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

March 2, 2026 updated by: Eli Lilly and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: clinical_inquiry_hub@lilly.com

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 Educacao, Pesquisa e Gestao em Saude
      • 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
        • Nucleo 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 Sao 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
        • Fakultní 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 - Hopital 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 Nápoles
    • 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 Politecnic 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 Sofia
    • 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 Catalán de Oncología - 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 Clínico 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
        • Uludağ Üniversitesi
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS)
Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
EFS
Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
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)
Time Frame: Randomization to death from any cause (estimated as up to 9 years)]
OS
Randomization to death from any cause (estimated as up to 9 years)]
EFS
Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]
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 Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
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)
Time Frame: Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)
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
Time Frame: Baseline
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
Time Frame: Baseline to treatment discontinuation (estimated as up to 3 years)
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
Time Frame: Baseline to treatment discontinuation (estimated as up to 3 years)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Loxo Oncology, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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