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
- Contact Person Email
- xavier.quantin@icm.unicancer.fr
- 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
- Contact Person Email
- maurice.perol@lyon.unicancer.fr
- 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
- Contact Person Email
- PIRechOncoThoracique@chu-grenoble.fr
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
- Principal Investigator Email
- jean-charles.goeminne@chuuclnamur.uclouvain.be
- Contact Person Name
- Jean-Charles Goeminne
- Contact Person Email
- jean-charles.goeminne@chuuclnamur.uclouvain.be
- 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
- Contact Person Email
- mprovencio.ensayosclinicos@gmail.com
- 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
- Contact Person Email
- petra.hoffknecht@niels-stensen-kliniken.de
- 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
- Contact Person Email
- helge.bischoff@med.uni-heidelberg.de
- 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
- Contact Person Email
- a.morabito@istitutotumori.na.it
- 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
- Contact Person Email
- emilio.bria@policlinicogemelli.it
- 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
- Contact Person Email
- salvatore.siena@ospedaleniguarda.it
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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