A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (LIBRETTO-432)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Placebo; Drug: Selpercatinib

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast University Hospital
    • Rockhampton, Queensland, Australia, 4700
      • Rockhampton Hospital
    • Townsville, Queensland, Australia, 4814
      • The Townsville Hospital
  • Victoria
    • Ballarat Central, Victoria, Australia, 3350
      • Ballarat Health Services
    • Bendigo, Victoria, Australia, 3550
      • Bendigo Health Care Group
    • Shepparton, Victoria, Australia, 3630
      • Goulburn Valley Health
    • Warrnambool, Victoria, Australia, 3280
      • South West Healthcare
    • Wodonga, Victoria, Australia, 3690
      • Border Medical Oncology
• Austria
  • Vienna, Austria, 1210
    • Klinik Floridsdorf
  • Vorarlberg
    • Feldkirch, Vorarlberg, Austria, 6800
      • Landeskrankenhaus Feldkirch
• Belgium
  • Namur, Belgium, 5000
    • CHU UCL Namur/Site Sainte Elisabeth
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Antwerp University Hospital
  • Bruxelles-Capitale, Région de
    • Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
      • Cliniques Universitaires Saint-Luc
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
  • Wallonne, Région
    • Ottignies, Wallonne, Région, Belgium, 1340
      • Clinique Saint Pierre
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • AZ Delta vzw
• Brazil
  • Rio de Janeiro, Brazil, 22775001
    • Instituto de Educação, Pesquisa e Gestão em Saúde
  • São Paulo, Brazil, 05652-900
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 04014-002
    • Núcleo de Pesquisa Clínica da Rede São Camilo
  • São Paulo, Brazil, 01452-000
    • Centro Paulista de Oncologia Clínica
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40170-070
      • Núcleo de Oncologia da Bahia
  • Federal District
    • Brasília, Federal District, Brazil, 70200-730
      • Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30180-060
      • Oncocentro de Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38408-150
      • Centro Oncológico do Triângulo
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-170
      • Multihemo
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital São Lucas da PUCRS
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01321-001
      • Hospital BP
    • São Paulo, São Paulo, Brazil, 04543-000
      • Instituto D'Or de Pesquisa e Ensino (IDOR)
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
• China
  • Wuhan, China, 430030
    • Tongji Medical College of Huazhong University of Science and Technology
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Provincial Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China, 510515
      • Southern Medical University Nanfang Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital, Central South University
  • Jilin
    • Changchun, Jilin, China, 130000
      • Jilin Cancer Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital, Fudan University
    • Shanghai, Shanghai Municipality, China, 200433
      • Shanghai Pulmonary Hospital
    • Shanghai, Shanghai Municipality, China, 200030
      • Shanghai Chest Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
    • Chengdu, Sichuan, China, 610031
      • The Third People's Hospital of Chengdu
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • First Affiliated Hosp of College of Med, Zhejiang University
• Czechia
  • Brno-město
    • Brno, Brno-město, Czechia, 656 53
      • Masarykuv onkologicky ustav
  • Ostrava Město
    • Ostrava, Ostrava Město, Czechia, 703 84
      • Nemocnice AGEL Ostrava - Vitkovice a.s.
  • Praha 8
    • Prague, Praha 8, Czechia, 180 81
      • Fakultni Nemocnice Bulovka
• Denmark
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark, 5000
      • Odense Universitetshospital
• France
  • Paris, France, 75014
    • Hopitaux Universitaires Paris Centre-Hopital Cochin
  • Auvergne-Rhône-Alpes
    • Lyon, Auvergne-Rhône-Alpes, France, 69373
      • Centre Léon Bérard
  • Bouches-du-Rhône
    • Marseille, Bouches-du-Rhône, France, 13385
      • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
  • Haute-Normandie
    • Rouen, Haute-Normandie, France, 76031
      • CHU Charles Nicolle
  • Hauts-de-Seine
    • Le Plessis-Robinson, Hauts-de-Seine, France, 92350
      • Centre Chirurgical Marie Lannelongue
  • Rhône
    • Lyon, Rhône, France, 69677
      • Hospices Civils de Lyon - Hôpital Louis Pradel
  • Val-de-Marne
    • Villejuif, Val-de-Marne, France, 94800
      • Gustave Roussy
• Germany
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berlin
  • Berlin, Germany, 12203
    • Charite Universitatsmedizin Berlin Campus Benjamin Franklin
  • Hamburg, Germany, 21075
    • Asklepios Klinik Harburg
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69126
      • Thoraxklinik-Heidelberg Ggmbh
    • Löwenstein, Baden-Wurttemberg, Germany, 74245
      • Klinik Löwenstein
  • Bavaria
    • Gauting, Bavaria, Germany, 82131
      • Asklepios Fachkliniken München-Gauting
    • München, Bavaria, Germany, 80336
      • Klinikum der Ludwig-Maximilians-Universitaet Muenchen
  • Hesse
    • Immenhausen, Hesse, Germany, 34376
      • Lungenfachklinik Immenhausen
  • Lower Saxony
    • Georgsmarienhütte, Lower Saxony, Germany, 49124
      • Franziskus-Hospital Harderberg
    • Hanover, Lower Saxony, Germany, 30459
      • KRH, Klinikum Siloah
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universitätsklinikum Münster - Albert Schweitzer Campus
  • Schleswig-Holstein
    • Großhansdorf, Schleswig-Holstein, Germany, 22927
      • LungenClinic Grosshansdorf
• Greece
  • Achaḯa
    • Pátrai, Achaḯa, Greece, 26504
      • University Hospital of Patras
  • Attikí
    • Athens, Attikí, Greece, 115 22
      • Agios Savvas Regional Cancer Hospital
    • Athens, Attikí, Greece, 115 26
      • Errikos Dunant Hospital Center
    • Athens, Attikí, Greece, 11527
      • Sotiria Thoracic Diseases Hospital of Athens
  • Irakleío
    • Heraklion, Irakleío, Greece, 711 10
      • University General Hospital of Heraklion
  • Thessaloníki
    • Thessaloniki, Thessaloníki, Greece, 570 01
      • European Interbalkan Medical Center
    • Thessaloniki, Thessaloníki, Greece, 570 10
      • G. Papanikolaou General Hospital
• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • Hong Kong United Oncology Centre
  • Lai Chi Kok, Hong Kong, 999077
    • Princess Margaret Hospital
  • Yau Ma Tei, Hong Kong
    • Queen Elizabeth Hospital
• India
  • Kerala
    • Thiruvananthapuram, Kerala, India, 695011
      • Regional Cancer Centre - Thiruvananthapuram
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Tata Memorial Hospital
    • Nagpur, Maharashtra, India, 440027
      • Rashtrasant Tukdoji Regional Cancer Hospital
    • Nashik, Maharashtra, India, 422001
      • HCG Manavata Cancer Centre
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110085
      • Rajiv Gandhi Cancer Institute And Research Centre
• Israel
  • Central District
    • Ramat Gan, Central District, Israel, 5265601
      • Sheba Medical Center
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 9112001
      • Hadassah Medical Center
  • Ḥeifā
    • Haifa, Ḥeifā, Israel, 3109601
      • Rambam Health Care Campus
• Italy
  • Padua, Italy, 35128
    • Istituto Oncologico Veneto IRCCS
  • Apulia
    • Bari, Apulia, Italy, 70124
      • Instituto Tumori Giovanni Paolo II
  • Milano
    • Milan, Milano, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda
    • Rozzano, Milano, Italy, 20089
      • Humanitas
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Azienda Ospedaliera dei Colli
  • Torino
    • Orbassano, Torino, Italy, 10043
      • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
• Japan
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Hyōgo
    • Himeji, Hyōgo, Japan, 670-8520
      • Himeji Medical Center
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center
  • Niigata
    • Niigata, Niigata, Japan, 951-8566
      • Niigata Cancer Center Hospital
  • Shizuoka
    • Nakatogari, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Koto, Tokyo, Japan, 135-8550
      • Japanese Foundation for Cancer Research
  • Tottori
    • Yonago, Tottori, Japan, 683-8504
      • Tottori University Hospital
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44680
      • Actualidad Basada en la Investigación del Cáncer
  • Mexico City
    • Mexico City, Mexico City, Mexico, 03810
      • ONCARE Viaducto Napoles
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
    • Monterrey, Nuevo León, Mexico, 64710
      • Avix Investigación Clinica, S.C.
• Netherlands
  • Gelderland
    • Harderwijk, Gelderland, Netherlands, 3844 DG
      • Ziekenhuis St. Jansdal
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Radboudumc
• Norway
  • Oslo, Norway, 0450
    • Oslo Universitetssykehus Ullevål
• Poland
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-002
      • Krakowski Szpital Specjalistyczny im. Jana Pawa II
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials
• Romania
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic
• Russia
  • Saint Petersburg, Russia, 197758
    • Scientific research institution of oncology named after N.N. Petrov
  • Arkhangelskaya oblast
    • Arkhangelsk, Arkhangelskaya oblast, Russia, 163045
      • Arkhangelsk Clinical Oncological Dispensary
  • Moscow
    • Moscow, Moscow, Russia, 121205
      • Hadassah Medical
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 197022
      • First Pavlov State Medical University of Saint Petersburg
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 258500
      • Parkway Cancer Centre - Gleneagles Hospital
    • Singapore, Central Singapore, Singapore, 308433
      • Tan Tock Seng Hospital
• South Korea
  • Jeonranamdo
    • Hwasun, Jeonranamdo, South Korea, 58128
      • Chonnam National University Hwasun Hospital
  • Kyǒnggi-do
    • Goyang-si, Kyǒnggi-do, South Korea, 10408
      • National Cancer Center
    • Seongnam, Kyǒnggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
  • Pusan-Kwangyǒkshi
    • Busan, Pusan-Kwangyǒkshi, South Korea, 49241
      • Pusan National University Hospital
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3080
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3722
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 5505
      • Asan Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 6351
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 8308
      • Korea University Guro Hospital
  • Taegu-Kwangyǒkshi
    • Deagu, Taegu-Kwangyǒkshi, South Korea, 41404
      • Kyungpook National University Chilgok Hospital
• Spain
  • Albacete, Spain, 2006
    • Hospital General Universitario de Albacete
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center
  • Málaga, Spain, 29011
    • H.R.U Málaga - Hospital General
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe
  • A Coruña [La Coruña]
    • Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
      • CHUS - Hospital Clinico Universitario
  • Andalusia
    • Cadiz, Andalusia, Spain, 11009
      • Hospital Universitario Puerta Del Mar
    • Córdoba, Andalusia, Spain, 14004
      • Hospital Universitario Reina Sofía
  • Barcelona [Barcelona]
    • Badalona, Barcelona [Barcelona], Spain, 08916
      • Institut Català d'Oncologia (ICO) - Badalona
    • Barcelona, Barcelona [Barcelona], Spain, 8035
      • Hospital Universitari Vall d'Hebron
    • Barcelona, Barcelona [Barcelona], Spain, 8003
      • Parc de Salut Mar - Hospital del Mar
    • L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain, 8907
      • Instituto Catalan de Oncologia - Hospital Duran I Reynals
    • Mataró, Barcelona [Barcelona], Spain, 8304
      • Hospital de Mataró
  • Castille and León
    • León, Castille and León, Spain, 24071
      • Complejo Asistencial Universitario de León - Hospital de León
  • Catalunya [Cataluña]
    • Barcelona, Catalunya [Cataluña], Spain, 8036
      • Hospital Clinic de Barcelona
    • Barcelona, Catalunya [Cataluña], Spain, 8028
      • Hospital Universitari Dexeusa
  • Illes Balears [Islas Baleares]
    • Palma, Illes Balears [Islas Baleares], Spain, 7198
      • Hospital Son Llatzer
  • Lugo [Lugo]
    • Lugo, Lugo [Lugo], Spain, 27003
      • Hospital Lucus Augusti
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Hospital Universitario Ramon y Cajal
    • Madrid, Madrid, Comunidad de, Spain, 28041
      • Hospital Universitario 12 de Octubre
  • Murcia, Región de
    • El Palmar, Murcia, Murcia, Región de, Spain, 30120
      • Hospital Clinico Universitario Virgen de La Arrixaca
  • Ourense [Orense]
    • Ourense, Ourense [Orense], Spain, 32005
      • Complexo Hospitalario Universitario de Ourense
  • Pontevedra [Pontevedra]
    • Pontevedra, Pontevedra [Pontevedra], Spain, 36312
      • CHUVI- Hospital Alvaro Cunqueiro
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Santa Cruz De Tenerife
    • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Hospital Universitario de Canarias
  • Tarragona [Tarragona]
    • Reus, Tarragona [Tarragona], Spain, 43204
      • Hospital Universitari Sant Joan de Reus
• Sweden
  • Västra Götalands Län [se-14]
    • Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
      • Sahlgrenska Universitetssjukhuset
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
  • Changhua
    • Changhua County, Changhua, Taiwan, 50006
      • Changhua Christian Hospital
  • Kaohsiung
    • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
      • Chang Gung Memorial Hospital at Kaohsiung
  • Taichung
    • Taichung, Taichung, Taiwan, 402
      • Chung Shan Medical University Hospital
  • Tainan
    • Tainan, Tainan, Taiwan, 73657
      • Chi Mei Hospital - Liouying Branch
  • Taipei
    • Taipei City, Taipei, Taiwan, 112
      • Taipei Veterans General Hospital
    • Taipei City, Taipei, Taiwan, 106
      • National Taiwan University Cancer Center (NTUCC)
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1250
    • Baskent University Dr. Turgut Noyan Research and Training Center
  • Adana, Turkey (Türkiye), 1370
    • Adana City Hospital
  • Ankara, Turkey (Türkiye), 6200
    • Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
  • Ankara, Turkey (Türkiye), 6800
    • Ankara Bilkent Sehir Hastanesi
  • Antalya, Turkey (Türkiye), 7090
    • Memorial Antalya Hospital
  • Bursa, Turkey (Türkiye), 16059
    • Uludag Universitesi
  • Diyarbakır, Turkey (Türkiye), 21100
    • Dicle Üniversitesi
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University
  • Istanbul, Turkey (Türkiye), 34214
    • Medipol Mega Universite Hastanesi
  • Istanbul, Turkey (Türkiye), 34722
    • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34457
    • Acıbadem Maslak Hastanesi
  • Izmir, Turkey (Türkiye), 35620
    • Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
  • Malatya, Turkey (Türkiye), 44280
    • İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
  • İzmir
    • Bornova, İzmir, Turkey (Türkiye), 35100
      • Ege Universitesi Hastanesi
    • Izmir, Karsiyaka, İzmir, Turkey (Türkiye), 009035575
      • Izmir Medical Park Hospital
• Ukraine
  • Kyiv, Ukraine, 3115
    • Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City Counci -T
  • Dnipropetrovsk Oblast
    • Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50000
      • Medical Center "Mriya Med-Service"
  • Kharkivs’ka Oblast’
    • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61070
      • CNPE "Regional Center of Oncology"
  • Odesa Oblast
    • Odesa, Odesa Oblast, Ukraine, 65025
      • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
  • Sumska Oblast
    • Sumy, Sumska Oblast, Ukraine, 40022
      • Sumy regional clinical oncological dispensary
  • Vinnytsia Oblast
    • Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
      • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"
  • Zaporizhzhia Oblast
    • Zaporizhzhia, Zaporizhzhia Oblast, Ukraine, 69059
      • "Oncolife" LLC
• United Kingdom
  • Nottingham, United Kingdom, NG5 1PB
    • City Hospital, Nottingham University Hospitals
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
  • England
    • London, England, United Kingdom, SW10 9NH
      • Chelsea and Westminster Hospital NHS Foundation Trust
  • Kensington and Chelsea
    • London, Kensington and Chelsea, United Kingdom, SW3 6NP
      • Royal Brompton Hospital
  • London, City of
    • London, London, City of, United Kingdom, NW1 2PG
      • University College London Hospital
• United States
  • California
    • Los Angeles, California, United States, 90404
      • UCLA Hematology/Oncology - Santa Monica
    • Stockton, California, United States, 95204
      • Stockton Hematology Oncology Group
    • Torrance, California, United States, 90502
      • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Florida
    • Aventura, Florida, United States, 33180
      • GenesisCare
    • Boca Raton, Florida, United States, 33431
      • GenesisCare - Boca Raton
    • Palm Bay, Florida, United States, 32909
      • USO-Cancer Care Center of Brevard, Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester, Minnesota
  • New York
    • Latham, New York, United States, 12110
      • USO-New York Oncology Hematology, P.C
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Pennsylvania
    • Horsham, Pennsylvania, United States, 19044
      • USO - Alliance Cancer Specialists, PC
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute SCRI
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology Nashville
  • Texas
    • Austin, Texas, United States, 78705
      • USO-Texas Oncology-Central/South Texas
    • The Woodlands, Texas, United States, 77380
      • US Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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), 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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered orally.	Drug: Placebo; Administered orally.
Experimental: Selpercatinib; Selpercatinib administered orally.	Drug: Selpercatinib; Administered orally.; Other Names: LOXO-292; LY3527723

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-Free Survival (EFS)	EFS by Investigator Assessment in the Primary Analysis Population	Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EFS	EFS by investigator assessment in the overall population	Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Overall Survival (OS)	OS	Randomization to death from any cause (estimated as up to 9 years)]
EFS	EFS by blinded independent central review (BICR)	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)	Time to distant disease recurrence in the CNS by investigator assessment and BICR	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)	PFS2 by investigator assessment	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 Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test	PPV of RET Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test	Baseline
Mean Change from Baseline over Time in NSCLC Symptoms	NSCLC symptoms will be measured using the 7-item NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). The NSCLC-SAQ measures the severity/frequency of the following core symptoms: Cough, pain, dyspnea, fatigue, and appetite. Raw scores range from 0 to 4 and the total score ranges from 0-20. Higher scores represent worse symptoms.	Baseline to treatment discontinuation (estimated as up to 3 years)
Mean Change from Baseline over Time in Physical Function	Physical function will be measured by the 5 physical function items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (also known as the EORTC IL 19 questionnaire). Raw scores range from 0-20. Higher scores indicate worst function.	Baseline to treatment discontinuation (estimated as up to 3 years)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Loxo Oncology, Inc.
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

General Publications

• 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.

Helpful Links

• A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (LIBRETTO-432)

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Actual): January 12, 2026
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; selpercatinib
• Other Study ID Numbers: 18126; J2G-MC-JZJX (Other Identifier: Eli Lilly and Company); 2020-005191-35 (EudraCT Number); 2023-506784-33-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No