Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
750
Countries
16
Sites
87
Non-Small Cell Lung Cancer
to see if pumitamig controls cancer growth better and allows people to live longer compared to pembrolizumab
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-05-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-523586-18-00
- WHO UTN
- U1111-1326-9286
- ClinicalTrials.gov
- NCT07361510
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
to see if pumitamig controls cancer growth better and allows people to live longer compared to pembrolizumab
Secondary objectives 3
- to check how well pumitamig shrinks or eliminate the tumors compared to pembrolizumab
- to check how long those effects last
- to check how safe and tolerable each medicine is
Conditions and MedDRA coding
Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants (male and female) ≥ 18 years of age must have confirmed diagnosis of advanced stage NSCLC with documented high levels (≥ 50%) of a protein called PD-L1
- Participants must be in good overall health
- Participants should have not received prior systemic anti-tumor therapy for advanced NSCLC
Exclusion criteria 7
- Participants must not have any documented gene changes in their cancer for which there are already approved treatments available
- Participants must not have untreated brain metastases
- significant cardiovascular disease
- active autoimmune disease
- serious lung disease
- high risk of pulmonary bleeding
- abdominal fistula or gastrointestinal perforation within 6 months prior to randomization
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Progression-free survival (PFS) assessed by BICR, to see if pumitamig works better than pembrolizumab by evaluating how long it takes before the cancer starts growing again by radiographic imaging techniques
- Overall Survival (OS), to assess if people live longer when they take pumitamig compared to pembrolizumab
Secondary endpoints 3
- overall response of pumitamig versus pembrolizumab
- how safe each medicine is
- how well participants tolerate the medicines
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD13426964 · Product
- Active substance
- Pumitamig
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIONTECH SE
- Paediatric formulation
- No
- Orphan designation
- No
PRD13426963 · Product
- Active substance
- Pumitamig
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIONTECH SE
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
SUB167136 · Substance
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- removed from the carton, over-labeled, and repackaged
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Rules Based Medicine Inc. ORG-100043610
|
Austin, United States | Other |
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other, Interactive response technologies (IRT) |
| Iqvia Inc. ORG-100010622
|
Durham, United States | On site monitoring, Code 10, Code 11, Other, Code 2, Code 9 |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Discovery Life Sciences Biomarker Services GmbH ORG-100042520
|
Kassel, Germany | Other |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
Locations
16 EU/EEA countries · 87 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 9 | 3 |
| Belgium | Authorised, recruitment pending | 10 | 4 |
| Bulgaria | Authorised, recruitment pending | 10 | 4 |
| Czechia | Authorised, recruitment pending | 10 | 4 |
| Finland | Authorised, recruitment pending | 6 | 3 |
| France | Authorised, recruitment pending | 30 | 10 |
| Germany | Authorised, recruitment pending | 38 | 12 |
| Hungary | Authorised, recruitment pending | 10 | 5 |
| Italy | Authorised, recruitment pending | 24 | 8 |
| Netherlands | Authorised, recruitment pending | 20 | 4 |
| Norway | Authorised, recruitment pending | 6 | 2 |
| Poland | Authorised, recruitment pending | 13 | 5 |
| Portugal | Authorised, recruitment pending | 6 | 2 |
| Romania | Authorised, recruitment pending | 32 | 10 |
| Spain | Authorised, recruitment pending | 36 | 9 |
| Sweden | Not authorised | 5 | 2 |
| Rest of world
Taiwan, Chile, United Kingdom, Thailand, Canada, Mexico, Brazil, Colombia, Switzerland, Malaysia, United States, Australia, Peru, Singapore, Argentina, South Africa, Korea, Republic of, Turkey, India, Japan, China
|
— | 485 | — |
Investigational sites
Noe LGA Gesundheit Region Mitte GmbH
1 Medical Department, Dunant-Platz 1, 3100, St. Poelten
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Internal Medicine II Oncology, Hematology, Gastroenterology, Infectiology, Carinagasse 47, 6800, Feldkirch
Johannes Kepler University Linz
Department of Internal Medicine 4 - Pulmonology, Med Campus III, Krankenhausstrasse 9, Linz
UZ Leuven
Respiratory Oncology, Herestraat 49, 3000, Leuven
Algemeen Ziekenhuis Klina
Oncology, Augustijnslei 100, 2930, Brasschaat
Ziekenhuis Aan De Stroom
Thoracic Oncology, Oosterveldlaan 24, 2610, Antwerp
Chirec
Respiratory Disease, Triomflaan 201, 1160, Oudergem
University Multidisciplinary Hospital For Active Treatment Sveta Ekaterina EAD
Department – Medical Oncology Level III, Bulevard Pencho Slaveykov 52a, 1431, Sofia
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department – Medical Oncology Level III, Oborishte Distr., Ul.Byalo More 8, Sofia
Diagnostics And Consultation Center Convex Ltd.
n/a, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Complex Oncology Center Ruse EOOD
Department – Medical Oncology Level II, 2 Nezavisimost street, 7000, Ruse
Fakultni Nemocnice Hradec Kralove
Plicni klinika, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
University Hospital Olomouc
Klinika plicnich nemoci a tuberkulozy, Zdravotniku 248/7, 779 00, Olomouc
Nemocnice AGEL Ostrava-Vitkovice a.s.
Plicni oddeleni, Zaluzanskeho 1192/15, Vitkovice, Ostrava
Fakultni Nemocnice Plzen
Klinika pneumologie a ftizeologie, Edvarda Benese 1128/13, Jizni Predmesti, Plzen 3
Kuopio University Hospital
Onkology, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
Tampere University Hospital
Oncology, Elamanaukio 2, 33520, Tampere
Vaasa Central Hospital
Clinical Oncology, Hietalahdenkatu 2-4, 65130, Vaasa
Centre Hospitalier Universitaire De Bordeaux
Service des maladies respiratoires, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire Grenoble Alpes
Unité d'oncologie thoracique, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Assistance Publique Hopitaux De Paris
Unité d'oncologie thoracique, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Et Universitaire De Limoges
Pneumologie, 2 Avenue Martin Luther King, 87000, Limoges
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Pneumologie et oncologie thoracique, 185 Rue Raymond Losserand, 75014, Paris
Centre Hospitalier Intercommunal De Cornouaille
Pneumologie oncologie, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Institut Godinot
Centre d'oncologie, 1 Rue Du General Koenig, 51100, Reims
Institut De Cancerologie De L Ouest
Oncologie médicale, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Antoine Lacassagne
Oncologie, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Hospitalier Universitaire De Dijon
Oncologie thoracique, 1 Boulevard Jeanne D Arc, Bp 77908, Dijon
Krankenhaus Bethanien gGmbH
Klinik für Pneumologie und Allergologie Zentrum für Schlaf- und Beatmungsmedizin, Aufderhoeher Strasse 169, Ohligs/Aufderhoehe, Solingen
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Internistische Onkologie, Henricistrasse 92, Huttrop, Essen
HELIOS Klinikum Emil von Behring GmbH
Klinik für Pneumologie, Walterhoeferstrasse 11, Zehlendorf, Berlin
Westpfalz-Klinikum GmbH
Klinik für Innere Medizin 1, Hellmut-Hartert-Strasse 1, Innenstadt, Kaiserslautern
Romed Klinikum Rosenheim
N/A, Ellmaierstrasse 23, Ost, Rosenheim
Staedtisches Klinikum Braunschweig gGmbH
Medizinische Klinik III, Celler Strasse 38, 38114, Brunswick
Waldburg-Zeil Akutkliniken GmbH & Co. KG
Fachkliniken Wangen, Lungenzentrum Südwest, Klinik für Pneumologie, Beatmungsmedizin, Allergologie, Am Vogelherd 14, 88239, Wangen Im Allgaeu
HELIOS Klinikum Erfurt GmbH
I. Mediznische Klinik, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt
Gemeinschaftspraxis Fuer Haematologie Und Onkologie
Studienbüro Gemeinschaftspraxis für Hämatologie Und Onkologie, Roentgenstrasse 6-8, 63225, Langen (Hessen)
Universitaetsklinikum Schleswig-Holstein AöR
Medizinische Klinik III, Ratzeburger Allee 160, 23538, Luebeck
SRH Wald-Klinikum Gera GmbH
Zentrum für klinische Studien, Strasse Des Friedens 122, Debschwitz, Gera
Dr. Vehling-Kaiser MVZ GmbH
N/A, Achdorfer Weg 5, Achdorf, Landshut
Farkasgyepui Tudogyogyintezet
Department of Pulmonology, 049 Hrsz 2, 8582, Farkasgyepu
Orszagos Onkologiai Intezet
Department of Thoracic and Abdominal Tumors and Clinical Pharmacology, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Orszagos Koranyi Pulmonologiai Intezet
Department of Pulmonology, Koranyi Frigyes Ut 1, 1121, Budapest XII
Matrai Gyogyintezet
Department of Bronchology, Matrahaza Hrsz 7151, 3200, Gyongyos
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
County Oncology Center, Toszegi Ut 21, 5000, Szolnok
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Oncology, Via Santa Sofia 78, 95123, Catania
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology, Via Mariano Semmola 52, 80131, Naples
Ospedale San Raffaele S.r.l.
Oncology, Via Olgettina 60, 20132, Milan
University Hospital Of Ferrara
Oncology, Via Aldo Moro 8, 44124, Ferrara
Centro Di Riferimento Oncologico Di Aviano
Oncology, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Oncology, Corso Giuseppe Mazzini 18, 28100, Novara
IRCCS Ospedale Policlinico San Martino
Oncology, Largo Rosanna Benzi 10, 16132, Genoa
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Oncology, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Meander Medisch Centrum
Longgeneeskunde, Maatweg 3, 3813 TZ, Amersfoort
Jeroen Bosch Ziekenhuis Stichting
Longgeneeskunde, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Elisabeth-TweeSteden Ziekenhuis
Longgeneeskunde, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Radboud universitair medisch centrum Stichting
Longziekten, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Vestre Viken HF
Surgery, Oncology, Groenland 32, 3045, Drammen
Sykehuset Ostfold HF
Respiratory Medicine, Kalnesveien 300, 1714, Graalum
Instytut Centrum Zdrowia Matki Polki
-, Ul. Rzgowska 281/289, 93-338, Lodz
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Klinika Onkologii, Ul. Katowicka 66a, 45-061, Opole
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Oddzial Onkologii, Ul. Ceglana 35, 40-514, Katowice
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Oddzial Onkologiczny, Ul. Monte Cassino 18, 37-700, Przemysl
Pratia Hematologia Sp. z o.o.
-, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
CCAB Centro Clinico Academico Braga Associacao
Pulmonology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Santa Maria E.P.E.
Pulmonology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Spitalul Clinic Coltea
n/a, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Oncomed S.R.L.
n/a, Strada Porumbescu Ciprian 57-59, 300239, Timisoara
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
n/a, Strada Republicii 34-36, 400015, Cluj-Napoca
Radiotherapy Center Cluj S.R.L.
n/a, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Centrul De Diagnostic Si Tratament Provita S.A.
n/a, Bulevardul Dimitrie Pompeiu Nr 9-9a Iride Business Park Sector 2, 11273, Bucharest
Centrul De Oncologie-Euroclinic S.R.L.
n/a, Strada Conta Vasile 2, 700106, Iasi
Spitalul Universitar De Urgenta Bucuresti
n/a, Splaiul Independentei 169, 050098, Bucharest
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
n/a, 149th Ic Bratianu Street, 077015, Balotesti
Institutul Regional De Oncologie Iasi
n/a, Strada G-Ral Berthelot 2-4, 700483, Iasi
Centrul De Oncologie SF Nectarie S.R.L.
n/a, Strada Caracal Nr 109, 200542, Craiova
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital General Universitario Morales Meseguer
Oncology, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital Universitario De Cruces
Oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital De La Santa Creu I Sant Pau
Oncology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario De La Princesa
Oncology, Calle De Diego De Leon 62, 28006, Madrid
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 133 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-523586-18-00-redacted | PA 02 EU |
| Protocol (for publication) | D4_patient facing documents__statement_under license PL | N/A |
| Protocol (for publication) | D4_Patient facing documents_COA not for publication statement_CZ_CS_public | NA |
| Protocol (for publication) | D4_Patient facing documents_Statement under license_BE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Statement under license_FR | 1 |
| Protocol (for publication) | D4_patient facing documents_statement_under license_BG | 1 |
| Protocol (for publication) | D4_patient facing documents_statement_under license_RO | N/A |
| Protocol (for publication) | D4_patient facing questionnaire_statement under licence_FI | 1 |
| Protocol (for publication) | D4_patient facing questionnaire_statement under licence_NL | NA |
| Protocol (for publication) | D4_patient facing questionnaire_statement under licence_NO | 1 |
| Protocol (for publication) | D4_patient facing questionnaire_statement under licence_SE | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaire under licence_NSCLC-SAQ-EN | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_AT | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_DE | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_ES | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_HU | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_IT | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_PT | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_RO | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements and IC procedure_HU | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_AT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG_v1_23Jan2026 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements_FI | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NL | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NO | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_SE | 1 |
| Subject information and informed consent form (for publication) | L1 ICF PGx HU_redacted | 1 |
| Subject information and informed consent form (for publication) | L1 PIS PGx HU_redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main_HU_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Future Research HU redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Treatment Beyond Progression_HU | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted_EN | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted_RO | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Mural_EN | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Mural_RO | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research_Redacted_EN | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research_Redacted_RO | 1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Future Research Not Applicable | NA |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Main Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Pregnant participant Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Treatment Beyond Progression | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_SE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and Future Research IC_IT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond Progession_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research Redacted PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_SE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main for Bulgaria_BG_1_0_20Jan2026_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main for Bulgaria_EN_1_0_20Jan2026_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_ PL_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_DUT-BE_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ENG-BE_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FRE-BE_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FRE-BE_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_NO_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Research for Bulgaria_BG_1_0_13Jan2026_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Research for Bulgaria_EN_1_0_13Jan2026_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression for Bulgaria_BG_1_0_13Jan2026 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression for Bulgaria_EN_1_0_13Jan2026 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Treatment Beyond Progression_SE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future research_AT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future research_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_AT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DUT_TC_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DUT-BE_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ENG_TC_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ENG-BE_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FI_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FRE_TC_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional future research_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_participant who Becomes Pregnant_NO | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_sponsorstatement_Main IC_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TBP_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TBP_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TBP_ES | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_CZ_public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_DUT_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_DUT_TC_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_DUT-BE_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_DUT-BE_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_ENG_TC_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_ENG-BE_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_ENG-BE_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_FI | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_FRE_TC_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_FRE-BE_For Publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_FRE-BE_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ITA Reimbursement_IC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Main_IC Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Participant who Becomes Pregnant IC_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Privacy Notice IC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Treatment Beyond Progression IC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Treatment Beyond Progression_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Treatment Beyond Progression_RO | 1 |
| Subject information and informed consent form (for publication) | L2_other patient materials SPAC_PL | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PDP_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Alert Card_HU_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis CZ 2025-523586-18_CS_public | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS _2025-523586-18_Norwegian | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS 2025-523586-18 SE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523586-18_BE_DUT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523586-18_BE_FRE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523586-18_BE_GER | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-523586-18_FR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN-2025-523586-18-00 | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2025-523586-18_BG | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU CT 2025-523586-18_GER_AT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2025-523586-18_HU | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EU CT 2025-523586-18_PL | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2025-523586-18_RO | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2025-523586-18_ES | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2025-523586-18_IT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2025-523586-18_NL | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2025-523586-18_PT | 2 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-26 | Finland | Acceptable with conditions 2026-05-15
|
2026-05-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-27 | Acceptable with conditions 2026-05-15
|
2026-05-27 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-06-01 | Finland | Acceptable with conditions 2026-05-15
|
2026-06-01 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-06-03 | Acceptable with conditions 2026-05-15
|
2026-06-03 |