Clinical Trials Register

Summary
EudraCT Number:	2020-004114-35
Sponsor's Protocol Code Number:	ETOP17-20
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-11-12
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-004114-35

A.3

Full title of the trial

A multicentre single-arm phase II trial assessing the safety and efficacy of first-line osimertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR-mutant non-small cell lung cancer

Uno studio multicentrico, a braccio singolo, di fase II per valutare la sicurezza e l’efficacia in prima linea di osimertinib e radioterapia ablativa locale in pazienti affetti da carcinoma polmonare non a piccole cellule oligometastatico, sincrono, EGFR-mutato

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A clinical study exploring the effect of osimertinib and radiation therapy, in people with newly diagnosed non-small cell lung cancer (NSCLC) that has spread to a few other parts of the body and shows a change (mutation) in the EGFR gene.

Studio clinico per valutare l'effetto di osimertinib e della terapia radiante in soggetti con tumore del polmone non a piccole cellule che si è diffuso in alcune parti del corpo e che presenta un cambiamento (mutazione) al gene EGFR

A.3.2

Name or abbreviated title of the trial where available

STEREO

A.4.1

Sponsor's protocol code number

ETOP17-20

A.5.4

Other Identifiers

Name:

ESR-19-20384

Number:

ASTRA ZENECA NUMBER

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	EUROPEAN THORACIC ONCOLOGY PLATFORM
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AstraZeneca AG Switzerland
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ISTITUTO EUROPEO DI ONCOLOGIA
B.5.2	Functional name of contact point	UFFICIO STUDI CLINICI E ATTIVITA' R
B.5.3	Address:
B.5.3.1	Street Address	VIA RIPAMONTI 435
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20141
B.5.3.4	Country	Italy
B.5.4	Telephone number	0257489847
B.5.6	E-mail	atanasio.nonis@ieo.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Osimertinib
D.3.2	Product code	[AZD9291]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Osimertinib
D.3.9.1	CAS number	1421373-65-0
D.3.9.2	Current sponsor code	AZD9291
D.3.9.4	EV Substance Code	SUB176340
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Osimertinib
D.3.2	Product code	[AZD9291]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Osimertinib
D.3.9.1	CAS number	1421373-65-0
D.3.9.2	Current sponsor code	AZD9291
D.3.9.4	EV Substance Code	SUB176340
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Treatment naïve patients with synchronous, oligo-metastatic (primary tumour and maximum 5 metastases) EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC with or without T790M resistance mutation.

Pazienti non pretrattati affetti da NSCLC sincrono, oligometastatico (tumore primario e al massimo 5 metastasi) EGFR-mutato (delezione dell’esone 19 o mutazione L858R nell’esone 21) con o senza mutazione di resistenza T790M.

E.1.1.1

Medical condition in easily understood language

Newly diagnosed non-small cell lung cancer (NSCLC) that has spread to a few other parts of the body and shows a change (mutation) in the EGFR gene.

Pazienti con recente diagnosi di tumore polmonare non a piccole cellule che si è diffuso in poche altre sedi e che evidenzia un cambiamento (mutazione) del gene EGFR

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10029522
E.1.2	Term	Non-small cell lung cancer stage IV
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10059515
E.1.2	Term	Non-small cell lung cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this trial is to evaluate safety (in terms of grade, equal or greater to 2 pneumonitis, requiring medical treatment) and efficacy (in terms of PFS) in patients with synchronous oligo-metastatic EGFR-mutant NSCLC treated with osimertinib and locally ablative radiotherapy to all cancer sites.

L’obiettivo di questo studio è valutare la sicurezza (in termini di polmonite di grado superiore o uguale a 2 che necessita di cure mediche) e l’efficacia (in termini di PFS) in pazienti affetti da NSCLC oligometastatico sincrono, con EGFR mutato, trattato con osimertinib e radioterapia ablativa locale in tutti i siti tumorali.

E.2.2

Secondary objectives of the trial

1) To evaluate secondary measures of clinical efficacy including overall survival (OS), pattern of disease progression, distant PFS, objective response rate (ORR), and duration of response.
2) To assess the safety and tolerability of the treatment.
3) To evaluate changes in symptom-specific and global quality of life.

1) Valutare misure secondarie di efficacia clinica che comprendono: sopravvivenza globale (OS), dinamiche di progressione di malattia, sopravvivenza libera da progressione a distanza (distant PFS, tasso di risposta obiettiva (ORR) e durata della risposta.
2) Valutare sicurezza e tollerabilità del trattamento.
3) Valutare cambiamenti nella qualita di vita globale e quella legata a sintomi specifici.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Histologically confirmed, treatment naïve EGFR-mutant NSCLC, with or without T790M resistance mutation.
- Presence of sensitising EGFR-mutation (exon 19 deletion and/or exon 21 L858R) detected by an accredited laboratory.
- Synchronous oligo-metastatic stage IV disease (max 5 lesions).
- Measurable disease as defined according to RECIST v1.1.
- All lesions amenable for radical radiotherapy according to local judgment.
- ECOG performance status 0-2.
- Adequate haematological, renal and liver function.

- NSCLC confermato istologicamente, non pretrattato, con EGFR mutato, con o senza mutazione di resistenza T790M.
- Presenza di mutazione sensibilizzante del gene EGFR (delezione dell’esone 19 e/o dell’esone 21 L858R) individuata da un laboratorio accreditato.
- Malattia oligomestastatica sincrona di stadio IV (non oltre 5 lesioni).
- Malattia misurabile definita in base a RECIST v1.1.
- Tutte le lesioni devono essere suscettibili di radioterapia radicale a giudizio del team locale.
- Performance status ECOG 0-2.
- Adeguata funzionalità ematologica, renale ed epatica.

E.4

Principal exclusion criteria

- Prior chemotherapy, immunotherapy, radiotherapy or therapeutic surgery for NSCLC (an exception is the resection and postoperative radiotherapy of the resection cavity of CNS or adrenal metastases)
- More than 5 distant oligo-metastases (any second intra-thoracic lesion will count as a distant metastasis; regional nodal metastases will not count towards the 5 oligometastases) and more than 2 intrapulmonary lesions.
- Brain metastases not amenable for radiosurgery or neurosurgery
- Presence of leptomeningeal metastases
- Symptomatic spinal cord compression
- Extracranial metastatic locations not amenable for radical radiotherapy such as malignant ascites, pleural or pericardial effusion, diffuse lymphangiosis of skin or lung, diffuse bone marrow metastasis,metastasis invading the GI tract, abdominal masses/abdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques
- Currently receiving, or unable to stop use prior to enrolment or to receiving the first dose of osimertinib treatment, medications or herbal supplements known to be potent CYP3A4 inducers. Potent CYP3A4 inducers are contraindicated for the duration of the trial
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol. Patients with a resolved or chronic HBV infection are eligible if they are: Negative for HBsAg and positive for hepatitis B core antibody [anti-HBc-IgG] or Positive for HBsAg, negative for HBeAg but for >6 months have had transaminases levels below ULN and HBV DNA levels below 2000 IU/mL (i.e., are in an inactive carrier state).
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib
- Any of the following cardiac criteria: QTcF >470 msec, using the screening clinic ECG machine derived QTc value (QTcF: corrected QT interval using Fredericia's formula); Any clinically important abnormalities in rhythm, conduction or
morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block or second degree heart block); Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes (TdP).
- Past medical history of ILD, drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Idiopathic pulmonary fibrosis which is a contraindication to lung radiation
- History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib

- Precedente chemioterapia, immunoterapia, radioterapia o chirurgia terapeutica per il NSCLC (ad eccezione della resezione e della radioterapia postoperatoria della cavità di resezione delle metastasi che interessano il sistema nervoso centrale o il surrene)
- Più di 5 oligometastasi distanti (qualsiasi seconda lesione intratoracica conta come metastasi distante; le metastasi nodali regionali non sono incluse tra le 5 oligometastasi) e più di 2 lesioni intrapolmonari
- Metastasi cerebrali non suscettibili di radiochirurgia o neurochirurgia
- Presenza di metastasi leptomeningee
- Compressione sintomatica della colonna vertebrale
- Siti metastatici extracranici non suscettibili di radioterapia radicale come ascite maligna, versamento pleurico o pericardico, linfangite diffusa cutanea o polmonare, metastasi diffuse nel midollo osseo, metastasi dell’apparato gastrointestinale, masse addominali / organomegalia addominale, identificati tramite visita medica ma non misurabili con tecniche di diagnostica per immagini riproducibili
- Assunzione attuale, o impossibilità di interrompere l’assunzione prima dell’arruolamento o della prima dose del trattamento con osimertinib, di farmaci o integratori alle erbe noti per essere forti induttori di CYP3A4. I forti induttori di CYP3A4 sono controindicati durante lo studio
- Qualsiasi evidenza di malattie sistemiche gravi o non controllate, comprese ipertensione non controllata e diatesi emorragiche attive che, secondo il parere del ricercatore, rendono il paziente non idoneo a partecipare allo studio o che rischiano di compromettere l’aderenza al protocollo. I pazienti affetti da un’infezione da HBV risolta o cronica sono idonei se sono: negativi a HBsAg e positivi all’anticorpo core dell’epatite B [IgG anti-HBc] oppure positivi a HBsAg, negativi a HBeAg, ma con livelli di transaminasi inferiori a ULN e livelli di HBV DNA inferiori a 2000 UI/mL (ossia in uno stato di portatori inattivi) da >6 mesi
- Nausea e vomito refrattari, patologie gastrointestinali croniche, incapacità di inghiottire il prodotto formulato oppure previa resezione significativa dell’intestino che precluderebbe un assorbimento adeguato di osimertinib
- Uno o più dei seguenti criteri cardiaci: QTcF >470 msec, utilizzando il valore di QTc ottenuto dall’elettrocardiografo clinico di screening (QTcF: intervallo di QT corretto utilizzando la formula di Fredericia); Qualsiasi anomalia clinicamente rilevante del ritmo, della conduzione o della morfologia dell’ECG a riposo (ad es. blocco di branca sinistra completo, blocco cardiaco di terzo grado o di secondo grado); Qualsiasi fattore che aumenta il rischio di prolungamento del QTc o il rischio di eventi aritmici quali insufficienza cardiaca, ipokaliemia, sindrome del QT lungo congenita, familiarità di sindrome del QT lungo o morte idiopatica improvvisa al di sotto dei 40 anni tra i familiari di primo grado, oppure assunzione concomitante di farmaci che prolungano l’intervallo QT e provocano torsione di punta (TdP)
- Storia clinica pregressa di interstiziopatia polmonare (ILD), ILD indotta da farmaci, polmonite da radiazioni che ha richiesto un trattamento con steroidi o qualsiasi altra evidenza di ILD clinicamente attiva
- Fibrosi polmonare idiopatica che controindica la radiazione polmonare
- Antecedenti di ipersensibilità agli eccipienti attivi o inattivi di osimertinib o di farmaci con una struttura chimica simile o appartenenti alla stessa classe di osimertinib

E.5 End points

E.5.1

Primary end point(s)

1) Proportion of patients with grade, greater or equal to 2 pneumonitis, requiring medical treatment, by month 18
2) Progression-free survival (PFS)

1) Percentuale di pazienti affetti da polmonite di grado superiore o uguale a 2 che necessita di cure mediche entro il 18° mese
2) Sopravvivenza libera da progressione

E.5.1.1

Timepoint(s) of evaluation of this end point

1) Any time during the first 18 months on trial follow-up
2) From the date of enrolment until documented progression or death, if progression is not documented.

1) In qualsiasi momento durante i primi 18 mesi di follow-up
2) Dalla data di arruolamento fino a progressione documentata o decesso, se la progressione non viene documentata.

E.5.2

Secondary end point(s)

Overall survival (OS); Pattern of disease progression; Distant progression-free survival; Objective response rate (ORR); Duration of response (DoR); Toxicity by CTCAE v5.0; Symptom-specific and global quality of life (QoL)

Sopravvivenza globale (OS); Dinamiche di progressione della patologia; Sopravvivenza libera da progressione a distanza; Tasso di risposta obiettiva (ORR); Durata della risposta (DoR); Eventi avversi in base a CTCAE v5.0; Qualità della vita sintomo-specifica e globale

E.5.2.1

Timepoint(s) of evaluation of this end point

From the date of enrolment until death from any cause; from date of enrolment up to 18 months post enrolment.; from enrolment across all trial assessment time-points.; from enrolment across all trial assessment time-points.; from the date of first documentation of objective response to the date of first documented progression, relapse or death.; from date of enrolment until 6 weeks after all protocol treatment discontinuation; from baseline to 24 weeks on treatment.

Dalla data di arruolamento fino a morte per qualsiasi causa; Dalla data di arruolamente fino alla fine dei 18 mesi di follow-up; dall'arruolamento e fino all'ultimo controllo previsto dal trial; dall'arruolamento e fino all'ultimo controllo previsto dal trial; dalla data della prima documentazione di risposta obiettiva alla data della prima documentazione di progressione oppure ricaduta o morte; dalla data di arruolamento fino a 6 settimane dopo l'interruzione del trattamento; dall'inizio fino a 24 settimane in trattamento

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

disegno in aperto a braccio singolo

open design, single arm study

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Korea, Republic of

Singapore

Italy

Netherlands

Poland

Spain

Sweden

Switzerland

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

NONE

NESSUNO

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-03-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-15

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Clinical trials