres Principal Investigator
South West Healthcare \| Warrambool, Victoria, 3280, Australia	Recruiting	61355634211	Ian Collins Principal Investigator
Landeskrankenhaus Feldkirch \| Feldkirch, 6800, Austria	Recruiting	4355223030	Thomas Winder Principal Investigator
Klinik Floridsdorf - Abteilung für INNERE MEDIZIN UND PNEUMOLOGIE \| Wien, 1210, Austria	Recruiting	431277003855	Maximilian Johannes Hochmair Principal Investigator
Cliniques Universitaires Saint-Luc \| Bruxelles, Brussel, 1200, Belgium	Not yet recruiting	3227642832	Thierry Pieters Principal Investigator
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne \| Yvoir, Namur, 5530, Belgium	Not yet recruiting	3281423374	Sebahat Oçak Principal Investigator
Universitair Ziekenhuis Antwerpen \| Edegem, 2650, Belgium	Not yet recruiting	3238214719	Annelies Janssens Principal Investigator
Clinique Saint Pierre Ottignies \| Ottignies, 1340, Belgium	Not yet recruiting	3210437347	Luciano Carestia Principal Investigator
Núcleo de Oncologia da Bahia \| Salvador, Bahia, 41170-110, Brazil	Not yet recruiting	557140097085	Tercia Vilasboas Reis Principal Investigator
Oncocentro BH \| Belo Horizonte, Minas Gerais, 30260-680, Brazil	Not yet recruiting	553121268600	Flavia Amaral Duarte Principal Investigator
COT - Centro Oncológico do Triângulo S.A. \| Uberlândia, Minas Gerais, 38408-150, Brazil	Not yet recruiting	Fernando Maciel Barbosa Principal Investigator
Multihemo Servicos Medicos S/A \| Recife, Pernambuco, 500070-460, Brazil	Not yet recruiting	558132050505	Marcelo Ramos Tejo Salgado Principal Investigator
Hospital São Lucas da PUCRS \| Porto Alegre, Rio Grande Do Sul, 90610-000, Brazil	Not yet recruiting	555133203039	Ana Caroline Zimmer Gelatti Principal Investigator
Grupo COI - Clínicas Oncológicas Integradas \| Rio de Janeiro, RJ, 22793-080, Brazil	Not yet recruiting	552133852088	Luiz Henrique de Lima Araujo Principal Investigator
IBCC - Instituto Brasileiro de Controle do Câncer \| São Paulo, 04014-002, Brazil	Not yet recruiting	551134744222	Larissa Carvalho Lopes de Paula Principal Investigator
Centro Paulista de Oncologia \| São Paulo, 04538-133, Brazil	Not yet recruiting	551130675433	Andrey Soares Principal Investigator
Princess Margaret Hospital \| Toronto, Ontario, M5G 2M9, Canada	Not yet recruiting	4169464645	Penelope Bradbury Principal Investigator
Beijing Friendship Hospital \| Beijing, Beijing, 100050, China	Recruiting	13910761058	Mu Hu Principal Investigator
Beijing Cancer hospital \| Haidian District, Beijing, 100142, China	Recruiting	Yue Yang Principal Investigator
The First Affiliated Hospital Chongqing Medical University \| Chongqing, Chongqing, 400016, China	Not yet recruiting	862389012890	Yuxi Zhu Principal Investigator
Fujian Provincial Hospital \| Fuzhou, Fujian, 350001, China	Not yet recruiting	pan xiaojie Principal Investigator
Guangdong Provincial People's Hospital \| Guangzhou, Guangdong, 510080, China	Not yet recruiting	Xuening Yang Principal Investigator
Southern Medical University Nanfang Hospital \| Guangzhou, Guangdong, 510515, China	Not yet recruiting	020 61641888	Kaican Cai Principal Investigator
Harbin Medical University Cancer Hospital \| Harbin, Heilongjiang, 150081, China	Not yet recruiting	Yan Yu Principal Investigator
Tongji Medical College of Huazhong University of Science and Technology \| Wuhan, Hubei, 430022, China	Recruiting	027-85726114	Yongde Liao Principal Investigator
Xiangya Hospital, Central South University \| Changsha, Hunan, 410008, China	Not yet recruiting	Chunfang Zhang Principal Investigator
Hunan Cancer Hospital \| Changsha, Hunan, 410013, China	Not yet recruiting	Lin Wu Principal Investigator
Hunan Cancer Hospital \| Changsha, Hunan, 410013, China	Not yet recruiting	Wenxiang Wang Principal Investigator
Jilin Cancer Hospital \| Changchun, Jilin, 130000, China	Not yet recruiting	Ying Cheng Principal Investigator
Jinan Central Hospital \| Jinan, Shandong, 250013, China	Not yet recruiting	13370582181	Meili Sun Principal Investigator
Shanghai Chest Hospital \| Shanghai, Shanghai, 200030, China	Not yet recruiting	862162821990	Wentao Fang Principal Investigator
Zhongshan Hospital, Fudan University \| Shanghai, Shanghai, 200032, China	Not yet recruiting	Qun Wang Principal Investigator
Shanghai Pulmonary Hospital \| Shanghai, Shanghai, 200433, China	Not yet recruiting	2602165115006	Yuming Zhu Principal Investigator
Tang Du Hospital, The Second Teaching Hospital of FMMU \| Xi'an, Shanxi, 710038, China	Not yet recruiting	Tao Jiang Principal Investigator
the Third People's Hospital of Chengdu \| Chengdu, Sichuan, 610031, China	Not yet recruiting	Guoping Li Principal Investigator
West China Hospital of Sichuan University \| Chengdu, Sichuan, 610041, China	Not yet recruiting	Ke Wang Principal Investigator
First Affiliated Hosp of College of Med, Zhejiang University \| Hangzhou, Zhejiang, 310003, China	Not yet recruiting	Jianying Zhou Principal Investigator
Zhejiang Cancer Hospital \| Hangzhou, Zhejiang, China	Not yet recruiting	3858182310	Qixun Chen Principal Investigator
Beijing Peking Union Medical College Hospital \| Beijing, 100730, China	Not yet recruiting	861065296571	Shanqing Li Principal Investigator
Masarykuv onkologicky ustav \| Brno, Czech Republic, 656 53, Czechia	Recruiting	420543136226	Ondrej Bilek Principal Investigator
Nemocnice AGEL Ostrava-Vitkovice a.s.-Plicni oddeleni \| Ostrava - Vitkovice, 70384, Czechia	Recruiting	420595633400	JAROMIR ROUBEC Principal Investigator
Fakultni nemocnice Bulovka \| Praha 8, 180 81, Czechia	Recruiting	00420266082267	Jana Krejci Principal Investigator
Odense Universitetshospital \| Odense C, Syd, 5000, Denmark	Recruiting	4565412990	Karin Holmskov Hansen Principal Investigator
HCL-Hôpital Louis Pradel \| Lyon (Bron), 69677, France	Recruiting	0427857700	Michael Duruisseaux Principal Investigator
Centre Leon Berard \| Lyon Cedex 08, 69373, France	Not yet recruiting	33426556842	Maurice Perol Principal Investigator
Assistance Publique Hôpitaux de Marseille - Hôpital Nord \| Marseille Cedex 20, 13915, France	Recruiting	33491965903	Pascale Tomasini Principal Investigator
Hopital Cochin \| Paris, 75014, France	Recruiting	33158411889	Marie Wislez Principal Investigator
CHU Charles Nicolle in Rouen \| Rouen cedex, 76036, France	Recruiting	33232888247	Florian Guisier Principal Investigator
Gustave Roussy \| Villejuif Cedex, 94805, France	Recruiting	33142114157	Benjamin Besse Principal Investigator
Thoraxklinik-Heidelberg gGmbH \| Heidelberg, Baden-Württemberg, 69126, Germany	Not yet recruiting	4962213968304	Helge Bischoff Principal Investigator
Asklepios Fachkliniken München-Gauting \| Gauting, Bayern, 82131, Germany	Recruiting	4989857914111	Niels Reinmuth Principal Investigator
Lungenfachklinik Immenhausen \| Immenhausen, Hessen, 34376, Germany	Recruiting	495673501436	Achim Rittmeyer Principal Investigator
Franziskus-Hospital Harderberg \| Georgsmarienhütte, Lower Saxony, 49124, Germany	Recruiting	495415022466	Petra Hoffknecht Principal Investigator
LungenClinic Grosshansdorf \| Grosshansdorf, Schleswig-Holstein, 22927, Germany	Recruiting	4941026012101	Martin Reck Principal Investigator
Charité-Campus Benjamin Franklin-Hematology and Oncology \| Berlin, 12203, Germany	Recruiting	004930450513382	Damian Tobias Rieke Principal Investigator
University Hospital of Patras \| Patras, Achaḯa, 26504, Greece	Not yet recruiting	302610999791	Angelos Koutras Principal Investigator
Agios Savvas Regional Cancer Hospital \| Athens, Attikí, 115 22, Greece	Recruiting	302106409638	Stamatina Demiri Principal Investigator
Sotiria Thoracic Diseases Hospital of Athens \| Athens, Attikí, 11527, Greece	Recruiting	302107475034	Konstantinos N Syrigos Principal Investigator
University General Hospital of Heraklion \| Heraklion, Krete, 71110, Greece	Recruiting	302810392438	Dimitrios Mavroudis Principal Investigator
European Interbalkan Medical Center \| Thessaloniki, Thessaloníki, 570 01, Greece	Not yet recruiting	302310400368	Sofia Baka Principal Investigator
G. Papanikolaou General Hospital \| Thessaloniki, Thessaloníki, 570 10, Greece	Not yet recruiting	302313307251	THEODOROS KONTAKIOTIS Principal Investigator
Princess Margaret Hospital \| Lai Chi Kok, Kowloon, Hong Kong	Recruiting	85229902393	Ashley C Cheng Principal Investigator
Queen Elizabeth Hospital \| Hong Kong, Hong Kong	Recruiting	85235062851	Lee Tin-Yan Principal Investigator
Hong Kong United Oncology Centre \| Kowloon, 518000, Hong Kong	Recruiting	85223868002	Yu Chung Li Principal Investigator
Regional Cancer Centre \| Thiruvananthapuram, Kerala, 695011, India	Not yet recruiting	9249554405	Arun Sankar Principal Investigator
Tata Memorial Hospital \| Mumbai, Maharashtra, 400012, India	Not yet recruiting	2224177000	Amit Joshi Principal Investigator
Rashtrasant Tukdoji Regional Cancer Hospital and Research Centre (RSTRCH) \| Nagpur, Maharashtra, 440027, India	Not yet recruiting	917122744441	Kartar Singh Principal Investigator
HCG Manavata Cancer Centre \| Nashik, Maharashtra, 422001, India	Not yet recruiting	02532592666	Rajnish Nagarkar Principal Investigator
Rambam Medical Center \| Haifa, 3109601, Israel	Not yet recruiting	97247776750	Mirjana Wollner Principal Investigator
Hadassah Medical Center \| Jerusalem, 9112001, Israel	Recruiting	97226778636	Hovav Nechushtan Principal Investigator
Sheba Medical Center \| Ramat Gan, 5265601, Israel	Recruiting	97235307096	Jair Bar Principal Investigator
ASST Grande Ospedale Metropolitano Niguarda \| Milan, Milano, 20162, Italy	Recruiting	390264444044	Diego Signorelli Principal Investigator
Istituto Clinico Humanitas \| Rozzano, Milano, 20089, Italy	Recruiting	390282245945	Luca Toschi Principal Investigator
Azienda Sanitaria Ospedaliera S Luigi Gonzaga \| Orbassano, Torino, 10043, Italy	Recruiting	390119026539	Silvia Novello Principal Investigator
IRCCS Ospedale Oncologico di Bari \| Bari, 70124, Italy	Not yet recruiting	390805555418	Domenico Galetta Principal Investigator
Ospedale V. Monaldi \| Napoli, 80131, Italy	Recruiting	390817064300	Danilo Rocco Principal Investigator
Istituto Oncologico Veneto IRCCS \| Padova, 35128, Italy	Not yet recruiting	390498215931	Giulia Pasello Principal Investigator
Aichi Cancer Center Hospital \| Nagoya, Aichi, 464-8681, Japan	Not yet recruiting	81120023812	Yuko Oya Principal Investigator
National Cancer Center Hospital East \| Kashiwa, Chiba, 277-8577, Japan	Recruiting	81120023812	Masahiro Tsuboi Principal Investigator
Himeji Medical Center \| Himeji, Hyogo, 670-8520, Japan	Not yet recruiting	81120023812	Tetsuji Kawamura Principal Investigator
Kanagawa cancer center \| Yokohama, Kanagawa, 241-8515, Japan	Not yet recruiting	81120023812	Terufumi Kato Principal Investigator
Niigata Cancer Center Hospital \| Niigata-shi, Niigata, 951-8566, Japan	Recruiting	81120023812	Hiroshi Tanaka Principal Investigator
Kinki University Hospital \| Osaka-Sayama, Osaka, 589-8511, Japan	Not yet recruiting	81120023812	Tetsuya Mitsudomi Principal Investigator
Shizuoka Cancer Center \| Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777, Japan	Recruiting	81120023812	Hirotsugu Kenmotsu Principal Investigator
Juntendo University Hospital \| Bunkyo-ku, Tokyo, 113-8431, Japan	Not yet recruiting	81120023812	Kazuhisa Takahashi Principal Investigator
Japanese Foundation for Cancer Research \| Koto, Tokyo, 135-8550, Japan	Not yet recruiting	81120023812	Noriko Yanagitani Principal Investigator
Tottori University Hospital \| Yonago, Tottori, 683-8504, Japan	Recruiting	81120023812	Tomohiro Sakamoto Principal Investigator
Hiroshima University Hospital \| Hiroshima, 734-8551, Japan	Not yet recruiting	81120023812	Morihito Okada Principal Investigator
Osaka International Cancer Institute \| Osaka, 541-8567, Japan	Not yet recruiting	81120023812	Jiro Okami Principal Investigator
National Cancer Center \| Goyang-si, Gyeonggi-do, 10408, Korea, Republic of	Recruiting	82319201154	Ji-Youn Han Principal Investigator
Seoul National University Bundang Hospital \| Seongnam-si, Gyeonggi-do, 13620, Korea, Republic of	Recruiting	82317877041	Yu Jung Kim Principal Investigator
Chonnam National University Hwasun Hospital \| Hwasun-gun, Jeollanam Do, 58128, Korea, Republic of	Recruiting	82613797617	In Jae Oh Principal Investigator
Asan Medical Center \| Seoul, Korea, 05505, Korea, Republic of	Recruiting	82230105902	Chang-Min Choi Principal Investigator
Korea University Guro Hospital \| Seoul, Korea, 08308, Korea, Republic of	Recruiting	82226263030	Sung Yong Lee Principal Investigator
Seoul National University Hospital \| Seoul, Seoul, Korea, 03080, Korea, Republic of	Recruiting	82220722995	Dong-Wan Kim Principal Investigator
Kyungpook National University Medical Center Chilgok Hospital \| Daegu, 41404, Korea, Republic of	Recruiting	82532002632	Shin Yup Lee Principal Investigator
Severance Hospital, Yonsei University Health System \| Seoul, 03722, Korea, Republic of	Recruiting	82222288125	Hye Ryun Kim Principal Investigator
Samsung Medical Center \| Seoul, 06351, Korea, Republic of	Recruiting	82234101132	Se Hoon Lee Principal Investigator
Actualidad Basada en la Investigación del Cáncer \| Guadalajara, Jalisco, 44680, Mexico	Recruiting	3313141707	Emmanuel de la Mora Jiménez Principal Investigator
ONCARE Viaducto Nápoles \| Delegación Benito Juárez, Mexico City, Federal District, 03810, Mexico	Recruiting	525524846681	Jeronimo Rafael Rodriguez Cid Principal Investigator
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" \| Monterrey, Nuevo León, 64460, Mexico	Recruiting	8183338111	Victor Manuel Oyervides Juárez Principal Investigator
Avix Investigación Clinica, S.C. \| Monterrey, Nuevo León, 64710, Mexico	Recruiting	528181431112	Julia Angelina Sáenz Frías Principal Investigator
Ziekenhuis St. Jansdal \| Harderwijk, Gelderland, 3844 DG, Netherlands	Recruiting	31341463743	Steven J Gans Principal Investigator
Universitair Medisch Centrum St Radboud Nijmegen \| Nijmegen, 6525 GA, Netherlands	Recruiting	31243610325	Michel van den Heuvel Principal Investigator
Krakowski Szpital Specjalistyczny im. Jana Pawa II \| Krakow, Małopolskie, 30-002, Poland	Recruiting	48126142028	Jaroslaw Kuzdzal Principal Investigator
Uniwersyteckie Centrum Kliniczne \| Gdansk, 80-214, Poland	Not yet recruiting	48585844569	Anna Wrona Principal Investigator
Wojewodzki Zespol Specjalistyczny Chorob Pluc \| Poznan, 60-569, Poland	Not yet recruiting	616654200	Maciej Bryl Principal Investigator
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy \| Warszawa, 02-781, Poland	Not yet recruiting	48225462739	Adam Pluzanski Principal Investigator
Pan American Center for Oncology Trials, LLC \| Rio Piedras, 00935, Puerto Rico	Recruiting	7874073333	Noridza Rivera Principal Investigator
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca \| Cluj-Napoca, 400015, Romania	Recruiting	40745646368	Tudor Ciuleanu Principal Investigator
Arkhangelsk Clinical Oncological Dispensary \| Arkhangelsk, Arkhangel'skaya Oblast', 163045, Russian Federation	Recruiting	88182275774	Ekaterina Petrovna Solovyeva Principal Investigator
Hadassah Medical LTD \| Moscow, 121205, Russian Federation	Recruiting	74958001000	Maria Kazantseva Principal Investigator
National medical research center of oncology n. a. N. N. Petrov \| Saint Petersburg, 197758, Russian Federation	Recruiting	781243995551505	Evgeny Levchenko Principal Investigator
EuroCityClinic \| Saint-Petersburg, 197022, Russian Federation	Recruiting	78126180800	Sergey Orlov Principal Investigator
Parkway Cancer Centre \| Singapore, 258499, Singapore	Recruiting	6564720800	Chin Tan Min Principal Investigator
Tan Tock Seng Hospital \| Singapore, 308433, Singapore	Not yet recruiting	6562566011	Chia Puey Ling Principal Investigator
CHUS - Hospital Clinico Universitario \| Santiago de Compostela, A Coruña [La Coruña], 15706, Spain	Recruiting	981950511	Luis León Mateos Principal Investigator
Hospital Universitario Central de Asturias \| Oviedo, Asturias, 33011, Spain	Recruiting	34985106121	Emilio Esteban González Principal Investigator
Hospital de Mataró \| Mataró, Barcelona, 08304, Spain	Recruiting	34937417700	Laura Puntí Brun Principal Investigator
Hospital Universitario Virgen de la Arrixaca \| El Palmar, Murcia, 30120, Spain	Recruiting	34659007870	Jose L Alonso Romero Principal Investigator
Hospital Álvaro Cunqueiro \| Vigo, Pontevedra, 36212, Spain	Recruiting	34986825801	MARTIN LAZARO QUINTELA Principal Investigator
Hospital Universitario de Canarias \| Santa Cruz de Tenerife, Tenerife, 38320, Spain	Not yet recruiting	34922678000	Juana Oramas Rodriguez Principal Investigator
Hospital General de Albacete \| Albacete, 02066, Spain	Recruiting	34967239857	Lorenzo Gomez Aldaravi Principal Investigator
Hospital Germans Trias i Pujol \| Badalona, 08916, Spain	Recruiting	34934978925	Teresa Moran Bueno Principal Investigator
Hospital del Mar \| Barcelona, 08003, Spain	Recruiting	34932483117	Edurne Arriola Aperribay Principal Investigator
Hospital Universitari Dexeusa \| Barcelona, 08028, Spain	Recruiting	34935460143	Alejandro Martínez Bueno Principal Investigator
Hospital Universitari Vall d'Hebron \| Barcelona, 08035, Spain	Recruiting	34934894374	Alex Martinez Marti Principal Investigator
Hospital Clinic I Provincial \| Barcelona, 08036, Spain	Recruiting	0034663701518380748	Noemi Reguart Principal Investigator
Institut Catala d'Oncologia \| Barcelona, 08908, Spain	Recruiting	34932607744	Ernest Nadal Alforja Principal Investigator
Hospital Universitario Puerta del Mar \| Cadiz, 11009, Spain	Recruiting	34956002100	Esperanza Arriola Arellano Principal Investigator
Hospital Reina Sofia \| Cordoba, 14004, Spain	Recruiting	34957010000	Isidoro Barneto Aranda Principal Investigator
Complejo Asistencial de Leon \| Leon, 24071, Spain	Recruiting	34987237400	Pilar Diz Taín Principal Investigator
Hospital Lucus Augusti \| Lugo, 27003, Spain	Recruiting	34982296000	Sergio Vazquez Estevez Principal Investigator
MD Anderson \| Madrid, 28033, Spain	Recruiting	34917878600	Isabel Burgueño Lorenzo Principal Investigator
Hospital Universitario Ramón y Cajal \| Madrid, 28034, Spain	Recruiting	34913368302	Pilar Garrido Lopez Principal Investigator
Hospital Clinico San Carlos \| Madrid, 28040, Spain	Recruiting	34913303649	Mónica Antoñanzas Basa Principal Investigator
Hospital Universitario 12 de Octubre \| Madrid, 28041, Spain	Recruiting	34913908626	Luis Paz-Ares Rodriguez Principal Investigator
Hospital Regional Universitario \| Malaga, 29010, Spain	Recruiting	34951030543	Manuel Cobo Dols Principal Investigator
Hospital Santa Maria Nai \| Ourense, 15009, Spain	Recruiting	34988385471	José Luis Firvida Pérez Principal Investigator
Hospital Son Llàtzer-ONCOLOGY \| Palma de Mallorca, 07198, Spain	Recruiting	8712020001535	Francisco García Navalón Principal Investigator
Hospital Univ Sant Joan de Reus, S.A. \| Reus, 43204, Spain	Recruiting	3497731030055740	Clara Lucía Gozálvez Principal Investigator
Hospital Universitario Virgen Macarena \| Sevilla, 41009, Spain	Recruiting	34955008932	David Vicente Baz Principal Investigator
Hospital Universitario La Fe de Valencia \| Valencia, 46026, Spain	Recruiting	961245877	Oscar Juan Vidal Principal Investigator
Sahlgrenska Universitetssjukhuset \| Göteborg, 41345, Sweden	Recruiting	46700906097	Andreas Hallqvist Principal Investigator
Changhua Christian Hospital \| Changhua City, Changhua County, 50006, Taiwan	Recruiting	88647238595 ext 7791	Sheng-Hao Lin Principal Investigator
Chi Mei Hospital - Liouying Branch \| Tainan City, Tainan, 73657, Taiwan	Recruiting	8866622699973132	Yen-Hsun Chen Principal Investigator
Kaohsiung Medical University Hospital \| Kaohsiung, 80756, Taiwan	Recruiting	88673121101 ext. 5102	Inn-Wen Chong Principal Investigator
Chang Gung Memorial Hospital - Kaohsiung Branch \| Kaohsiung, 83301, Taiwan	Recruiting	886773171232644	Huang-Chih Chang Principal Investigator
Chung Shan Medical University Hospital \| Taichung, 402, Taiwan	Recruiting	88642473959534412	Gee-Chen Chang Principal Investigator
Taichung Veterans General Hospital \| Taichung, 40705, ROC, Taiwan	Recruiting	886423592525 ext. 3219	Tsung-Ying Yang Principal Investigator
National Taiwan University Cancer Centre \| Taipei City, 10048, Taiwan	Not yet recruiting	88623123456	Chih-Hsin Yang Principal Investigator
National Taiwan University Hospital \| Taipei City, 10048, Taiwan	Not yet recruiting	88623123456 ext. 67511	Chih-Hsin Yang Principal Investigator
Taipei Veterans General Hospital \| Taipei, 11217, Taiwan	Recruiting	886228757465	Yuh-Min Chen Principal Investigator
Chang Gung Memorial Hospital - Linkou \| Taoyuan City, 333, Taiwan	Recruiting	88633281200 ext. 2285	Cheng-Ta Yang Principal Investigator
Izmir Medical Park Hospital \| Izmir, Karşıyaka/İzmir, 35575, Turkey	Recruiting	02323995050	Cagatay Arslan Principal Investigator
Baskent University Dr. Turgut Noyan Research and Training Center \| Adana, 01250, Turkey	Recruiting	903223444444	Ozgur Ozyilkan Principal Investigator
Adana Sehir Hastanesi \| Adana, 4522, Turkey	Recruiting	905331447619	Timucin Cil Principal Investigator
Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital \| Ankara, 06200, Turkey	Recruiting	903123360909	Berna Oksuzoglu Principal Investigator
Ankara City Hospital \| Ankara, 06800, Turkey	Recruiting	903123241555	Mehmet Ali Nahit Sendur Principal Investigator
Uludag University Medical Faculty \| Bursa, 16059, Turkey	Recruiting	905336460546	Turkkan Evrensel Principal Investigator
Dicle University \| Diyarbakir, 21280, Turkey	Recruiting	905337677131	Muhammet Ali Kaplan Principal Investigator
Trakya University \| Edirne, 22030, Turkey	Recruiting	905322480988	Irfan Cicin Principal Investigator
Medipol Mega University Hospital \| Istanbul, 34214, Turkey	Recruiting	905053195935	Omer Fatih Olmez Principal Investigator
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi \| Istanbul, 34722, Turkey	Recruiting	902166065200	Mahmut Gumus Principal Investigator
Ege University Medicine of Faculty \| Izmir, 35100, Turkey	Recruiting	902323902468	Tuncay Goksel Principal Investigator
Izmir Katip Celebi University Training and Research Hospital Oncology \| Izmir, 35360, Turkey	Recruiting	905324078648	Ahmet Alacacioglu Principal Investigator
Memorial Antalya Hastanesi \| Kepez, 07020, Turkey	Recruiting	905076397700	Seyda Gunduz Principal Investigator
Inonu University Medical Faculty Oncology \| Malatya, 44280, Turkey	Recruiting	905326441884	Hakan Harputluoglu Principal Investigator
Maslak Acıbadem Hstanesi \| Sarıyer, 34457, Turkey	Recruiting	905062979770	Atakan Demir Principal Investigator
CNPE "Regional Center of Oncology" \| Kharkiv, Kharkivska Oblast, 61070, Ukraine	Recruiting	380573151248	Oleh Kobziev Principal Investigator
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" \| Vinnytsia, Vinnytska Oblast, 21029, Ukraine	Not yet recruiting	380432464635	Sergii Shevnya Principal Investigator
Medical Center "Mriya Med-Service", LLC \| Kryvyi Rig, 50019, Ukraine	Recruiting	380986274883	Maksym Viguro Principal Investigator
Kyiv City Clinical Oncological Center \| Kyiv, 03115, Ukraine	Recruiting	380444240114	Olga Ponomarova Principal Investigator
Communal Enterprise "Odesa Regional Clinical Hospital" \| Odesa, 65117, Ukraine	Recruiting	380972147211	Oleksandr Berzoy Principal Investigator
University clinic of Sumy State University \| Sumy, 40000, Ukraine	Recruiting	380542781306	Oleksandr I. Vynnychenko Principal Investigator
Medical center "Oncolife" \| Zaporizhya, 69000, Ukraine	Recruiting	380800334951	Artem Kadzhoian Principal Investigator
University College Hospital - London \| London, Greater London, NW1 2BU, United Kingdom	Recruiting	442034479091	Ming Lee Principal Investigator
The Clatterbridge Cancer Centre \| Bebbington, Merseyside, CH63 4JY, United Kingdom	Not yet recruiting	441515565430	Carles Escriu Principal Investigator
New Cross Hospital \| Wolverhampton, West Midlands, WV10 0QP, United Kingdom	Recruiting	441902695368	Ankit Jain Principal Investigator
City Hospital, Nottingham University Hospitals \| Nottingham, NG5 1PB, United Kingdom	Recruiting	44115969116957298	Sarah Khan Principal Investigator

Расположение Страны	Australia Austria Belgium Brazil Canada China Czechia Denmark France Germany Greece Hong Kong India Israel Italy Japan Korea, Republic of Mexico Netherlands Poland Puerto Rico Romania Russian Federation Singapore Spain Sweden Taiwan Turkey Ukraine United Kingdom United States
Дата проверки	2022-01-01
Ответственная сторона	Тип: Sponsor
Имеет расширенный доступ	No
Состояние Просмотр	Carcinoma, Non-Small-Cell Lung
Количество рук	2
Группа вооружений	Метка: Selpercatinib Тип: Experimental Описание: Selpercatinib administered orally. Метка: Placebo Тип: Placebo Comparator Описание: Placebo administered orally.
Акроним	LIBRETTO-432
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Triple (Participant, Investigator, Outcomes Assessor)

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)