Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
708
Countries
16
Sites
110
Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Part A: To compare the efficacy of olomorasib in combination with pembrolizumab versus placebo with pembrolizumab Part B: To compare the efficacy of olomorasib in combination with durvalumab versus placebo with durvalumab
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
- 6 Jun 2025 → ongoing
- Decision date (initial)
- 2025-05-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512302-25-00
- WHO UTN
- U1111-1314-6276
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Efficacy
Part A: To compare the efficacy of olomorasib in combination with pembrolizumab versus placebo with pembrolizumab Part B: To compare the efficacy of olomorasib in combination with durvalumab versus placebo with durvalumab
Conditions and MedDRA coding
Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-520580-40-01 | IMPD-Q-only application | AstraZeneca AB |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Histological or cytological confirmation of NSCLC. • Part A a. Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible. b. Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection. • Part B – Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy. • Must have disease with evidence of KRAS G12C mutation.
- Must have known programmed death-ligand 1 (PD-L1) expression
- Must have an ECOG performance status of 0 or 1.
- Able to swallow oral medication.
- Must have adequate laboratory parameters.
- Contraceptive use should be consistent with local regulations for those participating in clinical studies.
- Women of childbearing potential must • Have a negative pregnancy test. • Not be breastfeeding during treatment
Exclusion criteria 4
- Have known changes in the EGFR or ALK genes.
- Have another type of cancer that is progressing or required active treatment within the past 3 years before screening.
- Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
- Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Part A: Disease-free survival by investigator assessment Part B: PFS by BICR
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10219006 · Product
- Active substance
- LY3537982
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10219056 · Product
- Active substance
- LY3537982
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
SCP31706250 · ATC
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — DURVALUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6094344 · ATC
- Active substance
- Pembrolizumab
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — PEMBROLIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
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 23
| Organisation | City, country | Duties |
|---|---|---|
| Tier 1 Impact Pbc Inc. ORG-100050163
|
Covington, United States | Other |
| Evidera Inc. ORG-100028146
|
Bethesda, United States | Data management |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Reify Health Inc. ORG-100049669
|
Boston, United States | Other |
| CQ Fluency, Inc. ORL-000012874
|
Hackensack, United States | Data management |
| Labcorp Development (Asia) Pte Ltd ORG-100050418
|
Singapore, Singapore | Laboratory analysis |
| Medable Inc. ORG-100043083
|
Palo Alto, United States | Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Precision for Medicine ORL-000012872
|
Houston, United States | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| The Hibbert Co. ORG-100047639
|
Trenton, United States | Other |
| Icon Clinical Research LLC ORG-100039864
|
Rochester, United States | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Code 12, Code 2 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifisia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Tempus Compass LLC ORG-100052117
|
Chicago, United States | Laboratory analysis |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management |
| Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd. ORG-100043119
|
Shanghai, China | Laboratory analysis |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Code 10 |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| QIAGEN Manchester Limited ORL-000012869
|
United States | Laboratory analysis |
Locations
16 EU/EEA countries · 110 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruiting | 8 | 3 |
| Belgium | Authorised, recruiting | 11 | 4 |
| Czechia | Authorised, recruiting | 4 | 2 |
| France | Ongoing, recruiting | 41 | 16 |
| Germany | Ongoing, recruiting | 32 | 19 |
| Greece | Authorised, recruitment pending | 11 | 8 |
| Hungary | Authorised, recruiting | 6 | 3 |
| Italy | Ongoing, recruiting | 37 | 10 |
| Netherlands | Ongoing, recruiting | 17 | 7 |
| Norway | Ongoing, recruiting | 10 | 5 |
| Poland | Authorised, recruiting | 6 | 3 |
| Portugal | Ongoing, recruiting | 8 | 4 |
| Romania | Ongoing, recruiting | 10 | 4 |
| Slovakia | Ongoing, recruiting | 6 | 3 |
| Spain | Ongoing, recruiting | 55 | 18 |
| Sweden | Authorised, recruiting | 9 | 1 |
| Rest of world
Brazil, Korea, Republic of, Israel, Chile, Turkey, Switzerland, United States, Japan, Taiwan, Australia, United Kingdom, China, India
|
— | 437 | — |
Investigational sites
Ordensklinikum Linz GmbH
Abt. Pneumologie, Fadingerstrasse 1, 4020, Linz
Klinik Floridsdorf
Abteilung für Innere Medizin und Pneumologie, Brünner Straße 68, 1210, Wien
Medizinische Universität Graz
Innere Medizin Klin. Abt. Onkologie, Auenbruggerplatz 15, Graz, Graz
Algemeen Ziekenhuis Delta
NA, Deltalaan 1, 8800, Roeselare
Chirec
NA, Boulevard Du Triomphe 201, 1160, Brussels
UZ Leuven
NA, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Antwerpen
NA, Drie Eikenstraat 655, 2650, Edegem
Fakultni Nemocnice Bulovka
Klinika pneumologie, Budinova 67/2, Liben, Prague
Nemocnice AGEL Ostrava-Vitkovice a.s.
Plicní oddělení, Zaluzanskeho 1192/15, Vitkovice, Ostrava
Institut Jean Godinot
oncology, 1 Rue du Général Koenig 51726 Reims, 51726, Reims
Centre Leon Berard
N/A, 28 Rue Laennec,, 69373, Lyon
Institut Curie Paris
N/A, 26 Rue d'Ulm,, 75248, Paris
Centre Antoine Lacassagne
oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
N/A, Chemin de Bourrely, 13915 Marseille,, Marseille
Hôpital Robert Schuman
service de pneumologie, Rue du champ Montoy,, 57070, Vantoux
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
N/A, 185 Rue Raymond Losserand, 75014, Paris
Hospices Civils de Lyon – Hôpital Louis Pradel
N/A, 59 Boulevard Pinel,, 69677, Bron
Centre Hospitalier Universitaire De Rennes
N/A, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Institut de Cancérologie de l'Ouest
N/A, Boulevard Professeur Jacques Monod,, 44805, Saint Herblain
Hôpital Européen Georges Pompidou
N/A, 20 Rue Leblanc,, 75015, Paris
CHU de Poitiers
Pôle régional de cancérologie, 2 Rue de la Milétrie, 86021 Poitiers, Poitiers
CHU Grenoble Alpes
N/A, Boulevard de la Chantourne, La Tronche, La Tronche
CHU de Toulouse – Hôpital Larrey
service de pneumologie, 24 Chemin de Pouvourville, 31059 Toulouse, Toulouse
Institut Gustave Roussy
N/A, 114 Rue Edouard Vaillant, 94800, Villejuif
CHU Bordeaux Haut-Leveque
Oncologie-Thoracique, Avenue Magellan, 33600 Pessac, Pessac
Franziskus Hospital Harderberg
N/A, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette
St. Elisabeth-Krankenhaus Leipzig
Innere Abteilung 1, Biedermannstraße 84, Sachsen, Leipzig
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Klinik für Innere Medizin II, Roentgenstrasse 1, Doelau, Halle (saale)
Robert Bosch Krankenhaus GmbH
Haematologie, Onkologie und Palliativmedizin, Auerbachstrasse 110, Bad Cannstatt, Stuttgart
Asklepios Kliniken Hamburg GmbH
Pneumologie, Eissendorfer Pferdeweg 52, Heimfeld, Hamburg
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Pneumologie, Lindenberger Weg 27, Buch, Berlin
Thoraxklinik Heidelberg gGmbH
Studienzentrum Thoraxonkologie, Roentgenstrasse 1, Rohrbach, Heidelberg
Asklepios Klinik Gauting GmbH
Oncology, Robert-Koch-Allee 2, 82131, Gauting
Onkologie Donauwoerth (MVZ) GmbH
N/A, Neudegger Allee 10, Neudegger Siedlung, Donauwoerth
Klinikum Chemnitz
Klinik fuer Innere Medizin IV, Bürgerstraße 2, Sachsen, Chemnitz
Evangelisches Krankenhaus Herne - Eickel
N/A, Hordeler Strasse 7-9, Nordrhein-Westfalen, Herne
MV-Zentrum für Onkologie und Hämatologie
N/A, Sachsenring 69, Nordrhein-Westfalen, Cologne
Vivantes Netzwerk fuer Gesundheit GmbH
Hämatologie, Onkologie und Palliativmedizin, Landsberger Allee 49, Friedrichshain, Berlin
HELIOS Klinikum Erfurt GmbH
N/A, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt
Klinikum Nürnberg Nord
3. Med. Klinik / Pneumologie, Prof.-Ernst-Nathan-Strasse 1, Haus 14 SG, Nürnberg
DRK Kliniken Berlin
Pneumologie, Eg., Spandauer Damm 130, Berlin
LungenClinic Grosshansdorf GmbH
Onkologie, Woehrendamm 80, 22927, Grosshansdorf
Klinikum Köln-Merheim
N/A, Ostmerheimer Strasse 200, Nordrhein-Westfalen, Köln
Universitaetsklinikum Tuebingen AöR
Department of Internal Medicine VIII - Medical Oncology, ECTU, Pneumology, Otfried-Mueller-Strasse 14, Nordstadt, Tuebingen
St. Luke's Hospital S.A.
Department of Oncology, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
General University Hospital Of Larissa
Oncology Department, P. O. Box 1425, 411 10, Larissa
Henry Dunant Hospital Center
4th Department of Oncology and Clinial Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
General University Hospital Of Patras
Internal Medicine Clinic-Oncology Department, Rio, 265 04, Patras
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Thoracic General Hospital Of Athens I Sotiria
3rd University Internal Medicine Department, Messogion Avenue 152, 115 27, Athens
University General Hospital Of Heraklion
Internal Medicine-Oncology Clinic, Stavrakia And Voutes, 715 00, Heraklion
Saint Savvas Oncology Hospital
2nd Department of Internal Medicine-Oncoloy, Alexandras Avenue 171, 115 22, Athens
Farkasgyepui Tudogyogyintezet
Pulmonológia, 049 Hrsz 2, 8582, Farkasgyepu
Orszagos Onkologiai Intezet
Onkológiai Képalkotó és Invazív Diagnosztikai Központ, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Budapesti Uzsoki Utcai Korhaz
Pulmonológia, Uzsoki Utca 29-41, 1145, Budapest XIV
ASST Grande Ospedale Metropolitano Niguarda
Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliera Universitaria Integrata Verona
Oncology Unit, Piazzale Aristide Stefani 1, 37126, Verona
Azienda Ospedaliera Dei Colli
U.O.C Pneumologia Oncologica DH PNL ONC, Via Leonardo Bianchi, 80131, Naples
IRCCS Ospedale Policlinico San Martino
UOC Clinica di Oncologia Medica, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
UOC Oncologia Medica, Via Santa Sofia 78, 95123, Catania
Fondazione IRCCS San Gerardo Dei Tintori
Oncologia Loc. 3, Via Giovanni Battista Pergolesi 33, 20900, Monza
Istituto Nazionale Tumori Regina Elena
UOSD Sperimentazioni cliniche: Fase 1 e Medicina di precisione Loc. 1, Via Elio Chianesi 53, 00144, Rome
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
SCDU Oncologia Medica, Regione Gonzole 10, 10043, Orbassano
Istituto Tumori Bari Giovanni Paolo II
SSD Oncologia Medica per la Patologia Toracica Loc. 1, Viale Orazio Flacco 65, 70124, Bari
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Pulmonology, Plesmanlaan 121, 1066 CX, Amsterdam
Amsterdam UMC, locatie VUmc
Pulmonology, De Boelelaan 1117, ZH5-F28, Amsterdam
Isala, locatie Zwolle
Poli Longziekten, Dokter Van Heesweg 2, V 2.2, Zwolle
St. Antonius Ziekenhuis
Pulmonary disease, Soestwetering 1, 3543 AZ, Utrecht
ETZ Elisabeth
Department of Pulmonary Diseases, Hilvarenbeekseweg 60, Noord-Brabant, Tilburg
Ziekenhuis St Jansdal
Poli Longziekten, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Amphia Hospital
Long Oncologie, Molengracht 21, 4818 CK, Breda
Sykehuset Innlandet HF
Dept. of Oncology, Kyrre Grepps Gate 11, 2819, Gjoevik
Sorlandet Sykehus HF
Medical Department, Sykehusveien 1, 4838, Arendal
Vestre Viken HF
Dept. of surgery, section of Oncology, Groenland 32, 3045, Drammen
Oslo University Hospital HF
Dept. of Oncology, Taarnbygget, Kirkeveien 166, Oslo
Helse Bergen HF
Dept. of Thoracic Medicine, Jonas Lies Vei 65, 5021, Bergen
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
One Day Med Sp. z o.o.
N/A, Plac Rodla 8, 70-419, Szczecin
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Onkologii Klinicznej, Dzial Chemioterapii, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Hospital CUF Porto S.A.
Oncology, Estrada Da Circunvalacao N 14341, 4100-180, Porto
Hospital Da Luz S.A.
Oncology, Avenida Lusiada 100, 1500-650, Lisbon
Unidade Local De Saude De Coimbra E.P.E.
Oncology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Memorial Healthcare International S.R.L.
Oncology, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Lotus Med S.R.L.
Oncology, Strada Dornei 79-81, 012292, Bucharest
Ovidius Clinical Hospital S.R.L.
Oncology, Dn 2a Km 202 880, 905900, Ovidiu
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
F D Roosevelt University General Hospital Of Banska Bystrica
Oddelenie pneumologie a ftizeologie, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Vychodoslovensky Onkologicky Ustav a.s.
N/A, Rastislavova 43, Juh, Kosice
University Hospital Bratislava
N/A, Ruzinovska 6, Ruzinov, Bratislava
Hospital Clinico Universitario Lozano Blesa
Oncologia, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Quironsalud Madrid
Oncologia, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
University Hospital Son Espases
Oncologia, Carretera Valldemossa 79, 07120, Palma
Hospital General Universitario Gregorio Maranon
Oncologia, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinico Universitario De Valencia
Oncologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Regional De Malaga
Oncologia, Avenida De Carlos De Haya S/N, 29010, Malaga
Vall D Hebron Institute Of Oncology
Oncologia, Calle Natzaret 115, 08035, Barcelona
Hospital Universitario De Navarra
Oncologia, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Clinic De Barcelona
Oncologia, Calle Rosellon 138, 08036, Barcelona
Institut Catala D'oncologia
Oncologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Complejo Hospitalario Universitario Insular Materno Infantil
Oncologia, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario 12 De Octubre
Oncologia, Avenida De Cordoba Sn, 28041, Madrid
Hospital Del Mar
Oncologia, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario De Badajoz
Oncologia, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitario Ramon Y Cajal
Oncologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital De Jerez De La Frontera
Oncologia, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
University Hospital Virgen Del Rocio S.L.
Oncologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complexo Hospitalario Universitario De Santiago
Oncologia, Calle Choupana Da S/n, 15706, Santiago De Compostela
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department of oncology, Bruna Straket 16, 413 46, Gothenburg
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 | 2025-06-13 | ||||
| Belgium | 2025-07-18 | ||||
| Czechia | 2025-06-09 | ||||
| France | 2025-07-31 | 2025-10-16 | |||
| Germany | 2025-07-22 | 2026-03-04 | |||
| Hungary | 2025-07-03 | ||||
| Italy | 2025-06-27 | 2026-02-09 | |||
| Netherlands | 2025-06-25 | 2025-07-28 | |||
| Norway | 2026-02-02 | 2026-04-17 | |||
| Poland | 2025-06-06 | ||||
| Portugal | 2025-10-02 | 2026-03-19 | |||
| Romania | 2025-06-10 | 2025-08-27 | |||
| Slovakia | 2025-06-16 | 2026-02-24 | |||
| Spain | 2025-06-11 | 2025-09-24 | |||
| Sweden | 2025-10-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 269 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512302-25-00_GR_Redacted | c |
| Protocol (for publication) | D1_Protocol_2024-512302-25-00_GR_Redacted_ | 1 |
| Protocol (for publication) | D1_Protocol_2024-512302-25-00_Redacted | c |
| Protocol (for publication) | D4_2024-512302-25-00_Patient Documents Copyright_v1_14Nov2024_SE | 1 |
| Protocol (for publication) | D4_NO_Patient facing documents_Patient Documents Copyright_2024-512302-25-00 | 1 |
| Protocol (for publication) | D4_Patient Card_GR | 2 |
| Protocol (for publication) | D4_Patient Card_GR_Track changes | 1 |
| Protocol (for publication) | D4_Patient Documents Copyright_2024-512302-25-00 | 1 |
| Protocol (for publication) | D4_Patient facing documents_DIARY_paper | 1 |
| Protocol (for publication) | D4_Patient facing documents_DOSE-DIARY_Trans_Paper_Track changes_GR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Subject Diary_paper | 1 |
| Protocol (for publication) | D4_PT_Patient Facing Document_Patient Documents Copyright | 1 |
| Recruitment arrangements (for publication) | K1_List of participating sites | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and consenting procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF form | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_14Nov2024 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_AT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Informed consent and patient recruitment procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_List of Sites_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_PT | 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 Materials_Part A_site 49355 | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Materials_Part B_site 49355 | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K2_Dr_to_Patient_Master | 1 |
| Recruitment arrangements (for publication) | K2_Letter-Doctor-Referral_Master | 1 |
| Recruitment arrangements (for publication) | K2_Letter-Doctor-Referral_Master | 1 |
| Recruitment arrangements (for publication) | K2_Letter-Doctor-Referral_Master_RO | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Master_PT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangements_List of sites_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Doctor referral letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter_Doctor Referral | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter_Doctor Referral_Shortened | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Letter-Doctor-Referral_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-Referral_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-Referral_Master_v1_29Nov2024 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_NO_Clean | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study-Guide-Part-A_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study-Guide-Part-B_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank You End of Treatment_Master_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank You Participation Master_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank You Screening Master_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Awareness Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Awareness Brochure | 1 |
| Recruitment arrangements (for publication) | K2_recruitment Material_Trial Awareness Brochure_BEDU | 1 |
| Recruitment arrangements (for publication) | K2_recruitment Material_Trial Awareness Brochure_BEFR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial-Awareness-Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Visit Card Master_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Visit-Card_Master | 1 |
| Recruitment arrangements (for publication) | K2_Study-Guide-Part-A_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Study-Guide-Part-B_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Trial-Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Trial-Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Visit-Card_Master | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment material_Poster_Master | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Addendum Biopsy_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Addendum Genetic_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Addendum Interview_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main Part A_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main Part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_prescreening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Confidentiality Notice_GR | 1 |
| Subject information and informed consent form (for publication) | L1_CountrySpecific_ICF_Main_Part A_PT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Optional Biopsy_PRT_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Optional Prescreening_PRT_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_PartA_PRT_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_PartB_PRT_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Pregnancy_PRT_clean | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Interview ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional Biopsy ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Part A_GR_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Part B_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Part_A_de-AT_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_Part_B_de-AT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Pre-screening ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Prescreening_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Tumor Sample_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Optional biopsy ICF_RO_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Optional Interview ICF_RO_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Optional Prescreen ICF_RO_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Recruitment and Informed consent procedure | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Optional Biopsy_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Optional Genetic_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Optional Prescreening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Interview_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Optional Biopsy_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Optional biopsy_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Optional Interview_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Prescreening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Optional Biopsy_BEDU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Optional Biopsy_BEFR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Optional Biopsy_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Optional Interview_BEDU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Optional Interview_BEFR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Optional Interview_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Pre-screening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Prescreening_BEDU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Prescreening_BEFR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Prescreening_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Biopsy Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_NO_clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF part A_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part A_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part A_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Part A_ICF_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Part A_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Part A_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Part A_SWE_redacted | V4.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Part B_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part A_BEDU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part A_BEFR_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part A_ENG_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part A_redacted_NO | V4.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part B_BEDU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part B_BEFR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part B_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part B_NO_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part A_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part_A_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part_B_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biopsy Addendum ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional biopsy ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional biopsy ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional biopsy_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biopsy_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biopsy_redacted_NO | V1.0NOR5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional In-Trial Interview Addendum ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Interview_redacted_NO | V1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Prescreening Addendum ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Prescreening_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Prescreening_redacted_NO | V1.0NOR5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Part A_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Addendum ICF_clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_clean_NO | V1.0NOR4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Participant_BEDU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Participant_BEFR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Participant_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_BEDU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_BEFR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening ICF_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Trial level Consent_Part_A_RO_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Trial level Consent_Part_B_RO_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_confidentiality sheet | 1 |
| Subject information and informed consent form (for publication) | L2_Compensation Information Sheet_Part A_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Compensation Information Sheet_Part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Compensation Information Sheet_PRT_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Confidentiality Notice phase 3 and 4 trials_RO | 1 |
| Subject information and informed consent form (for publication) | L2_Confidentiality Notice_PRT | 1 |
| Subject information and informed consent form (for publication) | L2_Informed consent and patient recruitment procedure | 1 |
| 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 patient material_Study Participant Contact card_RO | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ EU Dispute Form | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_3D Secure Terms of Use | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Items | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bank Transfer FAQ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bank Transfer Standard Message | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder FAQ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder Msg | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Card_Carrier | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Fee_Schedule | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Generic_Image | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Privacy Policy | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_redacted | V2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_redacted_NO | V1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Sheet Part A_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Sheet Part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Confidentiality Notice | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice_Netherlands_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Reference Guide for Participants | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_ConneX Travel Contact Card_GR_Redacted | 10 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_ConneX Travel Reference Guide for Participants_GR_Redacted | 10 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ICF_Sponsor_Statement_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_KYC | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient information card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Poster_Master_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Study Guide Part A_BEDU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Study Guide Part A_BEFR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Guide Part A_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Study Guide Part B_BEDU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Study Guide Part B_BEFR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Guide Part B_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Guide_A_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study-Guide-Part-A_GR_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study-Guide-Part-A_Master_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study-Guide-Part-B_Master_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Trial-Brochure_Master_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Visit Card_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Visit Card_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit-Card_Master_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Card_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Card_GR_Track changes | 1 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Study-Guide-Part-A_Master_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Study-Guide-Part-B_Master_Redacted | 1 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Patient Emergency Card | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject material_Appreciation Items_Redacted | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Cards_AT | 1 |
| Subject information and informed consent form (for publication) | L3_Patient contact card | 1 |
| Subject information and informed consent form (for publication) | L4_Confidentiality Notice | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Imfinzi | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Imfinzi_12Feb2025 | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Imfinzi_31Mar2025 | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Keytruda | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Keytruda | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Keytruda | NA |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_PRT_2024-512302-25-00_redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis France 2024-512302-25-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL_2024-512302-25_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-512302-25-00_GR_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-512302-25-00_redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-512302-25-00_redacted_NO | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_2024-512302-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDE_2024-512302-25-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDU_2024-512302-25-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEFR_2024-512302-25-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2024-512302-25-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2024-512302-25-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2024-512302-25-00_redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2024-512302-25-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SE_2024-512302-25-00_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SK_2024-512302-25-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_HU_2024-512302-25-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_RO_2024-512302-25-00_Redacted | c |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-29 | Hungary | Acceptable with conditions 2025-05-19
|
2025-05-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-28 | Acceptable with conditions 2025-05-19
|
2025-05-28 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-05 | Acceptable with conditions | 2025-07-14 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-06 | Acceptable with conditions | 2025-06-11 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-15 | Acceptable with conditions | 2025-07-15 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-17 | Acceptable with conditions | 2025-07-17 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-04 | Hungary | Acceptable with conditions 2026-03-03
|
2026-03-03 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-25 | Hungary | Acceptable with conditions 2026-03-03
|
2026-03-25 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-30 | Acceptable with conditions | 2026-05-08 |