Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,150
Countries
12
Sites
112
Non-Small Cell Lung Cancer
1. To evaluate the safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Jun 2024 → 16 Dec 2025
- Decision date (initial)
- 2024-05-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- F. Hoffmann-La Roche AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
1. To evaluate the safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab
Conditions and MedDRA coding
Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10029519 | Non-small cell lung cancer stage III | 100000004864 |
| 21.1 | PT | 10029518 | Non-small cell lung cancer stage II | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 1. Eastern Cooperative Oncology Group performance status of 0 or 1
- 2. Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB (T3N2) NSCLC of either non-squamous or squamous histology
- 3. Participants must have had complete resection of NSCLC (no residual tumor and all surgical margins negative for invasive carcinoma)
- 4. At a minimum, mediastinal lymph node systematic sampling will have occurred, though complete mediastinal lymph node dissection (MLND) is preferred
- 5. Participants must have received between one to four cycles (four preferred) of adjuvant histology-based platinum doublet chemotherapy: cisplatin (preferred) or carboplatin, with pemetrexed (non-squamous), gemcitabine, docetaxel, vinorelbine, etoposide, or paclitaxel
- 6. Participants must have recovered adequately from surgery and from adjuvant chemotherapy (no Grade > 2 unresolved toxicity)
Exclusion criteria 5
- 1. Any history of prior NSCLC within the last 5 years
- 2. Previous NSCLC must have been treated with surgery only
- 3. Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy
- 4. NSCLC with a mutation in the EGFR gene or an ALK fusion oncogene
- 5. Prior treatment with systemic therapy (e.g., chemotherapy or immunotherapy) for the treatment of NSCLC, with the exception of adjuvant platinum-based chemotherapy as outlined in the inclusion criteria
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
—
PRD7537925 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/17/1220/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and labelling for clinical trial use
—
PRD7846761 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
—
N/A · Product
- Other product name
- N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Swm Partners Limited ORG-100047818
|
Berkhamsted, United Kingdom | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
12 EU/EEA countries · 112 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 20 | 2 |
| Belgium | Ended | 50 | 6 |
| France | Ended | 50 | 15 |
| Germany | Ended | 80 | 13 |
| Greece | Ended | 60 | 6 |
| Hungary | Ended | 25 | 7 |
| Ireland | Ended | 45 | 5 |
| Italy | Ended | 75 | 16 |
| Poland | Ended | 51 | 9 |
| Romania | Ended | 40 | 10 |
| Slovakia | Ended | 35 | 9 |
| Spain | Ended | 45 | 14 |
| Rest of world
Peru, Japan, Korea, Republic of, New Zealand, Argentina, Australia, Hong Kong, China, United States, Mexico, Canada, United Kingdom, Taiwan, Turkey, Switzerland, Brazil, Thailand
|
— | 574 | — |
Investigational sites
Ordensklinikum Linz GmbH
Department for Pneumology, Fadingerstrasse 1, 4020, Linz
Krankenhaus Nord Klinik Floridsdorf
Department for Respiratory and Critical Care Medicine, Bruenner Strasse 68, Floridsdorf, Vienna
Chirec
Pneumology and thoracic oncology, Boulevard Du Triomphe 201, 1160, Brussels
Algemeen Ziekenhuis Groeninge
Pulmonology, President Kennedylaan 4, 8500, Kortrijk
Het Ziekenhuisnetwerk Antwerpen
Pneumology, Lange Bremstraat 70, 2170, Antwerp
CHU Helora
Oncology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Jessa Ziekenhuis
Oncology, Stadsomvaart 11, 3500, Hasselt
Universitair Ziekenhuis Gent
Oncology, Corneel Heymanslaan 10, 9000, Gent
Clinique Clementville
Oncology Unit, 25 Rue De Clementville, 34070, Montpellier
Centre Hospitalier Regional Et Universitaire De Brest
Department of oncology, 5 Avenue Marechal Foch, Bp 824, Brest Cedex 2
Centre Hospitalier Universitaire De Rennes
Pneumology Unit, 2 Rue Henri Le Guilloux, 35000, Rennes
Unite De Recherche Clinique HIA Begin
Department of medical oncology, 69 Avenue De Paris, 94160, Saint-Mande
Centre Hospitalier Universitaire De Toulouse
Department of Pneumology, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Hospitalier Universitaire Amiens Picardie
Pneumology Unit, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Hospital Foch
Onco Pneumologie, 40 Rue Worth, 92150, Suresnes
Assoc Hospitaliere Nord Artois Clinique
Department of Pneumology, 118 Avenue Desandrouin, 59300, Valenciennes
Centre Hospitalier D Avignon
Thoracic Oncology, 305 Rue Raoul Follereau, 84000, Avignon
Centre Hospitalier Universitaire De Nantes
Medical Oncology Department, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire Reims
Pneumologie Oncologie-thoracique, 45 Rue Cognacq Jay, 51092, Reims Cedex
Centre Hospitalier Universitaire Grenoble Alpes
Pneumology Oncoloy Unit, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Polyclinique Bordeaux Nord Aquitaine
Oncology Radiotherapy Unit, 15 Rue Claude Boucher, Cs 31396, Bordeaux Cedex
Centre Antoine Lacassagne
Pneumology Unit, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Les Hopitaux Universitaires De Strasbourg
Department of Pneumology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Internistische Onkologie/Hämatologie mit Integrierter Palliativmedizin, Henricistrasse 92, Huttrop, Essen
Asklepios Kliniken Hamburg GmbH
Lungenabteilung, Studienabteilung/Thoraxonkologie, Eissendorfer Pferdeweg 52, Heimfeld, Hamburg
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie, II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Hämato-Onkologie Hamburg, Prof. Laack und Partner
N/A, Lehmweg 7, Standort Hoheluft, Hamburg
Kliniken der Stadt Koeln gGmbH
Lungenklinik, Ostmerheimer Strasse 200, Merheim, Cologne
Muenchen Klinik gGmbH
Klinik für Pneumologie und Pneumologische Onkologie, Englschalkinger Strasse 77, Bogenhausen, Munich
Universitaetsklinikum Schleswig-Holstein
Medizinische Klinik III, Studienzentrum Pneumologie - Onkologie, Ratzeburger Allee 160, 23538, Lübeck
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Klinik für Innere Medizin II, Roentgenstrasse 1, Doelau, Halle (saale)
SLK-Kliniken Heilbronn GmbH
Standort Fachklinik Löwenstein Med.Klinik II Onkologie, Geisshoelzle 62, Hirrweiler, Loewenstein
Universitaet Muenster
Medizinische Klinik A, Internistische Onkologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Justus-Liebig-Universitaet Giessen
Medizinische Klinik IV Organonkologie, Gaffkystrasse 5, 35392, Giessen
Lungenfachklinik Immenhausen
Pneumologische Onkologie, Robert-Koch-Str. 3, 34376, Immenhausen
Studienzentrum Onkologie Ravensburg GmbH
N/A, Elisabethenstrasse 19, 88212, Ravensburg
St. Luke's Hospital S.A.
Department of Medical Oncology, Harilaou Trikoupi Str. 3, 552 36, Thessaloniki
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Thoracic General Hospital Of Athens I Sotiria
3rd Department of Internal Medicine/ Oncology Unit, Messogion Avenue 152, 115 27, Athens
Henry Dunant Hospital Center
4th Clinic of Oncology, 107 Mesogeion Avenue, 115 26, Athens
Theageneio Cancer Hospital
Pulmonology – Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki
Metropolitan Hospital
4th Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas
Toeroekbalinti Tuedogyogyintezet
Onkologiai Ambulancia, Munkacsy Mihaly Utca 70, 2045, Torokbalint
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tudogyogyaszati osztaly, Dozsa Gyorgy Ut 77, 2800, Tatabanya
Koranyi National Institute For Pulmonology
XIV. Pulmonologiai Osztaly, Koranyi Frigyes Ut 1, 1121, Budapest XII
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiologiai Kozpont, Nyiri Ut 38, 6000, Kecskemet
Matrai Gyogyintezet
Onkologiai szakrendeles, Matrahaza Hrsz 7151, 3200, Gyongyos
Clinic Of Pulmonology Semmelweis University
Clinic of Pulmonology, Tomo Utca 25-29, 1083, Budapest Viii
University Of Pecs
Department of Oncotherapy, Edesanyak Utja 17, 7624, Pecs
Beaumont Hospital
Cancer Clinical Trials & Research Unit, Beaumont Road, Beaumont, Dublin 9
St James's Hospital
Cancer Clinical Trials Office, James's Street, D08 NHY1, Dublin 8
Tallaght University Hospital
Oncology/Haematology Clinical Trials, Tallaght, D24 NR0A, Dublin 24
St Vincent's University Hospital
Medical Oncology Research Department, Elm Park Merrion Road, D04 T6F4, Dublin 4
Mater Misericordiae University Hospital
Clinical Trials Research Unit, Eccles Street, D07 R2WY, Dublin 7
Azienda Unita Sanitaria Locale Della Romagna
Oncology unit, Viale Stradone 9, 48018, Faenza
Centro Di Riferimento Oncologico Di Aviano
SOC Oncologia medica e dei tumori immunocorrelati, Via Franco Gallini 2, 33081, Aviano
Fondazione IRCCS Istituto Nazionale Dei Tumori
medical oncology 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Sanitaria Locale Di Pescara
Oncologia, Via Renato Paolini 47, 65124, Pescara
Azienda Ospedaliera Papardo
Onco-hematology department, Viale Ferdinando Stagno D'alcontres Contrada Papardo, 98158, Messina
Azienda Unita Sanitaria Locale Della Romagna
Oncology unit, Via Alcide De Gasperi 8, 48121, Ravenna
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
U.O. Oncologia Toracica, Lung Unit, Via Monte Baldo 24, 37019, Peschiera Del Garda
Azienda Ospedaliera Dei Colli
U.O.C. Pneumologia Oncologica, Via Leonardo Bianchi, 80131, Naples
San Camillo Forlanini Hospital
UOSD Pneumo Oncology, Circonvallazione Gianicolense 87, 00152, Rome
Azienda Sanitaria Locale Al Di Alessandria
Medical structural department, Via Venezia N 6, 15121, Alexandria
Azienda Unita Sanitaria Locale Della Romagna
Oncology unit, Viale Dante 10, 48022, Lugo
Cliniche Gavazzeni S.p.A.
medical oncology, Via Mauro Gavazzeni 21, 24125, Bergamo
European Institute Of Oncology S.r.l.
Thoracic Oncology Division, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
Oncology, Viale Luigi Borri 57, 21100, Varese
Istituto Tumori Bari Giovanni Paolo II
SSD Medical oncology for thoracic pathology, Viale Orazio Flacco 65, 70124, Bari
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Department of oncology, Viale Vittorio Alfieri 36, 57124, Leghorn
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddział Onkologii z Pododdziałem Chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
National Institute Of Tuberculosis And Lung Diseases
3 Klinika Chorób Płuc i Onkologii, Ul. Plocka 26, 01-138, Warsaw
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Oddział Onkologii Klinicznej, Ul. Grabiszynska 105, 53-439, Wroclaw
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Oddział Onkologiczny z Pododdziałem Diagnostyki Nowotworów Klatki Piersiowej, Ul. Pradnicka 80, 31-202, Cracow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Chorób Rozrostowych, Ul. Pabianicka 62, 93-513, Lodz
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Centrum Innowacyjnych Terapii, Ul. Dr. K. Jaczewskiego 8, 20-954, Lublin
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Radiotherapy Center Cluj S.R.L.
Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Delta Health Care S.R.L.
Oncology, Str Nicolae Caramfil Nr 85a Sector 1, 014146, Bucharest
Institutul Regional De Oncologie Iasi
Oncology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Oncocenter Oncologie Clinica S.R.L.
Oncology, Strada Garii 1a, 300166, Timisoara
Medisprof S.R.L.
Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Spitalul Universitar De Urgenta Bucuresti
Oncology, Splaiul Independentei 169, 050098, Bucharest
Oncomed S.R.L.
Oncology, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara
Onco Card S.R.L.
Oncology, Strada Carierei 65 A, 500052, Brasov
Spital Judetean De Urgenta Satu Mare
Oncology, Piata Eroilor Revolutiei 1-2, 440055, Satu Mare
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Poko Poprad s.r.o.
Ambulancia klinickej onkológie, Mnohelova 2, 058 01, Poprad
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
Oddelenie klinickej onkológie, Spitalska 2, 071 01, Michalovce
Svet Zdravia a.s.
Oddelenie klinickej onkológie, Srobarova 1, 979 01, Rimavska Sobota
Vychodoslovensky Onkologicky Ustav a.s.
Oddelenie klinickej onkológie, Rastislavova 43, Juh, Kosice
Univerzitna Nemocnica Martin
Onkologické centrum, Kollarova 2, 036 01, Martin
Specializovana Nemocnica Sv. Svorada Zobor N.O.
Oddelenie klinickej onkológie, Klastorska 134, Zobor, Nitra
University Hospital Bratislava
Klinika pneumológie, ftizeológie a funkčnej diagnostiky SZU a UNB, Ruzinovska 6, Ruzinov, Bratislava
Nemocnica Na Okraji Mesta N.O.
Ambulancia klinickej onkológie, Nova Nemocnica 511, 958 01, Partizanske
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
Oddelenie klinickej onkológie, Jana Holleho 5898/14, 080 01, Presov
University Hospital Son Espases
Oncology, Carretera Valldemossa 79, 07120, Palma
Hospital De La Santa Creu I Sant Pau
Oncology, Carrer De San Quinti 89, 08041, Barcelona
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Consorcio Hospitalario Provincial De Castellon
Oncology, Avinguda Del Doctor Clara 19, 12006, Castello De La Plana
Hospital Universitario La Paz
Oncology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Clinico San Cecilio
Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Virgen De Valme
Oncology, Avenida Bellavista S/n, 41014, Sevilla
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Marques De Valdecilla
Oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Oncology, Rua Doctor Camilo Veiras 1, 15009, A Coruna
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 |
|---|---|---|---|---|---|
| Belgium | 2024-07-04 | ||||
| France | 2024-07-11 | 2024-07-22 | 2024-08-09 | ||
| Italy | 2024-07-05 | 2025-11-17 | 2024-07-09 | 2024-08-30 | |
| Poland | 2024-07-12 | 2024-07-18 | 2024-08-09 | ||
| Slovakia | 2024-06-18 | ||||
| Spain | 2024-06-24 | 2024-08-06 | 2024-08-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| GO45006_Final results summary SUM-134111
|
2026-05-14T15:09:01 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| GO45006_LPS reports | 2026-05-22T19:07:45 | Submitted | Laypersons Summary of Results |
Documents 57 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | GO45006 _ LPS_ final version_EN | NA |
| Laypersons summary of results (for publication) | GO45006-_-LPS_-final-version_ES-ES | NA |
| Laypersons summary of results (for publication) | GO45006-_-LPS_-final-version_FR-FR | NA |
| Laypersons summary of results (for publication) | GO45006-_-LPS_-final-version_IT-IT | NA |
| Laypersons summary of results (for publication) | GO45006-_-LPS_-final-version_PL-PL | NA |
| Laypersons summary of results (for publication) | GO45006-_-LPS_-final-version_SK-SK | NA |
| Protocol (for publication) | d1_pcl-2023-506696-10-00-redacted | 1 |
| Protocol (for publication) | D1_Protocol 2023-506696-10-00 GR Redacted | 2 (EEA) |
| Protocol (for publication) | D1_Protocol 2023-506696-10-00 Redacted | 3 (EEA) |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_DE-AT | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_DE-DE | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_ENG-IE | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_ES-ES | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_FR-BE | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_FR-FR | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_GR-GR | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_HU-HU | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_IT-IT | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_NL-BE | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_PL-PL | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_RO-RO | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_EQ5D5L_SK-SK | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_DE-AT | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_DE-DE | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_ENG-IE | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_ES-ES | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_FR-BE | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_FR-FR | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_GR-GR | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_HU-HU | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_IT-IT | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_NL-BE | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_PL-PL | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_RO-RO | NA |
| Protocol (for publication) | D4_Patient Facing Documents_QLQC30_QLQLC13_IL46_CTCAE_EQ5D5L_SK-SK | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Diversity_inclusion leaflet | 1 |
| Subject information and informed consent form (for publication) | L_SIS and ICF pregnancy partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form other subjects | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for the use and sharing of infant health information | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_REDACTED | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pre-screening | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 3.1 |
| Summary of results (for publication) | EU CT Final Results GO45006 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT-DE 2023-506696-10-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE 2023-506696-10-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR 2023-506696-10-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL 2023-506696-10-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol synopsis_eng 2023-506696-10-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2023-506696-10-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2023-506696-10-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR 2023-506696-10-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU 2023-506696-10-00 | 1.0 |
| Synopsis of the protocol (for publication) | d1_protocol synopsis_it-2023-506696-10-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2023-506696-10-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO 2023-506696-10-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SK 2023-506696-10-00 | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-25 | Slovakia | Acceptable with conditions 2024-05-20
|
2024-05-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-07 | Slovakia | Acceptable with conditions 2024-05-20
|
2024-06-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-17 | Slovakia | Acceptable 2024-09-03
|
2024-09-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-19 | Acceptable 2025-02-06
|
2025-03-13 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-22 | Slovakia | Acceptable 2025-08-26
|
2025-08-26 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-16 | Acceptable 2025-10-31
|
2025-11-05 |