Clinical trial NCT04819100: A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2021-03-26
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Event-Free Survival (EFS)
timeFrame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Secondary outcomes:
measure: EFS
timeFrame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
measure: Overall Survival (OS)
timeFrame: Randomization to death from any cause (estimated as up to 9 years)]
measure: EFS
timeFrame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]
measure: Time to Distant Disease Recurrence in the Central Nervous System (CNS)
timeFrame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
measure: Progression Free Survival on the Next Line of Treatment (PFS2)
timeFrame: Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)
measure: Positive Predictive Value (PPV) of Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test
timeFrame: Baseline
measure: Mean Change from Baseline over Time in NSCLC Symptoms
timeFrame: Baseline to treatment discontinuation (estimated as up to 3 years)
measure: Mean Change from Baseline over Time in Physical Function
timeFrame: Baseline to treatment discontinuation (estimated as up to 3 years)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica
state: California
city: Stockton
country: United States
facility: Stockton Hematology Oncology Group
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Aventura
country: United States
facility: GenesisCare
state: Florida
city: Boca Raton
country: United States
facility: GenesisCare - Boca Raton
state: Florida
city: Palm Bay
country: United States
facility: USO-Cancer Care Center of Brevard, Inc.
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
city: Latham
country: United States
facility: USO-New York Oncology Hematology, P.C
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Horsham
country: United States
facility: USO - Alliance Cancer Specialists, PC
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology Nashville
state: Tennessee
city: Austin
country: United States
facility: USO-Texas Oncology-Central/South Texas
state: Texas
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Rockhampton
country: Australia
facility: Rockhampton Hospital
state: Queensland
city: Townsville
country: Australia
facility: The Townsville Hospital
state: Queensland
city: Ballarat Central
country: Australia
facility: Ballarat Health Services
state: Victoria
city: Bendigo
country: Australia
facility: Bendigo Health Care Group
state: Victoria
city: Shepparton
country: Australia
facility: Goulburn Valley Health
state: Victoria
city: Warrnambool
country: Australia
facility: South West Healthcare
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
state: Vorarlberg
city: Wien
country: Austria
facility: Klinik Floridsdorf
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerpen
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Bruxelles-Capitale, Région De
city: Yvoir
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
state: Namur
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
state: Wallonne, Région
city: Roeselare
country: Belgium
facility: AZ Delta vzw
state: West-Vlaanderen
city: Namur
country: Belgium
facility: CHU UCL Namur/Site Sainte Elisabeth
city: Salvador
country: Brazil
facility: Nucleo de Oncologia da Bahia
state: Bahia
city: Brasilia
country: Brazil
facility: Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Oncocentro de Minas Gerais
state: Minas Gerais
city: Uberlândia
country: Brazil
facility: Centro Oncológico do Triângulo
state: Minas Gerais
city: Recife
country: Brazil
facility: Multihemo
state: Pernambuco
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Hospital BP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR)
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educação, Pesquisa e Gestão em Saúde
city: São Paulo
country: Brazil
facility: Centro Paulista de Oncologia Clínica
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo
city: São Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Xi'an
country: China
facility: Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: the Third People's Hospital of Chengdu
state: Sichuan
city: Hangzhou
country: China
facility: First Affiliated Hosp of College of Med, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Wuhan
country: China
facility: Tongji Medical College of Huazhong University of Science and Technology
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
state: Brno-město
city: Ostrava
country: Czechia
facility: Nemocnice AGEL Ostrava - Vitkovice a.s.
state: Ostrava Město
city: Prague
country: Czechia
facility: Fakultni nemocnice Bulovka
state: Praha 8
city: Odense
country: Denmark
facility: Odense Universitetshospital
state: Syddanmark
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
state: Bouches-du-Rhône
city: Rouen
country: France
facility: CHU Charles Nicolle
state: Haute-Normandie
city: Le Plessis-Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
state: Hauts-de-Seine
city: Lyon CEDEX 08
country: France
facility: Centre Leon Berard
state: Rhône-Alpes
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hopital Louis Pradel
state: Rhône
city: Villejuif
country: France
facility: Gustave Roussy
state: Val-de-Marne
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH
state: Baden-Württemberg
city: Löwenstein
country: Germany
facility: Klinik Löwenstein
state: Baden-Württemberg
city: Gauting
country: Germany
facility: Asklepios Fachkliniken München-Gauting
state: Bayern
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen
state: Bayern
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
state: Hessen
city: Georgsmarienhütte
country: Germany
facility: Franziskus-Hospital Harderberg
state: Niedersachsen
city: Hannover
country: Germany
facility: KRH, Klinikum Siloah
state: Niedersachsen
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Albert Schweitzer Campus
state: Nordrhein-Westfalen
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaḯa
city: Athens
country: Greece
facility: Agios Savvas Regional Cancer Hospital
state: Attikí
city: Athens
country: Greece
facility: Errikos Dunant Hospital Center
state: Attikí
city: Athens
country: Greece
facility: Sotiria Thoracic Diseases Hospital of Athens
state: Attikí
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Irakleío
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
state: Thessaloníki
city: Thessaloniki
country: Greece
facility: G. Papanikolaou General Hospital
state: Thessaloníki
city: Hong Kong
country: Hong Kong
facility: Hong Kong United Oncology Centre
city: Lai Chi Kok
country: Hong Kong
facility: Princess Margaret Hospital
city: Yau Ma Tei
country: Hong Kong
facility: Queen Elizabeth Hospital
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute And Research Centre
state: Delhi
city: Thiruvananthapuram
country: India
facility: Regional Cancer Centre - Thiruvananthapuram
state: Kerala
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Rashtrasant Tukdoji Regional Cancer Hospital
state: Maharashtra
city: Nashik
country: India
facility: HCG Manavata Cancer Centre
state: Maharashtra
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: Ḥeifā
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Milano
city: Rozzano
country: Italy
facility: Humanitas
state: Milano
city: Naples
country: Italy
facility: Azienda Ospedaliera Dei Colli
state: Napoli
city: Bari
country: Italy
facility: Instituto Tumori Giovanni Paolo II
state: Puglia
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga
state: Torino
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Himeji
country: Japan
facility: Himeji Medical Center
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa cancer center
state: Kanagawa
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Nagaizumi
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonranamdo
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Kyǒnggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Taegu-Kwangyǒkshi
city: Guadalajara
country: Mexico
facility: Actualidad Basada en la Investigación del Cáncer
state: Jalisco
city: Cdmx
country: Mexico
facility: Oncare Viaducto Napoles
state: México
city: Monterrey
country: Mexico
facility: Avix Investigación Clinica, S.C.
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Ullevål
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawa II
state: Małopolskie
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials
city: Cluj
country: Romania
facility: Institutul Oncologic
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary
state: Arkhangel'skaya Oblast'
city: Moscow
country: Russian Federation
facility: Hadassah Medical
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: First Pavlov State Medical University of Saint Petersburg
state: Sankt-Peterburg
city: Sankt-Peterburg
country: Russian Federation
facility: Scientific research institution of oncology named after N.N. Petrov
city: Singapore
country: Singapore
facility: Parkway Cancer Centre - Gleneagles Hospital
state: Central Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
state: Central Singapore
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario
state: A Coruña [La Coruña]
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
state: Andalucía
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Badalona
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Parc de Salut Mar - Hospital del Mar
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: L'Hospitalet Del Llobregat
country: Spain
facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals
state: Barcelona [Barcelona]
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona [Barcelona]
city: León
country: Spain
facility: Complejo Asistencial Universitario de León - Hospital de León
state: Castilla Y León
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeusa
state: Catalunya [Cataluña]
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [Cataluña]
city: Palma
country: Spain
facility: Hospital Son Llàtzer
state: Illes Balears [Islas Baleares]
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
state: Lugo [Lugo]
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid, Comunidad De
city: El Palmar, Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia, Región De
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
state: Ourense [Orense]
city: Pontevedra
country: Spain
facility: CHUVI- Hospital Alvaro Cunqueiro
state: Pontevedra [Pontevedra]
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona [Tarragona]
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Málaga
country: Spain
facility: H.R.U Málaga - Hospital General
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
state: Västra Götalands Län [se-14]
city: Changhua County
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taichung
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital - Liouying Branch
state: Tainan
city: Taipei City
country: Taiwan
facility: National Taiwan University Cancer Center (NTUCC)
state: Taipei
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Bornova
country: Turkey
facility: Ege Universitesi Hastanesi
state: İzmir
city: Izmir, Karsiyaka
country: Turkey
facility: Izmir Medical Park Hospital
state: İzmir
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center
city: Adana
country: Turkey
facility: Adana City Hospital
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi
city: Antalya
country: Turkey
facility: Memorial Antalya Hospital
city: Bursa
country: Turkey
facility: Uludag Universitesi
city: Diyarbakir
country: Turkey
facility: Dicle Üniversitesi
city: Edirne
country: Turkey
facility: Trakya University
city: Istanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi
city: İstanbul
country: Turkey
facility: Acıbadem Maslak Hastanesi
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
city: Izmir
country: Turkey
facility: Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi
city: Malatya
country: Turkey
facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
city: Kryvyi Rih
country: Ukraine
facility: Medical Center "Mriya Med-Service"
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: CNPE "Regional Center of Oncology"
state: Kharkivska Oblast
city: Odesa
country: Ukraine
facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
state: Odeska Oblast
city: Sumy
country: Ukraine
facility: Sumy regional clinical oncological dispensary
state: Sumska Oblast
city: Vinnytsia
country: Ukraine
facility: Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"
state: Vinnytska Oblast
city: Zaporizhzhia
country: Ukraine
facility: "Oncolife" LLC
state: Zaporizka Oblast
city: Kyiv
country: Ukraine
facility: Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City Counci -T
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: Royal Brompton Hospital
state: Kensington And Chelsea
city: London
country: United Kingdom
facility: University College London Hospital
state: London, City Of
city: Nottingham
country: United Kingdom
facility: City Hospital, Nottingham University Hospitals
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: 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.