Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
630
Countries
15
Sites
122
Locally Advanced or Metastatic Non-small Cell Lung Cancer
The main objective of this study is to assess the potential added benefit when Adagrasib is combined with the current standard of care treatment in patients with untreated advanced lung cancer with a KRAS G12C mutation.
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]
- Trial duration
- 12 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515698-85-00
- WHO UTN
- U1111-1309-5596
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety, Dose response
The main objective of this study is to assess the potential added benefit when Adagrasib is combined with the current standard of care treatment in patients with untreated advanced lung cancer with a KRAS G12C mutation.
Secondary objectives 1
- Study will assess further efficacy (how well the treatment works), safety, and effects on quality of life.
Conditions and MedDRA coding
Locally Advanced or Metastatic Non-small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and partners/clinical-trials-and-research/disclosure-commitment.html
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC.
- Locally advanced or metastatic disease.
- Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
- No prior systemic anti-cancer therapy given for advanced or metastatic disease.
- Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection)
- Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
Exclusion criteria 9
- Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years prior to randomization..
- Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment.
- Inadequate bone marrow function.
- Inadequate liver function.
- Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
- Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
- Certain significant ECG abnormalities.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
- Evidence of active infection requiring parenteral therapy in the 2 weeks prior to randomization.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- To compare PFS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.
- To compare OS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.
Secondary endpoints 1
- PFS per RECIST v1.1 according to BICR.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
SUB167136 · Substance
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR 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
- No
PRD8665001 · Product
- Active substance
- Adagrasib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- NOTASSIGN — -
- MA holder
- MIRATI THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- 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
Auxiliary 1
SUB09593MIG · Substance
- Active substance
- Palonosetron
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 9999 Aµg/ml microgram(s)/millilitre
- Max total dose
- 9999 Aµg/ml microgram(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
- No
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
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT Representative
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT Representative
Third parties 18
| Organisation | City, country | Duties |
|---|---|---|
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Labcorp Development (Asia) Pte Ltd ORG-100050418
|
Singapore, Singapore | Other |
| Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd. ORG-100043119
|
Shanghai, China | Other |
| Iqvia Holdings Inc. ORG-100043905
|
Durham, United States | Other |
| Massive Bio Inc. ORG-100044618
|
New York, United States | Other |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Madison, United States | Other |
| Labcorp Development Japan K.K. ORG-100047151
|
Chuo, Japan | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Burlington, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Illumina Inc. ORG-100049125
|
San Diego, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Endpoint Clinical Inc. ORG-100040567
|
Raleigh, United States | Other |
| Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd. ORG-100043119
|
Shanghai, China | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
Locations
15 EU/EEA countries · 122 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 6 | 5 |
| Belgium | Ongoing, recruiting | 13 | 6 |
| Bulgaria | Ongoing, recruiting | 6 | 4 |
| Croatia | Ongoing, recruiting | 9 | 5 |
| France | Ongoing, recruiting | 34 | 18 |
| Germany | Ongoing, recruiting | 35 | 19 |
| Greece | Ongoing, recruiting | 5 | 3 |
| Hungary | Ongoing, recruiting | 10 | 5 |
| Ireland | Ongoing, recruiting | 13 | 5 |
| Italy | Ongoing, recruiting | 30 | 11 |
| Netherlands | Ongoing, recruiting | 3 | 2 |
| Poland | Ongoing, recruiting | 18 | 8 |
| Portugal | Ongoing, recruiting | 8 | 3 |
| Romania | Ongoing, recruiting | 29 | 13 |
| Spain | Ongoing, recruiting | 38 | 15 |
| Rest of world
India, Thailand, Brazil, Saudi Arabia, Australia, Mexico, Japan, United States, Chile, Switzerland, Argentina, United Kingdom, Turkey, Colombia, China, Hong Kong, Canada, Israel, Taiwan, Korea, Republic of
|
— | 373 | — |
Investigational sites
Klinikum Wels-Grieskirchen GmbH
Department of Pneumology, Grieskirchner Strasse 42, 4600, Wels
Stadt Wien Wiener Gesundheitsverbund
Department of Internal Medicine and Pneumology, Bruenner Strasse 68, Floridsdorf, Vienna
Johannes Kepler University Linz
Department of Internal Medicine 4 - Pneumology, Med Campus III, Krankenhausstrasse 9, Linz
Medical University Of Vienna
Department of Medicine, Division of Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University Of Graz
Department of Oncology, Neue Stiftingtalstrasse 6, 8010, Graz
Jessa Ziekenhuis
Pulmonology & Thoracic Oncology, Stadsomvaart 11, 3500, Hasselt
UZ Brussel
Medische Oncologie, Laarbeeklaan 101, 1090, Jette
UZ Leuven
Respiratory oncology unit, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Pneumology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Az Maria Middelares Gent
Pneumology, Buitenring-Sint-Denijs 30, 9000, Gent
Centre hospitalier universitaire de Liege
Pneumology department, Avenue De L'Hopital 1, 4000, Liege
"Multiprofile Hospital for Active Treatment Serdikamed" EOOD
Department – Medical Oncology Level II, Base 2-district "Ovcha Kupel 2", 128 President Lincoln str., Sofia
MBAL Trakia EOOD
Department - Medical Oncology Level III, Ulitsa Dunav 1, 6004, Stara Zagora
Complex Oncology Center Ruse EOOD
Department - Medical Oncology Level II, 2 Nezavisimost street, 7000, Ruse
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department - Medical Oncology Level III, Georgi Benkovski Street 100, 4500, Panagyurishte
Opca Bolnica Dubrovnik
Oncology, Dr. Roka Misetica 2, 20000, Dubrovnik
Klinicki Bolnicki Centar Osijek
Oncology, Ulica Josipa Huttlera 4, 31000, Osijek
KBC Split
Pulmology, Spinciceva 1, 21000, Split
KBC Zagreb
Pulmology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Specijalna Bolnica Medico
Oncology, Agaticeva 8, 51000, Rijeka
Centre Hospitalier Universitaire De Nantes
Medical Oncology - Oncology thoracic Unit, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Regional Et Universitaire De Brest
Oncology, Boulevard Tanguy Prigent, 29200, Brest
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
CHU Gabriel-Montpied
Thoracic Oncology, 58 Rue Montalembert, 63000, Clermont Ferrand
CHRU De Nancy
Pneumology, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Regional De Marseille
Multidisciplinary Oncology & Therapeutic Innovations, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Universitaire Amiens Picardie
Pneumology, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Et Universitaire De Limoges
Oncology thoracic Unit, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Institut Regional Du Cancer De Montpellier
Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut Paoli Calmettes
Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Pneumology, 20 Avenue Du Docteur Rene Laennec, 68100, Mulhouse
Centre Hospitalier Universitaire D'Angers
Pneumology, 4 Rue Larrey, 49100, Angers
Institut Curie
Pneumology, 26 Rue D Ulm, 75005, Paris
Centre Francois Baclesse
Pneumology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut Gustave Roussy
Medicine, 114 Rue Edouard Vaillant, 94800, Villejuif
Assistance Publique Hopitaux De Paris
Pneumology - Thoracic Oncology Unit, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Hopital Ambroise Pare
Respiratory Diseases and Thoracic Oncology, 9 Avenue Charles De Gaulle, 92100, Boulogne Billancourt
Centre Hospitalier Universitaire Grenoble Alpes
Thoracic Oncology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Justus-Liebig-Universitaet Giessen
Medizinische Klinik IV - Organonkologie, Gaffkystrasse 5, 35392, Giessen
SRH Wald-Klinikum Gera GmbH
Klinik für Pneumologie/Infektiologie, Hämatologie/Onkologie, Rheumatologie, Strasse Des Friedens 122, Debschwitz, Gera
Onkologie am Raschplatz Dr. Ingo Zander & Dr. Eyck von der Heyde
Studienzentrum, Rundestraße 10, 30161, Hannover
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Evangelische Lungenklinik, Lindenberger Weg 27, Buch, Berlin
Universitaetsklinikum Jena KöR
Abteilung Hämatologie und internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Bundeswehrkrankenhaus Ulm
Innere Medizin und Hämatologie und Onkologie, Oberer Eselsberg 40, Eselsberg, Ulm
Universitaetsklinikum Wuerzburg AöR
Interdisziplinäres Studienzentrum mit ECTU, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Malteser Norddeutschland gGmbH
Medizinische Klinik I (Onkologie, Pneumologie, Diabetologie), Waldstrasse 17, Westliche Hoehe, Flensburg
Klinikum Esslingen GmbH
Pneumologie im Thoraxzentrum Südwest, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik V, Standort Innenstadt, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Medizinische Klinik III / Onkologische Tagesklinik, Mauerstrasse 5, Suedliche Innenstadt, Halle (Saale)
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Klinik für Pneumologie und Beatmungsmedizin, Kriegsbergstrasse 60, Mitte, Stuttgart
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Department of Pneumology, Theo-Funccius-Strasse 1, 58675, Hemer
Centrum für Hämatologie und Onkologie Bethanien
Hämatologie und Onkologie, Im Prüfling 17-19, 60389, Frankfurt am Main
Evangelische Krankenhausgemeinschaft Herne/Castrop-Rauxel gGmbH
Klinik für Pneumologie und Infektiologie, Wiescherstrasse 24, Herne-Mitte, Herne
Martin-Luther-Universitaet Halle-Wittenberg
Innere Medizin I (Gastroenterologie, Pneumologie), Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Kliniken der Stadt Koeln gGmbH
Studienzentrum der Lungenklinik, Ostmerheimer Strasse 200, Merheim, Cologne
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik für Innere Medizin – Hämatologie, Onkologie und Palliativmedizin, Rudower Strasse 48, Buckow, Berlin
Pius-Hospital Oldenburg
Klinik für Hämatologie und Onkologie, Georgstrasse 12, Innenstadt, Oldenburg
General University Hospital Of Larissa
Oncology Clinic, Chemotherapy Department, P. O. Box 1425, 411 10, Larissa
Henry Dunant Hospital Center
4th Oncology Department and Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
Thoracic General Hospital Of Athens I Sotiria
3rd Department of Internal Medicine, Oncology Unit & Laboratory, Messogion Avenue 152, 115 27, Athens
Orszagos Koranyi Pulmonologiai Intezet
National Korányi Institute of Pulmonology, Koranyi Frigyes Ut 1, 1121, Budapest XII
Farkasgyepui Tudogyogyintezet
I. Pulmonology, 049 Hrsz 2, 8582, Farkasgyepu
Semmelweis University
Clinic of Pulmonology, Tomo Utca 25-29, 1083, Budapest VIII
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department of Pulmonology, Vasvari Pal Utca 2-4, 9024, Gyor
Matrai Gyogyintezet
Bronchology Department, Matrahaza Hrsz 7151, 3200, Gyongyos
Beaumont Hospital
Medical Oncology, Beaumont Road, Beaumont, Dublin 9
St James's Hospital
Medical Oncology, James's Street, D08 NHY1, Dublin 8
Cork University Hospital
Medical Oncology, Wilton, T12 DC4A, Cork
Beacon Hospital
Oncology, Beacon Court, Sandyford Business Park, Dublin 18
Mater Private Hospital
Medical Oncology, Eccles Street, D07 WKW8, Dublin 7
Istituto Oncologico Veneto
Oncologia 2, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliero Universitaria Careggi
SOD ONCOLOGIA MEDICA, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
IRCCS Ospedale Policlinico San Martino
UOC Clinica di Oncologia Medica, Largo Rosanna Benzi 10, 16132, Genoa
Istituto Tumori Bari Giovanni Paolo II
SSD Oncologia medica toracica, Viale Orazio Flacco 65, 70124, Bari
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
Oncology, Viale Luigi Borri 57, 21100, Varese
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliera Dei Colli
U.O.C Pneumologia Oncologica, Via Leonardo Bianchi, 80131, Naples
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
SCDU Oncologia Medica, Regione Gonzole 10, 10043, Orbassano
Azienda Ospedaliero Universitaria Parma
UO Oncologia Medica, Viale Antonio Gramsci 14, 43126, Parma
Fondazione IRCCS Policlinico San Matteo
UOC Oncologia, Viale Camillo Golgi 19, 27100, Pavia
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Pulmonology, Plesmanlaan 121, 1066 CX, Amsterdam
Academisch Ziekenhuis Maastricht
Department of pulmonary diseases, P. O. Box 5800, 6202 AZ, Maastricht
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Oddzia Pulmonologii, Ul. Kuracyjna 30, 82-550, Prabuty
Med Polonia Sp. z o.o.
N/A, Obornicka 262, 60-693, Poznan
Pratia Onkologia Katowice
N/A, Kosciuszki 92, 40-519, Katowice
Szpital Specjalistyczny Im. Henryka Klimontowicza W Gorlicach
Klinika Onkologii, Ul. Wegierska Nr 21, 38-300, Gorlice
Pratia MCM Krakow
N/A, Pana Tadeusza 2, 30-727, Krakow
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Oddział Onkologii Klinicznej, Ul. Grabiszynska 105, 53-439, Wroclaw
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Centrum Innowacyjnych Terapii, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Oncology, Avenida Doutor Bissaya Barreto 98, 3000-075, Coimbra
Unidade Local De Saude De Santo Antonio E.P.E.
Oncology, Largo Professor Abel Salazar, 4050-011, Porto
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Pneumology, Rua Professor Lima Basto, 1099-023, Lisbon
Radiotherapy Center Cluj S.R.L.
Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Spitalul Municipal Ploiesti
Oncology, Strada Ipatescu Ana Nr 59, 100337, Ploiesti
Memorial Healthcare International S.R.L.
Oncology, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Centrul De Oncologie-Euroclinic S.R.L.
Oncology, Strada Conta Vasile 2, 700106, Iasi
Oncomed S.R.L.
Oncology, Strada Porumbescu Ciprian 57-59, 300239, Timisoara
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Affidea Romania S.R.L.
Oncology, Bulevardul Tomis 141a, 900591, Constanta
Ovidius Clinical Hospital S.R.L.
Oncology, Dn 2a Km 202 880, 905900, Ovidiu
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Cardiomed S.R.L.
Oncology, Strada Republicii Nr 30, 400015, Cluj-Napoca
Institutul Regional De Oncologie Iasi
Oncology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De San Martin De Porres 4, 28035, Madrid
Hospital Son Llatzer
Oncology, Carretera De Manacor Km 4, 07198, Palma
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Alvaro Cunqueiro
Oncology, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Arnau De Vilanova De Valencia
Oncology, Calle De San Clemente 12, 46015, Valencia
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 | 2025-06-26 | 2025-08-28 | |||
| Belgium | 2025-07-02 | 2025-09-02 | |||
| Bulgaria | 2025-07-17 | 2025-10-09 | |||
| Croatia | 2025-10-23 | 2025-10-27 | |||
| France | 2025-06-19 | 2025-07-04 | |||
| Germany | 2025-06-12 | 2025-06-19 | |||
| Greece | 2025-07-30 | 2025-08-08 | |||
| Hungary | 2025-07-29 | 2026-01-23 | |||
| Ireland | 2025-06-30 | 2025-09-24 | |||
| Italy | 2025-07-22 | 2025-10-06 | |||
| Netherlands | 2025-08-07 | 2026-03-03 | |||
| Poland | 2025-06-13 | 2025-10-23 | |||
| Portugal | 2025-07-30 | 2025-09-16 | |||
| Romania | 2025-06-13 | 2025-07-01 | |||
| Spain | 2025-06-23 | 2025-07-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 201 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-515698-85-00 redacted | EU 02 |
| Protocol (for publication) | D1_Protocol Admin letter 02 2024-515698-85-00 redacted | 2 |
| Protocol (for publication) | D1_Protocol Admin letter 03 2024-515698-85-00 redacted | 3 |
| Protocol (for publication) | D1_Protocol Admin letter 05 2024-515698-85-00 Redacted | 5 |
| Protocol (for publication) | D1_Protocol Admin letter 2024-515698-85-00 redacted | 1 |
| Protocol (for publication) | D1_Protocol_EU CT 2024-515698-85_GR_Redacted | 02 EU |
| Protocol (for publication) | D4 Statement on validated questionnaires under license_NL | N/A |
| Protocol (for publication) | D4_BG_Subject Participant Alert Card_V1_0_17Dec2024_BG_Bulgarian | 1.0 |
| Protocol (for publication) | D4_ES_Questionnaire_patient facing documents_statement_under license | NA |
| Protocol (for publication) | D4_patient facing documents__statement_under license PL | N/A |
| Protocol (for publication) | D4_Patient facing documents_Statement on Questionnaires under licence_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Statement on validated questionnaires under license_HR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Statement on validated questionnaires under license_IT | NA |
| Protocol (for publication) | D4_patient facing documents_statement under licence_IE_ENG | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_RO | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_AT | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_BE | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_BG | 01 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_DE | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_GR | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_HU | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_PT | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements_GR | 2.0 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements_PL | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_BG_Recruitment arrangements_bg | 1.0 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_NL_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure_FR_TC | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements and IC procedure_HU_Unredacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements IT | 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_DE_Clean | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_HR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IE_ENG | 1 |
| Recruitment arrangements (for publication) | K2_KRYSTAL4_PI-to-Patient Letter Template_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ PI to Patient Letter_IE_ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ recruitment brochure_IE_ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material__Krystal-4 Study_VisitGuide_BG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Krystal-4 _Recruitment Brochure_BG | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_KRYSTAL-4 Study_PI-to-Patient Letter Template_BG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Krystal-4_Recruitment_Brochure_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI to Patient Letter_AT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI to Patient Letter_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_AT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_DE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_PL | 1 |
| Subject information and informed consent form (for publication) | L1 ICF PGx_Redacted_HU | 2 |
| Subject information and informed consent form (for publication) | L1 PIS PGx_Redacted_HU | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main ICF_HR_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main ICF_HR_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main_HU_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Future Research_HR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Future Research_HR_redacted | 3 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Future Research_HU_redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Sample Collection_HR_Unredacted | 3 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Sample Collection_HU_redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnanat Participant_HR_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Participant_HU_redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Partner_HR_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Partner_HU_redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Partner_HU_Unredacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Secondary Contact_HR_Unredacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Treatment Beyond Progression_HR_Unredacted | 3 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Treatment Beyond Progression_HU_Unredacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 3.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Sample Collection_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Participant who Becomes Pregnant | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment Beyond Progression | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment Beyond Progression_IT | 3 |
| Subject information and informed consent form (for publication) | L1_BG_Main ICF for Bulgaria_v2_1_14Jan2026_BG_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_BG_Main ICF for Bulgaria_v2_1_14Jan2026_EN_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Treatment Beyond Progression | 2 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Main_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF Optional Future Research_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF_Optional Sample Collection_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF_Pregnant Participant | 2 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF_Pregnant Partner | 3 |
| Subject information and informed consent form (for publication) | L1_Greenphire ICF for Bulgaria_V1.0_13Jan2025_EN_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Greenphire ICF for Bulgaria_V1.0_14Jan2025_BG_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Future Research_V 1.0 _13Jan2025_EN_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Future Research_V1.0_14Jan2025_BG_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Sample Collection V1.0_13Jan2025_EN_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Sample Collection_1.0 dated 14Jan2025_BG_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Participant_V1.0_13Jan2025_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Participant_V1.0_14Jan2025_BG | 2.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF for Bulgaria_v1.0_13Jan2025_EN_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_Main ICF for Bulgaria_v1.0_14Jan2025_BG_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Main IC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Optional Future Research_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Optional Sample Collection_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Pregnant Participant | 2.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Pregnant Partner | 1.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF Treatment Beyond Progression | 2.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_v1.0 dated 13Jan2025_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_v1.0 dated 14Jan2025_BG | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Pregnant Partner_PL | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ Redacted_PL | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Participant who Becomes Pregnant_PL | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Collection_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Future Research_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Pregnant Partners | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Treatment Beyond Progression | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IE_ENG | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_New participants_FR_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PT_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_FR_Redacted | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_IE_ENG_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_PT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_Redacted_PL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_IE_ENG_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_IT_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_PT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_Redacted_PL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample_FR_Redacted | NA |
| 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 Pregnant participant_GR | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_IE_ENG_for publication | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_IE_ENG_Tracked changes | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_IT_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_PT_Unredacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ IT_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_IE_ENG_for publication | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PT_Unredacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy notice_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_GR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_IT_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_IE_ENG_for publication | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_IE_ENG_Tracked changes | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_PL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_PT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_ENG_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_FRA_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Main IC_NLD_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Optional Sample IC_ENG_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Optional Sample IC_FRA_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Optional Sample IC_NLD_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Participant IC_ENG_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Participant IC_FRA_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Participant IC_NLD_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner IC_ENG_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner IC_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Pregnant Partner IC_NLD_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_sponsorstatement BMS_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Treatment beyond progression_ENG_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Treatment beyond progression_FRA_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_BE_Treatment beyond progression_NLD_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_obsolete_Redacted_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted_AT | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted_DE | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_Redacted_AT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_redacted_DE | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_Redacted_AT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_redacted_DE | 2 |
| 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_Pregnant Participant_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_AT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_DE | 2 |
| Subject information and informed consent form (for publication) | L1_Treatment Beyond Progression IC_V1.0_13Jan2025_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_Treatment Beyond Progression ICF_V1.0_14Jan2025_BG | 2.0 |
| Subject information and informed consent form (for publication) | L2 List of submitted documents_HU Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Alert Card_HU_Redacted | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin | 8 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pemetrexed Accord | 15 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ Pembrolizumab | 68 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ Pembrolizumab_TC 66-67 | 67 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pembrolizumab_TC 64-66 | 66 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis EU CT 2024-515698-85_PL | 2 |
| Synopsis of the protocol (for publication) | D1_ES_Protocol synopsis_2024-515698-85_Spanish | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-515698-85_BG | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515698-85_Dutch_NL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515698-85_EN | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515698-85_FR | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515698-85_GER_AT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-515698-85_GR | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515698-85_IT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515698-85_PT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2024-515698-85_HR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2024-515698-85_HU | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2024-515698-85_BG | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2024-515698-85_RO | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_2024-515698-85_BE_Dutch | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_2024-515698-85_BE_Eng | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_2024-515698-85_BE_French | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_2024-515698-85_BE_German | 2.0 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-07 | Italy | Acceptable with conditions 2025-06-03
|
2025-06-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-10 | Acceptable with conditions 2025-06-03
|
2025-06-10 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-11 | Acceptable with conditions 2025-06-03
|
2025-06-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-11 | Acceptable with conditions | 2025-06-13 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-16 | Italy | 2025-06-16 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-06-16 | 2025-06-16 | ||
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-06-23 | 2025-06-23 | ||
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-06-26 | 2025-06-26 | ||
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-11 | Acceptable with conditions | 2025-07-29 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-11 | Italy | Acceptable 2025-12-19
|
2025-12-19 |
| 11 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-26 | Acceptable | 2026-02-10 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-02-10 | Italy | Acceptable | 2026-02-10 |
| 13 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-06 | Acceptable 2026-05-06
|
2026-05-07 |