Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
892
Countries
10
Sites
76
Advanced or Metastatic Non-Small Cell Lung Cancer
To demonstrate superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel by assessment of OS in participants with advanced NSCLC after second- or thirdline therapy and without actionable genomic alterations
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Oct 2022 → ongoing
- Decision date (initial)
- 2024-02-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
External identifiers
- EU CT number
- 2023-509429-37-00
- EudraCT number
- 2022-000493-26
- ClinicalTrials.gov
- NCT05450692
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacodynamic, Efficacy, Pharmacokinetic
To demonstrate superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel by assessment of OS in participants with advanced NSCLC after second- or thirdline therapy and without actionable genomic alterations
Secondary objectives 7
- To demonstrate superiority of ceralasertib plus durvalumab (C&D) combination therapy relative to docetaxel by assessment of PFS.
- To estimate the effectiveness of C&D combination therapy relative: • to docetaxel by assessment of ORR • to docetaxel by assessment of duration of response (DoR) • to docetaxel by assessment of time to response (TTR) • to docetaxel by assessment of disease control rate (DCR) at 18 weeks • to docetaxel by assessment of time to second progression or death (PFS2) • to docetaxel by assessment of OS at 12 months (OS12)
- To assess participant-reported health-related quality of life (QoL)
- To assess participant-reported physical functioning in participants treated with C&D combination therapy relative to docetaxel
- To evaluate participant-reported treatment tolerability
- To assess the PK of ceralasertib when administered in combination with durvalumab
- To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel
Conditions and MedDRA coding
Advanced or Metastatic Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Participant must be ≥ 18 years at the time of screening.
- Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
- Documented EGFR and ALK wild-type status as determined at a local laboratory.
- Documented radiological PD whilst on or after receiving the most recent treatment regimen.
- Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
- ECOG/WHO performance status of 0 or 1.
- Adequate organ function and marrow reserve
- Minimum life expectancy of 12 weeks.
- Body weight > 30 kg and no cancer-associated cachexia.
- Negative pregnancy test (serum test) for WOCBP.
Exclusion criteria 8
- Participant with mixed SCLC and NSCLC histology
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.
- Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
- Active or prior documented autoimmune or inflammatory disorders.
- Participants who have received more than one line of prior anti-PD- (L)1, either alone or in any combination.
- Participants: (a) Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy. (b) All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved. (c) Must not have experienced a Grade ≥ 3 imAE or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy. (d) Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
- Participants who have received more than one prior line of platinum- based chemotherapy in metastatic setting.
- Participants who have received a prior ATR inhibitor.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- OS is defined as time from randomisation until the date of death due to any cause. The comparison will include all randomised participants, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS.
Secondary endpoints 3
- To demonstrate superiority of ceralasertib plus durvalumab relative to docetaxel by assessment of PFS, ORR, DoR, TTR, DCR at 18 weeks, PFS2, OS at 12 months (OS12), participant-reported health-related quality of life (QoL), participant- reported physical functioning, participant-reported treatment tolerability.
- To assess the PK of ceralasertib when administered in combination with durvalumab.
- To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10810116 · Product
- Active substance
- Ceralasertib
- Substance synonyms
- AZD-6738, 4-(4-(1-((S(R))-S-METHYLSULFONIMIDOYL)CYCLOPROPYL)-6-((3R)-3-METHYL-4-MORPHOLINYL)-2-PYRIMIDINYL)-1H-PYRROLO(2,3-B)PYRIDINE, AZD6738
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD10419091 · Product
- Active substance
- Ceralasertib
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 43500 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC28 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 4
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2775 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel Hikma 80 mg/4 ml Konzentrat zur Herstellung einer Infusionslösung
PRD4495642 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2775 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- 93833.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2775 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2775 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 6
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 24 Month(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
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mycofit, 250 mg, kapsułki twarde
PRD391929 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- 16297
- MA holder
- ACCORD HEALTHCARE POLSKA SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Inflectra 100 mg powder for concentrate for solution for infusion
PRD6483369 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 5 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/854/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Remsima 100 mg powder for concentrate for solution for infusion
PRD2620218 · Product
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179, R-TPR-015
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/853/001
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- Norway
- 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
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Centre
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Centre
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, Code 8 |
Locations
10 EU/EEA countries · 76 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 33 | 4 |
| France | Ended | 95 | 14 |
| Germany | Ended | 22 | 9 |
| Hungary | Ended | 10 | 3 |
| Ireland | Ongoing, recruitment ended | 7 | 4 |
| Italy | Ended | 83 | 12 |
| Netherlands | Ended | 5 | 3 |
| Poland | Ongoing, recruitment ended | 50 | 6 |
| Romania | Ended | 73 | 11 |
| Spain | Ongoing, recruitment ended | 142 | 10 |
| Rest of world
Japan, Korea, Republic of, Hong Kong, Australia, India, Brazil, Serbia, China, Argentina, United States, Taiwan, United Kingdom, Canada
|
— | 372 | — |
Investigational sites
Grand Hopital De Charleroi
0504: Oncologie - Hématologie, Rue Du Campus Des Viviers 1, 6060, Charleroi
Hopital De Libramont
0502:Oncologie, Avenue De Houffalize 35, 6800, Libramont-Chevigny
Algemeen Ziekenhuis Delta
0501:Department of Pulmonary Diseas, Deltalaan 1, 8800, Roeselare
Universitair Ziekenhuis Gent
0503:Pneumologie, Corneel Heymanslaan 10, 9000, Gent
Institut Gustave Roussy
2302:Medecine Oncologique, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Hopitaux Prives De Metz
2305:Pneumologie, Parvis Schuman Rue Champs Montoy, Rue Pre Montois, Vantoux
Centre De Cancerologue Du Grand Montpellier
2309:Oncologie Médicale, 25 Rue De Clementville, 34070, Montpellier
Centre Jean Perrin
2314:Medecine, 58 Rue Montalembert, 63000, Clermont-Ferrand
Centre Hospitalier De Saint-Quentin
2307:Pneumologie, 1 Rue Michel De L Hospital, 02100, Saint Quentin
Centre Hospitalier Universitaire De Nantes
2315:Service d'Oncologie médicale, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire D'Angers
2306:Pneumologie, 4 Rue Larrey, 49100, Angers
Centre Leon Berard
2311:Département d'Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Institut De Cancerologie De L Ouest
2303:Service Oncologie Medicale, Bd Du Professeur Jacques Monod, 44800, St Herblain
HIA Sainte Anne
2308:Service de pneumologie, 2 Boulevard Sainte Anne, Bp 600, Toulon Cedex 9
Centre Hospitalier Universitaire De Bordeaux
2301:Maladies respiratoires, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Intercommunal Creteil
2304:Service de Pneumologie, 40 Avenue De Verdun, 94000, Creteil
Les Hopitaux Nord-Ouest
2313:Oncologie Medicale - Cancerologie, Plateau D Ouilly, Cs 80436 Gleize, Villefranche Sur Saone Cedex
Assistance Publique Hopitaux De Paris
2312:Pneumologie - unité d'oncologie thoracique, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Universitaetsklinikum Ulm AöR
2606 : Klinik fuer Innere Medizin II, Albert-Einstein-Allee 23, Eselsberg, Ulm
SLK-Kliniken Heilbronn GmbH
2605 : Standort Fachklinik Löwenstein, Med.Klinik II Onkologie mit Palliativmedizin, Geisshoelzle 62, Hirrweiler, Loewenstein
Medical Center - University Of Freiburg
2608 : Klinik für Innere Medizin I, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Klinikverbund Allgaeu gGmbH
2607 : Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin Klinikum Kempten, Robert Weixler Strasse 50, 87439, Kempten (Allgau)
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
2604 : Lungenkrebszentrum Moers, Bethanienstrasse 21, Innenstadt, Moers
Vivantes Netzwerk fuer Gesundheit GmbH
2603 : Hämatologie, Onkologie und Palliativmedizin, Rudower Strasse 48, Buckow, Berlin
Asklepios Fachkliniken Muenchen Gauting
2601 : Zentrum für Pneumologie und Thoraxchirurgie, Robert-Koch-Allee 2, 82131, Gauting
Evangelisches Klinikum Bethel gGmbH
2609 : Klinik für Innere Medizin, Schildescher Strasse 99, Schildesche, Bielefeld
Vincentius-Diakonissen-Kliniken gAG
2602 : Medizinische Klinik Abteilung2, Hämatologie, Onkologie, Immunologie und Palliativmedizin, Suedendstrasse 32, Suedweststadt, Karlsruhe
Toeroekbalinti Tuedogyogyintezet
3301:Onkológia Osztály, Munkacsy Mihaly Utca 70, 2045, Torokbalint
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
3302:Pulmonológiai Osztály, Seregelyesi Ut 3, 8000, Szekesfehervar
Koranyi National Institute For Pulmonology
3304:Pulmonológiai Osztály, Koranyi Frigyes Ut 1, 1121, Budapest XII
University College Cork
3901:Cancer Trials Cork, Glandore Centre, Wilton, T12 E8YV, Cork
Beaumont Hospital
3903:Oncology, Beaumont Road, Beaumont, Dublin 9
St Vincent's University Hospital
3902:2nd Floor, Elm Park Merrion Road, D04 T6F4, Dublin 4
University Hospital Limerick
3904:Mid-Western Cancer Centre, Saint Nessan's Road, V94 F858, Limerick
I.F.O. Istituti Fisioterapici Ospitalieri
4110: UOC Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliero Universitaria Parma
4102: Hemat/Transfusion Med, Viale Antonio Gramsci 14, 43126, Parma
Humanitas Research Hospital
4107: Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
4109: U.O. Oncologia Medica, Via Santa Sofia 78, 95123, Catania
IRCCS Istituto Nazionale Tumori Fondazione Pascale
4106: Oncologia Clinica Sperimentale Toraco-Polmonare, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Campus Bio-Medico
4113: UOC Oncologia Medica, Via Alvaro Del Portillo N 200, 00128, Rome
Centro Di Riferimento Oncologico Di Aviano
4103: U.O.Oncologia Medica e dei Tumori Immuno-correlati, Via Franco Gallini 2, 33081, Aviano
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
4101: Biostatistica, Via Piero Maroncelli 40, 47014, Meldola
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
4105: Oncologia Toracica, Via Monte Baldo 24, 37019, Peschiera Del Garda
Istituto Nazionale Dei Tumori
4108: Oncologia Medica Toraco Polmon, Via Giacomo Venezian 1, 20133, Milan
Fondazione IRCCS San Gerardo Dei Tintori
4112: S.C. Oncologia Medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
Istituto Oncologico Veneto
4104: Department of Clinical and Experimental Oncology, Via Gattamelata 64, 35128, Padova
St. Elisabeth Hospital Tilburg
5001:Pulmonology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Zuyderland Medisch Centrum Stichting
5004:Pulmonology, Henri Dunantstraat 5, 6419 PC, Heerlen
Gelre Hospitals
5002:Poli Longziekten afd research, Den Elterweg 77, 7207 AE, Zutphen
Copernicus Podmiot Leczniczy Sp. z o.o.
5705 : Oddzial Onkologii Klinicznej / Chemioterapii, Al. Zwyciestwa 31/32, 80-219, Gdansk
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
5701 : Oddzial Onkologii Klinicznej z Pododdzialem Dziennym, Os. Zlotej Jesieni 1, 31-826, Cracow
Uniwersyteckie Centrum Kliniczne
5706 : Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Pratia S.A.
5702 : Pratia MCM Krakow, Ul. Pana Tadeusza 2, 30-727, Cracow
Med Polonia Sp. z o.o.
5703 : MED-POLONIA Sp.z o.o., Obornicka 262, 60-693, Poznan
Pratia S.A.
5707 : Centrum Medyczne Pratia Poznan, Ul. Poznanska 14, 60-185, Skorzewo
Pelican Impex S.R.L.
6110:Oncologie, Calea Coposu Corneliu 14a-14b, 410469, Oradea
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
6102:Oncologie Medicala I, Soseaua Fundeni 252, 022328, Bucharest
Centrul De Oncologie SF Nectarie S.R.L.
6101:Oncology, Strada Caracal Nr 109, 200542, Craiova
Radiotherapy Center Cluj S.R.L.
6103:Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Medisprof S.R.L.
6109:Oncology, Bulevardul Muncii 96, 400641, Cluj-Napoca
Ovidius Clinical Hospital S.R.L.
6107:Oncology, Dn 2a Km 202 880, 905900, Ovidiu
Oncomed S.R.L.
6105:Medical Oncology, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
6106:Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Oncocenter Oncologie Clinica S.R.L.
6104:Oncology, Strada Garii 1a, 300166, Timisoara
Oncolab S.R.L.
6108:Medical oncology, Strada Bujorului 7, 200385, Craiova
Gral Medical S.R.L.
6111:Oncology, Strada Popovici Traian 79-91, 031422, Bucharest
Hospital De La Santa Creu I Sant Pau
7115:Oncología, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Institut Catala D'oncologia
7113:Oncología, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
7119:Oncología, Rua Doctor Camilo Veiras 1, 15009, A Coruna
Complejo Hospitalario Universitario De Ourense
7108:Oncología, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Clinico Universitario Lozano Blesa
7101:Oncología, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Virgen De Valme
7106:Oncología, Avenida Bellavista S/n, 41014, Sevilla
Hospital Universitario Regional De Malaga
7103:Oncología, Avenida De Carlos De Haya Sn, 29010, Malaga
Parc Tauli Hospital Universitari
7111:Oncología, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Universitario Fundacion Jimenez Diaz
7117:Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinico San Carlos
7114:Oncología, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
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 | 2022-10-28 | 2025-10-06 | 2022-11-09 | 2024-03-01 | |
| France | 2023-01-31 | 2025-10-06 | 2023-02-10 | 2024-03-01 | |
| Germany | 2023-02-02 | 2025-10-06 | 2023-03-24 | 2024-03-01 | |
| Hungary | 2022-10-03 | 2025-10-12 | 2023-06-21 | 2024-03-01 | |
| Ireland | 2023-08-25 | 2023-09-11 | 2024-03-01 | ||
| Italy | 2022-12-21 | 2025-10-06 | 2023-01-30 | 2024-03-01 | |
| Netherlands | 2023-03-23 | 2025-10-04 | 2023-09-25 | 2024-03-01 | |
| Poland | 2022-12-12 | 2022-12-19 | 2024-03-01 | ||
| Romania | 2022-11-21 | 2026-02-24 | 2022-12-13 | 2024-03-01 | |
| Spain | 2022-11-17 | 2022-11-23 | 2024-03-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 105 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2023-509429-37-00 English Public | 3.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report BEL Dutch D533BC00001 Public | 2.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report BEL English D533BC00001 Public | 5.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report BEL French D533BC00001 Public | 2.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report DEU German D533BC00001 Public | 3.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report English D533BC00001 Public | 5.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report ESP Spanish D533BC00001 Public | 2.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report FRA French D533BC00001 Public | 2.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report HUN Hungarian D533BC00001 Public | 3.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report IRL English D533BC00001 Public | 1.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report ITA Italian D533BC00001 Public | 2.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report ITA Ukrainian D533BC00001 Public | 1.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report NLD Dutch D533BC00001 Public | 3.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report POL Polish D533BC00001 Public | 2.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report POL Ukrainian D533BC00001 Public | 1.0 |
| Protocol (for publication) | D4 Patient facing documents App Subject Facing Screen Report ROU Romanian D533BC00001 Public | 2.0 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements NLD Public | 1.0 |
| Recruitment arrangements (for publication) | K1_HUN Recruitment Other Placeholer English D533BC00001 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements and Informed Consent Procedure Description_POL_ENG Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements ESP English Public | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BEL_English Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DEU_English | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IRL_English Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ITA_English Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Procedure Description_FRA _FR_EN Public | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ROU_English | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Other Hungarian Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main HUN Hungarian Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main PIS HUN Hungarian Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Protection_ITA_Italian Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Protection_ITA_Ukrainian Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research ESP Spanish Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research Adult_DEU_ German Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research ESP Spanish Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research HUN Hungarian Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research PIS HUN Hungarian Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_BEL_Dutch Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_BEL_English Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_BEL_French Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_FRA_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_IRL_English Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_NLD_English Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_ROU_Romanian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF HUN Country ICF Main Redacted Hungarian Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_DEU_German_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_FRA_French_Public | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_IRL_English_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_ROU_Romanian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Beyond Progression_FRA_French_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ESP Spanish Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main NLD Dutch Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main redacted_ITA_Ukrainian Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BEL_Dutch Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BEL_English Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BEL_French Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ITA_Italian Public | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ITA_Ukrainian Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Additional information_ITA_Italian Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Additional information_ITA_Ukrainian Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Beyond Progression_BEL_Dutch Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Beyond Progression_BEL_English Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Beyond Progression_BEL_French Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other IRB-IEC Approval_ITA_Italian Public | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other IRB-IEC Conditional Approval_ITA_Italian Public | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other IRB-IEC Initial Approval AoR_ITA_Italian Public | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Optional Treatment ESP Spanish Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Pregnant Medical Release Form_ITA_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Pregnant Medical Release Form_ITA_Ukrainian Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Pregnant Partner_BEL_Dutch Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Pregnant Partner_BEL_English Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Pregnant Partner_BEL_French Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Progression consent form_ITA_Italian Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Progression consent form_ITA_Ukrainian Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Other Trial Management Communications Email_ITA_Italian Public | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF POL Country ICF Genetic Research Polish D533BC00001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF POL Country ICF Genetic Research Ukrainian D533BC00001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF POL Country ICF Main Polish Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF POL Country ICF Main Ukrainian Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF POL Country ICF Other Pregnant Partner Polish Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF POL Country ICF Other Pregnant Partner Ukrainian Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy for Biological Parents_FRA_French_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner Adult_DEU_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner Adult_ROU_Romanian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner HUN Hungarian Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner NLD Dutch Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_IRL_English Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Procedure_BEL_English Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Procedure_DEU_English Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_IRL_English Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_ PP ICF ESP Spanish Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Information Material_Summary Information Sheet_IRL_English Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_subject information material ID Card_Public | NA |
| Subject information and informed consent form (for publication) | P1_GP Letter_ITA_Italian Public | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Docetaxel Hikma Public | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BEL-Dutch 2023-509429-37-00 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BEL-French 2023-509429-37-00 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BEL-German 2023-509429-37-00 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis English 2023-509429-37-00 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ESP-Spanish 2023-509429-37-00 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FRA -French 2023-509429-37-00 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis HUN-Hungarian 2023-509429-37-00 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ITA-Italian 2023-509429-37-00 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NLD-Dutch 2023-509429-37-00 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis POL-Polish 2023-509429-37-00 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ROU-Romanian 2023-509429-37-00 Public | 1.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-14 | Netherlands | Acceptable 2024-01-31
|
2024-01-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-15 | Netherlands | Acceptable 2024-06-24
|
2024-06-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-21 | Acceptable 2024-06-24
|
2024-08-21 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-03 | Netherlands | Acceptable 2025-05-13
|
2025-05-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-22 | Acceptable | 2025-08-29 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-17 | Acceptable 2026-04-30
|
2026-05-01 |