Clinical trial • Phase III • Oncology

SELPERCATINIB for Non-small cell lung cancer (RET fusion-positive)

Phase III trial of SELPERCATINIB for Non-small cell lung cancer (RET fusion-positive).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (RET fusion-positive)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-03-2024
First CTIS Authorization Date
23-05-2024

Trial design

Randomised, selpercatinib (oral capsules) versus placebo to match ly3527723; dose and schedule not specified in the available record-controlled Phase III trial in Poland, Denmark, Romania and others.

Randomised
Yes
Comparator
SELPERCATINIB (oral capsules) versus placebo to match LY3527723; dose and schedule not specified in the available record
Target Sample Size
152

Eligibility

Recruits 152 Vulnerable population selected. Informed consent is obtained using subject information and informed consent forms (multiple versions and translations are listed in the documents), with contact for queries provided via the Lilly Clinical Trials information desk (EU_lilly_clinical_trials@lilly.com). Specific assent/consent handling for minors or other vulnerable subgroups is not detailed in the available record..

Vulnerable Population
Vulnerable population selected. Informed consent is obtained using subject information and informed consent forms (multiple versions and translations are listed in the documents), with contact for queries provided via the Lilly Clinical Trials information desk (EU_lilly_clinical_trials@lilly.com). Specific assent/consent handling for minors or other vulnerable subgroups is not detailed in the available record.

Inclusion criteria

  • {"criterion_text":"- Participants must have early-stage non-small cell lung cancer (NSCLC)"}
  • {"criterion_text":"- Participants must have already had (and recovered from) surgery or radiation"}
  • {"criterion_text":"- Participants must be in fair to good health"}
  • {"criterion_text":"- Participants must be willing to use highly effective birth control during the study"}

Exclusion criteria

  • {"criterion_text":"- Participants must not have another serious medical condition"}
  • {"criterion_text":"- Participants must not have disease that has spread"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- EFS by investigator assessment in the primary analysis population","definition_or_measurement_approach":"Event-Free Survival (EFS) assessed by investigator assessment in the primary analysis population (comparing EFS between selpercatinib and placebo)"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
152
Recruitment Window Months
132
Consent Approach
Informed consent is obtained using subject information and informed consent forms (multiple versions and translations are provided in the documents list, including main, crossover and prescreening addenda). Multiple language versions are available (examples in the documents list include English, Greek, French, Spanish, Italian, Dutch, Norwegian, Swedish, German and regional variants). Contact for consent queries is the Lilly Clinical Trials information desk (EU_lilly_clinical_trials@lilly.com). No specific age-based assent procedures are described in the available record.

Methods

  • Digital outreach / Webtext / DigitalOutreach materials (documents labelled DigitalOutreach, Webtext, Digital outreach_FRBE etc.)
  • Printed brochures and bifold recruitment brochures (documents labelled BiFold Brochure / Recruitment Brochure / Brochure)
  • Appointment reminder cards and electronic appointment reminders (documents labelled ApptReminderCard, Appointment card, Appointment card dig)
  • Patient cards / emergency cards (documents titled Patient Card, Patient Information Card, Patient emergency card)
  • Site-based recruitment using K1/K2 recruitment arrangements and visit guides (documents titled K1_Recruitment Arrangements, K2_recruitment material_VisitGuide)
  • GP letters / site letters (documents labelled GP Letter or L2_GP Letter)

Geography

Total Number Of Sites
69
Total Number Of Participants
65

Poland

Latest Decision Or Authorization Date
27-05-2024
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Principal Investigator Name
Jaroslaw Kuzdzal
Principal Investigator Email
j.kuzdzal@mp.pl
Contact Person Name
Jaroslaw Kuzdzal
Contact Person Email
j.kuzdzal@mp.pl
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Principal Investigator Name
Katarzyna Stencel
Principal Investigator Email
kstencel@wcpit.org
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Uniwersyteckie Centrum Kliniczne, Centrum Medycyny Nieinwazyjnej, Klinika Onkologii i Radioterapii
Principal Investigator Name
Anna Wrona
Principal Investigator Email
wronania@gmail.com
Contact Person Name
Anna Wrona
Contact Person Email
wronania@gmail.com
Site Name
Narodowy Instytut Onkologii im.Marii Skłodowskiej-Curie,Klinika Nowotworów Płuca i Klatki Piersiowej
Principal Investigator Name
Adam Pluzanski
Principal Investigator Email
adam.pluzanski@pib-nio.pl
Contact Person Name
Adam Pluzanski
Contact Person Email
adam.pluzanski@pib-nio.pl

Denmark

Latest Decision Or Authorization Date
23-05-2024
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Odense University Hospital
Department Name
Department of oncology
Principal Investigator Name
Lotte Holm Land
Principal Investigator Email
lotte.holm.land@rsyd.dk
Contact Person Name
Lotte Holm Land
Contact Person Email
lotte.holm.land@rsyd.dk

Romania

Latest Decision Or Authorization Date
28-05-2024
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Medical Oncology
Principal Investigator Name
Tudor Ciuleanu
Principal Investigator Email
tudor_ciuleanu@hotmail.com
Contact Person Name
Tudor Ciuleanu
Contact Person Email
tudor_ciuleanu@hotmail.com

Greece

Latest Decision Or Authorization Date
07-06-2024
Number Of Sites
7
Number Of Participants
4

Sites

Site Name
University General Hospital Of Heraklion
Department Name
Internal Medicine-Oncology Clinic
Principal Investigator Name
Dimitrios Mavroudis
Principal Investigator Email
medoncsec@med.uoc.gr
Contact Person Name
Dimitrios Mavroudis
Contact Person Email
medoncsec@med.uoc.gr
Site Name
General University Hospital Of Patras
Department Name
lnternal Medicine Clinic-Oncology Department
Principal Investigator Name
Angelos Koutras
Principal Investigator Email
angkoutr@otenet.gr
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
St Savas Hospital
Department Name
2nd Department of Internal Medicine - Oncology
Principal Investigator Name
Anastasios Grivas
Principal Investigator Email
tssgrvs@gmail.com
Contact Person Name
Anastasios Grivas
Contact Person Email
tssgrvs@gmail.com
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd University Internal Medicine Department
Principal Investigator Name
Konstantinos Syrigos
Principal Investigator Email
ksyrigos.trials@gmail.com
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
University Pulmonary Department
Principal Investigator Name
Theodoros Kontakiotis
Principal Investigator Email
kontakiotis@gmail.com
Contact Person Name
Theodoros Kontakiotis
Contact Person Email
kontakiotis@gmail.com
Site Name
Henry Dunant Hospital Center
Department Name
4th Department of Oncology and Clinical Trials Unit
Principal Investigator Name
Ioannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com

Norway

Latest Decision Or Authorization Date
23-05-2024
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Oslo University Hospital HF
Department Name
Dept of Oncology and Dept of Cancer Genetics
Principal Investigator Name
Vilde Drageset Haakensen
Principal Investigator Email
VDD@ous-hf.no
Contact Person Name
Vilde Drageset Haakensen
Contact Person Email
VDD@ous-hf.no

Austria

Latest Decision Or Authorization Date
28-05-2024
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name
Internal Medicine II
Principal Investigator Name
Thomas Winder
Principal Investigator Email
thomas.winder@lkhf.at
Contact Person Name
Thomas Winder
Contact Person Email
thomas.winder@lkhf.at
Site Name
Krankenhaus Nord Klinik Floridsdorf
Department Name
Internal Medicine and Pneumology
Principal Investigator Name
Maximilian Hochmair
Principal Investigator Email
maximilian.hochmair@gesundheitsverbund.at
Contact Person Name
Maximilian Hochmair

Belgium

Latest Decision Or Authorization Date
23-05-2024
Number Of Sites
6
Number Of Participants
2

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Trial Office
Principal Investigator Name
Vincent Vanhaudenarde
Contact Person Name
Vincent Vanhaudenarde
Site Name
Algemeen Ziekenhuis Delta
Department Name
Pneumology
Principal Investigator Name
Ingel Demedts
Principal Investigator Email
ingel.demedts@azdelta.be
Contact Person Name
Ingel Demedts
Contact Person Email
ingel.demedts@azdelta.be
Site Name
Clinique Saint-Pierre
Department Name
Pneumology
Principal Investigator Name
Luciano Carestia
Principal Investigator Email
luciano.carestia@cspo.be
Contact Person Name
Luciano Carestia
Contact Person Email
luciano.carestia@cspo.be
Site Name
Antwerp University Hospital
Department Name
Thoracic Oncology
Principal Investigator Name
Annelies Janssens
Principal Investigator Email
annelies.janssens@uza.be
Contact Person Name
Annelies Janssens
Contact Person Email
annelies.janssens@uza.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur (Yvoir)
Department Name
Pneumology
Principal Investigator Name
Sebahat Ocak
Principal Investigator Email
sebahat.ocak@uclouvain.be
Contact Person Name
Sebahat Ocak
Contact Person Email
sebahat.ocak@uclouvain.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pneumology
Principal Investigator Name
Frank Aboubakar
Principal Investigator Email
frank.aboubakar@uclouvain.be
Contact Person Name
Frank Aboubakar
Contact Person Email
frank.aboubakar@uclouvain.be

Czechia

Latest Decision Or Authorization Date
24-05-2024
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexní onkologické péče
Principal Investigator Name
Ondřej Bilek
Principal Investigator Email
bilek@mou.cz
Contact Person Name
Ondřej Bilek
Contact Person Email
bilek@mou.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Klinika pneumologie
Principal Investigator Name
Jana Krejčí
Principal Investigator Email
jana.krejci@gmail.com
Contact Person Name
Jana Krejčí
Contact Person Email
jana.krejci@gmail.com
Site Name
Nemocnice AGEL Ostrava-Vitkovice a.s.
Principal Investigator Name
Jaromír Roubec
Principal Investigator Email
jaromir.roubec@vtn.agel.cz
Contact Person Name
Jaromír Roubec
Contact Person Email
jaromir.roubec@vtn.agel.cz

France

Latest Decision Or Authorization Date
24-05-2024
Number Of Sites
6
Number Of Participants
7

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Unité d'Oncologie Thoracique
Principal Investigator Name
Marie Wislez
Principal Investigator Email
marie.wislez@aphp.fr
Contact Person Name
Marie Wislez
Contact Person Email
marie.wislez@aphp.fr
Site Name
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Principal Investigator Name
Olaf Mercier
Principal Investigator Email
o.mercier@ghpsj.fr
Contact Person Name
Olaf Mercier
Contact Person Email
o.mercier@ghpsj.fr
Site Name
CHU De Rouen
Department Name
pneumology, intensive care and thoracic oncology
Principal Investigator Name
Florian Guisier
Principal Investigator Email
florian.guisier@chu-rouen.fr
Contact Person Name
Florian Guisier
Contact Person Email
florian.guisier@chu-rouen.fr
Site Name
Centre Leon Berard
Principal Investigator Name
Maurice Perol
Principal Investigator Email
maurice.perol@lyon.unicancer.fr
Contact Person Name
Maurice Perol
Site Name
Centre Hospitalier Regional De Marseille
Department Name
CEPCM
Principal Investigator Name
Pascale Tomasini
Principal Investigator Email
pascale.tomasini@ap-hm.fr
Contact Person Name
Pascale Tomasini
Contact Person Email
pascale.tomasini@ap-hm.fr
Site Name
Hospices Civils De Lyon
Principal Investigator Name
Michael Duruisseaux
Principal Investigator Email
michael.duruisseaux@chu-lyon.fr
Contact Person Name
Michael Duruisseaux

Germany

Latest Decision Or Authorization Date
24-05-2024
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Principal Investigator Name
Damian Rieke
Principal Investigator Email
damian.rieke@charite.de
Contact Person Name
Damian Rieke
Contact Person Email
damian.rieke@charite.de
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Studienzentrum Thoraxonkologie
Principal Investigator Name
Helge Bischoff
Principal Investigator Email
helge.bischoff@med.uni-heidelberg.de
Contact Person Name
Helge Bischoff

Italy

Latest Decision Or Authorization Date
28-05-2024
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Azienda Ospedaliera Dei Colli
Department Name
U.O.C Pneumologia Oncologica DH PNL ONC
Principal Investigator Name
Danilo Rocco
Principal Investigator Email
danilorocc@yahoo.it
Contact Person Name
Danilo Rocco
Contact Person Email
danilorocc@yahoo.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
SSD Oncologia Medica per la Patologia Toracica
Principal Investigator Name
Domenico Galletta
Principal Investigator Email
galetta@teseo.it
Contact Person Name
Domenico Galletta
Contact Person Email
galetta@teseo.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncologia Falck
Principal Investigator Name
Diego Signorelli
Principal Investigator Email
diego.signorelli@ospedaleniguarda.it
Contact Person Name
Diego Signorelli

Spain

Latest Decision Or Authorization Date
24-05-2024
Number Of Sites
27
Number Of Participants
13

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Principal Investigator Name
Oscar Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Oscar Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Universitario Lucus Augusti
Department Name
Oncology
Principal Investigator Name
Sergio Vazquez Estevez
Principal Investigator Email
sergio.vazquez.estevez@sergas.es
Contact Person Name
Sergio Vazquez Estevez
Site Name
Hospital Son Llatzer
Department Name
Oncology
Principal Investigator Name
Juan Coves Sarto
Principal Investigator Email
jcoves@hsll.es
Contact Person Name
Juan Coves Sarto
Contact Person Email
jcoves@hsll.es
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Oncology
Principal Investigator Name
Teresa Moran
Principal Investigator Email
mmoran@iconcologia.net
Contact Person Name
Teresa Moran
Contact Person Email
mmoran@iconcologia.net
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Noemi Reguart Aransay
Principal Investigator Email
nreguart@clinic.cat
Contact Person Name
Noemi Reguart Aransay
Contact Person Email
nreguart@clinic.cat
Site Name
Hospital General Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
Pascale Tomasini
Principal Investigator Email
pascale.tomasini@ap-hm.fr
Contact Person Name
Pascale Tomasini
Contact Person Email
pascale.tomasini@ap-hm.fr
Site Name
University Hospital Son Espases
Department Name
Oncology
Principal Investigator Name
Juan Coves Sarto
Principal Investigator Email
jcoves@hsll.es
Contact Person Name
Juan Coves Sarto
Contact Person Email
jcoves@hsll.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Manuel Cobo Dols
Principal Investigator Email
manuelcobodols@yahoo.es
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Universitario De Leon
Department Name
Oncology
Principal Investigator Name
Soledad Medina Valdivieso
Principal Investigator Email
soledadmedina@saludcastillayleon.es
Contact Person Name
Soledad Medina Valdivieso
Site Name
Hospital Universitario De Canarias
Department Name
Oncology
Principal Investigator Name
Juana Oramas
Principal Investigator Email
juanaoramas@gmail.com
Contact Person Name
Juana Oramas
Contact Person Email
juanaoramas@gmail.com
Site Name
Hospital Del Mar
Department Name
Oncology
Principal Investigator Name
Edurne Arriola Aperribay
Principal Investigator Email
earriola@parcdesalutmar.cat
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
earriola@parcdesalutmar.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Alex Martinez Marti
Principal Investigator Email
amartinezmarti@vhio.net
Contact Person Name
Alex Martinez Marti
Contact Person Email
amartinezmarti@vhio.net
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Principal Investigator Name
Alejandro Martinez Bueno
Principal Investigator Email
amartinez@oncorosell.com
Contact Person Name
Alejandro Martinez Bueno
Contact Person Email
amartinez@oncorosell.com
Site Name
Hospital General Universitario De Albacete
Department Name
Oncology
Principal Investigator Name
Lorenzo Gomez Aldaravi Gutierrez
Principal Investigator Email
jlorenzog@sescam.jccm.es
Contact Person Name
Lorenzo Gomez Aldaravi Gutierrez
Contact Person Email
jlorenzog@sescam.jccm.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncology
Principal Investigator Name
Emilio Esteban Gonzalez
Principal Investigator Email
eestebang@seom.org
Contact Person Name
Emilio Esteban Gonzalez
Contact Person Email
eestebang@seom.org
Site Name
MD Anderson Cancer Center (Spain)
Department Name
Oncology
Principal Investigator Name
Maria Pilar Lopez Criado
Principal Investigator Email
mplopez@mdanderson.es
Contact Person Name
Maria Pilar Lopez Criado
Contact Person Email
mplopez@mdanderson.es
Site Name
Salut Sant Joan De Reus
Department Name
Oncology
Principal Investigator Name
Clara Lucia Gonzalvez
Principal Investigator Email
clara.lucia@salutsantjoan.cat
Contact Person Name
Clara Lucia Gonzalvez
Contact Person Email
clara.lucia@salutsantjoan.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Luis Paz-Ares Rodriguez
Principal Investigator Email
lpazares@hotmail.com
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazares@hotmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncology
Principal Investigator Name
Jose Luis Alonso Romero
Principal Investigator Email
josel.alonso2@carm.es
Contact Person Name
Jose Luis Alonso Romero
Contact Person Email
josel.alonso2@carm.es
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Oncology
Principal Investigator Name
Esperanza Arriola
Principal Investigator Email
arriolaarellano@hotmail.com
Contact Person Name
Esperanza Arriola
Contact Person Email
arriolaarellano@hotmail.com
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
Oncology
Principal Investigator Name
Jose Luis Firvida Perez
Principal Investigator Email
jlfirvidap@gmail.com
Contact Person Name
Jose Luis Firvida Perez
Contact Person Email
jlfirvidap@gmail.com
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology
Principal Investigator Name
Alejandro Martinez Bueno
Principal Investigator Email
amartinez@oncorosell.com
Contact Person Name
Alejandro Martinez Bueno
Contact Person Email
amartinez@oncorosell.com
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Oncology
Principal Investigator Name
Ernest Nadal Alforja
Principal Investigator Email
esnadal@iconcologia.net
Contact Person Name
Ernest Nadal Alforja
Contact Person Email
esnadal@iconcologia.net
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Luis Angel Leon Mateos
Principal Investigator Email
luis.angel.leon.mateos@sergas.es
Contact Person Name
Luis Angel Leon Mateos
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Pilar Garrido Lopez
Principal Investigator Email
pilargarridol@gmail.com
Contact Person Name
Pilar Garrido Lopez
Contact Person Email
pilargarridol@gmail.com

Sweden

Latest Decision Or Authorization Date
24-05-2024
Number Of Sites
1
Number Of Participants
7

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Oncology
Principal Investigator Name
Andreas Hallqvist
Principal Investigator Email
andreas.hallqvist@vgregion.se
Contact Person Name
Andreas Hallqvist
Contact Person Email
andreas.hallqvist@vgregion.se

Netherlands

Latest Decision Or Authorization Date
23-05-2024
Number Of Sites
5
Number Of Participants
3

Sites

Site Name
Ziekenhuis St Jansdal
Department Name
Pulmonology
Principal Investigator Name
Lisenka Boom
Principal Investigator Email
ln.boom@stjansdal.nl
Contact Person Name
Lisenka Boom
Contact Person Email
ln.boom@stjansdal.nl
Site Name
Canisius Wilhelmina Hospital
Department Name
Respiratory Diseases
Principal Investigator Name
Chantal Smits - van der Graaf
Principal Investigator Email
chantal.smits-vandergraaf@radboudumc.nl
Contact Person Name
Chantal Smits - van der Graaf
Site Name
Isala Klinieken Stichting
Department Name
Pulmonology
Principal Investigator Name
Lisenka Boom
Principal Investigator Email
ln.boom@stjansdal.nl
Contact Person Name
Lisenka Boom
Contact Person Email
ln.boom@stjansdal.nl
Site Name
Jeroen Bosch Ziekenhuis
Department Name
Respiratory Diseases
Principal Investigator Name
Chantal Smits - van der Graaf
Principal Investigator Email
chantal.smits-vandergraaf@radboudumc.nl
Contact Person Name
Chantal Smits - van der Graaf
Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Respiratory Diseases
Principal Investigator Name
Chantal Smits - van der Graaf
Principal Investigator Email
chantal.smits-vandergraaf@radboudumc.nl
Contact Person Name
Chantal Smits - van der Graaf

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Iqvia Rds Inc.
Responsibilities
sponsorDuties codes: [1,5]
Name
Quintiles Laboratories Europe
Responsibilities
sponsorDuties codes: [4]
Name
Bioclinica Inc.
Responsibilities
Adjudication; sponsorDuties codes: [15,4]
Name
Labcorp Central Laboratory Services LP
Responsibilities
sponsorDuties codes: [4]
Name
Signant Health Global LLC
Responsibilities
sponsorDuties codes: [6]

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Praxis Communications LLC","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Rebar Interactive LLC","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Quintiles Laboratories Europe","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: [1,5]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Adjudication; sponsorDuties codes: [15,4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Brightech International LLC","duties_or_roles":"sponsorDuties codes: [10]","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Other - Clinical Trial Reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Life Technologies","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Industry"}
  • {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"sponsorDuties codes: [1,12,15,2,5] (includes negotiation/execution of clinical trial agreements and study payments per provided text)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
SELPERCATINIB
Active Substance
SELPERCATINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Investigational Product Name
Placebo to match LY3527723
Modality
Other

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