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NCT04819100

PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2021-12-20

Completion Date

2028-05

Last Updated

2026-03-04

Healthy Volunteers

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Selpercatinib

Administered orally.

DRUG

Placebo

Administered orally.

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).

Locations (211)

UCLA Hematology/Oncology - Santa Monica

Los Angeles, California, United States

Stockton Hematology Oncology Group

Stockton, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

GenesisCare

Aventura, Florida, United States

GenesisCare - Boca Raton

Boca Raton, Florida, United States

USO-Cancer Care Center of Brevard, Inc.

Palm Bay, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

USO-New York Oncology Hematology, P.C

Latham, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

USO - Alliance Cancer Specialists, PC

Horsham, Pennsylvania, United States

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, United States

Tennessee Oncology Nashville

Nashville, Tennessee, United States

USO-Texas Oncology-Central/South Texas

Austin, Texas, United States

US Oncology

The Woodlands, Texas, United States

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Rockhampton Hospital

Rockhampton, Queensland, Australia

The Townsville Hospital

Townsville, Queensland, Australia

Ballarat Health Services

Ballarat Central, Victoria, Australia

Bendigo Health Care Group

Bendigo, Victoria, Australia

Goulburn Valley Health

Shepparton, Victoria, Australia

South West Healthcare

Warrnambool, Victoria, Australia

Border Medical Oncology

Wodonga, Victoria, Australia

Landeskrankenhaus Feldkirch

Feldkirch, Vorarlberg, Austria

Klinik Floridsdorf

Vienna, Austria

Antwerp University Hospital

Edegem, Antwerpen, Belgium

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, Belgium

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

Yvoir, Namur, Belgium

Clinique Saint Pierre

Ottignies, Wallonne, Région, Belgium

AZ Delta vzw

Roeselare, West-Vlaanderen, Belgium

CHU UCL Namur/Site Sainte Elisabeth

Namur, Belgium

Nucleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul

Brasília, Federal District, Brazil

Oncocentro de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Centro Oncológico do Triângulo

Uberlândia, Minas Gerais, Brazil

Multihemo

Recife, Pernambuco, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital BP

São Paulo, São Paulo, Brazil

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, São Paulo, Brazil

Instituto de Educação, Pesquisa e Gestão em Saúde

Rio de Janeiro, Brazil

Centro Paulista de Oncologia Clínica

São Paulo, Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jilin Cancer Hospital

Changchun, Jilin, China

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

Xi'an, Shaanxi, China

Jinan Central Hospital

Jinan, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

the Third People's Hospital of Chengdu

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

First Affiliated Hosp of College of Med, Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

Masarykuv onkologicky ustav

Brno, Brno-město, Czechia

Nemocnice AGEL Ostrava - Vitkovice a.s.

Ostrava, Ostrava Město, Czechia

Fakultni nemocnice Bulovka

Prague, Praha 8, Czechia

Odense Universitetshospital

Odense, Region Syddanmark, Denmark

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, Bouches-du-Rhône, France

CHU Charles Nicolle

Rouen, Haute-Normandie, France

Centre Chirurgical Marie Lannelongue

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

Hospices Civils de Lyon - Hopital Louis Pradel

Lyon, Rhône, France

Gustave Roussy

Villejuif, Val-de-Marne, France

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, France

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Baden-Wurttemberg, Germany

Klinik Löwenstein

Löwenstein, Baden-Wurttemberg, Germany

Asklepios Fachkliniken München-Gauting

Gauting, Bavaria, Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Bavaria, Germany

Lungenfachklinik Immenhausen

Immenhausen, Hesse, Germany

Franziskus-Hospital Harderberg

Georgsmarienhütte, Lower Saxony, Germany

KRH, Klinikum Siloah

Hanover, Lower Saxony, Germany

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany

LungenClinic Grosshansdorf

Großhansdorf, Schleswig-Holstein, Germany

Charite Universitätsmedizin Berlin Campus Benjamin Franklin

Berlin, Germany

Evangelische Lungenklinik Berlin

Berlin, Germany

Asklepios Klinik Harburg

Hamburg, Germany

University Hospital of Patras

Pátrai, Achaḯa, Greece

Agios Savvas Regional Cancer Hospital

Athens, Attikí, Greece

Errikos Dunant Hospital Center

Athens, Attikí, Greece

Sotiria Thoracic Diseases Hospital of Athens

Athens, Attikí, Greece

University General Hospital of Heraklion

Heraklion, Irakleío, Greece

European Interbalkan Medical Center

Thessaloniki, Thessaloníki, Greece

G. Papanikolaou General Hospital

Thessaloniki, Thessaloníki, Greece

Hong Kong United Oncology Centre

Hong Kong, Hong Kong

Princess Margaret Hospital

Lai Chi Kok, Hong Kong

Queen Elizabeth Hospital

Yau Ma Tei, Hong Kong

Regional Cancer Centre - Thiruvananthapuram

Thiruvananthapuram, Kerala, India

Tata Memorial Hospital

Mumbai, Maharashtra, India

Rashtrasant Tukdoji Regional Cancer Hospital

Nagpur, Maharashtra, India

HCG Manavata Cancer Centre

Nashik, Maharashtra, India

Rajiv Gandhi Cancer Institute And Research Centre

New Delhi, National Capital Territory of Delhi, India

Sheba Medical Center

Ramat Gan, Central District, Israel

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Rambam Health Care Campus

Haifa, Ḥeifā, Israel

Instituto Tumori Giovanni Paolo II

Bari, Apulia, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milano, Italy

Humanitas

Rozzano, Milano, Italy

Azienda Ospedaliera Dei Colli

Naples, Napoli, Italy

Azienda Sanitaria Ospedaliera S Luigi Gonzaga

Orbassano, Torino, Italy

Istituto Oncologico Veneto IRCCS

Padova, Italy

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Himeji Medical Center

Himeji, Hyōgo, Japan

Kanagawa cancer center

Yokohama, Kanagawa, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Shizuoka Cancer Center

Nakatogari, Shizuoka, Japan

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

Tottori University Hospital

Yonago, Tottori, Japan

Hiroshima University Hospital

Hiroshima, Japan

Osaka International Cancer Institute

Osaka, Japan

Actualidad Basada en la Investigación del Cáncer

Guadalajara, Jalisco, Mexico

Oncare Viaducto Napoles

Mexico City, Mexico City, Mexico

Avix Investigación Clinica, S.C.

Monterrey, Nuevo León, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Ziekenhuis St. Jansdal

Harderwijk, Gelderland, Netherlands

Radboudumc

Nijmegen, Gelderland, Netherlands

Oslo Universitetssykehus Ullevål

Oslo, Norway

Krakowski Szpital Specjalistyczny im. Jana Pawa II

Krakow, Lesser Poland Voivodeship, Poland

Pan American Center for Oncology Trials

Rio Piedras, Puerto Rico

Institutul Oncologic

Cluj-Napoca, Romania

Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, Arkhangelskaya oblast, Russia

Hadassah Medical

Moscow, Moscow, Russia

First Pavlov State Medical University of Saint Petersburg

Saint Petersburg, Sankt-Peterburg, Russia

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

Saint Petersburg, Russia

Parkway Cancer Centre - Gleneagles Hospital

Singapore, Central Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Central Singapore, Singapore

Chonnam National University Hwasun Hospital

Hwasun, Jeonranamdo, South Korea

National Cancer Center

Goyang-si, Kyǒnggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Pusan National University Hospital

Busan, Pusan-Kwangyǒkshi, South Korea

Seoul National University Hospital