Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer

2024-512998-27-00 Protocol GCT1046-06 Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 21 Feb 2025 · Status Ongoing, recruitment ended · 15 EU/EEA countries · 138 sites · Protocol GCT1046-06

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 702
Countries 15
Sites 138

Non-Small Cell Lung Cancer

Determine the clinical efficacy of acasunlimab in combination with pembrolizumab versus docetaxel as second-/third-line (2/3L) therapy in metastatic non-small cell lung cancer (NSCLC) after PD-1/PD-L1-inhibitor- and platinum containing standard of care (SOC)

Key facts

Sponsor
Genmab A/S
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
21 Feb 2025 → ongoing
Decision date (initial)
2025-01-27
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Genmab A/S

External identifiers

EU CT number
2024-512998-27-00
ClinicalTrials.gov
NCT06635824

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Therapy, Pharmacokinetic, Safety, Efficacy

Determine the clinical efficacy of acasunlimab in combination with pembrolizumab versus docetaxel as second-/third-line (2/3L) therapy in metastatic non-small cell lung cancer (NSCLC) after PD-1/PD-L1-inhibitor- and platinum containing standard of care (SOC)

Secondary objectives 4

  1. Assess the efficacy and antitumor activity of acasunlimab in combination with pembrolizumab versus docetaxel as 2/3L therapy in metastatic NSCLC after PD-1/PD-L1-inhibitor- and platinum containing SOC
  2. Evaluate the safety and tolerability of acasunlimab in combination with pembrolizumab
  3. Characterize the PK and immunogenicity of acasunlimab in combination with pembrolizumab
  4. Assess the subject’s perspective on treatment-related symptom burden and impact of acasunlimab in combination with pembrolizumab versus docetaxel

Conditions and MedDRA coding

Non-Small Cell Lung Cancer

VersionLevelCodeTermSystem organ class
27.0 PT 10059515 Non-small cell lung cancer metastatic 100000004864

Study design 4 periods

#TitleAllocationBlindingRoles blindedArms
1 Prescreening period
Optional prescreening period
 Not Applicable None
2 Screening period
Screening period
 Not Applicable None
3 Treatment period
Treatment period
 Randomised Controlled None Experimental: Arm A: Acasunlimab, 100 mg and pembrolizumab, 400 mg will be administered via intravenous (IV) infusion, once every 6 weeks (Q6W) (Cycle length=42 days).
Active Comparator: Arm B: Docetaxel, 75 mg/m^2 will be administered via IV infusion, once every 3 weeks (Q3W) (Cycle length=21 days).
4 Post-Treatment Period
Post-Treatment Period
 Randomised Controlled None Arm A: Participants who were randomized to Experimental Arm A
Arm B: Participants who were randomized to Active Comparator Arm B.

Regulatory references

Scientific advice from competent authorities
European Medicines Agency, Food And Drug Administration
EMA paediatric investigation plan (PIP)
EMEA-003606-PIP01-24
Plan to share IPD
No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV with known subtype).
  2. Participant has progressed radiographically on or after receiving: - One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the metastatic disease setting; OR - No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order) in the metastatic disease setting.
  3. Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determined prospectively on a tumor sample from the metastatic setting at a sponsor-designated central laboratory.
  4. Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
  5. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days of Cycle 1 Day 1.
  6. Participant has a life expectancy of ≥3 months.
  7. Participant must have adequate organ and bone marrow function, per laboratory test results, within 7 days of trial treatment.

Exclusion criteria 6

  1. Documentation of known targetable epidermal growth factor receptor (EGFR) sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET), ROS proto-oncogene 1; receptor tyrosine kinase (ROS1) rearrangement, Kirsten rat sarcoma virus (KRAS), B-Raf proto-oncogene (BRAF) mutations, and MET proto-oncogene; receptor tyrosine kinase (MET) exon 14 skipping mutations/MET amplification. NOTE: MET amplification testing is optional based on local availability of the test. – Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to approved targeted therapies.
  2. Participants with newly identified or known unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
  3. Prior treatment with docetaxel for NSCLC.
  4. Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy.
  5. Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.
  6. Note: Other protocol-defined inclusion and exclusion criteria may apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Overall survival (OS)

Secondary endpoints 9

  1. Progression-free survival (PFS)
  2. Confirmed objective response rate (ORR)
  3. Duration of response (DoR)
  4. Number of participants with adverse events (AEs)
  5. Time to treatment discontinuation due to AE
  6. Plasma concentration of acasunlimab
  7. Number of participants with anti-drug antibodies (ADAs) to acasunlimab
  8. Change from baseline in Functional Assessment of Cancer Therapy item GP5 (FACIT-GP5, version 4) score
  9. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Investigational products

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

Test 2

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323105 · Product

Active substance
Pembrolizumab
Substance synonyms
Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
400 mg milligram(s)
Max total dose
7200 mg milligram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Packaging and labelling

Acasunlimab

PRD6822274 · Product

Active substance
Acasunlimab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
100 mg milligram(s)
Max total dose
4400 mg milligram(s)
Max treatment duration
60 Month(s)
Authorisation status
Not Authorised
MA holder
GENMAB
Paediatric formulation
No
Orphan designation
No

Comparator 1

Docetaxel

SCP126226 · ATC

Active substance
Docetaxel
Substance synonyms
DOCETAXEL ANHYDROUS
Route of administration
CONCENTRATE FOR SOLUTION FOR INFUSION
Max daily dose
75 mg/m2 milligram(s)/square meter
Max total dose
6525 mg/m2 milligram(s)/sq. meter
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
L01CD02 — DOCETAXEL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Packaging and labelling

Auxiliary 6

Prednisolone

SCP107216203 · ATC

Active substance
Prednisolone
Substance synonyms
(8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
Route of administration
ORAL AND IV
Max daily dose
100 mg milligram(s)
Max total dose
5400 mg milligram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
H02AB07 — PREDNISONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

CellCept 500 mg film-coated tablets

PRD2153968 · Product

Active substance
Mycophenolate Mofetil
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1000 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation
EU/1/96/005/002
MA holder
ROCHE REGISTRATION GMBH
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
If locally sourced, there would be no modification to the medicinal product. If centrally sourced by the sponsor, the modification to the medicinal product is: labelling and packaging.

RoActemra 20 mg/mL concentrate for solution for infusion

PRD2159336 · Product

Active substance
Tocilizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
2400 mg milligram(s)
Max total dose
3200 mg milligram(s)
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
L04AC07 — -
Marketing authorisation
EU/1/08/492/005
MA holder
ROCHE REGISTRATION GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
If locally sourced, there would be no modification to the medicinal product. If centrally sourced by the sponsor, the modification to the medicinal product is: labelling and packaging.

Anakinra

SCP183367 · ATC

Active substance
Anakinra
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
200 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
L04AC03 — ANAKINRA
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
If locally sourced, there would be no modification to the medicinal product. If centrally sourced by the sponsor, the modification to the medicinal product is: labelling and packaging.

Betamethasone Sodium Phosphate

SCP10332310 · ATC

Active substance
Betamethasone Sodium Phosphate
Substance synonyms
BETAMETHASONE DISODIUM PHOSPHATE
Route of administration
INTRAVENOUS
Max daily dose
10 mg/kg milligram(s)/kilogram
Max total dose
4176 mg milligram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lidocaine Hydrochloride Monohydrate

SCP101878658 · ATC

Active substance
Lidocaine Hydrochloride Monohydrate
Route of administration
INTRAVENOUS USE
Max daily dose
1000 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
60 Month(s)
Authorisation status
Authorised
ATC code
H02AB04 — METHYLPREDNISOLONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genmab A/S

26 Total trials 4 Recruiting 20 Ended
Commercial
Sponsor organisation
Genmab A/S
Address
Carl Jacobsens Vej 30
City
Valby
Postcode
2500
Country
Denmark

Scientific contact point

Organisation
Genmab A/S
Contact name
Regulatory Affairs Genmab

Public contact point

Organisation
Genmab A/S
Contact name
Genmab Trial Information

Third parties 19

OrganisationCity, countryDuties
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Other
IQVIA Limited
ORG-100008655
 Reading, United Kingdom On site monitoring, Code 11, Code 12, Other, Code 2, Code 5, Data management, E-data capture, Code 8
CellCarta
ORG-100039881
 Antwerp, Belgium Other
Perceptive Informatics Inc.
ORG-100013171
 Billerica, United States Other
Fortrea Development Limited
ORG-100009463
 Maidenhead, United Kingdom Other, Code 8
Genmab B.V.
ORG-100039717
 Utrecht, Netherlands Other
IQVIA RDS Hellas Single Member S.A.
ORG-100048380
 Chalandri, Greece On site monitoring, Other, Code 2, Code 8
Almac Clinical Services Limited
ORG-100017464
 Craigavon, United Kingdom (Northern Ireland) Other
Endpoint Clinical Inc.
ORG-100040567
 Wakefield, United States Interactive response technologies (IRT)
Massive Bio Inc.
ORG-100044618
 New York, United States Other
Fortrea Inc.
ORG-100012602
 Durham, United States Other, Code 8
PPD Development LP
ORG-100011560
 Richmond, United States Other
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Celerion Inc.
ORG-100029202
 Lincoln, United States Other
Q Squared Solutions LLC
ORG-100043195
 Durham, United States Laboratory analysis
Hangzhou Tigermed Consulting Co. Ltd.
ORG-100022909
 Hangzhou, China Other
Guardant Health Inc.
ORG-100042461
 Redwood City, United States Other
Q Squared Solutions Limited
ORG-100042527
 Reading, United Kingdom Other, Laboratory analysis
Genmab US Inc.
ORG-100046328
 Plainsboro, United States Other

Locations

15 EU/EEA countries · 138 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruitment ended 15 4
Belgium Ongoing, recruitment ended 27 9
Bulgaria Ongoing, recruitment ended 20 6
Croatia Ended 15 5
Estonia Ended 5 2
France Ongoing, recruitment ended 55 19
Germany Ongoing, recruitment ended 93 16
Greece Ongoing, recruitment ended 10 7
Hungary Ended 12 5
Ireland Ongoing, recruitment ended 8 6
Italy Ongoing, recruitment ended 33 15
Netherlands Ongoing, recruitment ended 18 9
Poland Ongoing, recruitment ended 46 10
Portugal Ended 13 5
Spain Ongoing, recruitment ended 28 20
Rest of world
Japan, Chile, Canada, Argentina, Turkey, Brazil, United Kingdom, Australia, Taiwan, United States, Korea, Republic of
 — 304 —

Investigational sites

Austria

4 sites · Ongoing, recruitment ended
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Internal Medicine, Carinagasse 47, 6800, Feldkirch
Stadt Wien Wiener Gesundheitsverbund
Department of Respiratory and Critical Care Medicine, Bruenner Strasse 68, Floridsdorf, Vienna
Kepler Universitaetsklinikum GmbH
Department of Internal Medicine 4 – Pulmonology, Krankenhausstrasse 9, 4020, Linz
Stadt Wien Wiener Gesundheitsverbund
Department of Respiratory and Lung Diseases, Baumgartner Hoehe 1, Penzing, Vienna

Belgium

9 sites · Ongoing, recruitment ended
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Jessa Ziekenhuis
Pneumology, Stadsomvaart 11, 3500, Hasselt
A.Z. Sint-Maarten
Pneumology, Liersesteenweg 435, 2800, Mechelen
Algemeen Ziekenhuis Delta
Pneumology, Deltalaan 1, 8800, Roeselare
Grand Hopital De Charleroi
Pneumology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Centre Hospitalier Universitaire De Liege
Pneumology, Avenue De L'hopital 1, 4000, Liege
CHU Saint Pierre
Pneumology, Hoogstraat 322, 1000, Brussels
UZ Brussel
Oncology, Laarbeeklaan 101, 1090, Jette
Cliniques Universitaires Saint-Luc
Pneumology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe

Bulgaria

6 sites · Ongoing, recruitment ended
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department of medical oncology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Clinic of medical oncology, Pierre Curie Street 2, 5804, Pleven
Mbal Za Zhensko Zdrave Nadezhda OOD
Clinic of Medical Oncology, Blaga Vest Street 3, 1330, Sofia
University Multiprofile Hospital For Active Treatment Sofiamed OOD
Department of Medical Oncology, Bulevard D-R G.m.dimitrov 16, 1797, Sofiya
Complex Oncological Center Plovdiv EOOD
Department of medical oncology and oncology diseases in pneumology, Bulevard Aleksandir Stamboliyski 2a, 4004, Plovdiv
Multiprofile Hospital For Active Treatment Serdicamed EOOD
Second Department of medical Oncology, Bulevard Prezident Linkiln 128, 1632, Sofia

Croatia

5 sites · Ended
Pula General Hospital Ospedale Generale di Pola
Oncology, Santoriova Ulica 24a, Pula, Pula - Pola
Klinicki bolnicki centar Sestre milosrdnice
Oncology, Vinogradska Cesta 29, Zagreb, Grad Zagreb
KBC Zagreb
Oncology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Specijalna Bolnica Medico
Oncology, Agaticeva 8, 51000, Rijeka
Opca Bolnica Dubrovnik
Oncology, Dr. Roka Misetica 2, 20000, Dubrovnik

Estonia

2 sites · Ended
North Estonia Medical Centre Foundation
N/A, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Tartu University Hospital
N/A, A006, L. Puusepa Tn 8, Tartu Linn

France

19 sites · Ongoing, recruitment ended
Centre Hospitalier Universitaire De Lille
Pulmonology and Thoracic Oncology, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Pneumology, 54 Rue Henri Sainte Claire Deville, Cs 91400, Toulon Cedex
L'Hopital Prive Du Confluent
Oncology, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Hopital Ambroise Pare
Respiratory Diseases and Thoracic Oncology, 9 Avenue Charles De Gaulle, 92100, Boulogne Billancourt
Centre Hospitalier De La Cote Basque
Medical Pneumology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Pneumo-Oncology and Allergology, 185 Rue Raymond Losserand, 75014, Paris
Ramsay Generale De Sante
Oncology, 2 Allee Docteur Robert Lafon, 64100, Bayonne
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Paoli Calmettes
Service d'Oncologie Médicale, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Regional De Marseille
Oncology, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Universitaire De Rennes
Pneumology, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Intercommunal Creteil
Public health and Social Medicine, 40 Avenue De Verdun, 94010, Creteil Cedex
Institut Sainte Catherine
Oncology, 250 Chemin De Baigne Pieds, 84000, Avignon
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Pneumology, 20 Avenue Du Docteur Rene Laennec, 68100, Mulhouse
Institut Curie
Pneumology, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Regional D'Angers
Pneumology, 4 Rue Larrey, 49100, Angers

Germany

16 sites · Ongoing, recruitment ended
Klinikum Esslingen GmbH
Kardiologie, Angiologie und Pneumologie, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Universitaetsklinikum Schleswig-Holstein AöR
Medizinische Klinik III – Pneumologie, Ratzeburger Allee 160, 23538, Luebeck
Asklepios Kliniken Hamburg GmbH
Lungenabteilung, Eissendorfer Pferdeweg 52, Heimfeld, Hamburg
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Innere Medizin II, Roentgenstrasse 1, Doelau, Halle (saale)
Vivantes Netzwerk fuer Gesundheit GmbH
Innere Medizin – Schwerpunkt Hämatologie und Onkologie, Landsberger Allee 49, Friedrichshain, Berlin
Technische Universitaet Dresden
Medizinische Klinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Klinik für Pneumologie, Langenbeckstrasse 1, Oberstadt, Mainz
Medizinische Hochschule Hannover
Klinik für Pneumologie und Infektiologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Justus-Liebig-Universitaet Giessen
Medizinische Klinik IV, Organonkologie, Gaffkystrasse 5, 35392, Giessen
Universitaetsmedizin Goettingen
Abteilung Hämatologie und Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
Medical Center - University Of Freiburg
Innere Medizin I - Hämatologie und Onkologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Thoraxklinik Heidelberg gGmbH
Studienzentrum Thoraxonkologie, Roentgenstrasse 1, Rohrbach, Heidelberg
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Klinik für Pneumologie, Lindenberger Weg 27, Buch, Berlin
Vivantes Netzwerk fuer Gesundheit GmbH
Hämatologie, Onkologie und Gastroenterologie, Neue Bergstrasse 6, Spandau, Berlin
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik für Innere Medizin- Hämatologie, Onkologie und Palliativmedizin, Rudower Strasse 48, Buckow, Berlin
LungenClinic Grosshansdorf GmbH
LungenClinic, Woehrendamm 80, 22927, Grosshansdorf

Greece

7 sites · Ongoing, recruitment ended
General University Hospital Of Larissa
Department of Medical Oncology, P. O. Box 1425, 411 10, Larissa
Athens Medical Center S.A.
Oncology Department, Clinical Research Unit, Pylea, Asklipiou 10, Thessaloniki
Bioclinic S.A.
Oncology Department, Mitropoleos 86, 546 22, Thessaloniki
Henry Dunant Hospital Center
4th Oncology Clinic and Clinical Trials Department, 107 Mesogeion Avenue, 115 26, Athens
Alexandra Hospital
Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
University General Hospital Of Heraklion
Department of Medical Oncology, Stavrakia And Voutes, 715 00, Heraklion
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
4th University Department of Internal Medicine, Rimini 1, 124 61, Chaidari

Hungary

5 sites · Ended
Tolna Varmegyei Balassa Janos Korhaz
Onkologiai Osztaly, Beri Balogh Adam Utca 5-7, 7100, Szekszard
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiologiai Kozpont, Nyiri Ut 38, 6000, Kecskemet
Matrai Gyogyintezet
-, Matrahaza Hrsz 7151, 3200, Gyongyos
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pulmonologiai Osztaly, Vasvari Pal Utca 2-4, 9024, Gyor
Orszagos Koranyi Pulmonologiai Intezet
VI.Pulmonologiai Osztaly, Koranyi Frigyes Ut 1, 1121, Budapest XII

Ireland

6 sites · Ongoing, recruitment ended
University Hospital Waterford
Oncology, Dunmore Road, X91 ER8E, Waterford
St James's Hospital
Oncology, James's Street, D08 NHY1, Dublin 8
Cork University Hospital
Oncology, Wilton, T12 DC4A, Cork
University Hospital Limerick
Oncology, Saint Nessan's Road, V94 F858, Limerick
St Vincent's University Hospital
Oncology, Nutley Lane Donnybrook, Elm Park, Dublin 4
Beaumont Hospital
Oncology, Beaumont Road, Beaumont, Dublin 9

Italy

15 sites · Ongoing, recruitment ended
Centro Di Riferimento Oncologico Di Aviano
SOC Oncologia Medica e dei tumori immunocorrelati, Via Franco Gallini 2, 33081, Aviano
I.F.O. Istituti Fisioterapici Ospitalieri
Oncology, Via Elio Chianesi N 53, 00144, Rome
Fondazione IRCCS San Gerardo Dei Tintori
UOC Oncologia Medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Oncologia, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncology, Via Piero Maroncelli 40, 47014, Meldola
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Oncology, Piazza Oms 1, 24127, Bergamo
Humanitas Mirasole S.p.A.
Oncology, Via Alessandro Manzoni 56, 20089, Rozzano
Centro Ricerche Cliniche Di Verona S.r.l.
Oncology Unit, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oncologia Medica-UOS Oncologia Toraco-Polmonare, Largo Francesco Vito 1, 00168, Rome
Azienda Unita Sanitaria Locale Della Romagna
Oncology, Viale Vincenzo Randi 5, 48121, Ravenna
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Oncology, Piazza Luigi Miraglia 2, 80138, Naples
IRCCS Ospedale Policlinico San Martino
Oncology, Largo Rosanna Benzi 10, 16132, Genoa
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Universitaria Senese
Oncology, Strada Delle Scotte 14, 53100, Siena
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncology, Regione Gonzole 10, 10043, Orbassano

Netherlands

9 sites · Ongoing, recruitment ended
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Pulmonary Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Zuyderland Medisch Centrum Stichting
Pulmonology, Henri Dunantstraat 5, 6419 PC, Heerlen
Ziekenhuis St Jansdal
Pulmonology, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Isala Klinieken Stichting
Pulmonology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Leids Universitair Medisch Centrum (LUMC)
Pulmonology, Albinusdreef 2, 2333 ZA, Leiden
Radboud universitair medisch centrum / RADBOUDUMC
Respiratory Diseases, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Pulmonology, Plesmanlaan 121, 1066 CX, Amsterdam
Universitair Medisch Centrum Utrecht
Pulmonology, Heidelberglaan 100, 3584 CX, Utrecht
Academic Medical Center at the University of Amsterdam
Oncology, De Boelelaan 1117, 1081 HV, Amsterdam

Poland

10 sites · Ongoing, recruitment ended
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
National Institute Of Tuberculosis And Lung Diseases
N/A, Ul. Plocka 26, 01-138, Warsaw
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
N/A, Os. Zlotej Jesieni 1, 31-826, Cracow
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
N/A, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
N/A, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Instytut Centrum Zdrowia Matki Polki
N/A, Ul. Rzgowska 281/289, 93-338, Lodz
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
N/A, Ul. Ksiecia Jozefa Poniatowskiego 26, 08-110, Siedlce
Med Polonia Sp. z o.o.
N/A, Obornicka 262, 60-693, Poznan
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Oddział Kliniczny Onkologii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Instytut Genetyki I Immunologii Genim Sp. z o.o.
N/A, Ul. Filaretow 27/2, 20-609, Lublin

Portugal

5 sites · Ended
Unidade Local De Saude Da Arrabida E.P.E.
Oncology, Rua Camilo Castelo Branco, 2910-446, Setubal
Hospital CUF Porto S.A.
Oncology, Estrada Da Circunvalacao N 14341, 4100-180, Porto
Unidade Local De Saude De Matosinhos E.P.E.
Oncology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Unidade Local De Saude De Coimbra E.P.E.
Oncology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude De Santo Antonio E.P.E.
Oncology, Largo Professor Abel Salazar, 4050-011, Porto

Spain

20 sites · Ongoing, recruitment ended
Hospital Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Institut Catala D'oncologia
Oncology, Avinguda De Franca S/n, 17007, Girona
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Virgen De La Victoria
Oncology, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Universidade De Santiago De Compostela
Oncology, Rua Da Choupana Sn, 15706, Santiago De Compostela
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
H.C. Hospitales S.L.
Oncology, Urb. Las Mimosas, Calle Santa Isabel S/N, Marbella
Hospital General Universitario Dr. Balmis
Oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

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 2025-07-28 2025-07-28 2025-12-30
Belgium 2025-04-01 2025-04-01 2025-12-30
Bulgaria 2025-03-31 2025-03-31 2025-12-30
Croatia 2025-08-06 2025-12-30 2025-08-06 2025-12-30
Estonia 2025-07-01 2025-12-30 2025-07-01 2025-12-30
France 2025-02-21 2025-02-21 2025-12-30
Germany 2025-08-19 2025-08-19 2025-12-30
Greece 2025-05-15 2025-05-15 2025-12-30
Hungary 2025-10-08 2025-12-30 2025-10-08 2025-12-30
Ireland 2025-08-29 2025-08-29 2025-12-30
Italy 2025-05-15 2025-05-15 2025-12-30
Netherlands 2025-02-24 2025-02-24 2025-12-30
Poland 2025-06-26 2025-06-26 2025-12-30
Portugal 2025-08-28 2026-02-25 2025-08-28 2025-12-30
Spain 2025-05-15 2025-05-15 2025-12-30

Oversight and notifications

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

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Unexpected event UE-114319

Event date
2025-12-30
Date aware
2025-12-30
Submission date
2026-01-13
Member states affected
Austria, Belgium, Bulgaria, Croatia, Estonia, France, Germany, Hungary, Ireland, Italy, Portugal, Spain, Netherlands, Poland, Greece
Event description
To prematurely end the recruitment in the Phase 3 study ABBIL1TY NSCLC-06, effective 30 Dec 2025. This decision is not related to any new safety findings or concerns regarding the conduct of the study.

Results and documents

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

Documents 471 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol Clarification Letter 04_EN_2024-512998-27_REDACTED 1.0
Protocol (for publication) D1_Protocol Clarification Letter 05_EN_2024-512998-27_REDACTED 1.0
Protocol (for publication) D1_Protocol Clarification Letter_07_EN_ 2024-512998-27_REDACTED 1.0
Protocol (for publication) D1_Protocol_el_GR_2024-512998-27_Redacted Am1; v2.0
Protocol (for publication) D1_Protocol_EN_2024-512998-27_REDACTED Am1; v2.0
Protocol (for publication) D4_ePRO_statement for publication_2024-512998-27 1.0
Recruitment arrangements (for publication) K0_Cover letter Part II_red-san 1.0
Recruitment arrangements (for publication) K0_Cover letter_SM-7_clean_red-san N/A
Recruitment arrangements (for publication) K0_Cover letter_SM-8_clean_red-san N/A
Recruitment arrangements (for publication) K1_ informedconsent_patientrecruitment_procedure_san V3.0DEU1.0
Recruitment arrangements (for publication) K1_ Initial eConsent Submission Letter- Germany_san N/A
Recruitment arrangements (for publication) K1_2024-512998-27_Recruitment Arrangements_FRA_San V5
Recruitment arrangements (for publication) K1_Consent Security and Privacy Overview 1.5
Recruitment arrangements (for publication) K1_Consent Security and Privacy Overview_POL_san 1.5
Recruitment arrangements (for publication) K1_Consent Security and Privacy Overview_san 1.5
Recruitment arrangements (for publication) K1_GCT1046-06_Recruitment arrangements NL V3.0
Recruitment arrangements (for publication) K1_Initial eConsent Submission Letter NA
Recruitment arrangements (for publication) K1_Initial eConsent Submission Letter_POL_san 1.0
Recruitment arrangements (for publication) K1_NREC_CT_Recruitment_and_informed_consent_procedure_template 3.0IRE1.2
Recruitment arrangements (for publication) K1_Patient Advocacy Group Letter_san 2.0
Recruitment arrangements (for publication) K1_Patient Brochure_san 2.0
Recruitment arrangements (for publication) K1_Patient Flyer_san 2.0
Recruitment arrangements (for publication) K1_Patient Poster_san 1
Recruitment arrangements (for publication) K1_patientrecruitment_procedure_MassiveBio N/A
Recruitment arrangements (for publication) K1_Physician Referral Brochure_san 2.0
Recruitment arrangements (for publication) K1_Physician Referral Letter_red-san V02DEU(de)
Recruitment arrangements (for publication) K1_Physician Study Information Pack Folder_san 2.0
Recruitment arrangements (for publication) K1_Physician Study Information Pack_san 2.0
Recruitment arrangements (for publication) K1_Recruitment and Consent_Procedure 3.0
Recruitment arrangements (for publication) K1_Recruitment and informed consent procedure_BG_san 2.0
Recruitment arrangements (for publication) K1_Recruitment and informed consent procedure_EN_san 2.0
Recruitment arrangements (for publication) K1_Recruitment and Informed Consent Procedure_san 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangaments_PL_san V4.0
Recruitment arrangements (for publication) K1_Recruitment arrangements V2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 3.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_san V3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_san V2.0
Recruitment arrangements (for publication) K1_recruitment material_Patient Flyer V02DEUde
Recruitment arrangements (for publication) K1_Recruitment procedure V1.0
Recruitment arrangements (for publication) K1_Recruitment procedure V2.0
Recruitment arrangements (for publication) K1_Recruitment_Massive Bio_Direct and Indirect Patient Workflow_PL_san N/A
Recruitment arrangements (for publication) K2 Banner Ads_san 1
Recruitment arrangements (for publication) K2_ GCT1046-06_Social Media and Clinical Trial Posts V02NLD(nl)
Recruitment arrangements (for publication) K2_ Recruitment Material_Digital Patient Brochure_san V02ITA(it)
Recruitment arrangements (for publication) K2_1_ABBIL1TY NSCLC-06_Banner Ads_IRL_en_san NA
Recruitment arrangements (for publication) K2_1_Recruitment material_Physician Referral Letter_BG_red-san V02 BGR
Recruitment arrangements (for publication) K2_10_Recruitment material_Patient Brochure_BG_san V02 BGR
Recruitment arrangements (for publication) K2_11_IQVIA Complete Consent_Participant-Facing Screenshots v1-4 31Jan24_redacted 1.4
Recruitment arrangements (for publication) K2_11_Recruitment material_Patient Flyer_BG_san V02 BGR
Recruitment arrangements (for publication) K2_12_Recruitment material_Patient Poster_BG_san V01 BGR
Recruitment arrangements (for publication) K2_13_IQVIA Getting Started Patient-facing landing page v1-1 English_redacted 1.1
Recruitment arrangements (for publication) K2_13_Recruitment material_Social Media and Clinical Trial Posts_BG_san V02 BGR
Recruitment arrangements (for publication) K2_14_ABBIL1TY NSCLC 06_Glossary_Master English_V01 09Oct2024 01
Recruitment arrangements (for publication) K2_14_Recruitment material_Study Patient Information_BG_san V02 BGR
Recruitment arrangements (for publication) K2_15_ABBIL1TY NSCLC 06_Video Storyboard_MAIN eConsent_V03 24Mar2025_san 03
Recruitment arrangements (for publication) K2_2_ABBIL1TY NSCLC-06_D_I Community Engagement Slides_V02 IRL_en_Notes_san 02
Recruitment arrangements (for publication) K2_2_Recruitment material_Physician Referral Letter_EN_red-san V01 Global
Recruitment arrangements (for publication) K2_2024-512998-27_eConsent_Overview and Security_FRA_San V1.5
Recruitment arrangements (for publication) K2_2024-512998-27_eConsent_Submission Letter_FRA_San V1.0
Recruitment arrangements (for publication) K2_3_ABBIL1TY NSCLC-06_Dr-to-Patient Letter_V02 IRL_en_A4_san 02
Recruitment arrangements (for publication) K2_3_Recruitment material_Physician Referral Brochure_BG_san V02 BGR
Recruitment arrangements (for publication) K2_4_ABBIL1TY NSCLC-06_Patient Advocacy Group Letter_V02 IRL_en_01_A4_san 02
Recruitment arrangements (for publication) K2_4_Recruitment material_Study Information Slides_BG_san V02 BGR
Recruitment arrangements (for publication) K2_5_ABBIL1TY NSCLC-06_Patient Brochure_V02 IRL_en_san 02
Recruitment arrangements (for publication) K2_5_Recruitment material_Site Poster_BG_san V02BGR(bg)
Recruitment arrangements (for publication) K2_5_Recruitment material_Site Poster_EN_san V02
Recruitment arrangements (for publication) K2_6_ABBIL1TY NSCLC-06_Patient Flyer_V02 IRL_en 02
Recruitment arrangements (for publication) K2_6_Recruitment material_Dr-to-Patient Letter_BG_san V02 BGR
Recruitment arrangements (for publication) K2_7_ABBIL1TY NSCLC-06_Patient Poster_V01 IRL_en_san 01
Recruitment arrangements (for publication) K2_7_Recruitment material_Patient Advocacy Group Letter_BG_san V02 BGR
Recruitment arrangements (for publication) K2_8_Digital Patient Brochure GBR EN V02
Recruitment arrangements (for publication) K2_8_Recruitment material_Banner Ads_BG_san N/A
Recruitment arrangements (for publication) K2_9_ABBIL1TY NSCLC-06_Social Media _ Clinical Trial Posts_V02 IRL_en_san 02
Recruitment arrangements (for publication) K2_9_Recruitment material_D_I Community Engagement Slides_BG_san V02 BGR
Recruitment arrangements (for publication) K2_Complete Consent Security and Privacy Overview 1.5
Recruitment arrangements (for publication) K2_Complete Consent Security and Privacy Overview 1.5
Recruitment arrangements (for publication) K2_Complete Consent Security and Privacy Overview V1.5
Recruitment arrangements (for publication) K2_Complete Consent Security and Privacy Overview_san 1.5
Recruitment arrangements (for publication) K2_D_I Community Engagement Slides_san V02
Recruitment arrangements (for publication) K2_Digital Patient Brochure_san V02
Recruitment arrangements (for publication) K2_Dr-to-Patient Letter_san V02
Recruitment arrangements (for publication) K2_eConsent Getting Started Patient-facing landing page_san v1.1
Recruitment arrangements (for publication) K2_eConsent Glossary_san V01
Recruitment arrangements (for publication) K2_eConsent Participant-Facing Screenshots_san V1.4
Recruitment arrangements (for publication) K2_eConsent Video Storyboard_san V03
Recruitment arrangements (for publication) K2_GCT1046-06_Banner Ads N/A
Recruitment arrangements (for publication) K2_GCT1046-06_D_I_Community_Engagement_Slides V02NLD(nl)
Recruitment arrangements (for publication) K2_GCT1046-06_Dr-to-Patient Letter V02NLD01
Recruitment arrangements (for publication) K2_GCT1046-06_Patient Advocacy Group Letter V02NLD01
Recruitment arrangements (for publication) K2_GCT1046-06_Patient Brochure V02NLD01
Recruitment arrangements (for publication) K2_GCT1046-06_Patient Brochure_Digital version V02NLD01
Recruitment arrangements (for publication) K2_GCT1046-06_Patient Flyer V02NLD(nl)
Recruitment arrangements (for publication) K2_GCT1046-06_Patient Poster V01NLD(nl)
Recruitment arrangements (for publication) K2_Initial eConsent Submission Letter N/A
Recruitment arrangements (for publication) K2_Initial eConsent Submission Letter N/A
Recruitment arrangements (for publication) K2_Initial eConsent Submission Letter_san NA
Recruitment arrangements (for publication) K2_Intro to eConsent for Sites_san NA
Recruitment arrangements (for publication) K2_Other subject information material eConsent Submission Letter n/a
Recruitment arrangements (for publication) K2_Patient Advocacy Group Letter_san V02
Recruitment arrangements (for publication) K2_Patient Brochure_san V02
Recruitment arrangements (for publication) K2_Patient Flyer_san V02
Recruitment arrangements (for publication) K2_Patient material__Patient Advocacy Group Letter_san_Redacted V02GRC01
Recruitment arrangements (for publication) K2_Patient material_D_I Community Engagement Slides_san_Redacted V02GRC01
Recruitment arrangements (for publication) K2_Patient material_Dr-to-Patient Letter_san V02GRC01
Recruitment arrangements (for publication) K2_Patient material_Patient Flyer_san_Redacted V02GRC01
Recruitment arrangements (for publication) K2_Patient material_Patient Poster_san_Redacted V01GRC01
Recruitment arrangements (for publication) K2_Patient material_Patient Study Guide_san V02GRC01
Recruitment arrangements (for publication) K2_Patient material_Thank You Card_san V01GRC01
Recruitment arrangements (for publication) K2_Patient material_Visit Reminder Card_san V01GRC01
Recruitment arrangements (for publication) K2_Patient Poster_san V01
Recruitment arrangements (for publication) K2_Physician Referral Brochure V02GBR(en)
Recruitment arrangements (for publication) K2_Physician Referral Letter_red V02AUT(de)
Recruitment arrangements (for publication) K2_Recruitment and Consent_Procedure_Spain Massive Bio NA
Recruitment arrangements (for publication) K2_Recruitment material_ D_I Community Engagement Slides _EN V02BEL(en)
Recruitment arrangements (for publication) K2_Recruitment material_ D_I Community Engagement Slides _FR V02BEL(fr)
Recruitment arrangements (for publication) K2_Recruitment material_ D_I Community Engagement Slides _NL V02BEL(nl)
Recruitment arrangements (for publication) K2_Recruitment material_ Digital Patient Brochure_EN V02Global
Recruitment arrangements (for publication) K2_Recruitment material_ Digital Patient Brochure_FR V02BEL(fr)
Recruitment arrangements (for publication) K2_Recruitment material_ Digital Patient Brochure_NL V02BEL(nl)
Recruitment arrangements (for publication) K2_Recruitment material_ Dr To Patient Letter_EN V02Global
Recruitment arrangements (for publication) K2_Recruitment material_ Dr To Patient Letter_FR V02BEL01
Recruitment arrangements (for publication) K2_Recruitment material_ Dr To Patient Letter_NL V02BEL01
Recruitment arrangements (for publication) K2_Recruitment material_ Patient Brochure_EN V02Global
Recruitment arrangements (for publication) K2_Recruitment material_ Patient Brochure_FR V02BEL(fr)
Recruitment arrangements (for publication) K2_Recruitment material_ Patient Brochure_NL V02BEL(nl)
Recruitment arrangements (for publication) K2_recruitment material_Banner Ads NA
Recruitment arrangements (for publication) K2_Recruitment material_Banner Ads_EN V01Global
Recruitment arrangements (for publication) K2_Recruitment material_Banner Ads_FR N/A
Recruitment arrangements (for publication) K2_Recruitment material_Banner Ads_NL N/A
Recruitment arrangements (for publication) K2_Recruitment material_Banner Ads_san 1
Recruitment arrangements (for publication) K2_Recruitment Material_Banners Ad_San 01
Recruitment arrangements (for publication) K2_Recruitment Material_Community Engagement Slides_san V02ITA(it)
Recruitment arrangements (for publication) K2_Recruitment material_Consent Security and Privacy Overview 1.5
Recruitment arrangements (for publication) K2_recruitment material_D_I Community Engagement Slides V02DEU(de)
Recruitment arrangements (for publication) K2_Recruitment material_D_I Community Engagement Slides_et_san V02(et)02
Recruitment arrangements (for publication) K2_Recruitment material_D_I Community Engagement Slides_PL_san V02POL(pl)
Recruitment arrangements (for publication) K2_Recruitment material_D_I Community Engagement Slides_ru_san V02(ru)02
Recruitment arrangements (for publication) K2_Recruitment material_D_I Community Engagement Slides_san 02ESP(es)
Recruitment arrangements (for publication) K2_Recruitment material_D_I Community Engagement Slides_san V02 PRTpt
Recruitment arrangements (for publication) K2_Recruitment material_Digital Patient Brochure_et_san V02(et)02
Recruitment arrangements (for publication) K2_Recruitment material_Digital Patient Brochure_PL_san V02POL(pl)
Recruitment arrangements (for publication) K2_Recruitment material_Digital Patient Brochure_ru_san V02(ru)02
Recruitment arrangements (for publication) K2_Recruitment material_Digital Patient Brochure_san 02ESP(es)
Recruitment arrangements (for publication) K2_Recruitment material_Digital Patient Brochure_san V02PRTpt02
Recruitment arrangements (for publication) K2_Recruitment material_Dr to Patient Letter_et_san V02(et)02
Recruitment arrangements (for publication) K2_Recruitment material_Dr to Patient Letter_PL_san V2POL(pl)1
Recruitment arrangements (for publication) K2_Recruitment material_Dr to Patient Letter_ru_san V02(ru)02
Recruitment arrangements (for publication) K2_recruitment material_Dr-to-Patient Letter V2DEUde1
Recruitment arrangements (for publication) K2_Recruitment material_Dr-to-Patient Letter_san 2ESP(es)1
Recruitment arrangements (for publication) K2_Recruitment Material_Dr-to-Patient Letter_san V02ITA01
Recruitment arrangements (for publication) K2_Recruitment material_Dr-to-Patient Letter_san V02PRTpt01
Recruitment arrangements (for publication) K2_Recruitment material_eConsent Glossary_san V01 PRTpt
Recruitment arrangements (for publication) K2_Recruitment material_eConsent Storyboard_san V01PRTpt
Recruitment arrangements (for publication) K2_Recruitment material_eConsent submission letter N/A
Recruitment arrangements (for publication) K2_Recruitment material_Glossary_san 1Spain(sp)
Recruitment arrangements (for publication) K2_Recruitment material_Glossary_san 01.1
Recruitment arrangements (for publication) K2_Recruitment material_Initial eConsent Submission Letter- Greece_san 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Massive Bio N/A
Recruitment arrangements (for publication) K2_Recruitment material_Online adverisements_Social Media & Clinical Trial Posts_PL_san V02POL(pl)
Recruitment arrangements (for publication) K2_Recruitment material_Online advertisements_Banner_et_san EST(et)01
Recruitment arrangements (for publication) K2_Recruitment material_Online advertisements_Banner_PL_san N/A
Recruitment arrangements (for publication) K2_Recruitment material_Online advertisements_Banner_ru_san EST(ru)01
Recruitment arrangements (for publication) K2_Recruitment material_Online advertisements_Social Media_Clinical Trial Posts_et_san V02(et)02
Recruitment arrangements (for publication) K2_Recruitment material_Online advertisements_Social Media_Clinical Trial Posts_ru_san V02(ru)02
Recruitment arrangements (for publication) K2_Recruitment material_Participant-Facing Screenshots_red_san v1.4
Recruitment arrangements (for publication) K2_Recruitment material_Participant-Facing Screenshots_san_Redacted 1.5
Recruitment arrangements (for publication) K2_Recruitment material_Patient Advocacy Group Letter_EN V02Global
Recruitment arrangements (for publication) K2_Recruitment material_Patient Advocacy Group Letter_FR V02BEL01
Recruitment arrangements (for publication) K2_Recruitment material_Patient Advocacy Group Letter_NL V02BEL01
Recruitment arrangements (for publication) K2_Recruitment material_Patient Advocacy Group Letter_PL_san V2POL(pl)1
Recruitment arrangements (for publication) K2_Recruitment Material_Patient Advocacy Group Letter_san V02ITA01
Recruitment arrangements (for publication) K2_Recruitment material_Patient Advocacy Group Letter_san V02PRTpt01
Recruitment arrangements (for publication) K2_recruitment material_Patient Advocacy Group Letter_V02 DEUde01_A4 V02DEUde01
Recruitment arrangements (for publication) K2_recruitment material_Patient Brochure V02DEUde
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_et_san V02(et)02
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_PL_san V02POL(pl)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_ru_san V02(ru)02
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_san 02ESP(es)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_san V02GRC01
Recruitment arrangements (for publication) K2_Recruitment Material_Patient Brochure_san V02ITA(it)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_san V02PRTpt01
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_EN V02Global
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_et_san V02(et)02
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_FR V02BEL(fr)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_NL V02BEL(nl)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_PL_san V02POL(pl)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_ru_san V02(ru)02
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_san 02ESP(es)
Recruitment arrangements (for publication) K2_Recruitment Material_Patient Flyer_san V02ITA(it)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_san V02PRTpt02
Recruitment arrangements (for publication) K2_Recruitment material_Patient ID Card_san V01GRC01
Recruitment arrangements (for publication) K2_recruitment material_Patient Poster V01DEU(de)
Recruitment arrangements (for publication) K2_recruitment material_Patient Poster_EN V01Global
Recruitment arrangements (for publication) K2_Recruitment material_Patient Poster_et_san V02(et)02
Recruitment arrangements (for publication) K2_recruitment material_Patient Poster_FR V01BEL(fr)
Recruitment arrangements (for publication) K2_recruitment material_Patient Poster_NL V01BEL(nl)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Poster_PL_san V01POL(pl)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Poster_ru_san V02(ru)02
Recruitment arrangements (for publication) K2_Recruitment material_Patient Poster_san 01ESP(es)
Recruitment arrangements (for publication) K2_Recruitment Material_Patient Poster_san V01ITA(it)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Poster_san V01PRTpt02
Recruitment arrangements (for publication) K2_Recruitment material_Patient-facing landing page_red_san v1.1
Recruitment arrangements (for publication) K2_Recruitment material_Patient-facing landing page_san 1.2
Recruitment arrangements (for publication) K2_Recruitment material_Physician Referral Brochure_EN V02Global
Recruitment arrangements (for publication) K2_Recruitment material_Physician Referral Brochure_FR V02BEL(fr)
Recruitment arrangements (for publication) K2_Recruitment material_Physician Referral Brochure_NL V02BEL(nl)
Recruitment arrangements (for publication) K2_Recruitment material_Physician Referral Brochure_san 02ESP(es)
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Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_de_BE_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_el_GR_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_EN_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_es_ES_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_fr_BE_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_fr_FR_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_hr_HR_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_hu_HU_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_it_IT_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_nl_BE_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_nl_NL_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_pl_PL_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol LaySynopsis_pt_PT_2024-512998-27 Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol SciSynopsis_de_AT_2024-512998-27_REDACTED Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol SciSynopsis_el_GR_2024-512998-27_REDACTED Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol SciSynopsis_EN_2024-512998-27_REDACTED Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol SciSynopsis_it_IT_2024-512998-27_REDACTED Am1; v2.0
Synopsis of the protocol (for publication) D1_Protocol SciSynopsis_pt_PT_2024-512998-27_REDACTED Am1; v2.0

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-16 Portugal Acceptable with conditions
2025-01-21
 2025-01-22
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-01-29 Portugal Acceptable with conditions
2025-01-21
 2025-01-29
3 SUBSTANTIAL MODIFICATION SM-1 2025-02-10 Acceptable with conditions 2025-03-21
4 SUBSTANTIAL MODIFICATION SM-2 2025-02-10 Acceptable with conditions 2025-03-03
5 SUBSTANTIAL MODIFICATION SM-3 2025-02-10 Portugal Acceptable with conditions 2025-03-11
6 SUBSTANTIAL MODIFICATION SM-5 2025-02-10 Acceptable with conditions 2025-04-15
7 SUBSTANTIAL MODIFICATION SM-4 2025-02-11 Acceptable with conditions 2025-02-14
8 SUBSTANTIAL MODIFICATION SM-6 2025-02-18 Acceptable with conditions 2025-03-06
9 NON SUBSTANTIAL MODIFICATION NSM-2 2025-04-16 2025-04-16
10 NON SUBSTANTIAL MODIFICATION NSM-3 2025-04-16 2025-04-16
11 SUBSTANTIAL MODIFICATION SM-7 2025-04-30 Portugal Acceptable
2025-07-07
 2025-07-07
12 SUBSTANTIAL MODIFICATION SM-8 2025-08-20 Portugal Acceptable
2025-10-20
 2025-10-21
13 NON SUBSTANTIAL MODIFICATION NSM-4 2025-11-27 Acceptable
2025-10-20
 2025-11-27

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