Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
850
Countries
14
Sites
91
Unresectable Stage III non-small cell lung cancer without progression
The main goal of the study is to compare pumitamig and durvalumab to see which medicine does a better job at slowing down the worsening of the stage III NSCLC.
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)
- 2026-05-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-523576-23-00
- WHO UTN
- U1111-1326-9190
- ClinicalTrials.gov
- NCT07361497
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The main goal of the study is to compare pumitamig and durvalumab to see which medicine does a better job at slowing down the worsening of the stage III NSCLC.
Secondary objectives 3
- to see which medicine helps participants live longer
- to see how safe each medicine is
- to see how well people can tolerate the medicine
Conditions and MedDRA coding
Unresectable Stage III non-small cell lung cancer without progression
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10025052 | Lung cancer non-small cell stage III | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- participants with unresectable Stage III NSCLC whose cancer did not get worse after chemoradiation
- Participants can have any level of PD-L1 expression and must be in good overall health
Exclusion criteria 6
- significant cardiovascular disease
- significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease or pneumonitis requiring treatment with systemic steroids
- significant risk of pulmonary hemorrhage
- a history of abdominal fistula or gastrointestinal perforation within 6 months prior of randomization
- certain types of mutations (EGFR mutations or ALK rearrangements)
- evidence of major coagulation disorders
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- to find out which medicine works better at delaying cancer growth (progression-free survival; PFS by BICR)
Secondary endpoints 7
- To see if participants live longer when taking pumitamig instead of durvalumab (Overall Survival; OS)
- Measuring how long it takes for the cancer to get worse, as judged by the participant’s doctor (PFS by investigator)
- Seeing how many participant’s tumors shrink or disappear with each medicine (Objective Response; OR)
- Seeing how many participants have their cancer stay the same size or shrink (Disease Control Rate; DCR)
- Measuring how long tumors stay smaller or stable after improving (Duration of Response; DOR)
- Timing how quickly tumors start to shrink after treatment (Time to Response; TTR)
- Look at how safe each medicine is and how well participants tolerate them
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
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
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
Comparator 1
SUB176342 · Substance
- Active substance
- Durvalumab
- 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
- 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 8
| Organisation | City, country | Duties |
|---|---|---|
| Massive Bio Inc. ORG-100044618
|
New York, United States | Other |
| Discovery Life Sciences Biomarker Services GmbH ORG-100042520
|
Kassel, Germany | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
| Rules Based Medicine Inc. ORG-100043610
|
Austin, United States | Other |
Locations
14 EU/EEA countries · 91 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 8 | 3 |
| Belgium | Authorised, recruitment pending | 24 | 7 |
| Bulgaria | Authorised, recruitment pending | 15 | 5 |
| France | Authorised, recruitment pending | 30 | 12 |
| Germany | Authorised, recruitment pending | 43 | 13 |
| Greece | Authorised, recruitment pending | 16 | 6 |
| Hungary | Authorised, recruitment pending | 10 | 5 |
| Ireland | Authorised, recruitment pending | 8 | 3 |
| Italy | Authorised, recruitment pending | 22 | 8 |
| Netherlands | Authorised, recruitment pending | 25 | 5 |
| Poland | Authorised, recruitment pending | 10 | 4 |
| Romania | Authorised, recruitment pending | 32 | 8 |
| Spain | Authorised, recruitment pending | 27 | 9 |
| Sweden | Authorised, recruitment pending | 9 | 3 |
| Rest of world
Turkey, India, Mexico, Canada, Hong Kong, Taiwan, Korea, Republic of, Japan, Thailand, Singapore, Brazil, Argentina, United States, China, Australia, Switzerland, United Kingdom, Chile
|
— | 571 | — |
Investigational sites
Medical University Of Vienna
Department of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Medizinische Universitaet Innsbruck
Hematology and Oncology, Anichstrasse 35, 6020, Innsbruck
Ordensklinikum Linz GmbH
Pneumology, Fadingerstrasse 1, 4020, Linz
Institut Jules Bordet
Thoracic Oncology Clinic, Mijlenmeersstraat 90, 1070, Anderlecht
UZ Leuven
Pneumology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Pneumology, Corneel Heymanslaan 10, 9000, Gent
Vitaz
Pulmonary and Infectious Diseases, Moerlandstraat 1, 9100, Sint-Niklaas
Algemeen Ziekenhuis Klina
Oncology, Augustijnslei 100, 2930, Brasschaat
Grand Hopital De Charleroi
Pneumology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Ziekenhuis Oost Limburg
Respiratory Oncology, Synaps Park 1, 3600, Genk
Diagnostics And Consultation Center Convex Ltd.
n/a, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
University Multidisciplinary Hospital For Active Treatment Sveta Ekaterina EAD
Medical Oncology Level III, Bulevard Pencho Slaveykov 52a, 1431, Sofia
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
Medical Oncology Level II, Bulevard Siedinenie 49, 6304, Haskovo
Complex Oncology Center Ruse EOOD
Medical Oncology Level II, 2 Nezavisimost street, 7000, Ruse
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Medical Oncology Level III, Oborishte Distr., Ul.Byalo More 8, Sofia
Centre Hospitalier Universitaire De Nantes
Oncology medical, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Leon Berard
Oncology medical, 28 Rue Laennec, 69008, Lyon
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Universitaire De Lille
Pneumology, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Institut Gustave Roussy
Radiation Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Et Universitaire De Limoges
Pneumology, 2 Avenue Martin Luther King, 87000, Limoges
Institut Regional Du Cancer De Montpellier
Thoracic oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Assistance Publique Hopitaux De Paris
Pneumology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Regional De Marseille
Thoracic oncology, 265 Chemin Des Bourrely, 13015, Marseille
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Hospitalier Universitaire De Toulouse
Pneumology, 24 Chemin De Pouvourville, 31400, Toulouse
Institut Curie
Pneumology, 26 Rue D Ulm, 75005, Paris
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Oncology, Roentgenstrasse 1, Doelau, Halle (saale)
Lungenfachklinik Immenhausen
Onkologische Ambulanz, Robert Koch Strasse 3, 34376, Immenhausen
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin II Abt. Hämatologie / Onkologie, Am Klinikum 1, Lobeda, Jena
Universitaetsmedizin Goettingen
Hematology and Oncology, Robert-Koch-Strasse 40, Weende, Goettingen
Katholisches Klinikum Koblenz Montabaur gGmbH
Klinik für Pneumologie, Onkologie und Beatmungsmedizin, Rudolf-Virchow-Strasse 7, Rauental, Koblenz
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Medizinische Klinik A Hämatologie und Onkologie, Bremserstrasse 79, Friesenheim, Ludwigshafen Am Rhein
LungenClinic Grosshansdorf GmbH
Onkologie, Woehrendamm 80, 22927, Grosshansdorf
Asklepios Klinik Gauting GmbH
Onkologisches Studienzentrum, Robert-Koch-Allee 2, 82131, Gauting
Universitaetsklinikum Regensburg AöR
ZKS - Zentrum fuer Klinische Studien Büro: B3 1.32, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Schleswig-Holstein AöR
Studienzentrum Pneumologie Medizinische Klinik III, Ratzeburger Allee 160, 23538, Luebeck
HELIOS Klinikum Emil von Behring GmbH
Klinik für Pneumologie, Walterhoeferstrasse 11, Zehlendorf, Berlin
Universitaetsklinikum Augsburg
II. Medizinische Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg
Charite Universitaetsmedizin Berlin KöR
Fächerverbund Infektiologie, Pneumologie und Intensivmedizin, Augustenburger Platz 1, Wedding, Berlin
Henry Dunant Hospital Center
4th Department of Oncology & Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
General University Hospital Of Larissa
Oncology Clinic, Chemotherapy Department, P. O. Box 1425, 411 10, Larissa
Thoracic General Hospital Of Athens I Sotiria
3rd Department of Internal Medicine, Oncology Unit & Laboratory, Messogion Avenue 152, 115 27, Athens
General Hospital Of Thessaloniki Papageorgiou
Clinic of Medical Oncology, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Laiko General Hospital Of Athens
1st Department of Internal Medicine, Sevastoupoleos 16, 115 26, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Pulmonary Clinic of Aristotle University of Thessaloniki, Exochi, 570 10, Thessaloniki
Orszagos Koranyi Pulmonologiai Intezet
Department of Pulmonology, Koranyi Frigyes Ut 1, 1121, Budapest XII
Reformatus Pulmonologiai Centrum
Reformed Pulmonology Center, Munkacsy Mihaly Utca 70, 2045, Torokbalint
Farkasgyepui Tudogyogyintezet
Department of Pulmonology, 049 Hrsz 2, 8582, Farkasgyepu
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
County Oncology Center, Toszegi Ut 21, 5000, Szolnok
Bacs-Kiskun Varmegyei Oktatokorhaz
Oncoradiology Center, Nyiri Ut 38, 6000, Kecskemet
St James's Hospital
Medical Oncology, James's Street, D08 NHY1, Dublin 8
Mater Private Hospital
Medical Oncology, Eccles Street, D07 WKW8, Dublin 7
Beaumont Hospital
Medical Oncology, Beaumont Road, Beaumont, Dublin 9
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Thoracopulmonary, Via Mariano Semmola 52, 80131, Naples
Azienda Unita Sanitaria Locale Della Romagna
Oncology and Hematology, Via Alcide De Gasperi 8, 48121, Ravenna
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Centro Di Riferimento Oncologico Di Aviano
Oncology, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncology, Regione Gonzole 10, 10043, Orbassano
Azienda Ospedaliero Universitaria Parma
Oncology, Viale Antonio Gramsci 14, 43126, Parma
Ospedale San Raffaele S.r.l.
Oncology, Via Olgettina 60, 20132, Milan
Universita' Campus Bio-medico Di Roma
Radiation Oncology, Via Alvaro Del Portillo 21, 00128, Rome
Universitair Medisch Centrum Groningen
Pulmonology, Hanzeplein 1, 9713 GZ, Groningen
Radboud universitair medisch centrum Stichting
Pulmonary diseases, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Amsterdam UMC Stichting
Pulmonary medicine, De Boelelaan 1117, 1081 HV, Amsterdam
Amphia Hospital
Pulmonology, Molengracht 21, 4818 CK, Breda
Isala Klinieken Stichting
Pulmonology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Oddział Onkologii Klinicznej, Ul. Ceglana 35, 40-514, Katowice
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
---, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
---, Ul. Monte Cassino 18, 37-700, Przemysl
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Klinika Onkologii z Odcinkiem Dziennym, Ul. Katowicka 66a, 45-061, Opole
Institutul Regional De Oncologie Iasi
Oncologie, Strada G-Ral Berthelot 2-4, 700483, Iasi
Centrul De Oncologie-Euroclinic S.R.L.
n/a, Strada Conta Vasile 2, 700106, Iasi
Radiotherapy Center Cluj S.R.L.
n/a, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Asociatia Oncohelp
n/a, Strada Porumbescu Ciprian 59, 300239, Timisoara
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
n/a, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Universitar De Urgenta Bucuresti
n/a, Splaiul Independentei 169, 050098, Bucharest
Centrul De Oncologie SF Nectarie S.R.L.
n/a, Strada Caracal Nr 109, 200542, Craiova
Centrul De Diagnostic Si Tratament Provita S.A.
n/a, Bulevardul Dimitrie Pompeiu Nr 9-9a Iride Business Park Sector 2, 11273, Bucharest
Institut Catala D'oncologia
Oncology, Avinguda De Franca S/n, 17007, Girona
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Virgen De La Victoria
oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario De Cruces
Oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital De La Santa Creu I Sant Pau
Oncology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
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 01 EU_2025-523576-23_GR_Redacted | 01 EU |
| Protocol (for publication) | D1_Protocol_2025-523576-23_GR_Redacted | 02 EU |
| Protocol (for publication) | D1_Protocol_2025-523576-23-00-redacted | PA 02 EU |
| Recruitment arrangements (for publication) | K_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_GR | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_RO | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_AT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures Form_DE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement form_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement Form_SE | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements and IC procedure_HU | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG_v1_23Jan2026 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Guide | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Guide_AT | NA |
| 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 | 1.1 |
| 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 Pregnant Partner_HU_redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Treatment Beyond Progression_HU_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main Adult _IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research_IT_Redacted | 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_ SIS and ICF Pregnant Partecipant _IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner _IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Privacy Notice _IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Reimbursment_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment Beyond Progression_IT_unredacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Future research_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Future research_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main_clean_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Participant_clean_no redactions | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner_clean_no redactions | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner_clean_no redactions | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Treatment beyond progression_clean_no redactions | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Treatment beyond progression_clean_no redactions | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research for Bulgaria_1_0_13 Jan 2026_BG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research for Bulgaria_1_0_13 Jan 2026_EN_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main for Bulgaria_1_0_19 Jan 2026_BG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main for Bulgaria_1_0_19 Jan 2026_EN_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main IC_NL_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted_RO | 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_FR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional future research_NL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant paricipant_NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner for Bulgaria_1_0_13 Jan 2026_BG | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner for Bulgaria_1_0_13 Jan 2026_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_GR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_RO | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_GR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond Progession_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression for Bulgaria_1_0_13Jan2026_BG | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression for Bulgaria_1_0_13Jan2026_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_GR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_NL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main ICF_DUT_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main ICF_ENG_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main ICF_FRE_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main ICF_FRE_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Global IC Optional Future Research_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Global IC Treatment Beyond Progression IC PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Global IC_ Pregnant Partner IC_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Global IC_Participant who Becomes Pregnant IC_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adults Consent Form_Redacted_IE | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adults_Redacted_SE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_DUT_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ENG_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research Consent Form_Redacted_IE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional future research_ES_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_Redacted_SE | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Consent Form_Non-Redacted_IE_Track Changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_DUT_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_DUT_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ENG_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_ENG_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_ES | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FRE_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FRE_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_site contact list_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sponsor statement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TBP_ES | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression Consent Form_Non-Redacted_IE_Track Changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_DUT_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_DUT_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_ENG_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_ENG_TC_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_FRE_For Publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_FRE_TC_For Publication | 1.1 |
| 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 Subject Information_Mural Health Privacy Policy_IE | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mural Health_Terms and Conditions_IE | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mural Link Participant App Fun Facts_IE | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mural Link Participant Mobile Web and App Screenshots_IE | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mural Link Participant Reference Guide_IE | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Mural Link Patient Travel Reference Guide_IE | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Notifications for Mural Link_IE | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Alert Card_HU_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Durvalumab | na |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis _2025-523576-23_IT | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-523576-23_GER_AT | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NLD 2025-523576-23 Dutch | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523576-23_BE_DUT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523576-23_BE_FRE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523576-23_BE_GER | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523576-23_FR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523576-23_GR | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-523576-23_PL | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2025-523576-23-00 | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2025-523576-23_BG | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2025-523576-23_HU | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2025-523576-23_RO | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2025-523576-23_ES | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IE_2025-523576-23-00_Eng | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SE_2025-523576-23-00_Swe | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-02 | Ireland | Acceptable 2026-05-22
|
2026-05-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-29 | Ireland | Acceptable 2026-05-22
|
2026-05-29 |