Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
217
Countries
14
Sites
70
RET fusion-Positive NSCLC
To compare EFS of participants in the primary analysis population with Stage II-IIIA RET fusion-positive NSCLC treated with selpercatinib versus placebo
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Jan 2021 → ongoing
- Decision date (initial)
- 2024-05-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506784-33-00
- EudraCT number
- 2020-005191-35
- WHO UTN
- U1111-1302-5195
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenetic, Efficacy, Safety, Therapy, Pharmacodynamic, Pharmacokinetic
To compare EFS of participants in the primary analysis population with Stage II-IIIA RET fusion-positive NSCLC treated with selpercatinib versus placebo
Conditions and MedDRA coding
RET fusion-Positive NSCLC
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participants must have early-stage non-small cell lung cancer (NSCLC)
- Participants must have already had (and recovered from) surgery or radiation
- Participants must be in fair to good health
- Participants must be willing to use highly effective birth control during the study
Exclusion criteria 2
- Participants must not have another serious medical condition
- Participants must not have disease that has spread
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- EFS by investigator assessment in the primary analysis population
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB193120 · Substance
- Active substance
- Selpercatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Drug substance (DS) for clinical trials (CTs) and for commercial use (CU) have been produced utilizing the same sequence of synthetic steps, starting materials, and intermediates. Same manufacturing process and unit formula are utilized for CTs and CU DP. Materials, may be manufactured, packaged, and labeled at different facilities. Commitments relative to materials, specifications, and shelf-life for CT and CU materials may be different but of comparable quality and ensure product safety.
SUB193120 · Substance
- Active substance
- Selpercatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Drug substance (DS) for clinical trials (CTs) and for commercial use (CU) have been produced utilizing the same sequence of synthetic steps, starting materials, and intermediates. Same manufacturing process and unit formula are utilized for CTs and CU DP. Materials, may be manufactured, packaged, and labeled at different facilities. Commitments relative to materials, specifications, and shelf-life for CT and CU materials may be different but of comparable quality and ensure product safety.
Placebo 2
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Alturas Analytics Inc. ORG-100045347
|
Moscow, United States | Laboratory analysis |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Quintiles Laboratories Europe ORL-000004941
|
West Lothian, United Kingdom | Laboratory analysis |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Brightech International LLC ORL-000002985
|
Somerset, New Jersey, United States | Code 10 |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifisia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Life Technologies ORL-000005153
|
Carlsbad, CA,, United States | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Code 5 |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other, Laboratory analysis |
| Rebar Interactive LLC ORG-100045545
|
Austin, United States | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
Locations
14 EU/EEA countries · 70 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 2 | 2 |
| Belgium | Ongoing, recruitment ended | 2 | 6 |
| Czechia | Ongoing, recruitment ended | 2 | 3 |
| Denmark | Ended | 4 | 1 |
| France | Ongoing, recruitment ended | 7 | 6 |
| Germany | Ongoing, recruitment ended | 6 | 2 |
| Greece | Ended | 4 | 7 |
| Italy | Ongoing, recruitment ended | 6 | 3 |
| Netherlands | Ongoing, recruitment ended | 3 | 5 |
| Norway | Ended | 2 | 1 |
| Poland | Ended | 5 | 4 |
| Romania | Ended | 2 | 1 |
| Spain | Ongoing, recruitment ended | 13 | 28 |
| Sweden | Ongoing, recruitment ended | 7 | 1 |
| Rest of world
India, United Kingdom, Brazil, United States, Hong Kong, Canada, Australia, Korea, Republic of, Japan, Israel, Russian Federation, China, Turkey, Ukraine, Mexico, Singapore, Taiwan
|
— | 152 | — |
Investigational sites
Krankenhaus Nord Klinik Floridsdorf
Internal Medicine and Pneumology, Bruenner Strasse 68, Floridsdorf, Vienna
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Internal Medicine II, Carinagasse 47, 6800, Feldkirch
Clinique Saint-Pierre
Pneumology, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
Cliniques Universitaires Saint-Luc
Pneumology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Thoracic Oncology, Drie Eikenstraat 655, 2650, Edegem
Algemeen Ziekenhuis Delta
Pneumology, Deltalaan 1, 8800, Roeselare
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Pneumology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Trial Office, Place Louise Godin 15, 5000, Namur
Fakultni Nemocnice Bulovka
Klinika pneumologie, Budinova 67/2, Liben, Prague
Masarykuv Onkologicky Ustav
Klinika komplexní onkologické péče, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Nemocnice AGEL Ostrava-Vitkovice a.s.
N/A, Zaluzanskeho 1192/15, Vitkovice, Ostrava
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
N/A, 133 Avenue De La Resistance, 92350, Le Plessis-Robinson
Centre Leon Berard
N/A, 28 Rue Laennec, 69008, Lyon
CHU De Rouen
pneumology, intensive care and thoracic oncology, 1 Rue De Germont, Bp 96031, Rouen Cedex
Hospices Civils De Lyon
N/A, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Assistance Publique Hopitaux De Paris
Unité d'Oncologie Thoracique, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Regional De Marseille
CEPCM, 264 Rue Saint Pierre, 13005, Marseille
Thoraxklinik Heidelberg gGmbH
Studienzentrum Thoraxonkologie, Roentgenstrasse 1, Rohrbach, Heidelberg
Charite Universitaetsmedizin Berlin KöR
N/A, Hindenburgdamm 30, Lichterfelde, Berlin
Geniko Nosokomeio Thessalonikis George Papanikolaou
University Pulmonary Department, Exochi, 570 10, Thessaloniki
University General Hospital Of Heraklion
Internal Medicine-Oncology Clinic, Stavrakia And Voutes, 715 00, Heraklion
St Savas Hospital
2nd Department of Internal Medicine - Oncology, Alexandras Avenue 171, 115 22, Athens
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
General University Hospital Of Patras
lnternal Medicine Clinic-Oncology Department, Rio, 265 04, Patras
Thoracic General Hospital Of Athens I Sotiria
3rd University Internal Medicine Department, Messogion Avenue 152, 115 27, Athens
Henry Dunant Hospital Center
4th Department of Oncology and Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
Istituto Tumori Bari Giovanni Paolo II
SSD Oncologia Medica per la Patologia Toracica, Viale Orazio Flacco 65, 70124, Bari
Azienda Ospedaliera Dei Colli
U.O.C Pneumologia Oncologica DH PNL ONC, Via Leonardo Bianchi, 80131, Naples
ASST Grande Ospedale Metropolitano Niguarda
Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Canisius Wilhelmina Hospital
Respiratory Diseases, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Jeroen Bosch Ziekenhuis
Respiratory Diseases, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
Ziekenhuis St Jansdal
Pulmonology, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Isala Klinieken Stichting
Pulmonology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Radboud universitair medisch centrum / RADBOUDUMC
Respiratory Diseases, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Oslo University Hospital HF
Dept of Oncology and Dept of Cancer Genetics, Taarnbygget, Kirkeveien 166, Oslo
Krakowski Szpital Specjalistyczny im. Jana Pawła II
NA, ul. Prądnicka 80, 31-202, Kraków
Narodowy Instytut Onkologii im.Marii Skłodowskiej-Curie,Klinika Nowotworów Płuca i Klatki Piersiowej
NA, ul. Roentgena 5, 02-781, Warszawa
Uniwersyteckie Centrum Kliniczne, Centrum Medycyny Nieinwazyjnej, Klinika Onkologii i Radioterapii
NA, ul. Smoluchowskiego 17, 80-214, Gdansk
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
NA, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Medical Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
University Clinical Hospital Virgen De La Arrixaca
Oncology, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Lucus Augusti
Oncology, Rua Dr. Ulises Romero 1, 27003, Lugo
Salut Sant Joan De Reus
Oncology, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario De Leon
Oncology, C Altos De Nava S/n, 24071, Leon
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario Puerta Del Mar
Oncology, Avenida De Ana De Viya 21, 11009, Cadiz
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Central De Asturias
Oncology, Avenida De Roma S/n, 33011, Oviedo
Hospital General Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
Hospital Alvaro Cunqueiro
Oncology, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Universitario De Canarias
Oncology, Calle Ofra Sn La Cuesta, 38320, La Laguna
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Consorci Sanitari Del Maresme
Oncology, Carretera De Cirera 230, 08304, Mataro
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Complejo Hospitalario Universitario De Ourense
Oncology, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Son Llatzer
Oncology, Carretera De Manacor Km 4, 07198, Palma
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital General Universitario De Albacete
Oncology, Calle Hermanos Falco 37, 02006, Albacete
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2021-08-04 | 2022-03-11 | 2025-02-26 | ||
| Belgium | 2022-04-08 | 2023-08-10 | 2025-02-26 | ||
| Czechia | 2021-09-07 | 2022-08-25 | 2025-02-26 | ||
| Denmark | 2022-03-03 | 2025-02-26 | |||
| France | 2022-01-25 | 2022-06-14 | 2025-02-26 | ||
| Germany | 2021-09-30 | 2023-02-17 | 2025-02-26 | ||
| Greece | 2022-01-28 | 2025-02-26 | |||
| Italy | 2021-11-30 | 2023-02-06 | 2025-02-26 | ||
| Netherlands | 2022-03-02 | 2024-06-17 | 2025-02-26 | ||
| Norway | 2024-01-31 | 2025-04-07 | |||
| Poland | 2021-12-09 | 2024-03-15 | |||
| Romania | 2021-11-16 | 2025-02-26 | |||
| Spain | 2021-01-19 | 2023-09-22 | 2025-02-26 | ||
| Sweden | 2024-05-27 | 2024-05-27 | 2025-03-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 175 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506784-33-00_GR_Redacted | i |
| Protocol (for publication) | D1_Protocol 2023-506784-33-00_Redacted | j |
| Protocol (for publication) | D4_JZJX_Patient Documents Copyright | 1.0 |
| Recruitment arrangements (for publication) | JZJX_Blank document | 1 |
| Recruitment arrangements (for publication) | JZJX_Blank document | 1 |
| Recruitment arrangements (for publication) | JZJX_Blank document | 1.0 |
| Recruitment arrangements (for publication) | JZJX_Blank document | 1 |
| Recruitment arrangements (for publication) | JZJX_Blank_document | 1 |
| Recruitment arrangements (for publication) | JZJX_Recruitment Arrangements_07Jan2025 | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_SWE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_List of sites_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_ Patient emergency card | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Appointment card dig_1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Appointment card_1 | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_ApptReminderCard Elec_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_ApptReminderCard Elec_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_ApptReminderCard Print_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_ApptReminderCard Print_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_BiFold Brochure_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_BiFold Brochure_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_BifoldBrochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_1 | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Digital outreach_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Digital outreach_FRBE | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_DigitalOutreach | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Quick reference guide_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Quick reference guide_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Thank you Card_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Thank you Card_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Visit Guide AmendD_BEDU_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Visit Guide AmendD_BEFR_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_VisitGuide_AmendD_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Webtext | 1 |
| Subject information and informed consent form (for publication) | JZJX_Blank_document | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Summary of Changes__Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Summary of Changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Crossover ICF_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_Crossover ICF_V7_07Sep2023_RO_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_EC Communication_SOC_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Optional Samples_FR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Pre Screening_FR_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Pre Screening_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Cross Over_FR_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Crossover_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Greenphire_RO_22Apr2021 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_V7_05Sep23_RO_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Prescreening_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_SoC_Main and Crossover_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Inform Consent Procedure_GR | 1 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Summary of Changes 01-EU -Main and Cross Over- 05 Dec 2024 - Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_FR_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_Prescreening addendum ICF_25May2023_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Prescreening ICF_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_Reimbursement ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker research Addendum_v1 15Apr2021_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cross over_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover Addendum ICF_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover_2_11Sep2023 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover_2_11Sep2023_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover_8_20Oct2023_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy Addendum_v1 15Apr2021_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_2_11Sep2023_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_8_20Oct2023_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Oncomine Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PK research Addendum_v1 15Apr2021_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening Addendum_1 2_22may2023_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening Addendum_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SoC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of changes 1_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of changes 2_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Privacy Crossover_ ITA_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Privacy Main_ ITA_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Biomarker_ IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Pharmacogenetics_ IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Progresssion Biomarker_ IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover ICF_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_ ITA_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_BEDU_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_EN_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_FRBE_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Guide to using eDiary_1_20Jan2021 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Guide to using eDiary_1_20Jan2021 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Summary of changes_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Summary of changes_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Summary of changes_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informed Consent Summary of Changes_Clean_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informed Consent Summary of Changes_Redacted_SWE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informed Consent Summary of Changes_redacted_SWE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ ITA_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BEDU_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FRBE_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MainEN_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-Screening Addendum_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Preescreening_ IT_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ICF_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ICF_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreen_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening addendum_BEDU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening addendum_BEFR_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening addendum_EN_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC_October2025_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC_Redacted_10Oct2025 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC_Redacted_27Jan2026 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_ITA_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Visit Guide_2_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Summary of Changes 1_Redcated | 2 |
| Subject information and informed consent form (for publication) | L2_ Italy Patient Card_ITA | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material eCOA Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Visit Cards Reminder | 1.0 |
| Subject information and informed consent form (for publication) | L2_eCOA Guide_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_BifoldBrochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_DigitalOutreach_DE | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Patient Card_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Print_ApptReminderCard | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_redacted | 4 |
| Subject information and informed consent form (for publication) | L2_Recruitment Brochure_FR | 1 |
| Subject information and informed consent form (for publication) | L2_Thank you Card_ITA | 1 |
| Subject information and informed consent form (for publication) | L2_Visit Card_FR | 1 |
| Subject information and informed consent form (for publication) | L2_Visit Guide_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Hochmair | 2 |
| Subject information and informed consent form (for publication) | L3_Patient card_Winder | 2 |
| Subject information and informed consent form (for publication) | L3_Patient cards | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient Information Card_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_RO_2023-506784-33-00_TC | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-506784-33-00_ENG | i |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2023-506784-33-00_GR | i |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2023-506784-33-00_Track Changes_GR | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506784-33-00_ENG_Track change | i |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDE_2023-506784-33-00 | i |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDU_2023-506784-33-00 | i |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEFR_2023-506784-33-00 | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2023-506784-33-00_Redacted | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-506784-33-00 | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-506784-33-00_Track changes | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2023-506784-33-00_Redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GER_2023-506784-33-00 | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2023-506784-33-00 | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_TC_2023-506784-33-00 | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO_2023-506784-33-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_2023-506784-33-00 | i |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SWE_2023-506784-33-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SWE_2023-506784-33-00_TC | i |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_IT_2023_506784-33-00 | i |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_IT_2023_506784-33-00_TC | i |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-14 | Italy | Acceptable 2024-05-23
|
2024-05-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-07 | Italy | Acceptable 2025-05-19
|
2025-05-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-24 | Acceptable 2025-05-19
|
2025-07-24 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-07 | Italy | Acceptable 2026-02-27
|
2026-03-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-27 | Acceptable 2026-06-01
|
2026-06-02 |