Clinical Trials Register

Summary
EudraCT Number:	2014-000594-39
Sponsor's Protocol Code Number:	D5160C00003
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-07-09
Trial results	View 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

2014-000594-39

A.3

Full title of the trial

A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene (AURA3)

Studio di Fase III, In Aperto, Randomizzato con AZD9291 Versus una Doppietta di Chemioterapia a Base di Platino in Pazienti con Tumore Polmonare Non a Piccole Cellule Localmente Avanzato o Metastatico la cui Malattia è Progredita a seguito di un Precedente Trattamento con un Inibitore Tirosinchinasico del Recettore del Fattore di Crescita Epidermico e il Cui Tumore Porta la Mutazione T790M all’Interno del Gene del Recettore del Fattore di Crescita Epidermico (AURA3)

A.3.1

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

AZD9291 versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

AZD9291 Versus una Doppietta di Chemioterapia a Base di Platino in Pazienti con Tumore Polmonare Non a Piccole Cellule Localmente Avanzato o Metastatico.

A.3.2

Name or abbreviated title of the trial where available

AURA3

AURA 3

A.4.1

Sponsor's protocol code number

D5160C00003

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.5.3.4	Country	United States
B.5.6	E-mail	information.centre@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	AZD9291 80 mg film-coated tablet
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	Not yet assigned
D.3.9.1	CAS number	1421373-66-1
D.3.9.2	Current sponsor code	AZD9291 mesylate
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	AZD9291 40 mg film-coated tablet
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	Not yet assigned
D.3.9.1	CAS number	1421373-66-1
D.3.9.2	Current sponsor code	AZD9291 mesylate
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Comparator
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	CARBOPLATINO
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA PHARMA B.V. Computerweg, 10 - 3542 DR Utrecht (Olanda)
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Carboplatin
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	Carboplatin
D.3.9.3	Other descriptive name	CARBOPLATIN
D.3.9.4	EV Substance Code	SUB06614MIG
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 4
D.1.2 and D.1.3	IMP Role	Comparator
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	CISPLATINO
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva Italia S.r.l.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Cisplatin
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	cisplatin
D.3.9.3	Other descriptive name	CISPLATIN
D.3.9.4	EV Substance Code	SUB07483MIG
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 5
D.1.2 and D.1.3	IMP Role	Comparator
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	ALIMTA
D.2.1.1.2	Name of the Marketing Authorisation holder	Ely Lilly Netherland B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Pemetrexed
D.3.4	Pharmaceutical form	Powder for 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	PEMETREXED
D.3.9.3	Other descriptive name	PEMETREXED
D.3.9.4	EV Substance Code	SUB09655MIG
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Locally Advanced or Metastatic Non-Small Cell Lung Cancer where Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and where Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

Tumore al polmone non a piccole cellule localmente avanzato o metastatico la cui Malattia è Progredita a seguito di un Precedente Trattamento con un Inibitore Tirosinchinasico del Recettore del Fattore di Crescita Epidermico e il Cui Tumore Porta la Mutazione T790M all’Interno del Gene del Recettore del Fattore di Crescita Epidermico.

E.1.1.1

Medical condition in easily understood language

Specific type of lung cancer called “non-small cell lung cancer” (NSCLC)

Specifico tipo di tumore al polmone chiamato "tumore al polmone 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	17.0
E.1.2	Level	PT
E.1.2	Classification code	10029515
E.1.2	Term	Non-small cell lung cancer recurrent
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 AZD9291 compared with platinum-based doublet chemotherapy by assessment of Progression Free Survival (PFS)

Valutare l’efficacia di AZD9291 confrontato con una doppietta di chemioterapia a base di platino attraverso la valutazione della sopravvivenza libera da progressione (PFS).

E.2.2

Secondary objectives of the trial

To further assess the efficacy of AZD9291 compared with platinum-based doublet chemotherapy in terms of:
- Objective Response Rate (ORR)
- Duration of Response (DoR)
- Disease Control Rate (DCR)
- Overall Survival (OS)
- Tumour shrinkage

To assess the effect of AZD9291 compared to platinum-based doublet chemotherapy on subjects’ disease-related symptoms and health related quality of life (HRQoL).

To characterise the pharmacokinetics (PK) of AZD9291, AZ5104 and AZ7550 in subjects receiving AZD9291.

Safety Objective

Valutare ulteriormente l’efficacia di AZD9291 paragonata con la doppietta di chemioterapia a base di platino in termini di:
- Tasso di Risposta Oggettivo (ORR)
- Durata della Risposta (DoR)
- Tasso di controllo della malattia (DCR)
- Sopravvivenza globale (OS)
- Riduzione della dimensione del tumore

Valutare l’effetto di AZD9291 confrontandolo con una doppietta di chemioterapia a base di platino sui sintomi della malattia e la qualità della vita in relazione allo stato salute (HRQoL).

Caratterizzare la farmacocinetica (PK) di AZD9291e dei metaboliti AZ5104 e AZ7550 nei soggetti che ricevono AZD9291.

Obiettivi di sicurezza.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subjects with histologically- or cytologically-documented NSCLC.
- Locally advanced or metastatic NSCLC.
- Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment.
- Eligible to receive treatment with the selected doublet-chemotherapy.
- Confirmation of EGFR mutation.
- Central confirmation of T790M+ mutation status.
- World Health Organisation (WHO) performance status 0-1.
- At least one lesion, not previously irradiated.

- Diagnosi istologica e citologica confermata di NSCLC (Tumore Polmonare Non a Piccole Cellule).
- NSCLC localmente avanzato o metastatico.
- Progressione radiologica della malattia documentata a seguito di un trattamento di prima linea con EGFR-TKI con nessun ulteriore trattamento.
- eleggibili a ricevere il trattamento con una doppietta di chemioterapia a base di platino in accordo alle prescrizioni locali.
- Mutazione dell’EGFR documentata.
- conferma centralizzata dello status di mutazione T790M+ del tumore.
- Performance status 0-1 secondo l’Organizzazione Mondiale della Sanità (OMS).
- Almeno una lesione, non precedentemente irradiata.

E.4

Principal exclusion criteria

- Treatment with more than one prior line of treatment for advanced NSCLC.
- Treatment with an approved EGFR-TKI (eg, erlotinib, gefitinib, afatinib) within 8 days or approximately 5 x half-life of the first dose of study treatment.
- Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- Previous treatment with an unapproved EGFR-TKI.

-Trattamento con più di un precedente trattamento per il NSCLC avanzato.
- Trattamento con un EGFR-TKI approvato (erlotinib,gefitinib,o afatinib) entro 8 giorni o circa 5 emivite, dalla prima dose del trattamento in studio.
-Qualsiasi chemioterapia citotossica, agenti sperimentali o altri farmaci antitumorali di un precedente regime di trattamento o studio clinico entro 14 giorni prima della randomizzazione.
- Precedente trattamento con un EGFR TKI non approvato.

E.5 End points

E.5.1

Primary end point(s)

Progression Free Survival (PFS) using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).

Sopravvivenza libera da progressione (PFS) sulla base delle valutazioni dello sperimentatore secondo i criteri RECIST 1.1.

E.5.1.1

Timepoint(s) of evaluation of this end point

At baseline and every 6 weeks from randomization until progression.

Al baseline ed ogni 6 settimane dalla randomizzazione fino a progressione.

E.5.2

Secondary end point(s)

ORR, DoR, DCR and tumour shrinkage using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).

Analysis of overall survival.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items (EORTC QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Lung Cancer 13 items (EORTC QLQ-LC13).

EORTC QLQ-C30:
Questionnaire consisting of 30 items measuring subjects general cancer symptoms and functioning.

EORTC QLQ-LC13:
A complementary questionnaire measuring lung cancer symptoms and side effects from conventional chemo- and radiotherapy.

PK exposure parameters derived from plasma concentrations of AZD9291, and metabolites AZ5104 and AZ7550.
PK Parameters (such as Clss/F, Css, min and Css, max AUCss) will be derived using population PK analysis and reported separately to the CSR. Data from this study may form part of a pooled analysis with data from other studies.

Safety endpoints:
- Adverse events (graded by Common Terminology Criteria for Adverse Event (CTCAE v4)
- Clinical chemistry, haematology and urinalysis
- Vital signs (pulse and blood pressure), Physical Examination, Weight
- Centrally reviewed digital Electrocardiogram (ECG)
- Echocardiogram/ Multi Gated Acquisition Scan (MUGA) (for Left Ventricular Ejection Fraction)
- World Health Organization (WHO) performance status

OOR, DoR, DCR e riduzione della dimensione del tumore secondo i criteri RECIST 1.1 sulla base delle valutazioni effettuate dallo sperimentatore.

Analisi della sopravvivenza globale.

EORTC QLQ-C30(Organizzazione Europea per la Ricerca e il Trattamento del Tumore Questionario sulla Qualità della Vita- 30 domande) e Organizzazione Europea per la Ricerca e il Trattamento del Tumore Questionario sulla Qualità della Vita- Tumore Polmonare 13 domande (EORTC QLQ-LC13).

EORTC QLQ-C30:
Questionario composto da 30 domande per misurare i sintomi generali del tumore e la funzionalità polmonare.

EORTC QLQ LC13:
Un questionario aggiuntivo per misurare i sintomi del tumore al polmone.

Parametri farmacocinetici di esposizione derivanti dalla concentrazione di AZD9291 plasmatica, e i metaboliti AZ5104 e AZ7550.
I parametri di PK (CLss/F, Css, min e Css, max AUCss) saranno calcolati usando analisi PK di popolazione e riportati separatamente nel Report dello Studio Clinico (CSR). I dati ottenuti da questo studio potrebbero diventare parte di un’analisi complessiva con dati di altri studi.

Endpoint di sicurezza:
Eventi Avversi (classificati secondo il CTCAE “Criteri di Terminologia Comune per un Evento Avverso” versione 4)
- Chimica Clinica, ematologia e analisi delle urine
- Segni vitali (frequenza cardiaca e pressione sanguigna), esami fisici, peso
- ECG digitale revisionato in modo centralizzato
- Ecocardiogramma/MUGA (Multiple Gated Acquisition Scan ) (per LVEF:Frazione di Eiezione Ventricolare Sinistra)
- Stato della Performance secondo l’OMS.

E.5.2.1

Timepoint(s) of evaluation of this end point

At baseline and every 6 weeks from randomization until progression.

Al baseline e ogni 6 settimane dalla randomizzazione fino a progressione.

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

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.3.1

Comparator description

doppietta di chemioterapia a base di platino.

platinum-based doublet chemotherapy

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

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

Australia

Canada

China

European Union

Hong Kong

Japan

Korea, Republic of

Mexico

Taiwan

United States

E.8.7

Trial has a data monitoring committee

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

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:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

210

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

117

F.4.2.2

In the whole clinical trial

610

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)

Subjects randomized to AZD9291 may continue to receive AZD9291 as long as they are continuing to show clinical benefit, as judged by the investigator, and in the absence of discontinuation criteria.

I soggetti potranno continuare a ricevere il trattamento con AZD9291 fin quando continuano a trarre beneficio, a seconda del giudizio dello sperimentatore, e in assenza di criteri che ne giustifichino l’interruzione.

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

2014-09-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-03

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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