Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
558
Countries
16
Sites
82
Extensive stage small cell lung cancer (ES-SCLC)
To compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS)
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
- 21 Nov 2024 → ongoing
- Decision date (initial)
- 2024-06-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Amgen Inc.
External identifiers
- EU CT number
- 2023-505989-29-00
- WHO UTN
- U1111-1297-7464
- ClinicalTrials.gov
- NCT06211036
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy, Pharmacokinetic
To compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS)
Secondary objectives 7
- Compare the efficacy of tarlatamab plus durvalumab with durvalumab alone as assessed by progression free survival (PFS) based on investigator assessment per RECIST 1.1
- Compare the efficacy of tarlatamab plus durvalumab with durvalumab alone as assessed by objective response (OR), disease control (DC), and duration of response (DoR) based on investigator assessment per RECIST 1.1 against baseline at the time of randomization
- Compare the efficacy of tarlatamab plus durvalumab with durvalumab alone as assessed by PFS at 6 months, 1 year, and 2 years from randomization, OS at 6 months, 1 year, 2 years, and 3 years from randomization, and time to progression (TTP) based on investigator assessment per RECIST 1.1
- Compare the safety and tolerability of tarlatamab plus durvalumab with durvalumab alone
- Characterize the pharmacokinetics of tarlatamab when administered in combination with durvalumab
- Evaluate the immunogenicity of tarlatamab
- Compare the treatment effect of tarlatamab and durvalumab with durvalumab alone on disease symptoms, physical function, and quality of life
Conditions and MedDRA coding
Extensive stage small cell lung cancer (ES-SCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041068 | Small cell lung cancer extensive stage | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Period Subjects randomized with a 1:1 allocation ratio to be in the Investigational Arm (Tarlatamab+PD-LI inhibitor) or the Control Arm (PD-L1 inhibitor monotherapy)
|
Randomised Controlled | None | Investigational Arm: Treatment with Tarlatamab+PD-L1 inhibitor Control Arm: Treatment with PD-L1 inhibitor monotherapy |
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. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available on ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT06376045) and on the Amgen Clinical Trials portal (http://www.amgen.com/datasharing).
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- Completed 4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of ES-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per RECIST 1.1. · Patients with 3 cycles of concurrent durvalumab are eligible, provided 4 cycles of platinum-etoposide chemotherapy are completed.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Minimum life expectancy > 12 weeks.
- Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.
- Adequate organ function, defined as follows: Refer to protocol section 5.1 for more details.
Exclusion criteria 26
- Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
- Evidence of ILD or active, non infectious pneumonitis.
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
- Has received or is planning to receive consolidative chest radiation, for extensive stage disease. • Prophylactic cranial irradiation is permitted, but must be completed prior to enrollment.
- Prior history of severe or life-threatening events from any immune‑mediated therapy.
- Treatment in an alternative investigational trial prior to enrollment.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- History of other malignancy within the past 2 years
- Active or prior documented autoimmune or inflammatory disorders
- History of solid organ transplantation.
- Myocardial infarction and/or symptomatic congestive heart failure within 6 months prior to first dose of study treatment.
- Major surgical procedures prior to first dose of study treatment.
- History of arterial thrombosis within 6 months prior to first dose of study treatment.
- Prior therapy with any selective inhibitor of the DLL3 pathway.
- Receiving another anticancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
- Male subjects unwilling to abstain from donating sperm during treatment
- Female subjects who are breastfeeding or who plan to breastfeed while on study
- Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment see Appendix 5 (Section 11.5)
- Presence of active HIV or hepatitis infection
- Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
- Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence or use contraception during treatment. see Appendix 5 (Section 11.5)
- History of allergic reactions or acute hypersensitivity reactions to antibody therapies, platinum chemotherapy, or etoposide.
- Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment
- Live and live-attenuated vaccines within 4 weeks prior to the first dose of study treatment. Inactive vaccinesand live viral non-replicating vaccines within 30 days prior to first dose of study treatment.
- Female subjects planning to become pregnant or donate eggs while on study
- History or evidence of any other clinically significant disorder, condition or disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- OS
Secondary endpoints 8
- PFS
- Incidence of treatment emergent adverse events after randomization
- PFS rate at 6 months 1 year and 2 years from randomization OS rate at 6 months 1 year 2 years, and 3 years from randomization TTP
- Serum concentrations of tarlatamab
- Change from baseline up to week 13 and week 25 in disease symptoms of Cough Chest Pain and Dyspnea "
- Incidence of anti-tarlatamab antibody formation
- OR, DC, DoR.
- Time to first deterioration (TTD) for Physical function Global health status/Quality of life
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10282188 · Product
- Active substance
- Tarlatamab
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 000 mg milligram(s)
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AMGEN INC
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/23/2876
PRD10282194 · Product
- Active substance
- Tarlatamab
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AMGEN INC
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/23/2876
SUB176342 · Substance
- Active substance
- Durvalumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 Other
- Max total dose
- 9999 Other
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 12
SUB07337MIG · Substance
- Active substance
- Etoposide
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 Other
- Max total dose
- 9999 Other
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32552 · Substance
- Active substance
- Siltuximab
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 11 mg/Kg milligram(s)/kilogram
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02681MIG · Substance
- Active substance
- Infliximab
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 Other
- Max total dose
- 9999 Other
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1081917 · ATC
- Active substance
- Buclizine Hydrochloride
- Substance synonyms
- Buclizine dihydrochloride
- Route of administration
- ORAL USE
- Max daily dose
- 9999 Other
- Max total dose
- 9999 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Betamethasone Sodium Phosphate
SCP1158234 · ATC
- Active substance
- Betamethasone Sodium Phosphate
- Substance synonyms
- BETAMETHASONE DISODIUM PHOSPHATE
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1023586 · ATC
- Active substance
- Mannitol
- Substance synonyms
- Mannitol (E 421)
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1 l litre(s)
- Max total dose
- 00 l litre(s)
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 8 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 9999 Other
- Max total dose
- 9999 Other
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20313 · Substance
- Active substance
- Tocilizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 8 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 Other
- Max total dose
- 9999 Other
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 Other
- Max total dose
- 9999 Other
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP30321681 · ATC
- Active substance
- Argipressin
- Substance synonyms
- ARGININE VASOPRESSIN
- Route of administration
- ORAL USE
- Max daily dose
- 9999 Other
- Max total dose
- 9999 Other
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01BA01 — VASOPRESSIN (ARGIPRESSIN)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- 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 13
| Organisation | City, country | Duties |
|---|---|---|
| Ventana Medical Systems Inc. ORG-100043193
|
Oro Valley, United States | Laboratory analysis |
| Medical Equipment Supplies And Management Limited ORG-100044212
|
Chorley, United Kingdom | Other |
| Kayentis ORG-100037894
|
Meylan, France | E-data capture |
| Syngene International Limited ORG-100012176
|
Bengaluru, India | Laboratory analysis |
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Nea Filadelfia, Greece | On site monitoring |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| Clariness GmbH ORG-100045306
|
Hamburg, Germany | Code 2 |
| Rad Md LLC ORG-100044816
|
Conshohocken, United States | Other |
| Bioiatriki Private Medical Polyclinic S.A. ORG-100047061
|
Athens, Greece | Other, Laboratory analysis |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Reify Health Inc. ORG-100049669
|
Boston, United States | Other |
Locations
16 EU/EEA countries · 82 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 8 | 3 |
| Belgium | Ongoing, recruitment ended | 35 | 9 |
| Bulgaria | Ended | 8 | 4 |
| Czechia | Ongoing, recruitment ended | 23 | 5 |
| Denmark | Ongoing, recruitment ended | 6 | 2 |
| France | Ongoing, recruitment ended | 50 | 15 |
| Germany | Ongoing, recruitment ended | 35 | 8 |
| Greece | Ongoing, recruitment ended | 18 | 7 |
| Hungary | Ongoing, recruitment ended | 24 | 5 |
| Ireland | Ended | 2 | 1 |
| Italy | Ongoing, recruitment ended | 38 | 1 |
| Netherlands | Ongoing, recruitment ended | 8 | 3 |
| Poland | Ongoing, recruitment ended | 13 | 4 |
| Portugal | Ongoing, recruitment ended | 9 | 3 |
| Romania | Ongoing, recruitment ended | 5 | 2 |
| Spain | Ongoing, recruitment ended | 36 | 10 |
| Rest of world
Korea, Republic of, Brazil, United States, China, Switzerland, Israel, Argentina, Japan, Hong Kong, Turkey, Australia, Taiwan, Canada, Mexico
|
— | 240 | — |
Investigational sites
Universitaetsklinikum Krems
Klinische Abteilung für Pneumologie, Mitterweg 10, 3500, Krems An Der Donau
Medical University Of Graz
Klinische Abteilung für Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Interne Abteilung, Station Interne E, Onkologie, Carinagasse 47, 6800, Feldkirch
CHU Helora
Oncologie-Hématologie, Boulevard President Kennedy 2, 7000, Mons
Az Maria Middelares Gent
Longziekten, Buitenring-Sint-Denijs 30, 9000, Gent
UZ Brussel
Medische Oncologie, Laarbeeklaan 101, 1090, Jette
Institut Jules Bordet
Thoracic Oncology Clinic, Mijlenmeersstraat 90, 1070, Anderlecht
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Pneumologie, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Antwerp University Hospital
Pulmonology, Drie Eikenstraat 655, 2650, Edegem
Cliniques Universitaires Saint-Luc
Pulmonology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Ziekenhuis Oost Limburg
Respiratoire Oncologie, Synaps Park 1, 3600, Genk
Azorg
Pneumologie, Moorselbaan 164, 9300, Aalst
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-Uni Hospital Ltd.
Department of Medical Oncology, Georgi Benkovski Street 100, 4500, Panagyurishte
MBAL Serdika Ltd.
Second Department of Medical Oncology, Bulevard Prezident Linkiln 128, 1632, Sofia
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department of Medical Oncology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Nemocnice AGEL Ostrava-Vitkovice a.s.
Plicní oddělení, Zalužanského 1192/15, 703 00 Ostrava-Vítkovice, Zaluzanskeho 1192/15, Vitkovice, Ostrava
Fakultni Nemocnice Brno
Klinika nemoci plicních a tuberkulózy, Jihlavská 20, 625 00 Brno, Jihlavska 340/20, Bohunice, Brno
University Hospital Olomouc
Onkologická klinika, Zdravotníků 248/7, 779 00 Olomouc, Zdravotniku 248/7, 779 00, Olomouc
Vseobecna Fakultni Nemocnice V Praze
Onkologická klinika 1. LF UK a VFN Praha, Karlovo nám. 32 (Fakultní poliklinika), 128 08, Praha 2, Karlovo Namesti 554/32, Nove Mesto, Prague 2
Fakultni Nemocnice V Motole
Pneumologická klinika 2.LF UK a FN Motol, V Úvalu 84, 150 06 Praha 5, V Uvalu 84/1, Motol, Prague
Odense University Hospital
Department of Oncology, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Assistance Publique Hopitaux De Paris
Service d Oncologie Thoracique, 46 rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Universitaire De Toulouse
Service Pneumologie, 24 chemin de Pouvourville, TSA 30030, Toulouse
Assistance Publique Hopitaux De Paris
Service Oncologie Thoracique, 27 rue du Faubourg Saint Jacques, Batiment Cornil, Paris
Institut Bergonie
Oncologie medicale, 229 cours de l Argonne, 33000, Bordeaux
Les Hopitaux Universitaires De Strasbourg
Service Pneumologie, 1 place de l’Hopital, 67091, Strasbourg Cedex
Centre Hospitalier Le Mans
Service de Pneumologie et Oncologie Thoracique, 194 Avenue Rubillard, Pneumologie et Oncologie Thoracique, Le Mans Cedex 9
Centre Hospitalier Et Universitaire De Limoges
Unite d’Oncologie Thoracique (Service pneumologie), 2 avenue Martin Luther King, Unite d Oncologie Thoracique, Limoges Cedex
Centre Hospitalier Intercommunal Creteil
Service Oncologie médicale, 40 avenue de Verdun, 94010, Créteil Cedex
Centre Hospitalier Universitaire De Nantes
Service Oncologie Thoracique, Boulevard du Pr Jacques Monod, Institut de Cancérologie de l’Ouest, Saint Herblain
Assistance Publique Hopitaux De Marseille
Departement Oncologie, 265 Chemin Des Bourrely, Departement Oncologie, Marseille
Institut Regional Du Cancer De Montpellier
Service Oncologie medicale, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut Curie
Service Pneumologie (Oncologie Médicale), Institut Curie – Site Paris, Departement Oncologie Médicale, Paris
Centre Hospitalier Regional Et Universitaire De Brest
Oncologie, CHU BREST-Cavale Blanche, ICI-Institut de Cancerologie et d'Imagerie, Brest
Centre Leon Berard
Cancerologie medicale, 28 Rue Laennec, 69008, Lyon
Assoc Hospitaliere Nord Artois Clinique
Service Oncologie, 118 Avenue Desandrouin, Clinique Teissier, Valenciennes
Universitaet Muenster
Medizinische Klinik und Poliklinik A, Albert-Schweitzer-Campus 1, Sentrup, Muenster
LungenClinic Grosshansdorf GmbH
Lungenclinic, Woehrendamm 80, 22927, Grosshansdorf
Technische Universitat Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Thoraxklinik Heidelberg gGmbH
Studienzentrum Thoraxonkologie, Roentgenstrasse 1, Rohrbach, Heidelberg
Asklepios Klinik Gauting GmbH
Thorakale Onkologie, Robert-Koch-Allee 2, 82131, Gauting
Universitaetsklinikum Essen AöR
Innnere Klinik - Tumorforschung, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Wuerzburg AöR
Comprehensive Cancer Center – Mainfranken, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Kliniken der Stadt Koeln gGmbH
Lungenklinik / Lungenkrebszentrum Köln- Merheim, Ostmerheimer Strasse 200, Merheim, Cologne
Metropolitan Hospital
4th Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Metropolitan Hospital
2nd Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Oncologic Clinical Trials and Research Clinic, Leoforos Mesogeion 264, 155 62, Cholargos
St. Luke's Hospital S.A.
Oncology Department, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Henry Dunant Hospital Center
4th Oncology Department and Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
Athens Medical Center S.A.
4th Department of Medical Oncology, Pylea, Asklipiou 10, Thessaloniki
Reformatus Pulmonologiai Centrum
Onko-pulmonológiai és járobetegellátó Centrum, Munkacsy Mihaly Utca 70, 2045, Torokbalint
Matrai Gyogyintezet
III. Pulmonologia, Matrahaza Hrsz 7151, 3200, Gyongyos
Semmelweis University
Pulmonológiai Klinika, Tomo Utca 25-29, 1083, Budapest VIII
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pulmonológiai Osztály, Vasvari Pal Utca 2-4, 9024, Gyor
Koranyi National Institute For Pulmonology
Pulmonologiai osztaly, Koranyi Frigyes Ut 1, 1121, Budapest XII
Istituto Tumori Bari Giovanni Paolo II
Unità Operativa Oncologia Medica, Viale Orazio Flacco 65, 70124, Bari
University Hospital Maastricht
Lung Diseases, P Debyelaan 25, 6229 HX, Maastricht
Universitair Medisch Centrum Groningen
Pulmonary Diseases, Hanzeplein 1, 9713 GZ, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Pulmonary Diseases, Dr. Molewaterplein 40, 3015 GD, Rotterdam
National Institute Of Tuberculosis And Lung Diseases
oncology, Ul. Plocka 26, 01-138, Warsaw
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
oncology, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Uniwersyteckie Centrum Kliniczne
oncology, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
oncology, Ul. Grabiszynska 105, 53-439, Wroclaw
Hospital Da Luz S.A.
Serviço de Oncologia, Avenida Lusiada 100, 1500-650, Lisbon
Hospital CUF Porto S.A.
Serviço de Oncologia, Estrada Da Circunvalacao N 14341, 4100-180, Porto
Hospital Cuf Descobertas S.A.
Serviço de Oncologia, Rua Mario Botas 1, 1998-018, Lisbon
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Municipal Ploiesti
Oncology, Strada Ipatescu Ana Nr 59, 100337, Ploiesti
Clinica Universidad De Navarra
Oncología, Avenue Pio XII 36, 31008, Pamplona
Hospital Clinic De Barcelona
Oncologia, Calle Villarroel 170, 08036, Barcelona
Hospital De La Santa Creu I Sant Pau
Oncologia, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Clinica Universidad De Navarra
Oncología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Ramon Y Cajal
Servicio de Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Virgen De La Macarena
Servicio de Oncología, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitari Vall D Hebron
Servicio de Oncologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Regional De Malaga
Servicio de Oncología Médica, Avenida De Carlos De Haya Sn, 29010, Malaga
Institut Catala D'oncologia
Servicio de Oncología Médica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Y Politecnico La Fe
Oncologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-02-11 | 2025-07-18 | 2025-02-28 | 2025-03-28 | |
| Belgium | 2024-11-28 | 2025-01-09 | 2025-03-28 | ||
| Czechia | 2025-01-06 | 2025-02-06 | 2025-03-28 | ||
| Denmark | 2024-11-26 | 2024-12-12 | 2025-03-28 | ||
| France | 2024-11-29 | 2025-01-15 | 2025-03-28 | ||
| Germany | 2024-12-05 | 2025-02-11 | 2025-06-27 | ||
| Greece | 2024-12-05 | 2024-12-11 | 2025-03-28 | ||
| Hungary | 2024-12-05 | 2024-12-16 | 2025-03-28 | ||
| Ireland | 2025-01-20 | 2025-06-20 | 2025-02-26 | 2025-03-28 | |
| Italy | 2025-02-07 | 2025-03-27 | 2025-03-28 | ||
| Netherlands | 2024-12-06 | 2025-01-03 | 2025-03-28 | ||
| Poland | 2024-12-04 | 2024-12-10 | 2025-03-28 | ||
| Portugal | 2024-11-25 | 2024-12-05 | 2025-03-28 | ||
| Romania | 2024-12-04 | 2024-12-06 | 2025-03-28 | ||
| Spain | 2024-11-21 | 2024-11-28 | 2025-04-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 215 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_ENG_2023-505989-29_20200041_For Publication | 3 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements For Publication | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements_For Publication | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Tracked Changes_For Publication | 1.1 |
| 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 |
| 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_FP | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_FP | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Germany_20200041_FP | 2.0 |
| Recruitment arrangements (for publication) | K2 Recruitment material Dr to Dr Letter for publication | 2.0 |
| Recruitment arrangements (for publication) | K2 Recruitment material Patient Brochure For Publication | 1.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material GP letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Dr to Dr Letter_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_GP Letter__For Publication | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_GP Letter_Tracked Changes_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Dr to Dr Letter | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Dr to Dr Letter FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Dr to Dr Letter_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Dr-to-Dr Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Study Brochure | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Patient Study Brochure FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Visit reminder_FP | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Recruitment Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Brochure_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dear Dr Letter physician facing_EN_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dear Dr Letter physician facing_RO_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor to Doctor letter_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Dr to Dr letter V2_20200041_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Dr Letter_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Dr Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Dr Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Dr Letter_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Dr Letter_Tracked Changes_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Dr refferal letter_For publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Brochure Layout_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Study Brochure V1_20200041_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Brochure_EN_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Brochure_For publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Brochure_For Publication | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Brochure_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Brochure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Brochure_RO_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main ITA_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pre-screening_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF pregnancy Father ITA 1 of 29Apr24 FP | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnancy Mother ITA 1 of 29Apr24 FP | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Substudy1_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Substudy2_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pharmacogenetic_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Prescreening_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Withdrawal_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Genetic Research Substudy_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main Study Tracked Changes_For Publication | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main Study_For Publication | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pre Screening Study Tracked Changes_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pre Screening Study_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Study_EN_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Study_FR_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Study_NL_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pre-Screening_EN_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pre-Screening_FR_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pre-Screening_NL_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnancy_EN_FP | 1.6 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnancy_FR_FP | 1.6 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnancy_NL_FP | 1.6 |
| Subject information and informed consent form (for publication) | L1_Informed consent procedure_Germany_20200041_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Female participant pregnancy_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Female partner pregnancy info_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_English_For Publication | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Translation Bulgarian_For Publication | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Translation Bulgarian_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Clincard Adult_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Confidantial FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Confidential Adult_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Confidential_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research Adult_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire Adults | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Informed Consent Procedure FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF legal representative Main _For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF legal representative Pharmacogenetic_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF legal representative Prescreening_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF legal representative Withdrawal_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_For Publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Study FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Study_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pharmacogenetic_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening Adult_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pre-screening_English_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pre-screening_Translation Bulgarian_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pre-screening_Translation Bulgarian_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy FUP_father | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy FUP_mother | 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 Pregnancy Woman_For Publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PreScreening | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement through Greenphire FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Tumor Biopsy_FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Withdraw | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Withdrawal Adult_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidential_FP | 3.0 |
| 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_Greenphire_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EN_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_For Publication | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RO_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening_EN_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-Screening_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening_RO_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Father Form_FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Mother Form_FP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PreScreening_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Confidential_20200041_Germany_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_FR_20200041_Germany_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main with BfS_20200041_Germany_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main without BfS_20200041_Germany_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pre-Screening_20200041_Germany_FP | 2.1 |
| Subject information and informed consent form (for publication) | L2 Other subject information material GP letter_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L2 Other subject information material Patient visit reminder | 1 |
| Subject information and informed consent form (for publication) | L2 Other subject information material Thank you and Notification of Results | 1.0 |
| Subject information and informed consent form (for publication) | L2 Other subject information material_Informed consent procedure For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Informed Consent Procedure_For Publication | 3 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_BPI-SF_Accessible_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_BPI-SF_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_eCOA PROCTCAE_Accessible_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_eCOA PROCTCAE_For Publication | 3.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_EQ-5D-5L_Accessible_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_EQ-5D-5L_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_EQ-5D-5L-interview_Accessible_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_EQ-5D-5L-interview_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_FACTGP5_Accessible_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_FACTGP5_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_FTrain_Accessible_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_FTrain_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient Study Brochure_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Thank You Letter_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Web Platform Patient User Guide_For Publication | 1.0 |
| 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_For Publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_Informed Consent Procedure_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_List of patent materials_For publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other patient subj inf Reimbursement V Agrreem_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other patient subj inf Reimbursement V General_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_BPI_screenshots_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Bank Transfer Standard Message Template_FP | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Bank Transfer FAQ_FP | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EQ-5DL_screenshots_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EQ-5DL- interview_screenshots_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_FACT-GP5_screenshots_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GDPR_FP | 6.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed Consent Procedure_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed consent procedure_For publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed consent procedure_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed Consent Procedure_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Kayentis User Web Platform User Guide_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient study brochure_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient training_Screenshots of Questionnaires_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient visit reminder card_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient wallet card_FP | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PRO-CTCAE_screenshots_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject facing materials_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you letter_FP | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Your rights as a trial participant_For Publication | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Card_For publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Wallet Card_For publication | 1 |
| Subject information and informed consent form (for publication) | L2_Recruitment material_Dr to Dr Letter Layout_EN_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_Recruitment material_Dr to Dr Letter Layout_FR_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_Recruitment material_Dr to Dr Letter Layout_NL_FP | 2.0 |
| Subject information and informed consent form (for publication) | L2_Recruitment material_Patient Study Brochure Layout_EN_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Recruitment material_Patient Study Brochure Layout_FR_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Recruitment material_Patient Study Brochure Layout_NL_FP | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis PT_2023-505989-29_20200041_For Publication | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_IT_2023-505989-29_20200041_For Publication | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis scientific DE_2023-505989-29_20200041_For Publication | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_DE_2023-505989-29_20200041_For Publication | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BG_2023-505989-29_20200041_For Publication | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_BE_DE_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_BE_FR_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_BE_NL_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_CZ_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_ENG_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_ES_2023-505989-29_20200041_FP | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_FR_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_GR_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_HU_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_IT_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_NL_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_PL_2023-505989-29_20200041_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PLPS_RO_2023-505989-29_20200041_FP | 3 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-12 | Portugal | Acceptable with conditions 2024-06-03
|
2024-06-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-26 | Portugal | Acceptable with conditions 2024-11-04
|
2024-11-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-28 | Portugal | Acceptable with conditions 2025-03-24
|
2025-03-24 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-01 | Portugal | Acceptable with conditions 2025-03-24
|
2025-04-01 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-04-01 | Acceptable with conditions 2025-03-24
|
2025-04-01 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-11 | Portugal | Acceptable 2025-06-16
|
2025-06-17 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-18 | Acceptable 2025-06-16
|
2025-07-18 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-21 | Acceptable | 2025-08-08 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-21 | Acceptable | 2025-08-26 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-09-03 | Portugal | 2025-09-03 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-11-05 | Portugal | Acceptable 2026-01-19
|
2026-01-20 |