A Phase 3 Study of Front‑line Platinum Doublet Therapy With Sotorasib Versus Pembrolizumab in PD-L1 Negative KRAS p.G12C Positive Advanced/Metastatic NSCLC (CodeBreaK 202)

2022-501863-41-00 Protocol 20190341 Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 13 Nov 2023 · Status Ongoing, recruitment ended · 17 EU/EEA countries · 151 sites · Protocol 20190341

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 721
Countries 17
Sites 151

Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C

To compare progression-free survival (PFS) in the participants who receive sotorasib with chemotherapy versus pembrolizumab with chemotherapy To compare overall survival (OS) in the participants who receive sotorasib with chemotherapy versus pembrolizumab with chemotherapy

Key facts

Sponsor
Amgen Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
13 Nov 2023 → ongoing
Decision date (initial)
2023-10-30
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Amgen Inc.

External identifiers

EU CT number
2022-501863-41-00
WHO UTN
U1111-1293-2431
ClinicalTrials.gov
NCT05920356

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To compare progression-free survival (PFS) in the participants who receive sotorasib with chemotherapy versus pembrolizumab with chemotherapy

To compare overall survival (OS) in the participants who receive sotorasib with chemotherapy versus pembrolizumab with chemotherapy

Secondary objectives 1

  1. To compare the objective response rate in the participants who receive sotorasib with chemotherapy versus pembrolizumab with chemotherapy

Conditions and MedDRA coding

Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C

VersionLevelCodeTermSystem organ class
21.1 PT 10061873 Non-small cell lung cancer 100000004864

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Randomized Controlled Study Treatment Phase
This randomized open label study will evaluate the efficacy and safety of sotorasib in combination with carboplatin and pemetrexed versus pembrolizumab in combination with carboplatin and pemetrexed in front-line settings in subjects with Stage IV or advanced Stage IIIB/C nonsquamous PD-L1 negative and KRAS p.G12C- mutations positive NSCLC.
 Randomised Controlled None Investigational Treatment Group: Subjects in the investigational sotorasib treatment group will receive sotorasib in combination with carboplatin and pemetrexed followed by maintenance therapy with sotorasib and pemetrexed.
Control Treatment Group: Subjects in the pembrolizumab control treatment group will receive pembrolizumab in combination with carboplatin and pemetrexed followed by maintenance treatment with pembrolizumab and pemetrexed.

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes
IPD plan description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Men or women greater than or equal to 18 years old
  2. Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
  3. No history of systemic anticancer therapy in metastatic/non-curable settings
  4. ECOG ≤ 1

Exclusion criteria 6

  1. Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
  2. Subjects with tumors known to harbor molecular alterations for which targeted therapy is locally approved
  3. Symptomatic (treated or untreated) brain metastases
  4. Gastrointestinal (GI) tract disease causing the inability to take oral medication
  5. Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
  6. Prior therapy with a KRAS G12C inhibitor

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. PFS is defined as the length of time from randomization (when the participants are designated to receive either sotorasib or pembrolizumab with chemotherapy) until the disease has progressed (gotten worse) or resulted in death, whichever occurs first. Progression will be based on an independent assessment of disease response per a set of predefined criteria (Response Evaluation Criteria in Solid Tumors [RECIST] v1.1) by reviewers with no knowledge of the participant’s treatment assignment.

Secondary endpoints 2

  1. Objective response is defined as the best overall response of complete response (CR, disappearance of all signs of NSCLC in the body) or partial response (PR, decrease in the amount of NSCLC in the body) to study treatment based on RECIST v1.1, per BICR. A confirmatory scan after 4 weeks of initial response is required for CR and PR.
  2. OS is defined as the duration of time from randomization until death due to any cause.

Investigational products

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

Test 1

Sotorasib

SUB197397 · Substance

Active substance
Sotorasib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
9999 mg milligram(s)
Max total dose
9999 mg milligram(s)
Max treatment duration
735 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Please refer to the sotorasib IMPD-Q enclosed with the application

Comparator 1

Pembrolizumab

SUB167136 · Substance

Active substance
Pembrolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
9999 mg/ml milligram(s)/millilitre
Max total dose
9999 mg/ml milligram(s)/millilitre
Max treatment duration
735 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 6

Calcium Folinate

SCP776846 · ATC

Active substance
Calcium Folinate
Substance synonyms
LEUCOVORIN CALCIUM
Route of administration
ORAL
Max daily dose
9999 µg microgram(s)
Max total dose
9999 µg microgram(s)
Max treatment duration
763 Day(s)
Authorisation status
Authorised
ATC code
B03BB01 — FOLIC ACID
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin

SUB06614MIG · Substance

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
9999 mg milligram(s)
Max total dose
9999 mg milligram(s)
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Betamethasone Sodium Phosphate Ph. Eur

SCP1977137 · ATC

Active substance
Betamethasone Sodium Phosphate Ph. Eur
Route of administration
ORAL
Max daily dose
9999 mg milligram(s)
Max total dose
9999 mg milligram(s)
Max treatment duration
735 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed

SUB09655MIG · Substance

Active substance
Pemetrexed
Pharmaceutical form
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
9999 mg/m2 milligram(s)/sq. meter
Max total dose
9999 mg/m2 milligram(s)/sq. meter
Max treatment duration
735 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

A04A · Product

Pharmaceutical form
-
Route of administration
ORAL
Max daily dose
9999 mg milligram(s)
Max total dose
9999 mg milligram(s)
Max treatment duration
84 Day(s)
Authorisation status
Authorised
ATC code
A04A — ANTIEMETICS AND ANTINAUSEANTS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Hydroxocobalamin

SCP2116527 · ATC

Active substance
Hydroxocobalamin
Substance synonyms
HYDROXYCOBALAMIN
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
9999 µg microgram(s)
Max total dose
9999 µg microgram(s)
Max treatment duration
742 Day(s)
Authorisation status
Authorised
ATC code
B03BA03 — HYDROXOCOBALAMIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

81 Total trials 22 Recruiting 51 Ended
Commercial
Sponsor organisation
Amgen Inc.
Address
1 Amgen Center Drive
City
Thousand Oaks
Postcode
91320-1799
Country
United States

Scientific contact point

Organisation
Amgen Inc.
Contact name
Medical Information

Public contact point

Organisation
Amgen Inc.
Contact name
Medical Information

Third parties 14

OrganisationCity, countryDuties
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Azenta US Inc.
ORG-100016263
 Indianapolis, United States Other
Altasciences Compagnie Inc.
ORG-100037610
 Laval, Canada Laboratory analysis
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Laboratory analysis
Labcorp Central Laboratory Services S.a.r.l.
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
Excelya Greece CRO Single Member S.A.
ORG-100009224
 Nea Filadelfia, Greece On site monitoring
Emmes Biopharma Global s.r.o.
ORG-100027596
 Prague 1, Czechia On site monitoring
Guardant Health Inc.
ORG-100042461
 Redwood City, United States Laboratory analysis
Signant Health Global LLC
ORG-100040604
 Blue Bell, United States Other
Suvoda LLC
ORG-100043523
 Conshohocken, United States Interactive response technologies (IRT)
WCG Clinical Inc.
ORG-100040730
 Princeton, United States Other
Tempus Labs Inc.
ORG-100044006
 Chicago, United States Laboratory analysis
Icon Public Limited Company
ORG-100042517
 Dublin 18, Ireland Other
Massive Bio Inc.
ORG-100044618
 New York, United States Other

Locations

17 EU/EEA countries · 151 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruiting 15 6
Belgium Ongoing, recruiting 15 5
Bulgaria Ongoing, recruiting 12 4
Czechia Ongoing, recruiting 6 5
Denmark Ongoing, recruiting 14 2
France Ongoing, recruiting 55 29
Germany Ongoing, recruiting 9 5
Greece Ongoing, recruiting 19 14
Hungary Ongoing, recruiting 23 8
Italy Ongoing, recruiting 25 16
Latvia Ended 5 2
Netherlands Ongoing, recruiting 37 7
Poland Ongoing, recruiting 36 11
Portugal Ongoing, recruiting 14 6
Romania Ongoing, recruiting 28 8
Spain Ongoing, recruiting 45 20
Sweden Ongoing, recruiting 9 3
Rest of world
Turkey, Colombia, China, Peru, Chile, Brazil, Mexico, Singapore, Argentina, Malaysia, Canada, Australia, South Africa, United Kingdom, United States, Japan, Korea, Republic of, Taiwan, Thailand, Switzerland, Hong Kong
 — 354 —

Investigational sites

Austria

6 sites · Ongoing, recruiting
Burgenlaendische Krankenanstalten GmbH
Department of Oncology, Hematology and Palliative Medicine, Josef Hyrtl-Platz 4, 7000, Eisenstadt
Medical University Of Graz
Department of Oncology, Auenbruggerplatz 15, 8036, Graz
Klinikum Wels-Grieskirchen GmbH
Department of Pulmonary Diseases, Grieskirchner Strasse 42, 4600, Wels
Universitaetsklinikum Krems
Department of Pneumology, Mitterweg 10, 3500, Krems An Der Donau
Klinikum Klagenfurt Am Woerthersee
Department of Pulmonary Diseases, Feschnigstrasse 11, Klagenfurt,09.Bez.:Annabichl, Klagenfurt Am Woerthersee
Stadt Wien Wiener Gesundheitsverbund
Ludwig Boltzmann Institute for Lung Health, Baumgartner Hoehe 1, Penzing, Vienna

Belgium

5 sites · Ongoing, recruiting
Az Maria Middelares Gent
Pneumology, Buitenring-Sint-Denijs 30, 9000, Gent
A.Z. Sint-Maarten
Pneumology, Liersesteenweg 435, 2800, Mechelen
Chirec
Pneumology, Boulevard Du Triomphe 201, 1160, Brussels
UZ Leuven
Pneumology, Herestraat 49, 3000, Leuven
Centre Hospitalier Regional De La Citadelle
Pneumology, Bld Du Douzieme-De-Ligne 1, 4000, Liege

Bulgaria

4 sites · Ongoing, recruiting
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department of Medical Oncology, Georgi Benkovski Street 100, 4500, Panagyurishte
Mbal Za Zhensko Zdrave Nadezhda OOD
Clinic of Medical Oncology, Blaga Vest Street 3, 1330, Sofia
Acibadem City Clinic Tokuda University Hospital EAD
Department of Medical Oncology, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
Umhat Sveta Marina - Pleven OOD
Department of Medical Oncology, Bulgarian Aviation Street 1, 5800, Pleven

Czechia

5 sites · Ongoing, recruiting
University Hospital Olomouc
Onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Plzen
Klinika pneumologie a ftizeologie, Edvarda Benese 1128/13, Jizni Predmesti, Plzen 3
Fakultni Nemocnice Brno
Klinika nemoci plicnich a tuberkulozy, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Hradec Kralove
klinika onkologie a radiologie, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Masarykuv Onkologicky Ustav
klinika komplexni onkologicke pece, Zluty Kopec 543/7, Stare Brno, Brno-Stred

Denmark

2 sites · Ongoing, recruiting
Lillebaelt Hospital
Oncology, Beriderbakken 4, 7100, Vejle
Region Midtjylland
Oncology, Hospitalsparken 15, 7400, Herning

France

29 sites · Ongoing, recruiting
Assistance Publique Hopitaux De Paris
Service Oncologie Thoracique, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire De Toulouse
Pneumology, 24 Chemin De Pouvourville, 31400, Toulouse
Centre De Cancerologie Du Grand Montpellier
Oncology, 25 Rue De Clementville, 34070, Montpellier
Les Hopitaux Universitaires De Strasbourg
Pneumology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Hopital Ambroise Pare
Pneumology, 9 Avenue Charles De Gaulle, 92100, Boulogne-Billancourt
Centre Hospitalier Departemental Vendee
Service Pneumologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Regional Universitaire De Tours
Pneumology, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Hospitalier Le Mans
Pneumology - OncoPneumology, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Intercommunal Creteil
Pneumology, 40 Avenue De Verdun, 94000, Creteil
L'Hopital Prive Du Confluent
Service Oncologie Médicale, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2
Centre Hospitalier Universitaire De Bordeaux
Respiratory Disease Department, Avenue De Magellan, 33600, Pessac
Institut Curie
Pneumology, 26 Rue D Ulm, 75005, Paris
Assistance Publique Hopitaux De Marseille
Service D’Oncologie Multidisciplinaire et Innovations Thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Besancon University Hospital Center
Pneumology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire De Poitiers
Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Rennes
Pneumology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Caen Normandie
Service Pneumologie & d'Oncologie Thoracique, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Saint Etienne
Service de Pneumologie, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Antoine Lacassagne
Medical Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
CHU De Rouen
Pneumology, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Lille
Pulmonology and Thoracic Oncology, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Universitaire De Nimes
Pneumology, Place Du Professeur Robert Debre, 30900, Nimes
Centre Hospitalier Universitaire Reims
Service Maladies Respiratoires, Rue Du General Koenig, 51092, Reims Cedex
Direction Centrale Du Service De Sante Des Armees
Pneumology, 2 Boulevard Sainte Anne, Bp 600, Toulon Cedex 9
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Intercommunal De Cornouaille
Medical Oncology, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Hopital Nord-Oest - Villefranche sur Saône
Pulmonology and Thoracic Oncology, Plateau d'Ouilly - Gleizé, 69655, Villefranche sur Saône
Hopital Tenon
Pneumology, 4 Rue De La Chine, 75970, Paris Cedex 20
GIE Groupe hospitalier Paris Saint-Joseph
Pulmonology and Thoracic Oncology, 185 Rue Raymond Losserand, 75674, Paris Cedex 14

Germany

5 sites · Ongoing, recruiting
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik V, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Klinikverbund Allgaeu gGmbH
Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin, Im Stillen 2, 87509, Immenstadt I. Allgäu
Universitaetsmedizin Goettingen
Klinik für Hämatologie und med. Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin IV, Flemmingstrasse 2, Altendorf, Chemnitz
Asklepios Klinik Gauting GmbH
Thorakale Onkologie, Robert-Koch-Allee 2, 82131, Gauting

Greece

14 sites · Ongoing, recruiting
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center S.A.
4th Oncology Clinic, Kifissias Leoforos 37-39, 151 23, Filothei
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Metropolitan Hospital
2nd Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Clinic, Oncology Department, Rimini Street 1, 124 62, Athens
Alexandra Hospital
Oncology Department, Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
251 Air Force General Hospital
Oncology Clinic, Kanellopoulou Avenue 3, 115 25, Athens
University General Hospital Of Alexandroupoli
Oncology Department, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
General University Hospital Of Patras
Division of Oncology, Rio, 265 04, Patras
St. Luke's Hospital S.A.
Oncology Department, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Metaxa Cancer Center Hospital Of Piraeus
A Internal Medicine-Oncology Department, Botassi 51, 185 37, Pireas
Henry Dunant Hospital Center
4th Department of Oncology, 107 Mesogeion Avenue, 115 26, Athens
Iaso Private General Obstetrics Gynecological & Pediatric Clinic Diagnostic Therapeutic & Research Center S.A.
2nd Medical Oncology Department, Kifissias Leoforos 37-39, 151 23, Filothei
Theageneio Cancer Hospital
1st Department of Clinical Oncology, Simeonidi Alex 2, 546 39, Thessaloniki
Athens Medical Center S.A.
4th Department of Medical Oncology, Pylea, Asklipiou 10, Thessaloniki

Hungary

8 sites · Ongoing, recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pulmonológiai Osztály, Vasvari Pal Utca 2-4, 9024, Gyor
Matrai Gyogyintezet
III. Pulmonológia, Matrahaza Hrsz 7151, 3200, Gyongyos
Koranyi National Institute For Pulmonology
I Pulmonologiai Osztaly, Koranyi Frigyes Ut 1, 1121, Budapest XII
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Megyei Onkológiai Centrum, Toszegi Ut 21, 5000, Szolnok
Budapesti Uzsoki Utcai Korhaz
Tüdőgyógyászati Osztály, Uzsoki Utca 29-41, 1145, Budapest XIV
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Pulmonológiai Osztály, Seregelyesi Ut 3, 8000, Szekesfehervar
Farkasgyepui Tudogyogyintezet
I Pulmonologia, 049 Hrsz 2, 8582, Farkasgyepu
Reformatus Pulmonologiai Centrum
Onko-pulmonologiai es jarobetegellato Centrum, Munkacsy Mihaly Utca 70, 2045, Torokbalint

Italy

16 sites · Ongoing, recruiting
Careggi University Hospital
Oncologia Medica I, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica I, Via Giacomo Venezian 1, 20133, Milan
Hospital Santa Maria Della Misericordia
SC Oncologia Medica, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Oncologia Medica, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department of Precision Medicine, Via Sergio Pansini 5, 80131, Naples
Azienda Sanitaria Universitaria Friuli Centrale
Dipartimento di Oncologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Ospedaliero Universitaria Parma
Medical Oncology, Viale Antonio Gramsci 14, 43126, Parma
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Oncologia Medica, Via Santa Sofia 78, 95123, Catania
Istituto Tumori Bari Giovanni Paolo II
Oncologia Medica, Viale Orazio Flacco 65, 70124, Bari
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Ricerca Clinica e Innovazione, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica A, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliera Dei Colli
UOC Oncologia, Via Leonardo Bianchi, 80131, Naples
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Unit of Thoracic Oncology, Via Piero Maroncelli 40, 47014, Meldola
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Oncologia, Via Lombroso S/N, 61122, Pesaro
Fondazione IRCCS San Gerardo Dei Tintori
UO Oncologia, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliero Universitaria Pisana
Stabilimento Cisanello Unita Operativa di Pneumologia, Via Paradisa 2, 56124, Pisa

Latvia

2 sites · Ended
Pauls Stradins Clinical University Hospital
Oncology Clinic, Pilsonu Iela 13, 1002, Riga
Rigas Austrumu kliniska universitates slimnica SIA
Latvian Oncology Centre, Hipokrata Iela 4, 1079, Riga

Netherlands

7 sites · Ongoing, recruiting
University Medical Center Groningen
Pulmonary Diseases, Hanzeplein 1, 9713 GZ, Groningen
Isala Klinieken Stichting
Oncology, Dokter Van Heesweg 2, 8025 AB, Zwolle
University Hospital Maastricht
Lung Diseases, P Debyelaan 25, 6229 HX, Maastricht
St. Elisabeth Hospital Tilburg
Pulmonology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Meander Medisch Centrum Stichting
Pulmonary Diseases, Maatweg 3, 3813 TZ, Amersfoort
Ziekenhuis St Jansdal
Pulmonary Medicine, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Radboud universitair medisch centrum Stichting
Pulmonary diseases, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen

Poland

11 sites · Ongoing, recruiting
Med – Polonia Sp. z o.o.
Oncology, Ul. Obornicka 262, 60-693, Poznan
Instytut Centrum Zdrowia Matki Polki
Oncology, Ul. Rzgowska 281/289, 93-338, Lodz
Uniwersytecki Szpital Kliniczny W Bialymstoku
II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych, Zurawia 14, 15-540, Bialystok
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Oncology, Os. Zlotej Jesieni 1, 31-826, Cracow
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Oncology, Ul. Alfreda Sokolowskiego 4, 58-309, Walbrzych
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Kliniczny Oddzial Pneumologii, Alergologii Pumonologicznej i Chorob Wewnetrznych, Ul. Dr. K. Jaczewskiego 8, 20-954, Lublin
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Oncology, Ul. Monte Cassino 18, 37-700, Peremyshl
Centrum Pulmonologii I Torakochirurgii W Bystrej
Oncology, Ul. Juliana Falata 2, Bystra, Wilkowice
Szpitale Pomorskie Sp. z o.o.
Oncology, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Oncology, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oncology, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice

Portugal

6 sites · Ongoing, recruiting
Unidade Local De Saude De Matosinhos E.P.E.
Serviço de Oncologia, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Hospital Cuf Tejo S.A.
Serviço de Oncologia, Avenida 24 De Julho 171a, 1350-345, Lisbon
Hospital CUF Porto S.A.
Servico de Oncologia, Estrada Da Circunvalacao N 14341, 4100-180, Porto
Champalimaud Clinical Centre
Unidade de Pulmão, Avenida Brasilia S/n, 1400-038, Lisbon
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Hospital de Dia de Pneumologia Oncológica, Avenida Professor Egas Moniz, 1649-035, Lisbon
Hospital Da Luz S.A.
Serviço de Oncologia, Avenida Lusiada 100, 1500-650, Lisbon

Romania

8 sites · Ongoing, recruiting
Centrul De Oncologie SF Nectarie S.R.L.
Medical Oncology, Strada Caracal Nr 109, 200542, Craiova
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Medical Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Municipal Ploiesti
Medical Oncology, Strada Ipatescu Ana Nr 59, 100337, Ploiesti
Spitalul Universitar De Urgenta Bucuresti
Medical Oncology, Splaiul Independentei 169, 050098, Bucharest
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Medical Oncology, Soseaua Fundeni 252, 022328, Bucharest
Oncomed S.R.L.
Medical Oncology, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara
Institutul Regional De Oncologie Iasi
Medical Oncology, Strada Sararie 177b, 700451, Jassi
Medisprof S.R.L.
Medical Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca

Spain

20 sites · Ongoing, recruiting
University Hospital Son Espases
Servicio de Oncología Médica, Carretera Valldemossa 79, 07120, Palma
Hospital Clinico Universitario De Valladolid
Servicio de Oncologia, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Clinico San Carlos
Servicio de Oncología médica, Calle Del Profesor Martin Lagos S/n, 28040, Madrid
Hospital Universitario Marques De Valdecilla
Servicio de Oncología, 5 Planta, Avenida Valdecilla S/n, Santander
Hospital Universitario Virgen De La Macarena
Servicio de Oncologia, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Central De Asturias
Servicio de Oncología, Avenida De Roma S/n, 33011, Oviedo
Hospital De La Santa Creu I Sant Pau
Servicio de Oncología, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Oncología médica, Avenida De Los Reyes Catolicos 2, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
Servicio de Oncología médica, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Del Mar
Servicio de Oncología médica, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Clinico Universitario De Valencia
Servicio de Hematología y Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
Complejo Hospitalario Universitario Insular Materno Infantil
Servicio de Oncología médica, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario Puerta De Hierro De Majadahonda
Servicio de Oncología médica, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario Regional De Malaga
Oncología médica, Avenida De Carlos De Haya S/n, 29010, Malaga
Institut Catala D'oncologia
Servicio de Oncología, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
Servicio de Oncología médica, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Servicio de Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Clinico Universitario Lozano Blesa
Servicio de Oncología médica, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Y Politecnico La Fe
Servicio de Oncologia, Avenida Fernando Abril Martorell 106, 46026, Valencia
Complexo Hospitalario Universitario A Coruna
Servicio de Oncologia Medica, Lugar Jubias De Arriba 84, 15006, A Coruna

Sweden

3 sites · Ongoing, recruiting
Norrlands University Hospital
Cancer Center, Klintvagen 10, Alidhem, Umea
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Klinisk provningsenhet, Bla Straket 5, 413 46, Goteborg
Region Gaevleborg
Lungmottagningen, Lasarettsvagen 1, 803 24, Gavle

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 2023-11-28 2024-02-23
Belgium 2024-02-28 2024-03-05
Bulgaria 2023-12-14 2024-01-25
Czechia 2024-03-18 2024-09-30
Denmark 2023-12-15 2024-10-03
France 2023-12-20 2024-02-02
Germany 2024-01-19 2024-04-16
Greece 2023-11-30 2023-12-05
Hungary 2023-11-13 2023-12-12
Italy 2023-12-11 2023-12-28
Latvia 2024-01-23 2024-10-02 2026-05-21
Netherlands 2023-11-14 2024-03-25
Poland 2023-11-17 2024-03-01
Portugal 2024-02-27 2024-06-21
Romania 2023-11-28 2024-02-20
Spain 2023-12-14 2024-04-03
Sweden 2023-12-27 2025-06-12

Results and documents

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

Documents 283 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol_EEA CSS_ENG_2022-501863-41_20190341_For Publication 6
Protocol (for publication) D1_Protocol_EEA CSS_GR_2022-501863-41_20190341_For Publication 1
Protocol (for publication) D1_Protocol_ENG_2022-501863-41_20190341_BG CSS_For Publication 2
Protocol (for publication) D1_Protocol_ENG_2022-501863-41_20190341_For Publication 4
Protocol (for publication) D1_Protocol_ENG_2022-501863-41_20190341_Summary of Changes_For Publication 5
Protocol (for publication) D1_Protocol_ENG_2022-501863-41_20190341_Summary of Changes_FP 4
Protocol (for publication) D1_Protocol_IT_2022-501863-41_20190341_For Publication N/A
Recruitment arrangements (for publication) K1_ Recruitment arrangements_For Publication 4.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_For Publication 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_For Publication 3.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_For Publication 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_For Publication 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_For publication 1.1
Recruitment arrangements (for publication) K1_Recruitment arrangements_For Publication 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_FP 2
Recruitment arrangements (for publication) K1_Recruitment arrangements_FP 1.1
Recruitment arrangements (for publication) K1_Recruitment arrangements_FP 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_FP 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_FP 24JUN2025
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Germany_20190341_fP 1
Recruitment arrangements (for publication) K1_Recruitment procedure_For Publication 3.0
Recruitment arrangements (for publication) K1_Recruitment Procedure_For Publication 2
Recruitment arrangements (for publication) K1_Recruitment_arrangements_CZ_For_Publication 1
Recruitment arrangements (for publication) K2_Other subject information material Activities Overview_EN_For Publication 3.0
Recruitment arrangements (for publication) K2_Other subject information material Activities Overview_PT_For Publication 3.0
Recruitment arrangements (for publication) K2_Patient Brochure_FOR PUBBLICATION 2
Recruitment arrangements (for publication) K2_PI to MD letter_FOR PUBBLICATION 2.0
Recruitment arrangements (for publication) K2_Recruitment Material _GP letter_Germany_20190341_fP V3.0
Recruitment arrangements (for publication) K2_Recruitment Material _Patient activities overview_Germany_20190341_fP V3.0
Recruitment arrangements (for publication) K2_Recruitment Material _Patient brochure_Germany_20190341_fP 2
Recruitment arrangements (for publication) K2_Recruitment Material _Thank you letter_Germany_20190341_fP 3
Recruitment arrangements (for publication) K2_Recruitment material Brochure EU_Subject Facing FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material Brochure_EN_For Publication 2
Recruitment arrangements (for publication) K2_Recruitment material Brochure_PT_For Publication 2
Recruitment arrangements (for publication) K2_Recruitment material PI to MD Letter_EN_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment material PI to MD letter_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment material PI to MD Letter_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment Material PI to MD Letter_Physician facing FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material Recruitment Brochure_FP 2
Recruitment arrangements (for publication) K2_Recruitment material SOE Activities Overview Subject facing FP 3.0
Recruitment arrangements (for publication) K2_Recruitment material_ PI to MD letter_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Activities overview Subject facing_FP 3.0
Recruitment arrangements (for publication) K2_Recruitment material_Brochure EU Subject Facing_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Dr to Dr letter_FP 2
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Patient Study Brochure_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient Study Brochure_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_PI to MD letter_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment material_PI to MD Letter_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment material_PI to MD letter_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment material_PI to MD Letter_FP 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_PI to MD letter_Germany_20190341_fP V2.0
Recruitment arrangements (for publication) K2_Recruitment material_PI to MD Letter_Physician facing_For Publication 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_PI to MD Letter_Physician facing_FP 13JUN2025
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Brochure_FP 2
Recruitment arrangements (for publication) K2_Recruitment Material_SOE Activities Overview_For Publication 3.0
Recruitment arrangements (for publication) K2_Recruitment material_SOE Activities Overview_Subject Facing_For Publication 3.0
Subject information and informed consent form (for publication) L1_ SIS and ICF for Continued Treatment After Disease Progression_For Publication 3.1
Subject information and informed consent form (for publication) L1_ SIS and ICF for Main Study Adult_For publication 3.0
Subject information and informed consent form (for publication) L1_ SIS and ICF for Main Study Adults_For publication 3.2
Subject information and informed consent form (for publication) L1_ SIS and ICF for Main Study_For publication 2.2
Subject information and informed consent form (for publication) L1_ SIS and ICF for Pre-screening_For publication 4.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Genetic Research ITA For Publication 7
Subject information and informed consent form (for publication) L1_ SIS and ICF Informed Consent Procedure FP 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Main _For publication 8.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Main LV_Russian_For Publication 05DEC2025
Subject information and informed consent form (for publication) L1_ SIS-ICF_Biopsy_20190341_Germany_fP V2
Subject information and informed consent form (for publication) L1_ SIS-ICF_Future Research_20190341_Germany_fP V2
Subject information and informed consent form (for publication) L1_ SIS-ICF_Genetic_20190341_Germany_fP V2
Subject information and informed consent form (for publication) L1_ SIS-ICF_Main_20190341_Germany_fP 8.0
Subject information and informed consent form (for publication) L1_ SIS-ICF_Prescreening_20190341_Germany_fP 4.0
Subject information and informed consent form (for publication) L1_ SIS-ICF_Proteomic_20190341_Germany_fP V2
Subject information and informed consent form (for publication) L1_ SIS-ICF_Treatment after progression_20190341_Germany_FP V1
Subject information and informed consent form (for publication) L1_Continued Treatment ICF_EN_For Publication 2.0
Subject information and informed consent form (for publication) L1_Continued Treatment ICF_FR_For Publication 2.0
Subject information and informed consent form (for publication) L1_Continued Treatment ICF_NL_For Publication 2.0
Subject information and informed consent form (for publication) L1_Informed consent procedure_Germany_20190341_fP 1
Subject information and informed consent form (for publication) L1_Main ICF_EN_For Publication 5.0
Subject information and informed consent form (for publication) L1_Main ICF_FR_For Publication 5.0
Subject information and informed consent form (for publication) L1_Main ICF_NL_For Publication 5.0
Subject information and informed consent form (for publication) L1_Pre-screening ICF_EN_For Publication 4.0
Subject information and informed consent form (for publication) L1_Pre-screening ICF_FR_For Publication 4.0
Subject information and informed consent form (for publication) L1_Pre-screening ICF_NL_For Publication 4.0
Subject information and informed consent form (for publication) L1_Pregnancy ICF_EN_FP 1.6
Subject information and informed consent form (for publication) L1_Pregnancy ICF_FR_FP 1.6
Subject information and informed consent form (for publication) L1_Pregnancy ICF_NL_FP 1.6
Subject information and informed consent form (for publication) L1_SIS and Consent for Continued Treatment_English_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and Consent for Continued Treatment_Translation Bulgarian_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and Consent for Optional Proteomic Research_English_For Publication 3.1
Subject information and informed consent form (for publication) L1_SIS and Consent for Optional Proteomic Research_Translation Bulgarian_For Publication 3.1
Subject information and informed consent form (for publication) L1_SIS and Consent for Optional Tumor Biopsy_English_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and Consent for Optional Tumor Biopsy_Translation Bulgarian_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Addendum_For Publication 1
Subject information and informed consent form (for publication) L1_SIS and ICF Alternate Visit Latvian - For Publication 2
Subject information and informed consent form (for publication) L1_SIS and ICF Alternate Visit Russian - For Publication 1
Subject information and informed consent form (for publication) L1_SIS and ICF Alternate Visits FP 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF Alternate Visits_For Publication 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Clincard_For Publication 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Continued Treatment After Disease Progression FP 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF Continued Treatment after disease progression_For Publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF Continued Treatment FP 3
Subject information and informed consent form (for publication) L1_SIS and ICF Continued Treatment Latvian - For Publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF Continued Treatment Russian - For Publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF Continued treatment_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Continued Treatment_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Continued Treatment_Redacted For Publication 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF CTDP_FP 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Disease Progression_For Publication 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF Exceptional measures_For Publication 1
Subject information and informed consent form (for publication) L1_SIS and ICF for continued treatment EN_FP 4.1
Subject information and informed consent form (for publication) L1_SIS and ICF for continued treatment RO_ FP 4.1
Subject information and informed consent form (for publication) L1_SIS and ICF for prescreening EN_FP 5.2
Subject information and informed consent form (for publication) L1_SIS and ICF for prescreening RO_FP 5.2
Subject information and informed consent form (for publication) L1_SIS and ICF Future Research FP 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF Future Research Latvian - For Publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF Future Research Russian - For Publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF Future Research_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Future Research_For Publication 7
Subject information and informed consent form (for publication) L1_SIS and ICF Future Research_FP 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Genetic Research FP 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF Genetic Research Latvian - For Publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF Genetic Research Russian - For Publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF Genetic Research_FP 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Genetic_For Publication 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF Genetic_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Genetics_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Greenphire Latvian - For Publication 2
Subject information and informed consent form (for publication) L1_SIS and ICF Greenphire Russian - For Publication 2
Subject information and informed consent form (for publication) L1_SIS and ICF Greenphire_For Publication 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF main EN_FP 7.1
Subject information and informed consent form (for publication) L1_SIS and ICF main EN_FP_Tracked changes 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Main FP 09DEC2025
Subject information and informed consent form (for publication) L1_SIS and ICF Main LV_Latvian_For Publication 05DEC2025
Subject information and informed consent form (for publication) L1_SIS and ICF main RO_ FP 7.1
Subject information and informed consent form (for publication) L1_SIS and ICF main RO_FP_Tracked changes 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Main Study FP 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_For Publication 8.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_For Publication 6.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_For Publication 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_For Publication 09DEC2025
Subject information and informed consent form (for publication) L1_SIS and ICF Main_For Publication 5.1
Subject information and informed consent form (for publication) L1_SIS and ICF Main_For Publication 7
Subject information and informed consent form (for publication) L1_SIS and ICF Main_FP 7.1
Subject information and informed consent form (for publication) L1_SIS and ICF Main_Redacted For Publication 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF Mother_Pregnancy Follow-Up_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Proteomic Research FP 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Proteomic Research_For Publication 7
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Proteomics Research_For Publication 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Tumor Biopsy FP 7.0
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Tumor Biopsy Latvian - For Publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Tumor Biopsy Russian - For Publication 3
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Tumor Biopsy_For Publication 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Tumor Biopsy_For Publication 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF Optional Tumor Biopsy_For Publication 7
Subject information and informed consent form (for publication) L1_SIS and ICF Pharmacogenetic_For Publication 1
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-Screening FP 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-Screening FP 09DEC2025
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-screening LV_Latvian_For Publication 05DEC2025
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-screening LV_Russian_For Publication 05DEC2025
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-screening_For Publication 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-screening_For Publication 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-screening_For Publication 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-screening_For Publication 09DEC2025
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-screening_For Publication 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-screening_For Publication 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-Screening_Redacted For Publication 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregancy woman_For Publication 1
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnancy FUP_father_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnancy FUP_mother_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnancy man_For Publication 1
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnant Participant_FP 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnant Partner_FP 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Prescreening_FP 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Proteomic Research_FP 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Proteomic_Redacted For Publication 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Proteomics Research LV_Latvian_For Publication 20MAY2025
Subject information and informed consent form (for publication) L1_SIS and ICF Proteomics Research LV_Russian_For Publication 20MAY2025
Subject information and informed consent form (for publication) L1_SIS and ICF Proteomics Research_For Publication 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Reimbursement FP 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Remote Source Document Data Review and Verification_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Sotorasib or Pembrolizumab after disease progression_For Publication 7
Subject information and informed consent form (for publication) L1_SIS and ICF Treatment after disease prog_For Publication 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Tumor Biopsy_FP 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Tumor Biopsy_Redacted For Publication 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Use Of Samples For Diagnostic Testing_FP 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Withdrawal Adults_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Withdrawal_For Publication 1
Subject information and informed consent form (for publication) L1_SIS and ICF Withdrawal_For Publication 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Child_Father-Second holder of parental authorisation_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Child_Mother_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Disease progression_new subjects_FP 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Future research_new subjects_FP 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Genetic research_new subjects_FP 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Greenphire_new subjects_fp 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_new subjects_FP 8.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Proteomic_new subjects_FP 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Tumor biopsy_new subjects_FP 5.0
Subject information and informed consent form (for publication) L1_SIS and Main ICF_English_For Publication 5.1
Subject information and informed consent form (for publication) L1_SIS and Main ICF_Translation Bulgarian_For Publication 5.1
Subject information and informed consent form (for publication) L1_SIS and Male Consent Form_English_For Publication 1
Subject information and informed consent form (for publication) L1_SIS and Male Consent Form_Translation Bulgarian_For Publication 1.1
Subject information and informed consent form (for publication) L1_SIS and Pre-screening ICF_English_For Publication 4.1
Subject information and informed consent form (for publication) L1_SIS and Pre-screening ICF_Translation Bulgarian_For Publication 4.1
Subject information and informed consent form (for publication) L1_SIS_and_ICF_Disease progression enrolled_FP 5.0
Subject information and informed consent form (for publication) L1_SIS_and_ICF_Future research enrolled_FP 5.0
Subject information and informed consent form (for publication) L1_SIS_and_ICF_Genetic research enrolled_FP 5.0
Subject information and informed consent form (for publication) L1_SIS_and_ICF_Greenphire enrolled_fp 5.0
Subject information and informed consent form (for publication) L1_SIS_and_ICF_Main enrolled_FP 8.0
Subject information and informed consent form (for publication) L1_SIS_and_ICF_prescreening_FP 4.0
Subject information and informed consent form (for publication) L1_SIS_and_ICF_Proteomic enrolled_FP 5.0
Subject information and informed consent form (for publication) L1_SIS_and_ICF_Tumor biopsy enrolled_FP 5.0
Subject information and informed consent form (for publication) L1_Site specific Male Consent Form_BG_AArabadjiev_For Publication 1
Subject information and informed consent form (for publication) L1_Site specific Male Consent Form_BG_RKrasteva Ruseva_For Publication 1.0
Subject information and informed consent form (for publication) L2_ Other subject information material Diary_For Publication 2.0
Subject information and informed consent form (for publication) L2_ Other subject information material Diary_With Track changes_FP 2.0
Subject information and informed consent form (for publication) L2_ Other subject information material Informed Consent Procedure - For Publication 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Informed consent procedure_For Publication 3.0
Subject information and informed consent form (for publication) L2_Informed Consent Procedure 1
Subject information and informed consent form (for publication) L2_Informed consent procedure_For Publication 2.0
Subject information and informed consent form (for publication) L2_Informed Consent Procedure_FP 1
Subject information and informed consent form (for publication) L2_Other subject information material ClinCard_Bank Transfer Standard Message Template_FP 10
Subject information and informed consent form (for publication) L2_Other subject information material ClinCard_Bank Transfer_FP 10
Subject information and informed consent form (for publication) L2_Other subject information material GP Letter_For Publication 3
Subject information and informed consent form (for publication) L2_Other subject information material Informed Consent P_FP 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material Informed Consent Procedure FP 1
Subject information and informed consent form (for publication) L2_Other subject information material Informed Consent Procedure_For Publication 1
Subject information and informed consent form (for publication) L2_Other subject information material Informed Consent Procedure_FP 2
Subject information and informed consent form (for publication) L2_Other subject information material Particip Notific Results_For Publication 3.0
Subject information and informed consent form (for publication) L2_Other subject information material Patient Card_For Publication 1
Subject information and informed consent form (for publication) L2_Other subject information material Patient Card_FP 1.0
Subject information and informed consent form (for publication) L2_Other subject information material Reimbursement V Agreement_FP 3
Subject information and informed consent form (for publication) L2_Other subject information material Reimbursement V General_FP 3
Subject information and informed consent form (for publication) L2_Other subject information material Screen report_CZ_fp 3.0
Subject information and informed consent form (for publication) L2_Other subject information material_Informed Consent Procedure_For Publication 1
Subject information and informed consent form (for publication) L2_Other subject information material_Informed Consent Procedure_For Publication 2
Subject information and informed consent form (for publication) L2_Other subject information material_Informed consent procedure_FP 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_Signant Quick Reference Guide_Web Back Up Addendum_FP 3
Subject information and informed consent form (for publication) L2_Other subject information material_SOE activities_FP 3
Subject information and informed consent form (for publication) L2_Other subject information Your Rights as a Participant_For Publication 1
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Subject information and informed consent form (for publication) L2_Other_subject_information_material_Clincard_Carrier_CZ_fp 10
Subject information and informed consent form (for publication) L2_Other_subject_information_material_Clincard_FAQ_CZ_fp 10
Subject information and informed consent form (for publication) L2_Other_subject_information_material_Clincard_Fee_sched_CZ_fp 10
Subject information and informed consent form (for publication) L2_Other_subject_information_material_Clincard_Message_templates_CZ_fp 10
Subject information and informed consent form (for publication) L2_Other_subject_information_material_Documents_regarding_PartII_Regulation_fp 1
Subject information and informed consent form (for publication) L2_Other_subject_information_material_GDPR_CZ_fp 3.3
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Subject information and informed consent form (for publication) L2_Other_subject_information_material_signant_quick_reference_guide_CZ_fp 2
Subject information and informed consent form (for publication) L2_Other_subject_information_material_Subj_dosing_diaries_CZ_fp 1
Subject information and informed consent form (for publication) L2_Other_subject_information_material_Subj_dosing_diary_addend_CZ_fp 1
Subject information and informed consent form (for publication) L2_Other_subject_information_material_Subject_dosing_diary_CZ_fp 1
Subject information and informed consent form (for publication) L2_Other_subject_information_material_Thank_you_and_notif_letter_CZ_fp 3
Subject information and informed consent form (for publication) L2_Recruitment Brochure_EN_FP 2.1
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Subject information and informed consent form (for publication) L2_Recruitment Brochure_NL_FP 2.1
Subject information and informed consent form (for publication) L3_EORTC-QLQ-C30_ePRO_Bulgarian_For Publication 1
Subject information and informed consent form (for publication) L3_EORTC-QLQ-LC13_ePRO_Bulgarian_For Publication 1
Subject information and informed consent form (for publication) L3_EuroQoL_EQ-5D-5L_ePRO_Bulgarian_For Publication 1
Subject information and informed consent form (for publication) L3_FACT-G_GP5_ePRO_Bulgarian_For Publication 1
Subject information and informed consent form (for publication) L3_NCI_PRO-CTCAE_ePRO_Bulgarian_For Publication 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_pembrolizumab 4
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_pembrolizumab_TC 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BE_DE_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BE_FR_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BE_NL_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BG_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_CZ_2022-501863-41_20190341_For Publication 3
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Synopsis of the protocol (for publication) D1_Protocol Synopsis_DE_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ENG_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ES_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_FR_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_GR_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_HU_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_IT_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_IT_2022-501863-41_20190341_FP 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_NL_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_PL_2022-501863-41_20190341_For Publication 3
Synopsis of the protocol (for publication) D1_Protocol synopsis_PT_2022-501863-41_20190341_For Publication 1
Synopsis of the protocol (for publication) D1_Protocol Synopsis_PT_2022-501863-41_20190341_PLPS_For Publication 3
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Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-07-03 Belgium Acceptable with conditions
2023-10-20
 2023-10-20
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-11-06 Acceptable with conditions
2023-10-20
 2023-11-06
3 SUBSEQUENT ADDITION OF MSC APP-3 2023-11-15 2024-01-19
4 SUBSTANTIAL MODIFICATION SM-4 2023-11-22 Acceptable with conditions 2024-01-18
5 SUBSTANTIAL MODIFICATION SM-3 2023-12-04 Belgium Acceptable with conditions 2024-02-21
6 SUBSTANTIAL MODIFICATION SM-5 2024-04-02 Belgium Acceptable
2024-07-01
 2024-07-01
7 NON SUBSTANTIAL MODIFICATION NSM-2 2024-07-17 Acceptable
2024-07-01
 2024-07-17
8 SUBSTANTIAL MODIFICATION SM-6 2024-09-26 Belgium Acceptable
2025-01-16
 2025-01-16
9 NON SUBSTANTIAL MODIFICATION NSM-3 2025-01-23 Acceptable
2025-01-16
 2025-01-23
10 SUBSTANTIAL MODIFICATION SM-7 2025-02-10 Acceptable 2025-03-12
11 SUBSTANTIAL MODIFICATION SM-10 2025-02-11 Acceptable 2025-03-14
12 SUBSTANTIAL MODIFICATION SM-11 2025-02-12 Acceptable 2025-05-12
13 SUBSTANTIAL MODIFICATION SM-9 2025-02-13 Acceptable 2025-04-24
14 SUBSTANTIAL MODIFICATION SM-8 2025-02-21 Acceptable 2025-04-06
15 SUBSTANTIAL MODIFICATION SM-12 2025-02-21 Acceptable 2025-05-19
16 SUBSTANTIAL MODIFICATION SM-13 2025-02-27 Acceptable 2025-04-02
17 SUBSTANTIAL MODIFICATION SM-14 2025-04-16 Acceptable 2025-05-29
18 NON SUBSTANTIAL MODIFICATION NSM-4 2025-05-29 Acceptable 2025-05-29
19 NON SUBSTANTIAL MODIFICATION NSM-5 2025-06-12 Acceptable 2025-06-12
20 SUBSTANTIAL MODIFICATION SM-15 2025-07-09 Belgium Acceptable
2025-10-06
 2025-10-06
21 SUBSTANTIAL MODIFICATION SM-16 2026-01-14 Belgium Acceptable
2026-04-14
 2026-04-14
22 NON SUBSTANTIAL MODIFICATION NSM-6 2026-04-24 Acceptable
2026-04-14
 2026-04-24
23 SUBSTANTIAL MODIFICATION SM-21 2026-04-27 Acceptable 2026-05-21
24 SUBSTANTIAL MODIFICATION SM-20 2026-04-28 Acceptable 2026-06-01
25 SUBSTANTIAL MODIFICATION SM-22 2026-04-30 Acceptable 2026-05-25

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