ClinicalTrials.gov

History of Changes for Study: NCT04819100
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (LIBRETTO-432)
Latest version (submitted November 10, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 25, 2021 None (earliest Version on record)
2 April 1, 2021 Contacts/Locations and Study Status
3 April 1, 2021 Sponsor/Collaborators and Study Status
4 April 16, 2021 Contacts/Locations and Study Status
5 May 4, 2021 Contacts/Locations and Study Status
6 May 18, 2021 Contacts/Locations and Study Status
7 June 8, 2021 Contacts/Locations and Study Status
8 June 17, 2021 Contacts/Locations and Study Status
9 June 29, 2021 Eligibility and Study Status
10 July 5, 2021 Contacts/Locations and Study Status
11 July 15, 2021 Contacts/Locations and Study Status
12 August 4, 2021 Contacts/Locations and Study Status
13 August 17, 2021 Contacts/Locations and Study Status
14 September 2, 2021 Contacts/Locations and Study Status
15 September 20, 2021 Contacts/Locations and Study Status
16 October 4, 2021 Contacts/Locations and Study Status
17 October 15, 2021 Recruitment Status, Contacts/Locations, Study Status and Oversight
18 October 26, 2021 Contacts/Locations and Study Status
19 November 8, 2021 Contacts/Locations and Study Status
20 December 2, 2021 Recruitment Status, Contacts/Locations and Study Status
21 December 16, 2021 Contacts/Locations and Study Status
22 December 20, 2021 Recruitment Status, Study Status and Contacts/Locations
23 January 5, 2022 Contacts/Locations, Study Status and References
24 January 18, 2022 Contacts/Locations and Study Status
25 March 8, 2022 Contacts/Locations and Study Status
26 March 21, 2022 Contacts/Locations and Study Status
27 April 6, 2022 Contacts/Locations and Study Status
28 April 18, 2022 Contacts/Locations and Study Status
29 May 20, 2022 Contacts/Locations and Study Status
30 June 8, 2022 Contacts/Locations and Study Status
31 June 20, 2022 Contacts/Locations and Study Status
32 July 7, 2022 Study Status and Contacts/Locations
33 July 18, 2022 Contacts/Locations and Study Status
34 August 8, 2022 Contacts/Locations and Study Status
35 August 17, 2022 Contacts/Locations and Study Status
36 September 8, 2022 Contacts/Locations and Study Status
37 September 19, 2022 Outcome Measures, Eligibility and Study Status
38 October 11, 2022 Contacts/Locations and Study Status
39 October 19, 2022 Contacts/Locations and Study Status
40 November 10, 2022 Contacts/Locations and Study Status
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Study NCT04819100
Submitted Date:  March 25, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: 18126
Brief Title: A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (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
Secondary IDs: J2G-MC-JZJX [Eli Lilly and Company]
2020-005191-35 [EudraCT Number]
Open or close this module Study Status
Record Verification: March 15, 2021
Overall Status: Not yet recruiting
Study Start: March 31, 2021
Primary Completion: April 20, 2031 [Anticipated]
Study Completion: April 19, 2032 [Anticipated]
First Submitted: March 25, 2021
First Submitted that
Met QC Criteria:
March 25, 2021
First Posted: March 26, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 25, 2021
Last Update Posted: March 26, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Eli Lilly and Company
Responsible Party: Sponsor
Collaborators: Loxo Oncology, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 170 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Selpercatinib
Selpercatinib administered orally.
Drug: Selpercatinib
Administered orally.
Other Names:
  • LY3527723
  • LOXO-292
Placebo Comparator: Placebo
Placebo administered orally.
Drug: Placebo
Administered orally.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Event-Free Survival (EFS)
[ Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years) ]

EFS by Investigator Assessment in the Primary Analysis Population
Secondary Outcome Measures:
1. EFS
[ Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years) ]

EFS by investigator assessment in the overall population
2. Overall Survival (OS)
[ Time Frame: Randomization to death from any cause (estimated as up to 9 years)] ]

OS
3. EFS
[ Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)] ]

EFS by blinded independent central review (BICR)
4. Time to Distant Disease Recurrence in the Central Nervous System (CNS)
[ Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years) ]

Time to distant disease recurrence in the CNS by investigator assessment and BICR
5. Progression Free Survival on the Next Line of Treatment (PFS2)
[ Time Frame: Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years) ]

PFS2 by investigator assessment
6. Positive Predictive Value (PPV) of Local Lab Tests Compared to Central Lab Test to Detect Rearranged during Transfection (RET) Gene Fusion
[ Time Frame: Baseline ]

PPV of local lab tests compared to central lab test to detect RET gene fusion
7. Mean Change from Baseline over Time in NSCLC Symptoms
[ Time Frame: Baseline to treatment discontinuation (estimated as up to 3 years) ]

NSCLC symptoms will be measured using the 7-item NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). The NSCLC-SAQ measures the severity/frequency of the following core symptoms: Cough, pain, dyspnea, fatigue, and appetite. Raw scores range from 0 to 4 and the total score ranges from 0-20. Higher scores represent worse symptoms.
8. Mean Change from Baseline over Time in Physical Function
[ Time Frame: Baseline to treatment discontinuation (estimated as up to 3 years) ]

Physical function will be measured by the 5 physical function items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (also known as the EORTC IL 19 questionnaire). Raw scores range from 0-20. Higher scores indicate worst function.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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) or next generation sequencing (NGS).
  • Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC. (Receipt of systemic anti-cancer therapy is allowed but not required.)
  • Must have completely recovered from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy at the time of randomization.
  • 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.

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).
Open or close this module Contacts/Locations
Central Contact Person: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Telephone: 1-317-615-4559
Email: ClinicalTrials.gov@lilly.com
Study Officials: 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)
Study Director
Eli Lilly and Company
Locations: United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Contact:Contact: 310-633-8400
Contact:Principal Investigator: Jonathan W Goldman
UCLA Medical Center
Torrance, California, United States, 90502
Contact:Contact: 310-306-8223
Contact:Principal Investigator: Mykola Onyshchenko
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Contact:Contact: 617-632-6190
Contact:Principal Investigator: Jacob Sands
United States, Michigan
Henry Ford Hospital Detroit
Detroit, Michigan, United States, 48202-2689
Contact:Contact: 888-734-5322
Contact:Principal Investigator: Igor I Rybkin
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Contact:Contact: 5072660911
Contact:Principal Investigator: K Robert Shen
United States, New York
New York Oncology Hematology, P.C
Albany, New York, United States, 12208
Contact:Contact: 518-262-6696
Contact:Principal Investigator: Makenzi C Evangelist
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact:Contact: 646-449-1772
Contact:Principal Investigator: Alexander Drilon
United States, Oregon
Providence Cancer Center Oncology Hematology Care
Portland, Oregon, United States, 97213
Contact:Contact: 503-215-5696
Contact:Principal Investigator: Rachel Sanborn
United States, Tennessee
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States, 37203
Contact:Contact: 615-329-7274
Contact:Principal Investigator: SMO Sarah Cannon Research Inst.
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact:Contact: 713-745-6763
Contact:Principal Investigator: Yasir Elamin
US Oncology
The Woodlands, Texas, United States, 77380
Contact:Contact: 281-863-1000
Contact:Principal Investigator: SMO US Oncology
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05405
Contact:Contact: 802-847-8400
Contact:Principal Investigator: Hibba Rehman
Austria
Klinik Floridsdorf - Abteilung für INNERE MEDIZIN UND PNEUMOLOGIE
Wien, Austria, 1210
Contact:Contact: 43 1 27700 3855
Contact:Principal Investigator: Maximilian Johannes Hochmair
Austria, Vorarlberg
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria, 6800
Contact:Contact: 4355223030
Contact:Principal Investigator: Thomas Winder
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Contact:Contact: 3238214719
Contact:Principal Investigator: Annelies Janssens
CHU Dinant Godinne - UCL Namur
Yvoir, Belgium, 5530
Contact:Contact: 3281423374
Contact:Principal Investigator: Sebahat Oçak
Brazil
IBCC - Instituto Brasileiro de Controle do Câncer
São Paulo, Brazil, 03102-006
Contact:Contact: 551134744222
Contact:Principal Investigator: Larissa Carvalho Lopes de Paula
Centro Paulista de Oncologia
São Paulo, Brazil, 04538-133
Contact:Contact: 551130675433
Contact:Principal Investigator: Andrey Soares
Brazil, Bahia
Núcleo de Oncologia da Bahia
Salvador, Bahia, Brazil, 41170-110
Contact:Contact: 557140097085
Contact:Principal Investigator: Tercia Vilasboas Reis
Brazil, Minas Gerais
Oncocentro BH
Belo Horizonte, Minas Gerais, Brazil, 30260-680
Contact:Contact: 553121268600
Contact:Principal Investigator: Flavia Amaral Duarte
COT - Centro Oncológico do Triângulo S.A.
Uberlândia, Minas Gerais, Brazil, 38408-150
Contact:Principal Investigator: Fernando Maciel Barbosa
Brazil, Pernambuco
Multihemo Servicos Medicos S/A
Recife, Pernambuco, Brazil, 500070-460
Contact:Contact: 558132050505
Contact:Principal Investigator: Marcelo Ramos Tejo Salgado
Brazil, RJ
Instituto COI de Pesquisa Educação e Gestão
Rio de Janeiro, RJ, Brazil, 22793-080
Contact:Contact: 552133852088
Contact:Principal Investigator: Luiz Henrique de Lima Araujo
Brazil, Rio Grande Do Sul
Hospital São Lucas - PUCRS - ONCOLOGY
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Contact:Contact: 555133203039
Contact:Principal Investigator: Ana Caroline Zimmer Gelatti
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Contact:Contact: 4169464645
Contact:Principal Investigator: Natasha B. Leighl
Czechia
Nemocnice AGEL Ostrava-Vitkovice a.s.-Plicni oddeleni
Ostrava - Vitkovice, Czechia, 70384
Contact:Contact: +420 595 633 400
Contact:Principal Investigator: JAROMIR ROUBEC
Fakultni nemocnice Bulovka
Praha 8, Czechia, 180 81
Contact:Contact: 00420266 082 267
Contact:Principal Investigator: Jana Krejci
Denmark, Syd
Odense Universitetshospital
Odense C, Syd, Denmark, 5000
Contact:Contact: 4565412990
Contact:Principal Investigator: Karin Holmskov Hansen
Germany
Charité-Campus Benjamin Franklin-Hematology and Oncology
Berlin, Germany, 12200
Contact:Contact: 004930450513382
Contact:Principal Investigator: Damian Tobias Rieke
Germany, Baden-Württemberg
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Württemberg, Germany, 69126
Contact:Contact: 4962213968304
Contact:Principal Investigator: Helge Bischoff
Germany, Bayern
Asklepios Fachklinik München-Gauting
Gauting, Bayern, Germany, 82131
Contact:Contact: +4989857914111
Contact:Principal Investigator: Niels Reinmuth
Germany, Hessen
Lungenfachklinik Immenhausen
Immenhausen, Hessen, Germany, 34376
Contact:Contact: 495673501436
Contact:Principal Investigator: Achim Rittmeyer
Germany, Lower Saxony
Franziskus Hospital Harderberg
Georgsmarienhütte, Lower Saxony, Germany, 49124
Contact:Contact: 495415022466
Contact:Principal Investigator: Petra Hoffknecht
Germany, Schleswig-Holstein
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, Germany, 22927
Contact:Contact: m.reck@lungenclinic.de
Contact:Principal Investigator: Martin Reck
Greece
SOTIRIA General Hospital
Athens, Greece, 11527
Contact:Principal Investigator: Konstantinos N Syrigos
Greece, Achaia
University General Hospital of Patras
Patras, Achaia, Greece, 26504
Contact:Contact: 3061999740
Contact:Principal Investigator: Angelos Koutras
Greece, Attikí
Agios Savvas Regional Cancer Hospital
Athens, Attikí, Greece, 115 22
Contact:Principal Investigator: Stamatina Demiri
Greece, Krete
University General Hospital of Heraklion
Heraklion, Krete, Greece, 71110
Contact:Principal Investigator: Dimitrios Mavroudis
Greece, Thessaloniki
G.Papanikolaou General Hospital
Exohi, Thessaloniki, Greece, 57010
Contact:Principal Investigator: THEODOROS KONTAKIOTIS
Greece, Thessaloníki
European Interbalkan Medical Center
Thessaloniki, Thessaloníki, Greece, 570 01
Contact:Principal Investigator: Sofia Baka
Israel
Rambam Medical Center
Haifa, Israel, 3109601
Contact:Contact: 972-4-7776750
Contact:Principal Investigator: Mirjana Wollner
Hadassah Medical Center
Jerusalem, Israel, 9112001
Contact:Contact: 972-2-6778636
Contact:Principal Investigator: Hovav Nechushtan
Israel, Ramat Gan
Sheba Medical Center
Tel Hashomer, Ramat Gan, Israel, 5265601
Contact:Contact: 972-3-5307096
Contact:Principal Investigator: Jair Bar
Italy
IRCCS Ospedale Oncologico di Bari
Bari, Italy, 70124
Contact:Contact: 390805555418
Contact:Principal Investigator: Domenico Galetta
Ospedale Niguarda Ca Granda
Milano, Italy, 20162
Contact:Contact: 390264444044
Contact:Principal Investigator: Diego Signorelli
Ospedale V. Monaldi
Napoli, Italy, 80131
Contact:Contact: 390817064300
Contact:Principal Investigator: Danilo Rocco
Istituto Oncologico Veneto IRCCS
Padova, Italy, 35128
Contact:Contact: 390498215931
Contact:Principal Investigator: Giulia Pasello
Italy, Milano
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Contact:Contact: 390282245945
Contact:Principal Investigator: Luca Toschi
Italy, Torino
Azienda Ospedaliero - Universitaria S. Luigi Gonzaga
Orbassano, Torino, Italy, 10043
Contact:Contact: 390119026539
Contact:Principal Investigator: Silvia Novello
Mexico, DF
Medica Sur
Mexico, DF, Mexico, 14050
Contact:Contact: 54247282
Contact:Principal Investigator: Jeronimo Rafael Rodriguez Cid
Mexico, Jalisco
Actualidad Basada en la Investigación del Cáncer
Guadalajara, Jalisco, Mexico, 44680
Contact:Principal Investigator: Emmanuel de la Mora Jiménez
Mexico, Nuevo León
Avix Investigación Clínica, S.C
Monterrey, Nuevo León, Mexico, 64710
Contact:Contact: 528181431112
Contact:Principal Investigator: Julia Saenz
Netherlands
Universitair Medisch Centrum St Radboud Nijmegen
Nijmegen, Netherlands, 6525 GA
Contact:Contact: 31243610325
Contact:Principal Investigator: Michel van den Heuvel
Poland
Wojewodzki Zespol Specjalistyczny Chorob Pluc
Poznan, Poland, 60-569
Contact:Contact: +48603191683
Contact:Principal Investigator: Maciej Bryl
Puerto Rico
Puerto Rico Medical Research Center
Hato Rey, Puerto Rico, 00917
Contact:Contact: 7879005661
Contact:Principal Investigator: Rafael D Betancourt-Garcia
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico, 00935
Contact:Contact: 7874073333
Contact:Principal Investigator: Noridza Rivera
Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca, Romania, 400015
Contact:Contact: 40745646368
Contact:Principal Investigator: Tudor Ciuleanu
Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Russian Federation, 163045
Contact:Contact: 8 (8182) 27-57-74
Contact:Principal Investigator: Ekaterina Petrovna Solovyeva
Hadassah Medical LTD
Moscow, Russian Federation, 121205
Contact:Contact: +7 495 800 10 00
Contact:Principal Investigator: Maria Kazantseva
National medical research center of oncology n. a. N. N. Petrov
Saint Petersburg, Russian Federation, 197758
Contact:Contact: +7(812)439-95-55,1505
Contact:Principal Investigator: Evgeny Levchenko
Spain
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Contact:Contact: +34 93 4978925
Contact:Principal Investigator: Teresa Moran Bueno
Hospital del Mar
Barcelona, Spain, 08003
Contact:Contact: 34932483117
Contact:Principal Investigator: Edurne Arriola Aperribay
Hospital Universitari Quirón Dexeus
Barcelona, Spain, 08028
Contact:Contact: +34935460143
Contact:Principal Investigator: Alejandro Martínez Bueno
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Contact:Contact: 34 93 489 4374
Contact:Principal Investigator: Alex Martinez Marti
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Contact:Contact: (0034) 663701518 / Ext 380748
Contact:Principal Investigator: Noemi Reguart
Institut Catala d'Oncologia
Barcelona, Spain, 08907
Contact:Contact: 34932607744
Contact:Principal Investigator: Ernest Nadal
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Contact:Contact: 34913368302
Contact:Principal Investigator: Pilar Garrido Lopez
Hospital Clinico San Carlos
Madrid, Spain, 28040
Contact:Contact: 34913303649
Contact:Principal Investigator: Mónica Antoñanzas Basa
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Contact:Contact: 34 91 3908626
Contact:Principal Investigator: Luis Paz-Ares Rodriguez
Hospital Regional Universitario
Malaga, Spain, 29010
Contact:Contact: 34951030543
Contact:Principal Investigator: Manuel Cobo Dols
Hospital Son Llàtzer-ONCOLOGY
Palma de Mallorca, Spain, 07198
Contact:Contact: 871202000 ext 1535
Contact:Principal Investigator: Francisco García Navalón
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Contact:Contact: 34955008932
Contact:Principal Investigator: David Vicente Baz
Hospital Universitario La Fe de Valencia
Valencia, Spain, 46026
Contact:Contact: 961245877
Contact:Principal Investigator: Oscar Juan Vidal
Spain, La Coruna
CHUS - Hospital Clinico Universitario
Santiago de Compostela, La Coruna, Spain, 15706
Contact:Contact: 981 950 511
Contact:Principal Investigator: Luis León Mateos
Sweden
Sahlgrenska Universitetssjukhuset
Göteborg, Sweden, 41345
Contact:Contact: +46700906097
Contact:Principal Investigator: Andreas Hallqvist
Turkey
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, Turkey, 01250
Contact:Contact: +903223444444
Contact:Principal Investigator: Ozgur Ozyilkan
Adana Sehir Hastanesi
Adana, Turkey, 4522
Contact:Contact: +905331447619
Contact:Principal Investigator: Timucin Cil
Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
Ankara, Turkey, 06200
Contact:Contact: 903123360909
Contact:Principal Investigator: Berna Oksuzoglu
Ankara City Hospital Oncology
Ankara, Turkey, 06800
Contact:Contact: +903123241555
Contact:Principal Investigator: Mehmet Ali Sendur
Uludag University Medical Faculty
Bursa, Turkey, 16059
Contact:Contact: +905336460546
Contact:Principal Investigator: Turkkan Evrensel
Dicle University
Diyarbakir, Turkey, 21280
Contact:Contact: +905337677131
Contact:Principal Investigator: Muhammet Ali Kaplan
Trakya University
Edirne, Turkey, 22030
Contact:Contact: +905322480988
Contact:Principal Investigator: Irfan Cicin
Medipol Mega University Hospital
Istanbul, Turkey, 34214
Contact:Contact: +905053195935
Contact:Principal Investigator: Omer Fatih Olmez
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, Turkey, 34722
Contact:Contact: +902166065200
Contact:Principal Investigator: Mahmut Gumus
Ege University Medicine of Faculty
Izmir, Turkey, 35100
Contact:Contact: 902323902468
Contact:Principal Investigator: Tuncay Goksel
Izmir Katip Celebi University Training and Research Hospital Oncology
Izmir, Turkey, 35360
Contact:Contact: +905324078648
Contact:Principal Investigator: Ahmet Alacacioglu
Medical Park Izmir Hospital
Izmir, Turkey, 35575
Contact:Contact: +905052642353
Contact:Principal Investigator: Cagatay Arslan
Memorial Antalya Hastanesi
Kepez, Turkey, 07020
Contact:Contact: +905076397700
Contact:Principal Investigator: Seyda Gunduz
Inonu University Medical Faculty Oncology
Malatya, Turkey, 44280
Contact:Contact: +905326441884
Contact:Principal Investigator: Hakan Harputluoglu
Maslak Acıbadem Hstanesi
Sarıyer, Turkey, 34457
Contact:Contact: +905062979770
Contact:Principal Investigator: Atakan Demir
Open or close this module IPDSharing
Plan to Share IPD: 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.
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria:
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

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