Clinical trial • Phase III • Oncology

SELPERCATINIB for Non-small cell lung cancer | RET fusion-positive non-small cell lung cancer | Advanced or metastatic non-small cell lung cancer

Phase III trial of SELPERCATINIB for Non-small cell lung cancer | RET fusion-positive non-small cell lung cancer | Advanced or metastatic non-small cell l…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | RET fusion-positive non-small cell lung cancer | Advanced or metastatic non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
08-03-2024
First CTIS Authorization Date
15-05-2024

Trial design

Randomised, open-label, platinum-based therapy (carboplatin or cisplatin) plus pemetrexed, with or without pembrolizumab; doses and schedules not specified.-controlled, crossover Phase III trial in France, Belgium, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Platinum-based therapy (carboplatin or cisplatin) plus pemetrexed, with or without pembrolizumab; doses and schedules not specified.
Crossover
Yes
Target Sample Size
90

Eligibility

Recruits 90 No vulnerable population selected (isVulnerablePopulationSelected: false). Specific consent/assent handling for vulnerable groups is not specified in the record..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Specific consent/assent handling for vulnerable groups is not specified in the record.

Inclusion criteria

  • {"criterion_text":"- Participants must have advanced/metastatic non-squamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation therapy"}
  • {"criterion_text":"- Participants must have a RET gene fusion and sufficient tumor tissue available for confirmatory testing"}
  • {"criterion_text":"- Participants must be in fair to good health and not Have another serious medical condition"}
  • {"criterion_text":"- Participants must not have had prior chemotherapy for metastatic lung cancer. chemotherapy in the adjuvant/neoadjuvant setting is permitted"}
  • {"criterion_text":"- Participants must not have disease that has spread to the brain and is causing symptoms"}
  • {"criterion_text":"- Participants must be able to swallow capsules"}
  • {"criterion_text":"- Participants must be willing to use highly effective contraception during the study"}

Exclusion criteria

  • {"criterion_text":"- Participants must not have a heart condition that puts you at risk for abnormal heart rhythms."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PFS per REIST 1.1 by BICR","definition_or_measurement_approach":"Progression-free survival (PFS) measured per RECIST 1.1 and assessed by Blinded Independent Central Review (BICR)."}

Recruitment

Planned Sample Size
90
Recruitment Window Months
76
Consent Approach
Informed consent is obtained from participants (adult population). Multiple subject information and informed consent forms (ICFs) and related materials are provided, including main ICFs, crossover ICFs, prescreening addenda and treatment-beyond-progression addenda. ICFs/participant materials are available in multiple languages as evidenced by document titles (English, French, Dutch, Greek, Italian, German, Traditional Chinese and localised variants). No assent/minor-specific consent procedures are described in the record.

Methods

  • Site-based recruitment at participating hospitals/clinics (see site list).
  • Patient referral, recruitment, screening and/or retention conducted by third-party vendors (explicit duties listed for organisations such as Colpitts, Praxis Communications LLC, Rebar Interactive LLC and others).
  • Use of recruitment material documents (Emergency Patient Card, Visit Guide, Thank You card, Patient Card) in multiple languages as part of recruitment/retention materials.

Geography

Total Number Of Sites
50
Total Number Of Participants
42

France

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
712
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Principal Investigator Name
Xavier Quantin
Principal Investigator Email
xavier.quantin@icm.unicancer.fr
Contact Person Name
Xavier Quantin
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Principal Investigator Name
Maurice Perol
Principal Investigator Email
maurice.perol@lyon.unicancer.fr
Contact Person Name
Maurice Perol
Site Name
Hopitaux Universitaires Paris Centre-Hopital Cochin
Department Name
Pneumology and Physiology Department
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
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pneumology and Physiology Department
Principal Investigator Name
Denis Moro-Sibilot
Principal Investigator Email
PIRechOncoThoracique@chu-grenoble.fr
Contact Person Name
Denis Moro-Sibilot

Belgium

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
710
Number Of Sites
8
Number Of Participants
4

Sites

Site Name
A.Z. Sint-Maarten
Principal Investigator Name
Marc Lambrechts
Principal Investigator Email
marc.lambrechts@emmaus.be
Contact Person Name
Marc Lambrechts
Contact Person Email
marc.lambrechts@emmaus.be
Site Name
UZ Brussel
Department Name
Medische Oncologie
Principal Investigator Name
Lore Decoster
Principal Investigator Email
lore.decoster@uzbrussel.be
Contact Person Name
Lore Decoster
Contact Person Email
lore.decoster@uzbrussel.be
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
Vitaz
Principal Investigator Name
Koenraad Deschepper
Principal Investigator Email
koen.deschepper@vitaz.be
Contact Person Name
Koenraad Deschepper
Contact Person Email
koen.deschepper@vitaz.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Trial Office
Principal Investigator Name
Jean-Charles Goeminne
Contact Person Name
Jean-Charles Goeminne
Site Name
UZ Leuven
Department Name
Respiratory Oncology
Principal Investigator Name
Christophe Dooms
Principal Investigator Email
christophe.dooms@uzleuven.be
Contact Person Name
Christophe Dooms
Contact Person Email
christophe.dooms@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Pneumonolgy
Principal Investigator Name
Veerle Surmont
Principal Investigator Email
veerle.surmont@uzgent.be
Contact Person Name
Veerle Surmont
Contact Person Email
veerle.surmont@uzgent.be

Spain

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
712
Number Of Sites
20
Number Of Participants
7

Sites

Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Medical Oncology
Principal Investigator Name
Mariano Provencio
Principal Investigator Email
mprovencio.ensayosclinicos@gmail.com
Contact Person Name
Mariano Provencio
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Principal Investigator Name
Reyes Bernabe Caro
Principal Investigator Email
bernabeensayos@gmail.com
Contact Person Name
Reyes Bernabe Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Hospital Son Llatzer
Department Name
Oncology
Principal Investigator Name
Juan Coves
Principal Investigator Email
jcoves@hsll.es
Contact Person Name
Juan Coves
Contact Person Email
jcoves@hsll.es
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
Clinica Universidad De Navarra
Department Name
Medical Oncology
Principal Investigator Name
Miguel Fernández de Sanmamed Gutiérrez
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernández de Sanmamed Gutiérrez
Contact Person Email
msanmamed@unav.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical 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
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Principal Investigator Name
Carlos Aguado de la Rosa
Principal Investigator Email
carlos.aguado84@gmail.com
Contact Person Name
Carlos Aguado de la Rosa
Contact Person Email
carlos.aguado84@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Principal Investigator Name
David Vicente Baz
Principal Investigator Email
david.vbaz@gmail.com
Contact Person Name
David Vicente Baz
Contact Person Email
david.vbaz@gmail.com
Site Name
University Hospital Son Espases
Department Name
Oncology
Principal Investigator Name
Juan Coves
Principal Investigator Email
jcoves@hsll.es
Contact Person Name
Juan Coves
Contact Person Email
jcoves@hsll.es
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
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncology
Principal Investigator Name
Delvys Rodriguez Abreu
Principal Investigator Email
drodabr@gobiernodecanarias.org
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Medical Oncology
Principal Investigator Name
Margarita Majem Tarruella
Principal Investigator Email
mmajem@santpau.cat
Contact Person Name
Margarita Majem Tarruella
Contact Person Email
mmajem@santpau.cat
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 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
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Medical 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
Hospital Universitario De Valencia
Department Name
Oncology
Principal Investigator Name
Amelia Insa
Principal Investigator Email
ameliainsamolla@gmail.com
Contact Person Name
Amelia Insa
Contact Person Email
ameliainsamolla@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical 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
Hospital Universitario De Jaen
Department Name
Medical Oncology
Principal Investigator Name
Ana Laura Ortega Granados
Principal Investigator Email
analauraortega@gmail.com
Contact Person Name
Ana Laura Ortega Granados
Contact Person Email
analauraortega@gmail.com
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Medical Oncology
Principal Investigator Name
Miguel Fernández de Sanmamed Gutiérrez
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernández de Sanmamed Gutiérrez
Contact Person Email
msanmamed@unav.es

Greece

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
03-03-2026
Processing Time Days
711
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Athens Medical Center S.A.
Department Name
Oncology Clinic
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
710
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Oncology
Principal Investigator Name
Sayed Hashemi
Principal Investigator Email
s.hashemi@amsterdamumc.nl
Contact Person Name
Sayed Hashemi
Contact Person Email
s.hashemi@amsterdamumc.nl
Site Name
Jeroen Bosch Ziekenhuis
Department Name
Pulmonology
Principal Investigator Name
Bianca van Veggel
Principal Investigator Email
b.v.veggel@jbz.nl
Contact Person Name
Bianca van Veggel
Contact Person Email
b.v.veggel@jbz.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Oncology
Principal Investigator Name
Anne-Marie Dingemans
Principal Investigator Email
a.dingemans@erasmusmc.nl
Contact Person Name
Anne-Marie Dingemans
Contact Person Email
a.dingemans@erasmusmc.nl

Germany

Earliest CTIS Part Ii Submission Date
11-04-2024
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
692
Number Of Sites
7
Number Of Participants
5

Sites

Site Name
Klinikverbund Allgaeu gGmbH
Principal Investigator Name
Christian Schumann
Principal Investigator Email
Christian.schumann@kv-keoa.de
Contact Person Name
Christian Schumann
Contact Person Email
Christian.schumann@kv-keoa.de
Site Name
Franziskus Hospital Harderberg
Principal Investigator Name
Petra Hoffknecht
Principal Investigator Email
petra.hoffknecht@niels-stensen-kliniken.de
Contact Person Name
Petra Hoffknecht
Site Name
Charite Universitaetsmedizin Berlin KöR
Principal Investigator Name
Damien Reike
Principal Investigator Email
damian.rieke@charite.de
Contact Person Name
Damien Reike
Contact Person Email
damian.rieke@charite.de
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Onkologie
Principal Investigator Name
Martin Reck
Principal Investigator Email
m.reck@lungenclinic.de
Contact Person Name
Martin Reck
Contact Person Email
m.reck@lungenclinic.de
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Thoraxklinik Heidelberg gGmbH
Principal Investigator Name
Helge Bischoff
Principal Investigator Email
helge.bischoff@med.uni-heidelberg.de
Contact Person Name
Helge Bischoff
Site Name
Asklepios Klinik Gauting GmbH
Department Name
Oncology
Principal Investigator Name
Neils Reinmuth
Principal Investigator Email
n.reinmuth@asklepios.com
Contact Person Name
Neils Reinmuth
Contact Person Email
n.reinmuth@asklepios.com

Italy

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
717
Number Of Sites
7
Number Of Participants
16

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncologia medica Toraco-Polmonare
Principal Investigator Name
Alessandro Morabito
Principal Investigator Email
a.morabito@istitutotumori.na.it
Contact Person Name
Alessandro Morabito
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncologia Medica Ardizzoni
Principal Investigator Name
Andrea Ardizzoni
Principal Investigator Email
oncotrials.bologna@gmail.com
Contact Person Name
Andrea Ardizzoni
Contact Person Email
oncotrials.bologna@gmail.com
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
medical oncology
Principal Investigator Name
Alessandra Bearz
Principal Investigator Email
abearz@cro.it
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncologia Polmonare
Principal Investigator Name
Silvia Novello
Principal Investigator Email
silvia.novello@unito.it
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Medical Oncology
Principal Investigator Name
Emilio Bria
Principal Investigator Email
emilio.bria@policlinicogemelli.it
Contact Person Name
Emilio Bria
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica 2
Principal Investigator Name
Federico Cappuzzo
Principal Investigator Email
federico.cappuzzo@ifo.it
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncologia Falck
Principal Investigator Name
Salvatore Siena
Principal Investigator Email
salvatore.siena@ospedaleniguarda.it
Contact Person Name
Salvatore Siena

Sponsor

Primary sponsor

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

Contract research organisations

Name
Bioclinica Inc.
Responsibilities
Adjudication; laboratory and research/testing support
Name
Iqvia Rds Inc.
Responsibilities
Clinical operations support (duties codes 1 and 5 listed)
Name
Labcorp Central Laboratory Services LP / Labcorp Central Laboratory Services Sàrl / Labcorp Asia Pte Ltd
Responsibilities
Central laboratory services and related laboratory functions
Name
Alturas Analytics Inc.
Responsibilities
Laboratory/data analytics support (code 4)
Name
Azenta
Responsibilities
Laboratory storage

Third parties

  • {"country":"United Kingdom","full_name":"Colpitts","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Health care"}
  • {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"Negotiation and Execution of Clinical trial agreements with the participating sites, make study payments based on invoices (and other duties with codes 1, 12, 2, 5 listed)","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Azenta","duties_or_roles":"Laboratory Storage","organisation_type":"Industry"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services Sàrl","duties_or_roles":"Laboratory functions (code 4)","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Brightech International LLC","duties_or_roles":"Role with code 10 (unspecified in record)","organisation_type":"Health care"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Role with code 6 (unspecified in record)","organisation_type":"Pharmaceutical company"}
  • {"country":"Singapore","full_name":"Labcorp Asia Pte Ltd","duties_or_roles":"Laboratory functions (code 4)","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"Laboratory functions (code 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":"Bioclinica Inc.","duties_or_roles":"Adjudication; Laboratory/other support (codes: Adjudication and 4)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Rebar Interactive LLC","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"Role with code 6 (unspecified in record)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Roles including 1 and 5 (unspecified in record)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Laboratory functions (code 4)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
SELPERCATINIB
Active Substance
SELPERCATINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Combination Treatment
Yes

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