Clinical Trials Register

Summary
EudraCT Number:	2018-002572-41
Sponsor's Protocol Code Number:	D9103C00001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-07-27
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

2018-002572-41

A.3

Full title of the trial

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

Studio internazionale di fase III, randomizzato, placebo-controllato, in doppio cieco, multicentrico, di Durvalumab sequenziale alla radioterapia stereotassica corporea per il trattamento di pazienti con Tumore del Polmone Non a Piccole Cellule, non operabile, allo stadio I/II e linfonodo negativo (PACIFIC-4/RTOG-3515)

A.3.1

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

Study of durvalumab or placebo administered after radiation therapy for patients with early stage non-small cell lung cancer

Studio di Durvalumab o placebo somministrato dopo radioterapia a pazienti con stadio precoce del tumore al polmone non a piccole cellule

A.3.2

Name or abbreviated title of the trial where available

PACIFIC-4/RTOG-3515

A.4.1

Sponsor's protocol code number

D9103C00001

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	ASTRAZENECA AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Astrazeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Astrazeneca
B.5.2	Functional name of contact point	Information Center
B.5.3	Address:
B.5.3.1	Street Address	NA
B.5.3.2	Town/ city	NA
B.5.3.3	Post code	NA
B.5.3.4	Country	Sweden
B.5.4	Telephone number	000000
B.5.5	Fax number	000000
B.5.6	E-mail	information.center@astrazeneca.com

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.2.5	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	durvalumab
D.3.2	Product code	[MEDI4736]
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	durvalumab
D.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
D.2.1.1.1	Trade name	Cellcept 250mg Capsules
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
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	Cellcept 250mg Capsules
D.3.2	Product code	[Cellcept 250mg Capsules]
D.3.4	Pharmaceutical form	Capsule, hard
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	mycophenolate mofetil
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	mycophenolate mofetil
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	250
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: 3
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	Yes
D.2.1.1.1	Trade name	Remicade 100mg powder for concentrate for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biologics B.V.
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	Remicade 100mg powder for concentrate for solution for infusion
D.3.2	Product code	[Remicade 100mg powder for concentrate for solutio
D.3.4	Pharmaceutical form	Powder and solvent for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Infliximab
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Infliximab
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	100
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)	Yes
	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	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer

Pazienti con tumore al polmone non a piccole cellule al I/II stadio, non operabile, linfonodo negativo

E.1.1.1

Medical condition in easily understood language

Specific type of lung cancer called "Non-Small Cell Lung Cancer"

Tipologia specifica di tumore polmonare chiamata "Carcinoma Polmonare Non a Piccole Cellule" (NSCLC).

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	10061873
E.1.2	Term	Non-small cell lung cancer
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

To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS in patients with T1c to T3N0M0 NSCLC

Valutare l’efficacia della monoterapia a base di Durvalumab rispetto al placebo in termine di PFS nei pazienti con T1c a T3N0M0 (NSCLC)

E.2.2

Secondary objectives of the trial

To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS for all stage I/II NSCLC patients
To assess the efficacy of durvalumab monotherapy compared to placebo in terms of OS in patients with subset of T1-T3N0 NSCLC
To assess the efficacy of durvalumab monotherapy compared to placebo in terms of OS in patients with Stage I/II NSCLC
To further assess the efficacy of durvalumab monotherapy compared to placebo in terms of lung cancer-specific mortality
To further assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS24, TTP, TTDM, and PFS2
To assess the PK of durvalumab
To investigate the immunogenicity of durvalumab
To assess symptoms and health-related quality of life in patients treated with durvalumab monotherapy compared to placebo using the EORTC QLQ-C30
To assess the safety and tolerability profile of durvalumab monotherapy compared to placebo after administration of SBRT

Valutare l’effic della monot a base di Durvalumab rispetto al placebo in termine di PFS nei pazienti con NSCLC al I/II stadio
Valutare l’effic della monot a base di Durvalumab rispetto al placebo in termine di OS in pazienti con subset T1-T3N0 (NSCLC).
Valutare l’effic della monot a base di Durvalumab rispetto al placebo in termini di OS in paz con NSCLC al I/II stadio.
Valutare l’effic della monot a base di Durvalumab rispetto al placebo in termini di mortalità specifica per tumore al polmone
Valutare l’effic della monot a base di Durvalumab rispetto al placebo in termini di PFS24, TTP, TTDM ePFS2
Valutare la farmacocinetica (PK) di Durvalumab
Valutare l’immunogenicità di Durvalumab
Valutare i sintomi e QOL relativa alla salute nei pazienti trattati con la monot a base di durvalumab rispetto al placebo utilizzando il EORTC QLQ-C30
Valutare i profili di sicurezza e di tollerabilità della monoterapia a base di Durvalumab rispetto al placebo dopo la somministrazione di SBRT.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age =18 years
2. Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
3. Completion of SoC SBRT as definitive treatment prior to randomization
4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2
5. Life expectancy of at least 12 weeks
6. Body weight >30 kg
7. Submission of available tumor tissue sample
8. Adequate organ and marrow function required
9. Patients with central or peripheral lesions are eligible
10. Staging studies must be done within 10 weeks before randomization
11. Pulmonary Function Testing within 12 weeks of randomization
12. Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated definitively with radiation, surgery only, or surgery with adjuvant chemotherapy in whom all treatments completed >1 year prior to randomization are eligible.

1. Età =18 anni
2. NSCLC Stadio I / II confermato attraverso esame istologico o citologico, con stadiazione clinica I/II linfonodo negativo e grado di malattia compreso tra T1 e T3N0M0 candidati a ricevere il trattamento con radioterapia sterotassica corporea (SBRT).
Pazienti che sono clinicamente inoperabili o che sono clinicamente operabili ma che hanno rifiutato la chirurgia o che hanno scelto la SBRT come terapia definitiva
3. Completamento della SBRT (trattamento standard) come trattamento definitivo prima della randomizzazione
4. Performance status (PS) del World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) di 0, 1 o 2 all’arruolamento ed alla randomizzazione
5. Aspettativa di vita di almeno 12 settimane
6. Peso corporeo >30 kg
7. Consegna di un campione disponibile del tumore
8. Adeguata funzionalità degli organi e del midollo osseo
9. Sono eleggibili pazienti con lesioni centrali o periferiche
10. Gli esami per determinare la stadiazione devono essere fatti entro 10 settimane prima della randomizzazione
11. Test di funzionalità polmonare entro 12 settimane dalla randomizzazione
12. Pazienti con una storia di metacronus in stadio I / II (T1-T3N0M0) NSCLC trattato in modo definitivo con radioterapia, solo chirurgia o chirurgia con chemioterapia adiuvante in cui tutti i trattamenti sono stati completati più di 1 anno prima alla randomizzazione sono eleggibili.

E.4

Principal exclusion criteria

1. Mixed small cell and non-small cell cancer histology
2. History of allogeneic organ transplantation
3. History of another primary malignancy with exceptions
4. History of active primary immunodeficiency
5. Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade=2 from SBRT (Stereotactic Body Radiation Therapy)

1. Istologia del tumore mista a piccole cellule e non a piccole cellule
2. Storia di trapianto allogenico
3. Storia di un altro tumore primario senza eccezioni
4. Storia di un'immunodeficienza primaria attiva
5. Qualsiasi tossicità, non risolta dovuta alla SBRT di grado = 2 riportato dal National Cancer Institute (NCI) CTCAE, SBRT (Radioterapia stereotassica corporea)

E.5 End points

E.5.1

Primary end point(s)

PFS in patients with subset of T1-T3N0 by BICR

PFS in pazienti con sottotipo T1 a T3N0 secondo BICR

E.5.1.1

Timepoint(s) of evaluation of this end point

On-study tumor assessments occur 8 weeks after randomization, then every 12 weeks through week 116, then every 16 weeks through 3 years after randomization, then every 6 months thereafter until objective disease progression.

Le valutazioni del tumore si verificano 8 settimane dopo la randomizzazione, poi ogni 12 settimane fino alla 116ª settimana, poi ogni 16 settimane fino a 3 anni dopo la randomizzazione, e poi ogni 6 mesi fino a progressione

E.5.2

Secondary end point(s)

- PFS in patients with T1 to T3N0 NSCLC
- OS in patients with subset of T1-T3N0 NSCLC
- OS in patients with T1 to T3N0M0 NSCLC
- Lung cancer mortality
- PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1
- PFS2 using local assessment
- Concentration of durvalumab in blood
- Presence of ADA for durvalumab
- EORTC QLQ-C30: Change in symptoms, functioning and global health status/quality of life
- Safety and tolerability: AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings

- PFS in pazienti con NSCLC da T1 a T3N0
- OS in pazienti con sottotipo NSCLC da T1 a T3N0
- OS in pazienti con NSCLC da T1 a T3N0M0
- Mortalità del tumore al polmone
- PFS24, TTP, and TTDM usando valutazioni BICR in base ai criteri RECIST 1.1
- PFS2 con l’utilizzo della valutazione locale
- Concentrazione di durvalumab nel sangue
- Presenza di ADA per durvalumab
- EORTC QLQ-C30: Cambiamenti nei sintomi, funzionalità e stato/qualità della vita globale
- Sicurezza e Tollerabilità: eventi avversi, esami fisici, segni vitali, elettrocardiogrammi ed esami di laboratorio

E.5.2.1

Timepoint(s) of evaluation of this end point

OS: from randomization until death due to any cause
Lung cancer mortality: time from randomization until death due to lung cancer.
PFS24: 24 months
TTP: time from randomization until progression (excluding deaths)
TTDM: time from randomization until death or distant metastasis
PFS2: Time from randomization to second progression (local assessment)
ADA: will be collected at Baseline, at Cycles: 1, 8, 14, 26 then months 3 and 6 after completed/discontinued study treatment
EORTC QLQ-C30: Screening, at Baseline, Week 2, 4, 6, 8, 12, 16 and 20 weeks after randomization, then every 8 weeks until 3 years after randomization, then every 6 months until PFS2
Safety and tolerability - from randomization until 3 months after treatment discontinuation

OS: dalla randomizzazione fino alla morte per qualsiasi causa
Mortalità per carcinoma polmonare: tempo dalla randomizzazione fino alla morte per tumore polmonare
PFS24: 24 mesi
TTP: tempo dalla randomizzazione fino alla progressione (esclusi i decessi)
TTDM: tempo dalla randomizzazione alla morte o metastasi distanti
PFS2: tempo dalla randomizzazione alla seconda progressione (valutazione locale)
- ADA: saranno raccolti al baseline, ai cicli: 8, 14, 20, 26 successivamente dopo 3 e 6 mesi dopo il completamento/discontinuazione dal trattamento
- EORTC QLQ-C30: Screening al baseline, settimana 2, 4, 6, 8, 12, 16 e 20 settimane dopo la randomizzazione, poi ogni 8 settimane fino 3 anni dopo la randomizzazione, successivamente ogni 6 mesi fino PFS2 -

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability Symptoms and health-related quality of life Healthcare resource utilization

Tollerabilità, Sintomi e qualità della vita correlati alla salute, Utilizzo di risorse sanitarie

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

Belgium

Canada

China

France

Germany

Israel

Italy

Japan

Korea, Republic of

Netherlands

Poland

Spain

United Kingdom

United States

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

Last expected visit/contact of the last patient undergoing the study (last subject last visit)

Ultima visita prevista / contatto dell'ultimo paziente sottoposto allo studio (ultimo soggetto all'ultima visita)

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

406

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

A legal representative may provide consent on behalf of a subject incapable of giving consent personally, where permitted by local regulations.

Un rappresentante legale provvederà a fornire il consenso per un soggetto incapace di dare validamente il proprio consenso, come definito da leggi locali.

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

250

F.4.2.2

In the whole clinical trial

706

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)

Patients randomized to durvalumab monotherapy may undergo up to 24 months of retreatment.
Patients who discontinue treatment after RECIST 1.1-defined PD will be followed up for survival.
Patients who have discontinued treatment due to toxicity or symptomatic deterioration, or who have commenced subsequent anticancer therapy, will be followed up with tumor assessments until RECIST 1.1-defined PD plus 1 or more follow-up scans or until death (whichever comes first) and followed for survival.

I paz randomiz alla monot con durva possono essere sottoposti a un max di 24 mesi di ritrattamento.
I paz che interromp il trattam dopo PD come def da RECIST1.1 saranno seguiti per la sopravv.
I paz che hanno interrotto il trattam a causa di tossicità o deterioram sintom, o hanno iniziato la succes terap antitum, saranno seguiti con valutaz del tum fino a PD def sec RECIST1.1 e verranno loro effett 1o+ scan di f-u fino a decesso (a sec dell'ev che si verif per primo) e seguiti per la sopravv

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

2019-06-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-04-17

P. End of Trial
P.	End of Trial Status	Ongoing

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