A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT04819100
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
152 participants
INTERVENTIONAL
2021-12-20
2028-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Selpercatinib
Selpercatinib administered orally.
Selpercatinib
Administered orally.
Placebo
Placebo administered orally.
Placebo
Administered orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Selpercatinib
Administered orally.
Placebo
Administered orally.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR), next generation sequencing (NGS), or another molecular test per sponsor's approval.
* 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.
* 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
* 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).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Loxo Oncology, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
USO-Cancer Care Center of Brevard, Inc.
Palm Bay, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
USO-New York Oncology Hematology, P.C
Latham, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
USO - Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 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
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
Border Medical Oncology
Wodonga, Victoria, Australia
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria
Klinik Floridsdorf
Vienna, , 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, Estado de Bahia, Brazil
Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul
Brasília, Federal District, Brazil
Oncocentro de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Centro Oncológico do Triângulo
Uberlândia, Minas Gerais, Brazil
Multihemo
Recife, Pernambuco, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital BP
São Paulo, São Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, São Paulo, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro, , Brazil
Centro Paulista de Oncologia Clínica
São Paulo, , Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo
São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, , Brazil
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Beijing Cancer hospital
Beijing, Beijing Municipality, 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
Xiangya Hospital, Central South University
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 Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
the Third People's Hospital of Chengdu
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , 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, Region Syddanmark, Denmark
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, France
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
Hospices Civils de Lyon - Hopital Louis Pradel
Lyon, Rhône, France
Gustave Roussy
Villejuif, Val-de-Marne, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, , France
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
Klinik Löwenstein
Löwenstein, Baden-Wurttemberg, Germany
Asklepios Fachkliniken München-Gauting
Gauting, Bavaria, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Bavaria, Germany
Lungenfachklinik Immenhausen
Immenhausen, Hesse, Germany
Franziskus-Hospital Harderberg
Georgsmarienhütte, Lower Saxony, Germany
KRH, Klinikum Siloah
Hanover, Lower Saxony, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, 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
Pátrai, 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
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
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, India
Sheba Medical Center
Ramat Gan, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, Ḥeifā, Israel
Instituto Tumori Giovanni Paolo II
Bari, Apulia, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy
Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliera Dei Colli
Naples, Napoli, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Torino, Italy
Istituto Oncologico Veneto IRCCS
Padua, , Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Himeji Medical Center
Himeji, Hyōgo, Japan
Kanagawa cancer center
Yokohama, Kanagawa, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Shizuoka Cancer Center
Nakatogari, Shizuoka, Japan
Japanese Foundation for Cancer Research
Koto, Tokyo, Japan
Tottori University Hospital
Yonago, Tottori, Japan
Hiroshima University Hospital
Hiroshima, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Actualidad Basada en la Investigación del Cáncer
Guadalajara, Jalisco, Mexico
Oncare Viaducto Napoles
Mexico City, Mexico City, 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
Krakowski Szpital Specjalistyczny im. Jana Pawa II
Krakow, Lesser Poland Voivodeship, Poland
Pan American Center for Oncology Trials
Rio Piedras, , Puerto Rico
Institutul Oncologic
Cluj-Napoca, , Romania
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, Russia
Hadassah Medical
Moscow, Moscow, Russia
First Pavlov State Medical University of Saint Petersburg
Saint Petersburg, Sankt-Peterburg, Russia
Scientific research institution of oncology named after N.N. Petrov
Saint Petersburg, , Russia
Parkway Cancer Centre - Gleneagles Hospital
Singapore, Central Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Central Singapore, Singapore
Chonnam National University Hwasun Hospital
Hwasun, Jeonranamdo, South Korea
National Cancer Center
Goyang-si, Kyǒnggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
Pusan National University Hospital
Busan, Pusan-Kwangyǒkshi, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, South Korea
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [La Coruña], Spain
Hospital Universitario Puerta del Mar
Cadiz, Andalusia, Spain
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 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, Castille and 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 Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario de Canarias
San Cristóbal de 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
H.R.U Málaga - Hospital General
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , 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, Taichung, Taiwan
Chi Mei Hospital - Liouying Branch
Tainan, 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 City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Ege Universitesi Hastanesi
Bornova, İzmir, Turkey (Türkiye)
Izmir Medical Park Hospital
Izmir, Karsiyaka, İzmir, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, , Turkey (Türkiye)
Adana City Hospital
Adana, , Turkey (Türkiye)
Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi
Ankara, , Turkey (Türkiye)
Memorial Antalya Hospital
Antalya, , Turkey (Türkiye)
Uludag Universitesi
Bursa, , Turkey (Türkiye)
Dicle Üniversitesi
Diyarbakır, , Turkey (Türkiye)
Trakya University
Edirne, , Turkey (Türkiye)
Medipol Mega Universite Hastanesi
Istanbul, , Turkey (Türkiye)
Acıbadem Maslak Hastanesi
Istanbul, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
Izmir, , Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Malatya, , Turkey (Türkiye)
Medical Center "Mriya Med-Service"
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
CNPE "Regional Center of Oncology"
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
Odesa, Odesa Oblast, Ukraine
Sumy regional clinical oncological dispensary
Sumy, Sumska Oblast, Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"
Vinnytsia, Vinnytsia Oblast, Ukraine
"Oncolife" LLC
Zaporizhzhia, Zaporizhzhia Oblast, Ukraine
Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City Counci -T
Kyiv, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tsuboi M, Goldman JW, Wu YL, Johnson ML, Paz-Ares L, Yang JC, Besse B, Su W, Chao BH, Drilon A. LIBRETTO-432, a phase III study of adjuvant selpercatinib or placebo in stage IB-IIIA RET fusion-positive non-small-cell lung cancer. Future Oncol. 2022 Sep;18(28):3133-3141. doi: 10.2217/fon-2022-0656. Epub 2022 Aug 11.
Related Links
Access external resources that provide additional context or updates about the study.
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (LIBRETTO-432)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
J2G-MC-JZJX
Identifier Type: OTHER
Identifier Source: secondary_id
2020-005191-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506784-33-00
Identifier Type: OTHER
Identifier Source: secondary_id
18126
Identifier Type: -
Identifier Source: org_study_id