A Global Pivotal Placebo-Controlled Study of LY3537982 in Combination with Pembrolizumab and LY3537982 in Combination with Pembrolizumab, Pemetrexed and Platinum for the First-line Treatment of Participants with KRAS G12C-Mutant Advanced Non-Small Cell Lung cancer

2023-503412-33-00 Protocol J3M-MC-JZQB Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 29 Mar 2024 · Status Ongoing, recruiting · 16 EU/EEA countries · 134 sites · Protocol J3M-MC-JZQB

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 1,186
Countries 16
Sites 134

Stage IIIB-IIIC or Stage IV KRAS G12C-mutant non-small cell lung cancer

Dose Optimization: To determine the optimal dose of LY3537982 (50 or 100 mg BID) to be administered in combination with pembrolizumab Safety Lead-In Part B: To determine the dose of LY3537982 to be administered in combination with pembrolizumab, pemetrexed and platinum Part A: To compare the efficacy of LY3537982 in …

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
29 Mar 2024 → ongoing
Decision date (initial)
2024-03-11
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2023-503412-33-00
WHO UTN
U1111-1288-0565

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacoeconomic, Pharmacogenomic, Efficacy, Safety, Others

Dose Optimization: To determine the optimal dose of LY3537982 (50 or 100 mg BID) to be administered in combination with pembrolizumab
Safety Lead-In Part B: To determine the dose of LY3537982 to be administered in combination with pembrolizumab, pemetrexed and platinum
Part A: To compare the efficacy of LY3537982 in combination with pembrolizumab versus placebo with pembrolizumab
Part B: To compare the efficacy of LY3537982 in combination with pembrolizumab, pemetrexed and platinum compared to placebo with pembrolizumab, pemetrexed and platinum

Conditions and MedDRA coding

Stage IIIB-IIIC or Stage IV KRAS G12C-mutant non-small cell lung cancer

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Have non-small cell lung cancer that is advanced or has spread to another part(s) of the body.
  2. Have cancer with a change in the KRAS G12C gene.
  3. Have a known programmed death-ligand 1 (PD-L1) expression of 0-100%. PD-L1 expression may predict how well the body responds to some types of treatment.
  4. Be able to swallow capsules and/or tablets
  5. Be well enough to walk and do light work

Exclusion criteria 5

  1. Have other types of changes in genes such as EGFR, ALK, BRAF (V600E), HER2, MET (exon 14), ROS1, RET, or NTRK1/2/ that may be targeted treatments.
  2. Have cancer that can be cured with treatments that target a specific part of the body (like surgery or radiation) Have an active infection or any serious medical conditions (other than cancer)
  3. Have an active infection or any serious medical conditions (other than cancer)
  4. Have active heart disease causing symptoms; or, history of heart attack or chest pain within 6 months of starting the study.
  5. Have a known history of allergic reaction to components of the study drug (LY3537982), pembrolizumab, pemetrexed or platinum containing drugs

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. PFS per RECIST v1.1 by BICR

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

LY3537982

PRD10219006 · Product

Active substance
LY3537982
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Month(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

LY3537982

PRD10219056 · Product

Active substance
LY3537982
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Month(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to match LY3537982

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 4

Cisplatin

SCP134220 · ATC

Active substance
Cisplatin
Substance synonyms
Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
Route of administration
SOLUTION FOR INJECTION
Max daily dose
75 mg/m2 milligram(s)/sq. meter
Max total dose
300 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Disodium

SCP11423984 · ATC

Active substance
Pemetrexed Disodium
Route of administration
SOLUTION FOR INJECTION
Max daily dose
500 mg/m2 milligram(s)/sq. meter
Max total dose
7000 mg/m2 milligram(s)/sq. meter
Max treatment duration
14 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — PEMETREXED
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pembrolizumab

SCP6094344 · ATC

Active substance
Pembrolizumab
Substance synonyms
Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, CT P51, SYS6036, QL-2107, CMAB820, ABP 234
Route of administration
SOLUTION FOR INJECTION
Max daily dose
200 mg milligram(s)
Max total dose
7000 mg milligram(s)
Max treatment duration
105 Week(s)
Authorisation status
Authorised
ATC code
L01FF02 — PEMBROLIZUMAB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SCP10337134 · ATC

Active substance
Carboplatin
Route of administration
SOLUTION FOR INJECTION
Max daily dose
25 mg milligram(s)
Max total dose
25 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 13

OrganisationCity, countryDuties
Precision for Medicine (aka Quartz Bio)
ORL-000011252
 United States Laboratory analysis
Labcorp Central Laboratory Services S.a.r.l.
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
Iqvia Rds Inc.
ORG-100043858
 Durham, United States On site monitoring, Code 12, Code 2
QIAGEN Manchester Limited
ORL-000003539
 United States Laboratory analysis
Pharmaserve Lilly S.A.C.I.
ORG-100005347
 Kifisia, Greece On site monitoring, Code 12, Other, Code 2, Code 5
Biotel Research LLC
ORG-100039864
 Rochester, United States Laboratory analysis
Foundation Medicine Inc.
ORG-100040457
 Cambridge, United States Laboratory analysis
Pharmaceutical Product Development LLC
ORG-100016999
 Wilmington, United States Code 10
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Data management
Medable Inc.
ORG-100043083
 Palo Alto, United States Data management
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Ventana Medical Systems Inc.
ORG-100043193
 Oro Valley, United States Other
Q2 Solutions LLC
ORG-100017000
 Ithaca, United States Laboratory analysis

Locations

16 EU/EEA countries · 134 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruiting 12 3
Belgium Ongoing, recruiting 45 10
Czechia Ongoing, recruiting 13 2
Denmark Ongoing, recruiting 8 1
France Ongoing, recruiting 82 18
Germany Ongoing, recruiting 39 20
Greece Ongoing, recruiting 42 9
Hungary Ongoing, recruiting 10 5
Italy Ongoing, recruiting 54 10
Netherlands Ongoing, recruiting 46 9
Norway Ongoing, recruiting 15 7
Poland Ongoing, recruiting 8 3
Portugal Ongoing, recruiting 15 7
Romania Ongoing, recruiting 32 8
Spain Ongoing, recruiting 101 20
Sweden Authorised, recruiting 15 2
Rest of world
Japan, Canada, Taiwan, Brazil, Switzerland, Korea, Republic of, Turkey, Mexico, India, United States, Australia, China, United Kingdom
 — 649 —

Investigational sites

Austria

3 sites · Ongoing, recruiting
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Internal Medicine II, Carinagasse 47, 6800, Feldkirch
Ordensklinikum Linz GmbH
Pneumology, Fadingerstrasse 1, 4020, Linz
Krankenhaus Nord Klinik Floridsdorf
Innere Medizin und Pneumologie, Bruenner Strasse 68, Floridsdorf, Vienna

Belgium

10 sites · Ongoing, recruiting
A.Z. Sint-Maarten
Pneumology, Liersesteenweg 435, 2800, Mechelen
Het Ziekenhuisnetwerk Antwerpen
Pneumology, Lindendreef 1, 2020, Antwerp
Chirec
Chirec Cancer Institute, Boulevard Du Triomphe 201, 1160, Brussels
Az St-Jan Brugge-Oostende A.V.
Pneumology, Ruddershove 10, 8000, Brugge
Werken Glorieux
Pneumology, Stefaan Modest Glorieuxlaan 55, 9600, Ronse
Algemeen Ziekenhuis Groeninge
Pneumology, President Kennedylaan 4, 8500, Kortrijk
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Pneumology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
UZ Leuven
Pneumology, Herestraat 49, 3000, Leuven
Clinique Saint-Pierre
Pneumology, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
Universitair Ziekenhuis Gent
Pneumology, Corneel Heymanslaan 10, 9000, Gent

Czechia

2 sites · Ongoing, recruiting
Nemocnice AGEL Ostrava-Vitkovice a.s.
N/A, Zaluzanskeho 1192/15, Vitkovice, Ostrava
Fakultni Nemocnice Bulovka
Klinika pneumologie, Budinova 67/2, Liben, Prague

Denmark

1 site · Ongoing, recruiting
Region Sjaelland
Oncology, Sygehusvej 10, 4000, Roskilde

France

18 sites · Ongoing, recruiting
Hôpital Foch
Medical Oncology, 40 Rue Worth, 92151, Suresnes
Centre Hospitalier Universitaire De Rennes
Service de pneumologie, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
CHU Lille - Institut Coeur Poumon
Service de pneumologie et oncologie thoracique, Boulevard du Professeur Jules Leclercq, 59037 Lille Cedex, Lille
Les Hopitaux Universitaires De Strasbourg
Service de pneumologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire de Poitiers
Pôle régional de cancérologie, 2 Rue de la Milétrie, 86021 Poitiers, Poitiers
Centre Hospitalier Universitaire De Bordeaux
Oncologie-Thoracique, Avenue De Magellan, 33600, Pessac
CHU de Nancy – Hôpitaux de Brabois
Service de pneumologie, 1 rue du Morvan, Vandoeuvre lès, Nancy
Hôpital Robert Schuman
Pneumologie, Parvis Robert Schuman Rue du champ Montoy, 57070 Vantoux, Vantoux
Centre Antoine Lacassagne
Oncologie medicale, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Gustave Roussy
Oncologie, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Oncologie Medicale, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Oncologie, 54 Rue Henri Sainte Claire Deville, 83100, Toulon
Institut Jean Godinot
Oncologie médicale, 1 Rue du Général Koenig, 51726 Reims, Reims
Institut Curie Paris
Institut du Thorax, 26 Rue d'Ulm, 75248 Paris, Paris
Hospices Civils de Lyon – Hopital Louis Pradel
oncologie thoracique, 59 Boulevard Pinel, 69677 Bron, Bron
Sainte Catherine Institut Du Cancer Avignon-Provence
Oncologie, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Centre Leon Berard
Cancerologie Medicale, 28 Rue Laennec, 69373 Lyon cedex 08, Lyon
CHU de Toulouse – Hôpital Larrey
Service de Pneumologie, 24 Chemin de Pouvourville, 31059 Toulouse, Toulouse

Germany

20 sites · Ongoing, recruiting
Asklepios Kliniken Hamburg GmbH
N/A, Eissendorfer Pferdeweg 52, Heimfeld, Hamburg
HELIOS Klinikum Erfurt GmbH
N/A, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt
HELIOS Klinikum Emil von Behring GmbH
N/A, Walterhoeferstrasse 11, Zehlendorf, Berlin
Staedtisches Krankenhaus Kiel GmbH
N/A, Chemnitzstrasse 33, Schreventeich, Kiel
Universitaetsklinikum Tuebingen AöR
N/A, Otfried-Mueller-Strasse 14, Nordstadt, Tuebingen
Martha-Maria Krankenhaus Halle-Doelau gGmbH
N/A, Roentgenstrasse 1, Doelau, Halle (saale)
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
N/A, Lindenberger Weg 27, Buch, Berlin
Asklepios Fachkliniken Muenchen Gauting
N/A, Robert-Koch-Allee 2, 82131, Gauting
MVZ II der Niels-Stensen-Kliniken, Franziskus Hospital Harderberg
N/A, Alte Rothenfelder Straße 23, Zentrum für Internistische Onkologie, Georgsmarienhütte
Onkologiezentrum Donauwörth
N/A, Neudegger Allee 10, Bayern, Donauwörth
Charité Campus Virchow-Klinikum
N/A, Augustenburger Platz 1, 13353, Berlin
Thoraxklinik Heidelberg gGmbH
N/A, Roentgenstrasse 1, Rohrbach, Heidelberg
Universitaetsklinikum Muenster AöR
N/A, Albert-Schweitzer-Campus 1, Sentrup, Muenster
SRH Wald-Klinikum Gera GmbH
N/A, Strasse Des Friedens 122, Debschwitz, Gera
Medical Center - University Of Freiburg
N/A, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Klinikum Chemnitz, Klinik fuer Innere Medizin IV
N/A, Bürgerstraße 2, Sachsen, Chemnitz
MVZ fuer Haematologie und Onkologie Koeln Am Sachsenring GmbH
N/A, Sachsenring 69, Neustadt-Sued, Cologne
Studiengesellschaft Hämato-Onkologie Hamburg Prof. Laack und Partner
N/A, Lehmweg 7, 20251, Hamburg
Klinikum Nuernberg
N/A, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
LungenClinic Grosshansdorf GmbH
N/A, Woehrendamm 80, 22927, Grosshansdorf

Greece

9 sites · Ongoing, recruiting
Henry Dunant Hospital Center
Fourth Department of Oncology and Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
St Savas Hospital
2nd Medical Oncology Department, Alexandras Avenue 171, 115 22, Athens
University General Hospital Attikon
2nd Propaedeutic Pathology Clinic, Oncology Unit, Rimini Street 1, 124 62, Athens
University General Hospital Of Heraklion
Internal Medicine-Oncology, Stavrakia And Voutes, 715 00, Heraklion
General University Hospital Of Patras
Division of Oncology, Rio, 265 04, Patras
Thoracic General Hospital Of Athens I Sotiria
3rd Dept of Internal Medicine and Laboratory, Oncology Unit, Messogion Avenue 152, 115 27, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Pulmonary Clinic of Aristotle University of Thessaloniki, Exochi, 570 10, Thessaloniki
Theageneio Cancer Hospital
2nd Medical Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki

Hungary

5 sites · Ongoing, recruiting
Farkasgyepui Tudogyogyintezet
Pulmonologia, 049 Hrsz 2, 8582, Farkasgyepu
Koranyi National Institute For Pulmonology
XIV. Tudobelgyogyaszat, Koranyi Frigyes Ut 1, 1121, Budapest XII
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiologiai Kozpont, Nyiri Ut 38, 6000, Kecskemet
Budapesti Uzsoki Utcai Korhaz
Pulmonologia, Uzsoki Utca 29-41, 1145, Budapest XIV
Orszagos Onkologiai Intezet
Onkologiai Kepalkoto és Invaziv Diagnosztikai Kozpont, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII

Italy

10 sites · Ongoing, recruiting
Istituto Oncologico Veneto
Oncologia 2, Via Gattamelata 64, 35128, Padova
Istituto Tumori Bari Giovanni Paolo II
SSD Oncologia Medica per la Patologia Toracica, Viale Orazio Flacco 65, 70124, Bari
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
UOC Oncologia Medica - Struttura Complessa Oncologia Medica 1, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
SC Oncologia, Viale Luigi Borri 57, 21100, Varese
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncologia Medica Ardizzoni, Via Pietro Albertoni 15, 40138, Bologna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncologia Medica, Via Mariano Semmola 52, 80131, Naples
Fondazione IRCCS Istituto Nazionale Dei Tumori
Struttura Complessa Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Universitaria Integrata Verona
Unità di Oncologia, P.le Aristide Stefani 1, 37126, Verona
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome

Netherlands

9 sites · Ongoing, recruiting
Medisch Spectrum Twente
Longgeneeskunde, Koningsplein 1, 7512 KZ, Enschede
St. Elisabeth Hospital Tilburg
Department of Pulmonary Diseases, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Frisius MC
centrum voor longziekten, Henri Dunantweg 2, 8934 AD, Leeuwarden
Jeroen Bosch Ziekenhuis
Pulmonology, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Long oncologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Ziekenhuis St Jansdal
Poli Longziekten, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Academisch Ziekenhuis Leiden
Longziekten, Albinusdreef 2, 2333 ZA, Leiden
St. Antonius Ziekenhuis
Pulmonary disease, Soestwetering 1, 3543 AZ, Utrecht
Tergooiziekenhuizen
Pulmonology, Laan Van Tergooi 2, 1212 VG, Hilversum

Norway

7 sites · Ongoing, recruiting
Helse Bergen HF
Department of Thoracic Medicine, Jonas Lies Vei 65, 5021, Bergen
Oslo University Hospital HF
Dept of Oncology and Dept of Cancer Genetics, Taarnbygget, Kirkeveien 166, Oslo
Akershus University Hospital
Pulmonary Medicine, Sykehusveien 25, 1474, Loerenskog
Vestre Viken HF
Department of Oncology, Groenland 32, 3045, Drammen
St. Olavs Hospital HF
Department of Oncology, P. O. Box 3250, Torgarden, Trondheim
Helse Stavanger HF
Lung Department, P. O. Box 8100, 4068, Stavanger
Sykehuset Innlandet HF
Department of Oncology and Radiotherapy and Center for Palliative Care, Kyrre Grepps Gate 11, 2819, Gjoevik

Poland

3 sites · Ongoing, recruiting
One Day Med Sp. z o.o.
N/A, Plac Rodla 8, 70-419, Szczecin
Medicover Integrated Clinical Services Sp. z o.o.
N/A, Ul. Stefana Batorego 18/22, 87-100, Torun
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Onkologii Klinicznej, Dzial Chemioterapii, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce

Portugal

7 sites · Ongoing, recruiting
Hospital CUF Porto S.A.
Oncology, Estrada Da Circunvalacao N 14341, 4100-180, Porto
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Oncology, Alameda Das Linhas De Torres No 117, 1769-001, Lisbon
Champalimaud Clinical Centre
Pneumology, Avenida Brasilia S/n, 1400-038, Lisbon
Unidade Local De Saude De Santo Antonio E.P.E.
Oncology, Largo Professor Abel Salazar, 4050-011, Porto
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Centro Hospitalar E Universitario De Coimbra E.P.E.
Pneumology, Praceta Professor Mota Pinto, 3000-459, Coimbra
Hospital Da Luz S.A.
Oncology, Avenida Lusiada 100, 1500-650, Lisbon

Romania

8 sites · Ongoing, recruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Gral Medical S.R.L.
Oncology, Strada Popovici Traian 79-91, 031422, Bucharest
Memorial Healthcare International S.R.L.
Oncology, Soseaua Ionescu-Sisesti Gheorghe 1, 013821, Bucharest
Ovidius Clinical Hospital S.R.L.
Oncology, Dn 2a Km 202 880, 905900, Ovidiu
Oncocenter Oncologie Clinica S.R.L.
Oncology, Strada Garii 1a, 300166, Timisoara
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Oncomed SRL
Oncology, Strada Ciprian Porumbescu, Nr. 57-59, Timisoara
Lotus Med S.R.L.
Oncology, Strada Dornei 79-81, 012292, Bucharest

Spain

20 sites · Ongoing, recruiting
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De Cruces
Medical Oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario De Navarra
Oncology, Irunlarrea Kalea 3, 31008, Pamplona
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 Sn, 29010, Malaga
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital De Jerez De La Frontera
Oncology, Carretera De La Ronda Circunvalacion S/n, 11408, Jerez De La Frontera
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario Infanta Cristina
Oncology, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario De Leon
Oncology, C Altos De Nava S/n, 24071, Leon
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma

Sweden

2 sites · Authorised, recruiting
Malarsjukhuset Eskilstuna
Oncology, Kungsvagen 42, Tunafors, Eskilstuna
Vastmanlands sjukhus Vasteras
Department of Oncology, Region Västmanland Regionhuset, 721 89, Västerås

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2024-04-02 2024-04-24
Belgium 2024-03-29 2025-02-12
Czechia 2024-04-10 2024-05-24
Denmark 2025-04-22 2025-08-19
France 2025-07-11 2025-07-17
Germany 2024-04-02 2024-04-08
Greece 2024-05-09 2024-05-14
Hungary 2024-04-08 2025-03-19
Italy 2024-04-25 2024-05-10
Netherlands 2024-04-26 2025-02-03
Norway 2025-02-20 2025-02-20
Poland 2024-04-12 2025-09-10
Portugal 2024-05-30 2024-06-05
Romania 2024-03-29 2025-03-03
Spain 2024-03-29 2024-04-04
Sweden 2025-04-17

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 3 · Art. 38 CTR

Temporary halt TH-121109

Halt date
2026-01-16
Member states concerned
Sweden
Publication date
2026-02-26
Reason
Sponsor decision
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-121105

Halt date
2026-01-16
Member states concerned
Norway
Publication date
2026-02-26
Reason
Sponsor decision
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-127022

Halt date
2026-04-01
Member states concerned
Sweden
Publication date
2026-04-01
Reason
Sponsor decision
Explanation
As no patients have been recruited in Sweden, the “Start of Recruitment” has not been entered in CTIS, which is currently resulting in the clinical authorization being set to expire on 23 March 2026. A screening hold has been implemented in Sweden while waiting feedback from Swedish EC in this matter.
Benefit-risk balance changed
No
Treatment stopped
No

Corrective measures 1 · Art. 77 CTR

Corrective measure CM-IT-0001

Member state
Italy
Publication date
2026-03-13
Type
1
Reason
6
Reverted date
2026-03-13
Immediate action required
Yes
Notes
Reverted (2026-03-13)
Justification
Dear Applicant,
It was ascertained that the Territorial Ethics Committee due to technical issue did not assess the documentation submitted for the SM-08 EU CT 2023-503412-33-00 procedure (AIFA authorization provision n° 0158713-15/12/2025-AIFA-AIFA_USC-P).
Therefore, in compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 484 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2023-503412-33-00_i_redacted i
Protocol (for publication) D1_Protocol 2023-503412-33-00_Redacted k
Protocol (for publication) D1_Protocol 2023-503412-33-00_redacted h
Protocol (for publication) D1_Protocol_2023-503412-33-00_GR_Redacted k
Protocol (for publication) D1_Protocol_g_2023-503412-33-00_GR_Redacted g
Protocol (for publication) D1_Protocol_h_2023-503412-33-00_GR_Redacted h
Protocol (for publication) D1_Protocol_i_2023-503412-33-00_GR_Redacted i
Protocol (for publication) D4_Patient Card_GR 2
Protocol (for publication) D4_Patient Card_GR 2
Protocol (for publication) D4_Patient facing documents_Authentication_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_DOSING-DIARY 9.0
Protocol (for publication) D4_Patient facing documents_DOSING-DIARY_ 10.0
Protocol (for publication) D4_Patient facing documents_EORTC IL19_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_EORTC QLQ-C30_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_EQ-5D-5L_ScreenReport_IT 2
Protocol (for publication) D4_Patient facing documents_EQ-5D-5L_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_FACT-GP5_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_Notifications PAM_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_NSCLC-SAQ Missed_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_NSCLC-SAQ_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_PGIC-Cancer_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_PGIC-Lung_ScreenReport_eCOA_Medable 2
Protocol (for publication) D4_Patient facing documents_PGIC-Physical Status_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_PGIS-Cancer_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_PGIS-Lung_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_PGIS-STAT_ScreenReport_eCOA_Medable 2
Protocol (for publication) D4_Patient facing documents_Practice Answering Questions_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_PRO-CTCAE_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_Support Numbers_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) D4_Patient facing documents_Welcome! Start Here for App Orientation_ScreenReport_Trans_eCOA_Medable 1
Protocol (for publication) JZQB_Patient Documents Copyright 1
Recruitment arrangements (for publication) Blanket Statement - Document not published anymore 2
Recruitment arrangements (for publication) Blanket Statement - Document not published anymore_30Nov2023 2.0
Recruitment arrangements (for publication) K1_List of participating sites 3.0
Recruitment arrangements (for publication) K1_List of planned sites_CZ_Redacted 1.0
Recruitment arrangements (for publication) K1_Patient Recruitment Procedure_JZQB_v3-1_03Jan2025 3.1
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure template __1_21Nov2023 1
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure template __2_06Feb2024_clean 2
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 3.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_CZ 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_GR 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Netherlands 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_NO_v1_24Oct2023 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_SE_v1_24Oct2023 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_v1_10Oct2023_san 1
Recruitment arrangements (for publication) K1_Recruitment arrangments_JZQB_PL 1.0
Recruitment arrangements (for publication) K2 Recruitment Material_Letter-Doctor-Referral_Master 2
Recruitment arrangements (for publication) K2_Poster_Master_v1_20Sep2023_PT_san 1
Recruitment arrangements (for publication) K2_Poster_Master_v2_24Jan2024_PT_san 2
Recruitment arrangements (for publication) K2_Recruiment material_Poster_Master_PL 1
Recruitment arrangements (for publication) K2_Recruitment arrangments_Informed consent and patient recruitment procedure 1.0
Recruitment arrangements (for publication) K2_Recruitment material Brochure 1.1
Recruitment arrangements (for publication) K2_Recruitment Material Brochure 1.0
Recruitment arrangements (for publication) K2_Recruitment Material brochure 2.0
Recruitment arrangements (for publication) K2_Recruitment Material poster 1.0
Recruitment arrangements (for publication) K2_Recruitment material Poster 1.1
Recruitment arrangements (for publication) K2_Recruitment Material Poster 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Brochure 1
Recruitment arrangements (for publication) K2_Recruitment Material_Brochure_BEDU 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_BEFR 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Doctor Referral Letter 2.0
Recruitment arrangements (for publication) K2_Recruitment material_HU_Doctor referral letter 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Letter-Doctor-Referral_v1_17Jul2025 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Poster 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Poster_BEDU 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Poster_BEFR 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Poster_ES 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Poster_EU_Master 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Poster_GR 1
Recruitment arrangements (for publication) K2_Recruitment material_Poster_HU 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Poster_NO 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Poster_SE 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Poster-EU_Master_CZ 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Study-Guide-Part-A_CZ_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment Material_Study-Guide-Part-B_CZ_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_T-Aware-Brochure 2.0
Recruitment arrangements (for publication) K2_Recruitment material_T-Aware-Brochure-EU_Master 2
Recruitment arrangements (for publication) K2_Recruitment material_Thank You End of Treatment_SE_sv_v1_19Sep2023 1
Recruitment arrangements (for publication) K2_Recruitment material_Thank-You-End-Of-Treatment_SE 1
Recruitment arrangements (for publication) K2_Recruitment material_Thank-You-Participation_SE 3
Recruitment arrangements (for publication) K2_Recruitment material_Thank-You-Screening_SE 3
Recruitment arrangements (for publication) K2_Recruitment material_Thank-You-Screening_SE_sv__v1_19Sep2023 1
Recruitment arrangements (for publication) K2_Recruitment Material_Trial Awareness Brochure EU 2.1
Recruitment arrangements (for publication) K2_Recruitment material_Trial Awareness Brochure_ES 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Trial Awareness Brochure_GR 2
Recruitment arrangements (for publication) K2_Recruitment material_Trial_Awareness Brochure_Master_PL 2
Recruitment arrangements (for publication) K2_Recruitment material_Trial-Awareness-Brochure_NO 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Trial-Awareness-Brochure_SE 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Trial-Awareness-Brochure-EU_Maste 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Trial-Awareness-Brochure-EU_Master 2.0
Recruitment arrangements (for publication) K2_Recruitment material_TY End Of Treatment_v1 1
Recruitment arrangements (for publication) K2_Recruitment material_TY-Participation_v1_19Sep2023 1
Recruitment arrangements (for publication) K2_Recruitment material_TY-Screening 1
Recruitment arrangements (for publication) K2_Recruitment material_Visit_SE_sv_r_v1_19Sep2023 1
Recruitment arrangements (for publication) K2_Recruitment material_Visit-Card 1
Recruitment arrangements (for publication) K2_Recruitment material_Visit-Card_v1_19Sep2023 1
Recruitment arrangements (for publication) K2_Recruitment Materials Brochure 1
Recruitment arrangements (for publication) K2_Recruitment Materials Poster 2.0
Recruitment arrangements (for publication) K2_Recruitment materials_Doctor Referral Letter 1.0
Recruitment arrangements (for publication) K2_Recruitment materials_Doctor referral Letter 2.0
Recruitment arrangements (for publication) K2_Thank you card_End Of Treatment_EU_Master_v1_19Sep202_PT_san 1
Recruitment arrangements (for publication) K2_Thank you card_End Of Treatment_EU_Master_v2_26Jan2024_PT_san 2
Recruitment arrangements (for publication) K2_Thank You Participation_SE_sv_v1_19Sep2023 1
Recruitment arrangements (for publication) K2_Thank-You-Dropout_Master_PT 3
Recruitment arrangements (for publication) K2_Thank-You-End-Of-Treatment_Master_PT 1
Recruitment arrangements (for publication) K2_Visit Card_EU_Master_v1_19Sep2023_PT_san 1
Recruitment arrangements (for publication) K3_List of Planned Sites and Subjects_IT_Redacted 3.0
Recruitment arrangements (for publication) K3_List of Planned Sites_Belgium_ENG_Redacted 2.0
Recruitment arrangements (for publication) K3_List of planned sites-Poland_V1 2.0
Recruitment arrangements (for publication) K3_Patient Allocation 1.0
Subject information and informed consent form (for publication) D4_Patient facing document_Data_Laws_as_applied_to_GP 1.0
Subject information and informed consent form (for publication) D4_Patient facing document_Greenphire ClinCard Msg Templates 1.0
Subject information and informed consent form (for publication) D4_Patient facing document_Greenphire_ClinCard 1.0
Subject information and informed consent form (for publication) D4_Patient facing document_Greenphire_ClinCard_Cardholder_FAQ_EU 1.0
Subject information and informed consent form (for publication) D4_Patient facing document_Greenphire_Fee_Schedule 1.0
Subject information and informed consent form (for publication) D4_Patient facing document_Patient Information Card_CZ 1.0
Subject information and informed consent form (for publication) D4_patient facing document_Template_Greenphire EU Generic ClinCard 1.0
Subject information and informed consent form (for publication) G2_SmPC Cisplatina_CZ 1.0
Subject information and informed consent form (for publication) G2_SmPC Karboplatina_CZ 1.0
Subject information and informed consent form (for publication) G2_SmPC Pembrolizumab_CZ 1.0
Subject information and informed consent form (for publication) ICF Part A_clean_Redacted 1.4
Subject information and informed consent form (for publication) ICF Part A_clean_Redacted_V1.5 1.5
Subject information and informed consent form (for publication) ICF Part A_TC_Redacted 1.4
Subject information and informed consent form (for publication) ICF Part B_clean_Redacted 1.4
Subject information and informed consent form (for publication) ICF Part B_clean_Redacted_V1.5 1.5
Subject information and informed consent form (for publication) ICF Part B_TC_Redacted 1.4
Subject information and informed consent form (for publication) J3M-MC-JZQB_CountrySpecific_ICF_Main_Dose Optimization_V2_PRT_V3_15Feb2024_PT_clean_san_redacted 3
Subject information and informed consent form (for publication) J3M-MC-JZQB_CountrySpecific_ICF_Main_Part A_V3_PRT_V3_15Feb2024_PT_clean_san_redacted 3
Subject information and informed consent form (for publication) J3M-MC-JZQB_CountrySpecific_ICF_Main_Part B_V2_PRT_V3_15Feb2024_PT_clean_san_redacted 3
Subject information and informed consent form (for publication) J3M-MC-JZQB_CountrySpecific_ICF_Main_Safety Lead in Part B_V2_PRT_V3_15Feb2024_PT_clean_san_redacted 3
Subject information and informed consent form (for publication) J3M-MC-JZQB_CountrySpecific_ICF_Prescreening_PRT_V3_15Feb2024_PT_clean_san_redacted 3
Subject information and informed consent form (for publication) L1 SIS and ICF Dose Optimization_v4_TCED 29Aug2024_SWE v2_5Dec2024_Clean_Redacted 2
Subject information and informed consent form (for publication) L1 SIS and ICF_Dose Optimization_ Redacted 2.0
Subject information and informed consent form (for publication) L1 SIS and ICF_Dose Optimization_clean_Redacted 2
Subject information and informed consent form (for publication) L1 SIS and ICF_Future Research_clean_Redacted 3
Subject information and informed consent form (for publication) L1 SIS and ICF_Future Research_Redacted 5.0
Subject information and informed consent form (for publication) L1 SIS and ICF_Part A_Redacted 4
Subject information and informed consent form (for publication) L1 SIS and ICF_Safety Lead in Part B_clean_Redacted 2
Subject information and informed consent form (for publication) L1_Addendum ICF Progression_TC 2
Subject information and informed consent form (for publication) L1_Addendum ICF_Tissue Sample_Part A_Dose Optimization_clean_CZ_Redacted 2
Subject information and informed consent form (for publication) L1_Addendum ICF_Tissue Sample_Part B_clean_CZ_Redacted 2.0
Subject information and informed consent form (for publication) L1_Country Reimbursement and Reminder ICF Addendum_Redacted 2
Subject information and informed consent form (for publication) L1_CountrySpecific_ICF_Main_Part A_PT_redacted 1
Subject information and informed consent form (for publication) L1_CountrySpecific_ICF_Main_Part B_PT_redacted 1
Subject information and informed consent form (for publication) L1_CountrySpecific_ICF_Prescreening_PT_redacted 1
Subject information and informed consent form (for publication) L1_CountrySpecific_ICF_Progression_PT 1
Subject information and informed consent form (for publication) L1_CountrySpecific_SoC_DO_PT_redacted 1
Subject information and informed consent form (for publication) L1_DO and SL_Optional Tissue Sampling Addendum ICF_Redacted 1.1
Subject information and informed consent form (for publication) L1_DO and SL_Optional Tissue Sampling Addendum ICF_TC_Redacted 1.1
Subject information and informed consent form (for publication) L1_Dose Optimization Main ICF_TC_Redacted 1.1
Subject information and informed consent form (for publication) L1_ICF_Addendum_Post Progression_GR 2
Subject information and informed consent form (for publication) L1_ICF_Addendum_Post Progression_GR_Track Changes 2
Subject information and informed consent form (for publication) L1_ICF_Addendum_Post-Progression 2
Subject information and informed consent form (for publication) L1_ICF_Addendum_Prescreening_GR_Redacted 2
Subject information and informed consent form (for publication) L1_ICF_Addendum_Prescreening_GR_Track Changes 2
Subject information and informed consent form (for publication) L1_ICF_Addendum_Prescreening_Redacted 2
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Dose Optimization_V2_PRT_V1_12Oct2023_PT_clean_san_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_ICF_Main_Dose Optimization_V2_PRT_V2_18Jan_PT_clean_san_redacted 2
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_ICF_Main_Part A_V3_PRT_V2_18Jan2024_PT_clean_san_redacted 2
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_ICF_Main_Part B_V2_PRT_V2_18Jan2024_PT_clean_san_redacted 2
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_ICF_Main_Safety Lead in Part B_V2_PRT_V2_18Jan2024_PT_clean_san_redacted 2
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_ICF_Pregnancy_PRT_V2_18Jan2024_PT_clean_san 2
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_ICF_Prescreening_PRT_V2_18Jan2024_PT_clean_san_redacted 2
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_ICF_Progression_PRT_V2_18Jan2024_PT_clean_san 2
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Main_Dose Optimization_V3_PRT_V1_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Main_Dose Optimization_V4_PRT_V1_PT_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Main_Part A_V4_PRT_V1_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Main_Part A_V5_PRT_V1_PT_clean_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Main_Part B_V3_PRT_V1_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Main_Part B_V4_PRT_V1_PT_clean_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Main_Safety Lead in Part B_V3_PRT_V1_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_PartA_V3_PRT_V1_12Oct2023_PT_clean_san_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_PartB_V2_PRT_V1_12Oct2023_PT_clean_san_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Pregnancy_V1_PRT_V1_21Sep2023_PT_clean_san 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Prescreening_V1_PRT_V1_22Sep2023_PT_clean_san_redacted 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Progression_V1_PRT_V1_22Sep2023_PT_clean_san 1
Subject information and informed consent form (for publication) L1_ICF_CountrySpecific_Safety Lead in Part B_V1_PRT_V1_12Oct2023_PT_clean_san_redacted 1
Subject information and informed consent form (for publication) L1_ICF_Dose Optimization_GR_Redacted 4
Subject information and informed consent form (for publication) L1_ICF_Main_Part A_PT_redacted 1
Subject information and informed consent form (for publication) L1_ICF_Main_Part B_PT_redacted 1
Subject information and informed consent form (for publication) L1_ICF_Part A_GR_Redacted 6
Subject information and informed consent form (for publication) L1_ICF_Part B_GR_Redacted 6
Subject information and informed consent form (for publication) L1_ICF_Reimbursement and_or Reminder_Redacted 1.0
Subject information and informed consent form (for publication) L1_ICF_Safety Lead in_GR_Redacted 2
Subject information and informed consent form (for publication) L1_ICF_Safety Lead_ v2_ES_Redacted 2.0
Subject information and informed consent form (for publication) L1_ICF_SoC_Dose Optimization_GR_Redacted 1
Subject information and informed consent form (for publication) L1_JZQB_Prescreening_Addendum ICF_Redacted 3
Subject information and informed consent form (for publication) L1_JZQB_Progression_Addendum ICF 2
Subject information and informed consent form (for publication) L1_JZQB_Safety Lead-In Part B ICF_DE_Redacted 3.0
Subject information and informed consent form (for publication) L1_List of submitted documents_Part II 1.0
Subject information and informed consent form (for publication) L1_Main ICF Dose optimization_Redacted 5
Subject information and informed consent form (for publication) L1_Main ICF Part A_Redacted 6
Subject information and informed consent form (for publication) L1_Main ICF Part B_Redacted 6
Subject information and informed consent form (for publication) L1_Main ICF Safety Lead-In_Redacted 4
Subject information and informed consent form (for publication) L1_Main ICF_CZ_Dose Optimization_highlighted_Redacted 2
Subject information and informed consent form (for publication) L1_Main ICF_CZ_Part A_highlighted_Redacted 2
Subject information and informed consent form (for publication) L1_Main ICF_CZ_Part B_highlighted_Redacted 2
Subject information and informed consent form (for publication) L1_Main ICF_CZ_Safety Lead-in_highlighted_Redacted 2
Subject information and informed consent form (for publication) L1_Part A and B Optional Tissue Sampling Addendum ICF_Redacted 2.0
Subject information and informed consent form (for publication) L1_Part A and B_Optional Tissue Sampling Addendum ICF_TC_Redacted 1.1
Subject information and informed consent form (for publication) L1_Part A Main ICF_TC_Redacted 1.1
Subject information and informed consent form (for publication) L1_Part B Main ICF_TC_Redacted 1.1
Subject information and informed consent form (for publication) L1_Patient Reimbursement Program Germany_Redacted 2
Subject information and informed consent form (for publication) L1_Post Progression Addendum ICF_Redacted 1
Subject information and informed consent form (for publication) L1_Post Progression Addendum ICF_TC_Redacted 1.1
Subject information and informed consent form (for publication) L1_Pre-Screening Addendum ICF_Redacted 2.0
Subject information and informed consent form (for publication) L1_Pregnant Partner Addendum ICF_Clean_Redacted 2.0
Subject information and informed consent form (for publication) L1_Pregnant Partner Addendum ICF_Redacted 4.0
Subject information and informed consent form (for publication) L1_Prescreening Addendum ICF_TC_Redacted 1.1
Subject information and informed consent form (for publication) L1_Recruitment and Informed consent procedure 1
Subject information and informed consent form (for publication) L1_Safety Lead-In Part B Main ICF_TC_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF _Post progression Addendum 4
Subject information and informed consent form (for publication) L1_SIS and ICF _Post progression Addendum_TC 4
Subject information and informed consent form (for publication) L1_SIS and ICF _Pregnant Partner Addendum 1
Subject information and informed consent form (for publication) L1_SIS and ICF _Pregnant Partner Addendum_TC 3
Subject information and informed consent form (for publication) L1_SIS and ICF _Prescreening Addendum_Redacted 4
Subject information and informed consent form (for publication) L1_SIS and ICF _Prescreening Addendum_TC_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF Dose Optimization_clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Dose Optimization_NO_1_20Oct2023_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Dose Optimization_NO_2_01Feb2024_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF Dose Optimization_redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Dose Optimization_SV_1_18Oct2023_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Dose Optimization_SV_2_01Feb2024_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF Dose Optimization_v3_TCED 15Apr2024_SWE v1_16Apr2024_clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Dose Optimization_v4_TCED 29Aug2024_SWE v1_ 04Sep2024_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 Future Research_V2_19April 2024_clean_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF Part A _v3_TCED 15Apr2024_SWE v1_16Apr2024_clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part A__v3_TCED 15Apr2024_SWE v2_09Jul2024_clean_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF Part A_clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part A_NO_1_20Oct2023_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part A_NO_2_01Feb2024_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF Part A_SV_1_18Oct2023_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part A_SV_2_01Feb2024_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF Part A_V3_TCED 15 Apr 2024_ NOR V1_16Apr2024_clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part A_v4_TCED 29Aug2024_SWE v1_04Sep2024_clean_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part B_clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part B_NO_1_20Oct2023_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part B_SV_1_18Oct2023_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part B_V3_TCED 15 Apr 2024_ NOR V1_16Apr202_clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part B_v3_TCED 15Apr2024_SWE v1_16Apr2024_clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Part B_v3_TCED 15Apr2024_SWE v2_09Jul2024_clean_Redacted 2
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Subject information and informed consent form (for publication) L1_SIS and ICF prescreening and Abbreviated Consent Form_NO_1_22Sep2023_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening and Abbreviated Consent Form_SV_1_22Sep2023_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening Information and Abbreviated_NO_Redacted 1
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Subject information and informed consent form (for publication) L1_SIS and ICF Progression Patient Information_NO_clean 1
Subject information and informed consent form (for publication) L1_SIS and ICF Safety Lead in Part B _clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Safety Lead in Part B _V3_TCED 15 Apr 2024_ NOR V1_16Apr2024_clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Safety Lead in Part B_NO_1_20Oct2023_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Safety Lead in Part B_NO_2_01Feb2024_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF Safety Lead in Part B_SV_1_18Oct2023_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF Safety Lead in Part B_SV_2_01Feb2024_redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF Safety Lead in Part B_v3_TCED 15Apr2024_SWE v1_16Apr2024_clean_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_ Adenda Preinclusion_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ Adenda Progresion 3.0
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Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum ICF_Progression_clean 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_addendum optioanl biopsy_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum Pregnant Partner_Redacted 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF_addendum Prescreening_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum Progression Biopsy_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_addendum Progression_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum Tumor Tissue_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Country Reimbursement and Reminder Addendum ICF_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Data Privacy Addendum_CZ 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Dose Optimization ICF SoC_clean_CZ 1
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Subject information and informed consent form (for publication) L1_SIS and ICF_Future Research_NO_1_30Jan2024_Redacted 1
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Subject information and informed consent form (for publication) L1_SIS and ICF_Greenphire_CZ_Redacted 1.1
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Subject information and informed consent form (for publication) L1_SIS and ICF_ICF part A_EN_Redacted 5.0
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Subject information and informed consent form (for publication) L1_SIS and ICF_ICF_Dose_Optimization_BEDU_Redacted 2
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Subject information and informed consent form (for publication) L1_SIS and ICF_ICF_Part_A_BEDU_Redacted 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ICF_part_A_BEFR_Redacted 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ICF_Part_B_BEDU_Redacted 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ICF_part_B_BEFR_Redacted 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ICF_Prescreening_Addendum_BEDU_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ICF_Progression_Addendum_BEDU 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ICF_Safety_Lead_BEDU_Redacted 2
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Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF Part B_Redacted 8.0
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Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Dose optimization_Redacted 1.1
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Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Part A_Redacted 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Part A_TC_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Part B_Redacted 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Part B_Redacted 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Part B_TC_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Safety lead-in Part B_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Part A_Redacted 8.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Part A_redacted_NO 9.0NOR1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Part A_redacted_SE 9.0SWE1.0
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Subject information and informed consent form (for publication) L1_SIS and ICF_Main Part B_redacted_SE 7.0SWE1.0
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Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Dose Optimization_CZ_Redacted 2
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Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Part A_CZ_Redacted 2
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Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Part B_CZ_Redacted 2
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Subject information and informed consent form (for publication) L1_SIS and ICF_Optional biopsy Addendum ICF_Part A_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional biopsy Addendum ICF_Part B_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional biopsy Addendum ICF_Safety lead-in_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Part A _clean_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_Part A Main ICF_Redacted 5.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Part A_ IT_Redacted 6.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Part A_PL_Redacted 7
Subject information and informed consent form (for publication) L1_SIS and ICF_Part A_PL_Redacted_v6 6.0
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Subject information and informed consent form (for publication) L1_SIS and ICF_Part A_Redacted 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Part B Main ICF_Redacted 5.1
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Subject information and informed consent form (for publication) L1_SIS and ICF_Part B_clean_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_Part B_NO_2_01Feb2024_Redacted 2
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Subject information and informed consent form (for publication) L1_SIS and ICF_Part B_Redacted 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Part B_Redacted 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Part B_SV_2_01Feb2024_redacted 2
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Subject information and informed consent form (for publication) L1_SIS and ICF_Pre-screening Addendum ICF_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pre-Screening_ IT_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Participant ICF_BEDU 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Participant ICF_BEFR 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Participant ICF_ENG 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner ICF_BEDU 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner ICF_BEFR 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner ICF_ENG 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner ICF_Redacted 1
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Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening Addendum_EN_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening Addendum_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening_Addendum_BEFR_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening_AT_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening_SE_redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Progression Addendum_EN 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Progression Addendum ICF 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Progression ICF_AT 2.0
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Subject information and informed consent form (for publication) L1_SIS and ICF_Progression_ IT 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Progression_ IT_TC 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Progression_Addendum_BEFR 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Reimbursement ICF_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Safety Lead in Part B_ IT_Redacted 2
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Subject information and informed consent form (for publication) L1_SIS and ICF_Safety Lead-in_PL_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Safety_Redacted 3
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Subject information and informed consent form (for publication) L2_Fahrtkosten und Aufwandsentschadigung Formular_Redacted 2
Subject information and informed consent form (for publication) L2_JZQB_Study-Guide-Part-A_Master_PL_Redacted 2.0
Subject information and informed consent form (for publication) L2_JZQB_Study-Guide-Part-B_Master_PL_Redacted 2.0
Subject information and informed consent form (for publication) L2_JZQB_T-Aware-Brochure-EU_Master_PL 2.0
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Subject information and informed consent form (for publication) L2_Other information material_ Greenphire_ClinCard_Card_Carrier_EU 3.0
Subject information and informed consent form (for publication) L2_Other information material_cx01_ConneX Travel Reference Guide for Participants_IC_POL 10.0
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Subject information and informed consent form (for publication) L2_Other information material_EC_packet_w_Data_Privacy_as_applied_to_GP 9.0
Subject information and informed consent form (for publication) L2_Other information material_Greenphire ClinCard Msg Templates - ROW 6.0
Subject information and informed consent form (for publication) L2_Other information material_Greenphire EU Generic ClinCard 3.0
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Subject information and informed consent form (for publication) L2_Other information material_Greenphire_Fee_Schedule 3.0
Subject information and informed consent form (for publication) L2_Other subject info materials_EC_packet_Data_Privacy_as_applied_to_GP_v8 1
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Subject information and informed consent form (for publication) L2_Other subject info materials_Greenphire EU Generic ClinCard 3
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Subject information and informed consent form (for publication) L2_Other subject information material Emergency Card JZQB - Poland 1.0
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Subject information and informed consent form (for publication) L2_Other subject information material_Study Guide Part B_v1_06Oct2023_Redacted 1
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Subject information and informed consent form (for publication) L2_Other subject information material_Study-Guide_Part-A _v1_06Oct2023_Redacted 1
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Subject information and informed consent form (for publication) L2_Study-Guide-Part-B_Master_v1_06Oct2023_PT_san_redacted 1
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Subject information and informed consent form (for publication) L3_ Greenphire__EC_packet_w_Data_Privacy_as_applied_to_GP_v7 7
Subject information and informed consent form (for publication) L3_ Greenphire_ClinCard_Cardholder_FAQ_EU_V3 3.0
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Subject information and informed consent form (for publication) L3_Greenphire ClinCard Msg Templates - ROW_v6 Feb 2018 6.0
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Subject information and informed consent form (for publication) L3_Other patient material_Study Participant Contact card - Romania 1.0
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Subject information and informed consent form (for publication) L3_Other subject information material_Visit-Card 1.0
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Subject information and informed consent form (for publication) L3_Patient card_Rauter 1
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Subject information and informed consent form (for publication) L4_Annex 3_Recruitment and consenting procedure 1
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Synopsis of the protocol (for publication) D1_ Protocol Synopsis_ENG_2023_503412-33-00_Redacted i
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Synopsis of the protocol (for publication) D1_Protocol Synospis_2023-503412-33-00_GR_Redacted k
Synopsis of the protocol (for publication) D1_Protocol_synopsis c_HU_2023-503412-33-00_Redacted 1.1
Synopsis of the protocol (for publication) D1_Protocol_synopsis_IT_2023-503412-33-00_Redacted k
Synopsis of the protocol (for publication) D1-Protocol Synopsis f_02Sep2024_no_NO_clean_Redacted i

Application history

19 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-11-03 Hungary Acceptable with conditions
2024-03-04
 2024-03-05
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-03-19 Acceptable with conditions
2024-03-04
 2024-03-19
3 NON SUBSTANTIAL MODIFICATION NSM-2 2024-03-26 Acceptable with conditions
2024-03-04
 2024-03-26
4 NON SUBSTANTIAL MODIFICATION NSM-3 2024-04-05 Acceptable with conditions
2024-03-04
 2024-04-05
5 SUBSTANTIAL MODIFICATION SM-1 2024-05-03 Hungary Acceptable with conditions
2024-07-18
 2024-07-18
6 SUBSEQUENT ADDITION OF MSC APP-6 2024-08-13 2024-09-19
7 SUBSTANTIAL MODIFICATION SM-2 2024-09-30 Hungary Acceptable
2025-01-20
 2025-01-21
8 NON SUBSTANTIAL MODIFICATION NSM-4 2025-01-30 Acceptable
2025-01-20
 2025-01-30
9 SUBSEQUENT ADDITION OF MSC APP-9 2025-02-04 Acceptable
2025-01-20
 2025-04-24
10 SUBSTANTIAL MODIFICATION SM-3 2025-03-24 Acceptable 2025-04-24
11 SUBSTANTIAL MODIFICATION SM-4 2025-03-24 Acceptable 2025-04-15
12 SUBSTANTIAL MODIFICATION SM-5 2025-04-10 Acceptable 2025-05-21
13 NON SUBSTANTIAL MODIFICATION NSM-5 2025-05-28 Acceptable 2025-05-28
14 SUBSTANTIAL MODIFICATION SM-7 2025-06-13 Acceptable 2025-07-07
15 SUBSTANTIAL MODIFICATION SM-8 2025-09-02 Hungary Acceptable
2025-12-08
 2025-12-08
16 NON SUBSTANTIAL MODIFICATION NSM-6 2025-12-17 Acceptable
2025-12-08
 2025-12-17
17 SUBSTANTIAL MODIFICATION SM-9 2026-01-23 Hungary Acceptable
2026-04-22
 2026-04-22
18 NON SUBSTANTIAL MODIFICATION NSM-7 2026-05-01 Hungary Acceptable
2026-04-22
 2026-05-01
19 SUBSTANTIAL MODIFICATION SM-11 2026-05-14 Acceptable 2026-05-28