AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3LIBRETTO-432NCT04819100

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

A Phase 3 study testing Selpercatinib in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 211 sites in 32 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Selpercatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
211 sitesin 32 countries
Study dates
20 Dec 2021to May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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).

Trial locations and contacts

211 sites in 32 countries.

211 sites in 32 countries

Spain27 sites

  • Hospital General Universitario de Albacete

    Albacete, 2006

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [Barcelona], 08916

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, Barcelona [Barcelona], 8003

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 8035

  • Hospital Universitari Dexeusa

    Barcelona, Catalunya [Cataluña], 8028

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 8036

  • Hospital Universitario Puerta del Mar

    Cadiz, Andalusia, 11009

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, Murcia, Región de, 30120

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    L'Hospitalet Del Llobregat, Barcelona [Barcelona], 8907

  • Complejo Asistencial Universitario de León - Hospital de León

    León, Castille and León, 24071

  • Hospital Lucus Augusti

    Lugo, Lugo [Lugo], 27003

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Clinico San Carlos

    Madrid, 28040

  • H.R.U Málaga - Hospital General

    Málaga, 29011

  • Hospital de Mataró

    Mataró, Barcelona [Barcelona], 8304

  • Complexo Hospitalario Universitario de Ourense

    Ourense, Ourense [Orense], 32005

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Son Llàtzer

    Palma, Illes Balears [Islas Baleares], 7198

  • CHUVI- Hospital Alvaro Cunqueiro

    Pontevedra, Pontevedra [Pontevedra], 36312

  • Hospital Universitari Sant Joan de Reus

    Reus, Tarragona [Tarragona], 43204

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, A Coruña [La Coruña], 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

China19 sites

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100050

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • the Third People's Hospital of Chengdu

    Chengdu, Sichuan, 610031

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • First Affiliated Hosp of College of Med, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030

  • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army

    Xi'an, Shaanxi, 710038

Other trials in China

United States15 sites

  • USO-Texas Oncology-Central/South Texas

    Austin, Texas, 78705

  • GenesisCare

    Aventura, Florida, 33180

  • GenesisCare - Boca Raton

    Boca Raton, Florida, 33431

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • USO - Alliance Cancer Specialists, PC

    Horsham, Pennsylvania, 19044

  • USO-New York Oncology Hematology, P.C

    Latham, New York, 12110

  • UCLA Hematology/Oncology - Santa Monica

    Los Angeles, California, 90404

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • Tennessee Oncology Nashville

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • USO-Cancer Care Center of Brevard, Inc.

    Palm Bay, Florida, 32909

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, 55905

  • Stockton Hematology Oncology Group

    Stockton, California, 95204

  • US Oncology

    The Woodlands, Texas, 77380

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502

Other trials in United States

Turkey (Türkiye)15 sites

  • Baskent University Dr. Turgut Noyan Research and Training Center

    Adana, 1250

  • Adana City Hospital

    Adana, 1370

  • Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

    Ankara, 6200

  • Ankara Bilkent Şehir Hastanesi

    Ankara, 6800

  • Memorial Antalya Hospital

    Antalya, 7090

  • Ege Universitesi Hastanesi

    Bornova, İzmir, 35100

  • Uludag Universitesi

    Bursa, 16059

  • Dicle Üniversitesi

    Diyarbakır, 21100

  • Trakya University

    Edirne, 22030

  • Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Acıbadem Maslak Hastanesi

    Istanbul, 34457

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi

    Izmir, 35620

  • Izmir Medical Park Hospital

    Izmir, Karsiyaka, İzmir, 009035575

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

    Malatya, 44280

Other trials in Turkey (Türkiye)

Brazil12 sites

  • Oncocentro de Minas Gerais

    Belo Horizonte, Minas Gerais, 30180-060

  • Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul

    Brasília, Federal District, 70200-730

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Multihemo

    Recife, Pernambuco, 50070-170

  • Instituto de Educação, Pesquisa e Gestão em Saúde

    Rio de Janeiro, 22775001

  • Nucleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-070

  • Hospital BP

    São Paulo, São Paulo, 01321-001

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    São Paulo, São Paulo, 04543-000

  • Centro Paulista de Oncologia Clínica

    São Paulo, 01452-000

  • Núcleo de Pesquisa Clínica da Rede São Camilo

    São Paulo, 04014-002

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900

  • Centro Oncológico do Triângulo

    Uberlândia, Minas Gerais, 38408-150

Other trials in Brazil

Germany12 sites

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin

    Berlin, 12203

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Asklepios Fachkliniken München-Gauting

    Gauting, Bavaria, 82131

  • Franziskus-Hospital Harderberg

    Georgsmarienhütte, Lower Saxony, 49124

  • LungenClinic Grosshansdorf

    Großhansdorf, Schleswig-Holstein, 22927

  • Asklepios Klinik Harburg

    Hamburg, 21075

  • KRH, Klinikum Siloah

    Hanover, Lower Saxony, 30459

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg, 69126

  • Lungenfachklinik Immenhausen

    Immenhausen, Hesse, 34376

  • Klinik Löwenstein

    Löwenstein, Baden-Wurttemberg, 74245

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    München, Bavaria, 80336

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Japan10 sites

  • Himeji Medical Center

    Himeji, Hyōgo, 670-8520

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Shizuoka Cancer Center

    Nakatogari, Shizuoka, 411-8777

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Kanagawa cancer center

    Yokohama, Kanagawa, 241-8515

  • Tottori University Hospital

    Yonago, Tottori, 683-8504

Other trials in Japan

South Korea10 sites

  • Pusan National University Hospital

    Busan, Pusan-Kwangyǒkshi, 49241

  • Kyungpook National University Chilgok Hospital

    Deagu, Taegu-Kwangyǒkshi, 41404

  • National Cancer Center

    Goyang-si, Kyǒnggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeonranamdo, 58128

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 3080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 3722

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 5505

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 6351

  • Korea University Guro Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 8308

Other trials in South Korea

Taiwan10 sites

  • Changhua Christian Hospital

    Changhua County, Changhua, 50006

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

  • Chung Shan Medical University Hospital

    Taichung, Taichung, 402

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Chi Mei Hospital - Liouying Branch

    Tainan, Tainan, 73657

  • National Taiwan University Hospital

    Taipei, 10002

  • National Taiwan University Cancer Center (NTUCC)

    Taipei City, Taipei, 106

  • Taipei Veterans General Hospital

    Taipei City, Taipei, 112

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Australia8 sites

  • Ballarat Health Services

    Ballarat Central, Victoria, 3350

  • Bendigo Health Care Group

    Bendigo, Victoria, 3550

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Rockhampton Hospital

    Rockhampton, Queensland, 4700

  • Goulburn Valley Health

    Shepparton, Victoria, 3630

  • The Townsville Hospital

    Townsville, Queensland, 4814

  • South West Healthcare

    Warrnambool, Victoria, 3280

  • Border Medical Oncology

    Wodonga, Victoria, 3690

Other trials in Australia

France7 sites

  • Centre Chirurgical Marie Lannelongue

    Le Plessis-Robinson, Hauts-de-Seine, 92350

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69373

  • Hospices Civils de Lyon - Hopital Louis Pradel

    Lyon, Rhône, 69677

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    Paris, 75014

  • CHU Charles Nicolle

    Rouen, Haute-Normandie, 76031

  • Gustave Roussy

    Villejuif, Val-de-Marne, 94800

Other trials in France

Greece7 sites

  • Agios Savvas Regional Cancer Hospital

    Athens, Attikí, 115 22

  • Errikos Dunant Hospital Center

    Athens, Attikí, 115 26

  • Sotiria Thoracic Diseases Hospital of Athens

    Athens, Attikí, 11527

  • University General Hospital of Heraklion

    Heraklion, Irakleío, 711 10

  • University Hospital of Patras

    Pátrai, Achaḯa, 26504

  • European Interbalkan Medical Center

    Thessaloniki, Thessaloníki, 570 01

  • G. Papanikolaou General Hospital

    Thessaloniki, Thessaloníki, 570 10

Other trials in Greece

Ukraine7 sites

  • CNPE "Regional Center of Oncology"

    Kharkiv, Kharkiv Oblast, 61070

  • Medical Center "Mriya Med-Service"

    Kryvyi Rih, Dnipropetrovsk Oblast, 50000

  • Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City Counci -T

    Kyiv, 3115

  • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council

    Odesa, Odesa Oblast, 65025

  • Sumy regional clinical oncological dispensary

    Sumy, Sumska Oblast, 40022

  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"

    Vinnytsia, Vinnytsia Oblast, 21029

  • "Oncolife" LLC

    Zaporizhzhya, Zaporizhzhia Oblast, 69059

Other trials in Ukraine

Belgium6 sites

  • Cliniques universitaires Saint-Luc

    Brussels, Bruxelles-Capitale, Région de, 1200

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650

  • CHU UCL Namur/Site Sainte Elisabeth

    Namur, 5000

  • Clinique Saint Pierre

    Ottignies, Wallonne, Région, 1340

  • AZ Delta vzw

    Roeselare, West-Vlaanderen, 8800

  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne

    Yvoir, Namur, 5530

Other trials in Belgium

Italy6 sites

  • Instituto Tumori Giovanni Paolo II

    Bari, Apulia, 70124

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milano, 20162

  • Azienda Ospedaliera Dei Colli

    Naples, Napoli, 80131

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Torino, 10043

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Humanitas

    Rozzano, Milano, 20089

Other trials in Italy

India5 sites

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

  • Rashtrasant Tukdoji Regional Cancer Hospital

    Nagpur, Maharashtra, 440027

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422001

  • Rajiv Gandhi Cancer Institute And Research Centre

    New Delhi, National Capital Territory of Delhi, 110085

  • Regional Cancer Centre - Thiruvananthapuram

    Thiruvananthapuram, Kerala, 695011

Other trials in India

United Kingdom5 sites

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, England, SW10 9NH

  • Royal Brompton Hospital

    London, Kensington and Chelsea, SW3 6NP

  • University College London Hospital

    London, London, City of, NW1 2PG

  • City Hospital, Nottingham University Hospitals

    Nottingham, NG5 1PB

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Mexico4 sites

  • Actualidad Basada en la Investigación del Cáncer

    Guadalajara, Jalisco, 44680

  • Oncare Viaducto Napoles

    Mexico City, Mexico City, 03810

  • Avix Investigación Clinica, S.C.

    Monterrey, Nuevo León, 64710

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460

Other trials in Mexico

Russia4 sites

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • Hadassah Medical

    Moscow, Moscow, 121205

  • First Pavlov State Medical University of Saint Petersburg

    Saint Petersburg, Sankt-Peterburg, 197022

  • Scientific research institution of oncology named after N.N. Petrov

    Saint Petersburg, 197758

Other trials in Russia

Czechia3 sites

  • Masarykuv onkologicky ustav

    Brno, Brno-město, 656 53

  • Nemocnice AGEL Ostrava - Vitkovice a.s.

    Ostrava, Ostrava Město, 703 84

  • Fakultni nemocnice Bulovka

    Prague, Praha 8, 180 81

Other trials in Czechia

Hong Kong3 sites

  • Hong Kong United Oncology Centre

    Hong Kong, 000000

  • Princess Margaret Hospital

    Lai Chi Kok, 999077

  • Queen Elizabeth Hospital

    Yau Ma Tei

Other trials in Hong Kong

Israel3 sites

  • Rambam Health Care Campus

    Haifa, Ḥeifā, 3109601

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

Other trials in Israel

Austria2 sites

  • Landeskrankenhaus Feldkirch

    Feldkirch, Vorarlberg, 6800

  • Klinik Floridsdorf

    Vienna, 1210

Other trials in Austria

Netherlands2 sites

  • Ziekenhuis St. Jansdal

    Harderwijk, Gelderland, 3844 DG

  • Radboudumc

    Nijmegen, Gelderland, 6500HB

Other trials in Netherlands

Singapore2 sites

  • Parkway Cancer Centre - Gleneagles Hospital

    Singapore, Central Singapore, 258500

  • Tan Tock Seng Hospital

    Singapore, Central Singapore, 308433

Other trials in Singapore

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Denmark1 site

  • Odense Universitetshospital

    Odense, Region Syddanmark, 5000

Other trials in Denmark

Norway1 site

  • Oslo Universitetssykehus Ullevål

    Oslo, 0450

Other trials in Norway

Poland1 site

  • Krakowski Szpital Specjalistyczny im. Jana Pawa II

    Krakow, Lesser Poland Voivodeship, 30-002

Other trials in Poland

Puerto Rico1 site

  • Pan American Center for Oncology Trials

    Rio Piedras, 00935

Other trials in Puerto Rico

Romania1 site

  • Institutul Oncologic

    Cluj-Napoca, 400015

Other trials in Romania

Sweden1 site

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Västra Götalands Län [se-14], 413 45

Other trials in Sweden

About this study

Official title: LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC

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.

Being tested
Selpercatinib, Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelpercatinibDrug

    Also called LY3527723, LOXO-292

    Administered orally.

  • PlaceboDrug

    Administered orally.

Study groups in NCT04819100
Study groupRoleWhat they receive
SelpercatinibExperimentalSelpercatinib administered orally.
Receives: Drug: Selpercatinib
PlaceboPlacebo comparatorPlacebo administered orally.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-Free Survival (EFS)

    EFS by Investigator Assessment in the Primary Analysis Population

    Measured: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)

Secondary outcomes (8)

  1. EFS

    EFS by investigator assessment in the overall population

    Measured: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)

  2. Overall Survival (OS)

    OS

    Measured: Randomization to death from any cause (estimated as up to 9 years)]

  3. EFS

    EFS by blinded independent central review (BICR)

    Measured: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]

  4. Time to Distant Disease Recurrence in the Central Nervous System (CNS)

    Time to distant disease recurrence in the CNS by investigator assessment and BICR

    Measured: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)

  5. Progression Free Survival on the Next Line of Treatment (PFS2)

    PFS2 by investigator assessment

    Measured: Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)

  6. 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

    Measured: Baseline

  7. 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.

    Measured: Baseline to treatment discontinuation (estimated as up to 3 years)

  8. 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.

    Measured: Baseline to treatment discontinuation (estimated as up to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2021
  2. Study start20 Dec 2021
  3. Primary completion12 Jan 2026
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04819100
Sponsor's protocol ID
18126
Other IDs
J2G-MC-JZJX, 2020-005191-35, 2023-506784-33-00, 2023
Acronym
LIBRETTO-432
Status last verified
Mar 2026
First submitted
25 Mar 2021
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Wu YL, Hochmair M, Yang Y, Yang XN, Tsuboi M, Paz-Ares L, Yang JC, Wu L, Kim HR, Rieke DT, Johnson M, Besse B, Sharma N, Maeda P, Peterson P, Lin BK, Frimodt-Moller B, Goldman J, Drilon A; LIBRETTO-432 Trial Investigators. Selpercatinib in Early-Stage RET Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2026 May 31. doi: 10.1056/NEJMoa2602628. Online ahead of print.

    PubMed 42223087

  • 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.

    PubMed 35950566

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selpercatinib in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 211 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in Spain, China, United States, Turkey (Türkiye), Brazil and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-Free Survival (EFS) (time frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04819100, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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