Clinical trial • Phase III • Oncology
REPOTRECTINIB for Non-small cell lung cancer
Phase III trial of REPOTRECTINIB for Non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 05-09-2023
- First CTIS Authorization Date
- 10-01-2024
Trial design
Randomised, open-label, repotrectinib (tpx-0005) oral capsules (active substance: repotrectinib; max daily amount reported 320 mg) versus crizotinib (xalkori) oral capsules (active substance: crizotinib; marketed formulations 200 mg and 250 mg hard capsules; max daily amount reported 500 mg). exact scheduled dosing regimen not specified in the provided record.-controlled, crossover Phase III trial across 45 sites in Hungary, Greece, Netherlands and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Repotrectinib (TPX-0005) oral capsules (active substance: repotrectinib; max daily amount reported 320 mg) versus Crizotinib (XALKORI) oral capsules (active substance: crizotinib; marketed formulations 200 mg and 250 mg hard capsules; max daily amount reported 500 mg). Exact scheduled dosing regimen not specified in the provided record.
- Crossover
- Yes
- Target Sample Size
- 234
Eligibility
Recruits 234 adults.
Inclusion criteria
- {"criterion_text":"- Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC\n- Participant has a ROS1 gene rearrangement/fusion as detected by a local test.\n- At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator.\n- Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC\n- Up to 1 prior line of systemic treatment for NSCLC is permitted\n- ECOG Performance Status ≤ 2"}
Exclusion criteria
- {"criterion_text":"- Symptomatic brain metastases or symptomatic leptomeningeal involvement.\n- History of previous cancer requiring therapy within the previous 2 years, except for NSCLC under study, squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected.\n- Known actionable tumor targetable co-mutations or rearrangements\n- Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- PFS per BICR, according to RECIST v1.1","definition_or_measurement_approach":"Progression-Free Survival assessed per Blinded Independent Central Review (BICR) using RECIST v1.1"}
Secondary endpoints
- {"endpoint_text":"- Overall Survival\n- Objective Response Rate (ORR)\n- Duration of Response (DOR)\n- Time to Response (TTR) per BICR and per investigator according to RECIST v1.1\n- PFS per investigator according to RECIST v1.1\n- Time to intracranial progression per BICR according to RECIST v1.1\n- Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs)\n- AEs leading to study intervention discontinuation\n- Drug-related AEs and deaths\n- Proportion of participants without meaningful symptom deterioration as measured by the NSCLC-SAQ total score","definition_or_measurement_approach":"Overall Survival (OS): time to death from any cause (no further definition in record);\nObjective Response Rate (ORR): tumour response assessed (method not further specified in record);\nDuration of Response (DOR): duration of observed response (method not further specified);\nTime to Response (TTR) per BICR and per investigator: assessed according to RECIST v1.1 by BICR and by investigator;\nPFS per investigator: assessed according to RECIST v1.1 by investigator;\nTime to intracranial progression per BICR: assessed according to RECIST v1.1 by BICR;\nSafety endpoints (AEs/SAEs/AEs leading to discontinuation/drug-related AEs and deaths): incidence as reported in trial safety monitoring;\nProportion without meaningful symptom deterioration: measured by NSCLC-SAQ total score (protocol specifies this instrument and a meaningful deterioration threshold in translations but precise threshold described elsewhere as a change of at least 3 points in some translations)."}
Recruitment
- Planned Sample Size
- 234
- Recruitment Window Months
- 92
- Consent Approach
- Informed consent is obtained using L1 SIS and ICF subject information and informed consent form documents; country-/language-specific ICFs are available (documents present for English, French, German, Italian, Spanish, Dutch, Polish, Greek, Hungarian, Romanian and other local language versions). Separate ICFs are available for pregnant partners and for treatment beyond progression and crossover. No explicit text about assent or age-specific consent handling was present in the extracted record.
Geography
- Total Number Of Sites
- 45
- Total Number Of Participants
- 83
Hungary
- Earliest CTIS Part Ii Submission Date
- 29-11-2023
- Latest Decision Or Authorization Date
- 07-11-2024
- Processing Time Days
- 344
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Koranyi National Institute For Pulmonology
- Department Name
- Department of Pulmonology
- Principal Investigator Name
- Ostoros Gyula
- Principal Investigator Email
- info@koranyi.hu
- Contact Person Name
- Ostoros Gyula
- Contact Person Email
- info@koranyi.hu
Greece
- Earliest CTIS Part Ii Submission Date
- 28-11-2023
- Latest Decision Or Authorization Date
- 02-09-2025
- Processing Time Days
- 644
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- 3rd Internal Medicine Clinic
- 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
- Theageneio Cancer Hospital
- Department Name
- 1st Department of Medical Oncology
- Principal Investigator Name
- Pavlos Papakotoulas
- Principal Investigator Email
- papakotoulas@gmail.com
- Contact Person Name
- Pavlos Papakotoulas
- Contact Person Email
- papakotoulas@gmail.com
- Site Name
- University General Hospital Attikon
- Department Name
- Research Unit
- Principal Investigator Name
- Amanda Psyrri
- Principal Investigator Email
- ogkologiko@hotmail.com
- Contact Person Name
- Amanda Psyrri
- Contact Person Email
- ogkologiko@hotmail.com
- Site Name
- General University Hospital Of Patras
- Department Name
- Division of Oncology
- Principal Investigator Name
- Angelos Koutras
- Principal Investigator Email
- angkoutr@otenet.gr
- Contact Person Name
- Angelos Koutras
- Contact Person Email
- angkoutr@otenet.gr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 02-09-2025
- Processing Time Days
- 399
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Pulmonary Oncology
- Principal Investigator Name
- Sayed Hashemi
- Principal Investigator Email
- ctis@amsterdamumc.nl
- Contact Person Name
- Sayed Hashemi
- Contact Person Email
- ctis@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Pulmonary Oncology
- Principal Investigator Name
- A van der Wekken
- Principal Investigator Email
- a.j.van.der.wekken@umcg.nl
- Contact Person Name
- A van der Wekken
- Contact Person Email
- a.j.van.der.wekken@umcg.nl
Austria
- Earliest CTIS Part Ii Submission Date
- 24-11-2023
- Latest Decision Or Authorization Date
- 12-09-2025
- Processing Time Days
- 658
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Krankenhaus Nord Klinik Floridsdorf
- Department Name
- Internal Medicine and Pneumology
- Principal Investigator Name
- Johannes, Maximilian Hochmair
- Principal Investigator Email
- maximilian.hochmair@gesundheitsverbund.at
- Contact Person Name
- Johannes, Maximilian Hochmair
- Contact Person Email
- maximilian.hochmair@gesundheitsverbund.at
Romania
- Earliest CTIS Part Ii Submission Date
- 21-11-2023
- Latest Decision Or Authorization Date
- 10-09-2025
- Processing Time Days
- 659
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Oncology
- Principal Investigator Name
- Tudor Ciuleanu
- Principal Investigator Email
- office@iocn.ro
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- office@iocn.ro
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncology
- Principal Investigator Name
- Michael Schenker
- Principal Investigator Email
- centruldeoncologie@yahoo.ro
- Contact Person Name
- Michael Schenker
- Contact Person Email
- centruldeoncologie@yahoo.ro
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Oncology
- Principal Investigator Name
- Aurelia Alexandru
- Principal Investigator Email
- secretariat@iob.ro
- Contact Person Name
- Aurelia Alexandru
- Contact Person Email
- secretariat@iob.ro
- Site Name
- Spitalul De Oncologie Monza S.R.L.
- Department Name
- Oncology
- Principal Investigator Name
- Ingrid Iordan
- Principal Investigator Email
- relatiipublice@spitalulmonza.ro
- Contact Person Name
- Ingrid Iordan
- Contact Person Email
- relatiipublice@spitalulmonza.ro
- Site Name
- Centrul De Oncologie-Euroclinic S.R.L.
- Department Name
- Oncology
- Principal Investigator Name
- Constantin Volovat
- Principal Investigator Email
- wyx@yahoo.com
- Contact Person Name
- Constantin Volovat
- Contact Person Email
- wyx@yahoo.com
Spain
- Earliest CTIS Part Ii Submission Date
- 28-11-2023
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 838
- Number Of Sites
- 8
- Number Of Participants
- 9
Sites
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncology
- Principal Investigator Name
- María García Campelo
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- María García Campelo
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncology
- Principal Investigator Name
- Jorge Garcia Gonzalez
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Jorge Garcia Gonzalez
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncology
- Principal Investigator Name
- Alexandra Cantero
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Alexandra Cantero
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Jon Zugazagoitia Fraile
- Principal Investigator Email
- j.zugazagoitia.imas12@h12o.es
- Contact Person Name
- Jon Zugazagoitia Fraile
- Contact Person Email
- j.zugazagoitia.imas12@h12o.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Reyes Bernabe
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Reyes Bernabe
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Oncology
- Principal Investigator Name
- Mariano Provencio
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Mariano Provencio
- Contact Person Email
- xxx.xxx@xxx.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Principal Investigator Name
- Oscar Juan Vidal
- Principal Investigator Email
- xxx.xxx@xxx.es
- Contact Person Name
- Oscar Juan Vidal
- Contact Person Email
- xxx.xxx@xxx.es
Poland
- Earliest CTIS Part Ii Submission Date
- 27-11-2023
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 838
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Instytut Genetyki I Immunologii Genim Sp. z o.o.
- Principal Investigator Name
- Izabela Chmielewska
- Principal Investigator Email
- biuro@genim.pl
- Contact Person Name
- Izabela Chmielewska
- Contact Person Email
- biuro@genim.pl
- Site Name
- Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
- Department Name
- Oddzial Onkologii z Pododdzialem Chemioterapii
- Principal Investigator Name
- Jaroslaw Kolb-Sielecki
- Principal Investigator Email
- sekretariat@pulmonologia.olsztyn.pl
- Contact Person Name
- Jaroslaw Kolb-Sielecki
- Contact Person Email
- sekretariat@pulmonologia.olsztyn.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 11-12-2023
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 851
- Number Of Sites
- 9
- Number Of Participants
- 19
Sites
- Site Name
- Marienhaus Kliniken GmbH
- Department Name
- Klinik für Pneumologie, Beatmungs- und Schlafmedizin
- Principal Investigator Name
- Michael Kreuter
- Principal Investigator Email
- michael.kreuter@marienhaus.de
- Contact Person Name
- Michael Kreuter
- Contact Person Email
- michael.kreuter@marienhaus.de
- Site Name
- Lungenfachklinik Immenhausen
- Department Name
- Thoraxonkologie
- Principal Investigator Name
- Achim Rittmeyer
- Principal Investigator Email
- a.rittmeyer@lungenfachklinik-immenhausen.de
- Contact Person Name
- Achim Rittmeyer
- Contact Person Email
- a.rittmeyer@lungenfachklinik-immenhausen.de
- Site Name
- Asklepios Fachkliniken Muenchen Gauting
- Department Name
- Onkologie
- Principal Investigator Name
- Niels Reinmuth
- Principal Investigator Email
- n.reinmuth@asklepios.com
- Contact Person Name
- Niels Reinmuth
- Contact Person Email
- n.reinmuth@asklepios.com
- Site Name
- Technische Universitat Dresden
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Martin Wermke
- Principal Investigator Email
- martin.wermke@uniklinikum-dresden.de
- Contact Person Name
- Martin Wermke
- Contact Person Email
- martin.wermke@uniklinikum-dresden.de
- Site Name
- Pius-Hospital Oldenburg
- Department Name
- Pius Hospital Oldenburg
- Principal Investigator Name
- Frank Griesinger
- Principal Investigator Email
- frank.griesinger@pius-hospital.de
- Contact Person Name
- Frank Griesinger
- Contact Person Email
- frank.griesinger@pius-hospital.de
- Site Name
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
- Department Name
- Klinik für Pneumologie
- Principal Investigator Name
- Christian Grohe
- Principal Investigator Email
- christian.grohe@pgdiakonie.de
- Contact Person Name
- Christian Grohe
- Contact Person Email
- christian.grohe@pgdiakonie.de
- Site Name
- Klinikum Esslingen GmbH
- Department Name
- Klinikum Esslingen
- Principal Investigator Name
- Martin Faehling
- Principal Investigator Email
- m.faehling@klinikum-esslingen.de
- Contact Person Name
- Martin Faehling
- Contact Person Email
- m.faehling@klinikum-esslingen.de
- Site Name
- Klinikum Wuerzburg Mitte gGmbH
- Department Name
- Missionsärztliche Klinik
- Principal Investigator Name
- Jens Kern
- Principal Investigator Email
- jens.kern@kwm-klinikum.de
- Contact Person Name
- Jens Kern
- Contact Person Email
- jens.kern@kwm-klinikum.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- CIO / Innere Medizin I
- Principal Investigator Name
- Juergen Wolf
- Principal Investigator Email
- juergen.wolf@uk-koeln.de
- Contact Person Name
- Juergen Wolf
- Contact Person Email
- juergen.wolf@uk-koeln.de
Italy
- Earliest CTIS Part Ii Submission Date
- 19-09-2023
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 965
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Azienda Ospedaliera Dei Colli
- Department Name
- U.O.C. Oncologia
- Principal Investigator Name
- Danilo Rocco
- Principal Investigator Email
- danilorocc@yahoo.it
- Contact Person Name
- Danilo Rocco
- Contact Person Email
- danilorocc@yahoo.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Oncologia Medica 2
- Principal Investigator Name
- Lorenza Landi
- Principal Investigator Email
- lorenza.landi@ifo.it
- Contact Person Name
- Lorenza Landi
- Contact Person Email
- lorenza.landi@ifo.it
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- UO Oncologia Medica
- Principal Investigator Name
- Alessandra Bearz
- Principal Investigator Email
- abearz@cro.it
- Contact Person Name
- Alessandra Bearz
- Contact Person Email
- abearz@cro.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Struttura Complessa Oncologia Medica 1
- Principal Investigator Name
- Arsela Prelaj
- Principal Investigator Email
- Arsela.Prelaj@istitutotumori.mi.it
- Contact Person Name
- Arsela Prelaj
- Contact Person Email
- Arsela.Prelaj@istitutotumori.mi.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- S.C. Oncologia Medica
- Principal Investigator Name
- Diego Luigi Cortinovis
- Principal Investigator Email
- diegoluigi.cortinovis@irccs-sangerardo.it
- Contact Person Name
- Diego Luigi Cortinovis
- Contact Person Email
- diegoluigi.cortinovis@irccs-sangerardo.it
France
- Earliest CTIS Part Ii Submission Date
- 30-10-2023
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 892
- Number Of Sites
- 8
- Number Of Participants
- 19
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- oncology thoracic unit
- Principal Investigator Name
- Elvire PONS-TOSTIVINT
- Principal Investigator Email
- elvire.pons@chu-nantes.fr
- Contact Person Name
- Elvire PONS-TOSTIVINT
- Contact Person Email
- elvire.pons@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- pneumology-thoracic oncology unit
- 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
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- pneumology
- 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
- Centr Georges Francois Leclerc
- Department Name
- medical oncology
- Principal Investigator Name
- Aurélie LAGRANGE
- Principal Investigator Email
- alagrange@cgfl.fr
- Contact Person Name
- Aurélie LAGRANGE
- Contact Person Email
- alagrange@cgfl.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- respiratory medicine unit
- Principal Investigator Name
- Rémi VEILLON
- Principal Investigator Email
- remi.veillon@chu-bordeaux.fr
- Contact Person Name
- Rémi VEILLON
- Contact Person Email
- remi.veillon@chu-bordeaux.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- pneumology
- Principal Investigator Name
- Céline MASCAUX
- Principal Investigator Email
- celine.mascaux@chru-strasbourg.fr
- Contact Person Name
- Céline MASCAUX
- Contact Person Email
- celine.mascaux@chru-strasbourg.fr
- Site Name
- CHU De Rouen
- Department Name
- pneumology
- 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 Hospitalier Lyon Sud
- Department Name
- pulmonology
- Principal Investigator Name
- Sébastien COURAUD
- Principal Investigator Email
- sebastien.couraud@chu-lyon.fr
- Contact Person Name
- Sébastien COURAUD
- Contact Person Email
- sebastien.couraud@chu-lyon.fr
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Y-Prime, Inc.
- Responsibilities
- IVRS – treatment randomisation, Core Technology Services
Third parties
- {"country":"United States","full_name":"Y-Prime, Inc.","duties_or_roles":"IVRS – treatment randomisation, Core Technology Services","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- Repotrectinib (TPX-0005)
- Active Substance
- REPOTRECTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 1
- Maximum Dose
- 320 mg
- Investigational Product Name
- XALKORI 200 mg hard capsules
- Active Substance
- CRIZOTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 2
- Maximum Dose
- 500 mg
- Investigational Product Name
- XALKORI 250 mg hard capsules
- Active Substance
- CRIZOTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 2
- Maximum Dose
- 500 mg
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