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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Selpercatinib
Placebo
Sponsored by
Loxo Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) or next generation sequencing (NGS).

  • 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).

Sites / Locations

  • UCLA Hematology/Oncology - Santa MonicaRecruiting
  • Stockton Hematology Oncology GroupRecruiting
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterRecruiting
  • GenesisCare - Boca RatonRecruiting
  • Florida Cancer Specialists - SouthRecruiting
  • Florida Cancer Specialists - NorthRecruiting
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Mayo Clinic in Rochester, MinnesotaRecruiting
  • USO-New York Oncology Hematology, P.CRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Tennessee Oncology NashvilleRecruiting
  • USO - Texas Oncology - AustinRecruiting
  • US OncologyRecruiting
  • Border Medical OncologyRecruiting
  • Rockhampton HospitalRecruiting
  • Bendigo Health Care GroupRecruiting
  • Goulburn Valley HealthRecruiting
  • South West HealthcareRecruiting
  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site GodinneRecruiting
  • Clinique Saint PierreRecruiting
  • CHU UCL Namur/Site Sainte ElisabethRecruiting
  • Nucleo de Oncologia da BahiaRecruiting
  • Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul
  • Centro Oncológico do TriânguloRecruiting
  • Hospital de Câncer de RecifeRecruiting
  • Hospital BP
  • Instituto D'Or de Pesquisa e Ensino (IDOR)
  • Instituto de Educação, Pesquisa e Gestão em SaúdeRecruiting
  • Centro Paulista de Oncologia ClínicaRecruiting
  • Núcleo de Pesquisa Clínica da Rede São CamiloRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • Beijing Friendship HospitalRecruiting
  • Beijing Cancer hospitalRecruiting
  • Fujian Provincial HospitalRecruiting
  • Southern Medical University Nanfang HospitalRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
  • Xiangya Hospital, Central South UniversityRecruiting
  • Hunan Cancer HospitalRecruiting
  • Hunan Cancer HospitalRecruiting
  • Jilin Cancer HospitalRecruiting
  • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation ArmyRecruiting
  • Jinan Central HospitalRecruiting
  • Shanghai Chest HospitalRecruiting
  • Zhongshan Hospital, Fudan UniversityRecruiting
  • Shanghai Pulmonary HospitalRecruiting
  • the Third People's Hospital of ChengduRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • First Affiliated Hosp of College of Med, Zhejiang UniversityRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Fakultni nemocnice BulovkaRecruiting
  • Centre Leon BerardRecruiting
  • Hospices Civils de Lyon - Hopital Louis PradelRecruiting
  • Gustave RoussyRecruiting
  • Franziskus-Hospital HarderbergRecruiting
  • Evangelische Lungenklinik BerlinRecruiting
  • Asklepios Klinik HarburgRecruiting
  • Errikos Dunant Hospital CenterRecruiting
  • Sotiria Thoracic Diseases Hospital of AthensRecruiting
  • European Interbalkan Medical CenterRecruiting
  • Hong Kong United Oncology CentreRecruiting
  • Queen Elizabeth HospitalRecruiting
  • Regional Cancer Centre - ThiruvananthapuramRecruiting
  • Aichi Cancer Center HospitalRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Niigata Cancer Center HospitalRecruiting
  • Himeji Medical CenterRecruiting
  • Hikita Pediatric clinicRecruiting
  • Tominaga HospitalRecruiting
  • Japanese Foundation for Cancer ResearchRecruiting
  • Hiroshima University HospitalRecruiting
  • Osaka Medical Center for Cancer and Cardiovascular DiseasesRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Actualidad Basada en la Investigación del CáncerRecruiting
  • Oncare Viaducto NapolesRecruiting
  • Avix Investigación Clinica, S.C.Recruiting
  • Oslo Universitetssykehus Ullevål
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w WarszawieRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Pan American Center for Oncology TrialsRecruiting
  • Arkhangelsk Clinical Oncological DispensaryRecruiting
  • Parkway Cancer Centre - Gleneagles HospitalRecruiting
  • Tan Tock Seng HospitalRecruiting
  • CHUS - Hospital Clinico UniversitarioRecruiting
  • Institut Català d'Oncologia (ICO) - BadalonaRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Changhua Christian HospitalRecruiting
  • Chang Gung Memorial Hospital at KaohsiungRecruiting
  • Chung Shan Medical University HospitalRecruiting
  • Chi Mei Hospital - Liouying BranchRecruiting
  • National Taiwan University Cancer Center (NTUCC)Recruiting
  • Taipei Veterans General HospitalRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Taichung Veterans General HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Chang Gung Medical Foundation-Linkou BranchRecruiting
  • Trakya UniversityRecruiting
  • University College London HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Selpercatinib

Placebo

Arm Description

Selpercatinib administered orally.

Placebo administered orally.

Outcomes

Primary Outcome Measures

Event-Free Survival (EFS)
EFS by Investigator Assessment in the Primary Analysis Population

Secondary Outcome Measures

EFS
EFS by investigator assessment in the overall population
Overall Survival (OS)
OS
EFS
EFS by blinded independent central review (BICR)
Time to Distant Disease Recurrence in the Central Nervous System (CNS)
Time to distant disease recurrence in the CNS by investigator assessment and BICR
Progression Free Survival on the Next Line of Treatment (PFS2)
PFS2 by investigator assessment
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
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.
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.

Full Information

First Posted
March 25, 2021
Last Updated
October 18, 2023
Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04819100
Brief Title
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
Acronym
LIBRETTO-432
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
August 31, 2028 (Anticipated)
Study Completion Date
November 30, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Selpercatinib
Arm Type
Experimental
Arm Description
Selpercatinib administered orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally.
Intervention Type
Drug
Intervention Name(s)
Selpercatinib
Other Intervention Name(s)
LY3527723, LOXO-292
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Event-Free Survival (EFS)
Description
EFS by Investigator Assessment in the Primary Analysis Population
Time Frame
Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Secondary Outcome Measure Information:
Title
EFS
Description
EFS by investigator assessment in the overall population
Time Frame
Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Title
Overall Survival (OS)
Description
OS
Time Frame
Randomization to death from any cause (estimated as up to 9 years)]
Title
EFS
Description
EFS by blinded independent central review (BICR)
Time Frame
Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]
Title
Time to Distant Disease Recurrence in the Central Nervous System (CNS)
Description
Time to distant disease recurrence in the CNS by investigator assessment and BICR
Time Frame
Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)
Title
Progression Free Survival on the Next Line of Treatment (PFS2)
Description
PFS2 by investigator assessment
Time Frame
Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)
Title
Positive Predictive Value (PPV) of Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test
Description
PPV of RET Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test
Time Frame
Baseline
Title
Mean Change from Baseline over Time in NSCLC Symptoms
Description
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.
Time Frame
Baseline to treatment discontinuation (estimated as up to 3 years)
Title
Mean Change from Baseline over Time in Physical Function
Description
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.
Time Frame
Baseline to treatment discontinuation (estimated as up to 3 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Hematology/Oncology - Santa Monica
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Goldman
Facility Name
Stockton Hematology Oncology Group
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunny Philip
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charity Huang
Facility Name
GenesisCare - Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-409-1767
First Name & Middle Initial & Last Name & Degree
Edgardo Santos
Facility Name
Florida Cancer Specialists - South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lowell Hart
Facility Name
Florida Cancer Specialists - North
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maen Hussein
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Sands
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel B. Costa
Facility Name
Mayo Clinic in Rochester, Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K Robert Shen
Facility Name
USO-New York Oncology Hematology, P.C
City
Clifton Park
State/Province
New York
ZIP/Postal Code
12065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
518-262-6696
First Name & Middle Initial & Last Name & Degree
Makenzi Evangelist
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Drilon
Facility Name
Tennessee Oncology Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Johnson
Facility Name
USO - Texas Oncology - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
512-421-4108
First Name & Middle Initial & Last Name & Degree
Vivian Cline
Facility Name
US Oncology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
281-863-1000
First Name & Middle Initial & Last Name & Degree
SMO US Oncology
Facility Name
Border Medical Oncology
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Underhill
Facility Name
Rockhampton Hospital
City
Rockhampton
State/Province
Queensland
ZIP/Postal Code
4700
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudhakar Vemula
Facility Name
Bendigo Health Care Group
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Warren
Facility Name
Goulburn Valley Health
City
Shepparton
State/Province
Victoria
ZIP/Postal Code
3630
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Torres
Facility Name
South West Healthcare
City
Warrnambool
State/Province
Victoria
ZIP/Postal Code
3280
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Collins
Facility Name
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebahat Ocak
Facility Name
Clinique Saint Pierre
City
Ottignies
State/Province
Wallonne, Région
ZIP/Postal Code
1340
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciano Carestia
Facility Name
CHU UCL Namur/Site Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
003281720761
First Name & Middle Initial & Last Name & Degree
Jean-Charles Goeminne
Facility Name
Nucleo de Oncologia da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40170-070
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tercia Vilasboas Reis
Facility Name
Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70200-730
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luiza Dib Batista Bugiato Faria
Facility Name
Centro Oncológico do Triângulo
City
Uberlândia
State/Province
Minas Gerais
ZIP/Postal Code
38408-150
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Maciel Barbosa
Facility Name
Hospital de Câncer de Recife
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50040-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo Ramos Tejo Salgado
Facility Name
Hospital BP
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+5511985883170
First Name & Middle Initial & Last Name & Degree
Marcelo Corassa
Facility Name
Instituto D'Or de Pesquisa e Ensino (IDOR)
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04543-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
551138932632
First Name & Middle Initial & Last Name & Degree
Milena Perez Mak
Facility Name
Instituto de Educação, Pesquisa e Gestão em Saúde
City
Rio de Janeiro
ZIP/Postal Code
22775001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Luciana Agostinho Padoan
Facility Name
Centro Paulista de Oncologia Clínica
City
São Paulo
ZIP/Postal Code
01452-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrey Soares
Facility Name
Núcleo de Pesquisa Clínica da Rede São Camilo
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larissa Carvalho Lopes Paula
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penelope Bradbury
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13910761058
First Name & Middle Initial & Last Name & Degree
Mu Hu
Facility Name
Beijing Cancer hospital
City
Haidian District
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yue Yang
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
pan xiaojie
Facility Name
Southern Medical University Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaican Cai
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuening Yang
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Yu
Facility Name
Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
027-85726114
First Name & Middle Initial & Last Name & Degree
Yongde Liao
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunfang Zhang
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13170419973
First Name & Middle Initial & Last Name & Degree
Lin Wu
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenxiang Wang
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Facility Name
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Jiang
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13370582181
First Name & Middle Initial & Last Name & Degree
Meili Sun
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
862162821990
First Name & Middle Initial & Last Name & Degree
Wentao Fang
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Wang
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
2602165115006
First Name & Middle Initial & Last Name & Degree
Yuming Zhu
Facility Name
the Third People's Hospital of Chengdu
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoping Li
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke Wang
Facility Name
First Affiliated Hosp of College of Med, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianying Zhou
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
3858182310
First Name & Middle Initial & Last Name & Degree
Qixun Chen
Facility Name
Fakultni nemocnice Bulovka
City
Prague
State/Province
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jana Krejci
Facility Name
Centre Leon Berard
City
Lyon CEDEX 08
State/Province
Rhône-Alpes
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurice Perol
Facility Name
Hospices Civils de Lyon - Hopital Louis Pradel
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Duruisseaux
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Besse
Facility Name
Franziskus-Hospital Harderberg
City
Georgsmarienhütte
State/Province
Niedersachsen
ZIP/Postal Code
49124
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Hoffknecht
Facility Name
Evangelische Lungenklinik Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
00493094802545
First Name & Middle Initial & Last Name & Degree
Christian Grohe
Facility Name
Asklepios Klinik Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
49401818865008
First Name & Middle Initial & Last Name & Degree
Claas Wesseler
Facility Name
Errikos Dunant Hospital Center
City
Athens
State/Province
Attikí
ZIP/Postal Code
115 26
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IOANNIS MOUNTZIOS
Facility Name
Sotiria Thoracic Diseases Hospital of Athens
City
Athens
State/Province
Attikí
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Syrigos
Facility Name
European Interbalkan Medical Center
City
Thessaloniki
State/Province
Thessaloníki
ZIP/Postal Code
570 01
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Phone
302310400368
First Name & Middle Initial & Last Name & Degree
Sofia Baka
Facility Name
Hong Kong United Oncology Centre
City
Hong Kong
ZIP/Postal Code
000000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Chung Jacky Li
Facility Name
Queen Elizabeth Hospital
City
Yau Ma Tei
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Tin Yan
Facility Name
Regional Cancer Centre - Thiruvananthapuram
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arun Sankar
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noriaki Sakakura
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahiro Tsuboi
Facility Name
Niigata Cancer Center Hospital
City
Niigata
State/Province
Hokkaido
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Tanaka
Facility Name
Himeji Medical Center
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tetsuji Kawamura
Facility Name
Hikita Pediatric clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terufumi Kato
Facility Name
Tominaga Hospital
City
Nagaizumi
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hirotsugu Kenmotsu
Facility Name
Japanese Foundation for Cancer Research
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81120023812
First Name & Middle Initial & Last Name & Degree
Noriko Yanagitani
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morihito Okada
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiro Okami
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyǒnggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Jung Kim
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Pusan-Kwangyǒkshi
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Seop Eom
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
5505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Min Choi
Facility Name
Actualidad Basada en la Investigación del Cáncer
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44680
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel de la Mora Jimenez
Facility Name
Oncare Viaducto Napoles
City
Cdmx
State/Province
México
ZIP/Postal Code
03810
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeronimo Rafael Rodriguez Cid
Facility Name
Avix Investigación Clinica, S.C.
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Angelina Saenz Frias
Facility Name
Oslo Universitetssykehus Ullevål
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vilde Drageset Haakensen
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Pluzanski
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Wrona
Facility Name
Pan American Center for Oncology Trials
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noridza Rivera-Rodriguez
Facility Name
Arkhangelsk Clinical Oncological Dispensary
City
Arkhangelsk
State/Province
Arkhangel'skaya Oblast'
ZIP/Postal Code
163045
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekaterina P. Solovyeva
Facility Name
Parkway Cancer Centre - Gleneagles Hospital
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
258500
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tan Min Chin
Facility Name
Tan Tock Seng Hospital
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Puey Ling Ling CHIA
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Angel Leon Mateos
Facility Name
Institut Català d'Oncologia (ICO) - Badalona
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Teresa Moran
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Vicente Baz
Facility Name
Changhua Christian Hospital
City
Changhua County
State/Province
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Hao Lin
Facility Name
Chang Gung Memorial Hospital at Kaohsiung
City
Kaohsiung Niao Sung Dist
State/Province
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang-Chih Chang
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gee-Chen Chang
Facility Name
Chi Mei Hospital - Liouying Branch
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
73657
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen-Hsun Chen
Facility Name
National Taiwan University Cancer Center (NTUCC)
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
106
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Hsin Yang
Facility Name
Taipei Veterans General Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuh-Min Chen
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inn-Wen Chong
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsung-Ying Yang
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Hsin Yang
Facility Name
Chang Gung Medical Foundation-Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng-Ta Yang
Facility Name
Trakya University
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
Phone
905322480988
First Name & Middle Initial & Last Name & Degree
Bulent Erdogan
Facility Name
University College London Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siow Ming Lee

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/
Citations:
PubMed Identifier
35950566
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.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/7cM1z2xjPYI17laAP4YXvV
Description
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (LIBRETTO-432)

Learn more about this trial

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

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