Clinical Trials Register

Summary
EudraCT Number:	2019-001979-36
Sponsor's Protocol Code Number:	J2G-MC-JZJC
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:	2021-06-14
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

2019-001979-36

A.3

Full title of the trial

A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Platinum-Pemetrexed Chemotherapy Plus Investigator’s Choice of Pembrolizumab in Patients with Advanced, Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

LIBRETTO-431: Studio multicentrico, randomizzato, in aperto, di fase III, mirato a confrontare Selpercatinib alla terapia a base di platino e pemetrexed con o senza Pembrolizumab come trattamento di prima linea nel carcinoma polmonare non a piccole cellule in fase avanzata o metastatica con riarrangiamento del gene RET.

A.3.1

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

A Trial Comparing Selpercatinib to Chemotherapy in Patients with Non-Small Cell Lung Cancer

Sperimentazione clinica che confronta Selpercatinib con la chemioterapia in pazienti con cancro del polmone non a piccole cellule

A.3.2

Name or abbreviated title of the trial where available

LIBRETTO-431

A.4.1

Sponsor's protocol code number

J2G-MC-JZJC

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	ELI LILLY & COMPANY, LILLY CORPORATE CENTER
B.1.3.4	Country	United States
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	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center, DC 1526
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	46285
B.5.3.4	Country	United States
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.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	SELPERCATINIB
D.3.2	Product code	[LY3527723]
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	Selpercatinib
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB193120
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.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	SELPERCATINIB
D.3.2	Product code	[LY3527723]
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	Sepelrcatinib
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB193120
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: 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	Ribocarbo®-L
D.2.1.1.2	Name of the Marketing Authorisation holder	HIKMA FARMACÊUTICA (PORTUGAL), S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	carboplatino
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	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	Carboplatino
D.3.9.1	CAS number	41575-94-4
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB06614MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	10
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: 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	Cisplatin Accord
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Poland
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	cisplatino
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	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	CISPLATINO
D.3.9.1	CAS number	15663-27-1
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB07483MIG
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	1
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: 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	Keytruda
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme B.V.
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	Pembrolizumab
D.3.2	Product code	[NA]
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	HA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB167136
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	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	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: 6
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	Eli Lilly Nederland B.V.
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.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	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 DISODICO
D.3.9.1	CAS number	137281-23-3
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB09655MIG
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	500
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: 7
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	Keytruda
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme B.V.
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	Pembrolizumab
D.3.2	Product code	[na]
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	HA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB167136
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	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	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: 8
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	Eli Lilly Nederland B.V.
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.3.2	Product code	[na]
D.3.4	Pharmaceutical form	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 DISODICO
D.3.9.1	CAS number	137281-23-3
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB09655MIG
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)	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: 9
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	Carbomedac
D.2.1.1.2	Name of the Marketing Authorisation holder	Medac
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Carboplatino
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	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	CARBOPLATINO
D.3.9.1	CAS number	41575-94-4
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB06614MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	10
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: 10
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	Carboplatin – Teva
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva Pharma 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	Carboplatino
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	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	CARBOPLATINO
D.3.9.1	CAS number	41575-94-4
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB06614MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	10
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: 11
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	Cisplatin Neocorp®
D.2.1.1.2	Name of the Marketing Authorisation holder	Hexal AG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Cisplatino
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	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	CISPLATINO
D.3.9.1	CAS number	15663-27-1
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB07483MIG
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	1
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: 12
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	Cisplatin Teva®
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Cisplatino
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	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	CISPLATINO
D.3.9.1	CAS number	15663-27-1
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB07483MIG
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	1
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

Male or female patients with advanced, treatment-naïve RET Fusion-Positive Non-Squamous NSCLC

Pazienti di sesso maschile o femminile con NSCLC avanzato, con riarrangiamento del gene RET, naïve al trattamento

E.1.1.1

Medical condition in easily understood language

Non-Small Cell Lung Cancer

carcinoma polmonare non a piccole cellule

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

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare PFS of selpercatinib and platinum- based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab in patients with advanced or metastatic RET fusion-positive NSCLC

To compare PFS of selpercatinib with the combination of platinum based (carboplatin or cisplatin) and pemetrexed therapy, with or without pembrolizumab, in patients with advanced or metastatic RET fusion positive NSCLC

Confrontare la PFS della terapia con selpercatinib e della terapia a base di platino (carboplatino o cisplatino) e pemetrexed in associazione o meno a pembrolizumab, in pazienti con NSCLC avanzato o metastatico con fusione di RET

Per confrontare la PFS di selpercatinib con la combinazione terapia al platino (carboplatino o cisplatino) e terapia con pemetrexed, con o senza pembrolizumab, in pazienti con NSCLC avanzato o metastatico con fusione di RET

E.2.2

Secondary objectives of the trial

- To compare the efficacy of selpercatinib and with the combination of platinum-based (carboplatin or cisplatin) therapy, pemetrexed, and pembrolizumab in patients with advanced or metastatic RET fusion positive NSCLC
- To compare the efficacy of selpercatinib with the combination of platinum-based (carboplatin or cisplatin) and pemetrexed therapy, with or without pembrolizumab, in patients with advanced or metastatic RET fusion-positive NSCLC
- To assess safety and tolerability of selpercatinib compared to platinum based and pemetrexed therapy with pembrolizumab
- To assess safety and tolerability of selpercatinib compared to platinum based and pemetrexed therapy with or without pembrolizumab
- To assess/evaluate performance of RET local laboratory tests compared to a single, central test.

- Per confrontare l'efficacia di selpercatinib con la combinazione di terapia a base di platino (carboplatino o cisplatino), pemetrexed e pembrolizumab in pazienti con NSCLC avanzato o metastatico con fusione di RET
- Per confrontare l'efficacia di selpercatinib con la combinazione di terapia a base di platino (carboplatino o cisplatino) e pemetrexed, con o senza pembrolizumab, in pazienti con NSCLC avanzato o metastatico con fusione di RET
- Per valutare la sicurezza e la tollerabilità di selpercatinib rispetto alla terapia a base di platino e pemetrexed con pembrolizumab
- Per valutare la sicurezza e la tollerabilità di selpercatinib rispetto alla terapia a base di platino e pemetrexed con o senza pembrolizumab
- Per valutare le prestazioni dei test di laboratorio locale RET rispetto a un singolo test centrale.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Histologically confirmed Stage IIIB-IIIC or Stage IV non-squamous NSCLC that is not suitable for radical surgery or radiation therapy
- A RET gene fusion in tumor and/or blood from a qualified laboratory
- Measurable disease as determined by RECIST 1.1 by the investigator
- ECOG performance status of 0-2
- Adequate hematologic, hepatic and renal function
- Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 6 months after
- Written informed consent

-NSCLC non squamoso,stadio istologicamente o citologicamente confermato IIIB-IIIC or stadio IV che non è adatto per la chirurgia radicale o la radioterapia
- fusione genica RET nel tumore e/o nel sangue da un laboratorio qualificato
- Malattia misurabile come determinato da RECIST 1.1 dallo sperimentatore
- Stato delle prestazioni ECOG pari a 0-2
- Funzione ematologica, epatica e renale adeguata
- Volontà degli uomini e delle donne con potenziale riproduttivo di osservare il controllo delle nascite convenzionale ed efficace per la durata del trattamento e per 6 mesi dopo
- Consenso informato scritto

E.4

Principal exclusion criteria

- Additional validated oncogenic drivers in NSCLC if known
- Prior systemic therapy for metastatic disease
- Major surgery (excluding placement of vascular access) within 3 weeks prior to planned start of LOXO-292
- Radiotherapy for palliation within 1 week of the first dose of study treatment or within 6 months prior to the first dose of study treatment if more than 30 Gy to the lung
- Symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression
- Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO 292 or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) > 470 msec
- Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
- Require concomitant use of medications known to cause QTc prolongation
- Known hypersensitivity to any of the excipients of the study drugs
- Pregnancy or lactation
- Active second malignancy
- Versamento pericardico o pleurico incontrollato, correlato alla malattia che richiedono un trattamento cronico con steroidi
- Has known active Hepatitis B or C.

Exclusion Criteria for patients receiving pembrolizumab
- History of interstitial lung disease or interstitial pneumonitis
- Active autoimmune disease or any illness or treatment that could compromise the immune system

- Ulteriori fattori oncogeni convalidati in NSCLC se noti
- Precedente terapia sistemica per la malattia metastatica
- Chirurgia maggiore (escluso il posizionamento dell'accesso vascolare) entro 3 settimane dall'inizio previsto di selpercatinib
- Radioterapia per la palliazione entro 1 settimana dalla prima dose di trattamento di studio o entro 6 mesi prima della prima dose di trattamento di studio se più di 30 Gy al polmone
- Metastasi sintomatiche di SNC, carcinomatosi leptomeningeale o compressione del midollo spinale non trattata
- Malattia cardiovascolare attiva clinicamente significativa o storia di infarto miocardico entro 6 mesi prima dell'inizio pianificato di selpercatinib o il prolungamento dell'intervallo QT corretto per la frequenza cardiaca utilizzando la formula di Fridericia (QTcF) > 470 msec
- Infezione sistemica attiva incontrollata, virale o fungina o grave malattia intercorrente in corso, come ipertensione o diabete, nonostante il trattamento ottimale. Lo screening per le condizioni croniche non è necessario
- Sindrome da malassorbimento attiva clinicamente significativa o altra condizione che potrebbe influenzare l'assorbimento gastrointestinale del farmaco di studio
-Richiedere l'uso concomitante di medicazioni note per causare il prolungamento QTc
- Ipersensibilità nota a uno qualsiasi degli eccipienti dei farmaci di studio
- Gravidanza o allattamento
- Seconda malignità attiva
- Versamento pericardico o pleurico incontrollato, correlato alla malattia che richiedono un trattamento cronico con steroidi
- Ha l'epatite b o C attiva.

Criteri di esclusione per i pazienti che ricevono pembrolizumab
- Storia di malattia polmonare interstiziale o polmonite interstiziale
- Malattia autoimmune attiva o qualsiasi malattia o trattamento che possa compromettere il sistema immunitario

E.5 End points

E.5.1

Primary end point(s)

PFS per RECIST 1.1 by BICR nei pazienti che ricevono pembrolizumab e nella popolazione intent-to-treat (con o senza pembrolizumab) [Endpoint coprimario]

PFS per RECIST 1.1 by BICR in patients receiving pembrolizumab and in the intent-to-treat population (with or without pembrolizumab) [Coprimary endpoint]

E.5.1.1

Timepoint(s) of evaluation of this end point

Time Frame: Baseline through Disease Progression or Death (Estimated at up to 24 Months)

tempistiche: baseline fino a progressione di malattia o morte (stima fino a 24 settimane)

E.5.2

Secondary end point(s)

1. PFS per RECIST 1.1 by investigator assessment (with pembrolizumab)
2. PFS per RECIST 1.1 by investigator assessment (with or without pembrolizumab)
3. ORR per RECIST 1.1 by BICR (with pembrolizumab)
4. ORR per RECIST 1.1 by BICR (with or without pembrolizumab)
5. DOR per RECIST 1.1 by BICR (with pembrolizumab)
6. DOR per RECIST 1.1 by BICR (with or without pembrolizumab)
7. DCR per RECIST 1.1 by BICR (with pembrolizumab)
8. DCR per RECIST 1.1 by BICR (with or without pembrolizumab)
9. ORR per RECIST 1.1 by investigator assessment (with
pembrolizumab)
10. ORR per RECIST 1.1 by investigator assessment (with or without
pembrolizumab)
11. DOR per RECIST 1.1 by investigator assessment (with
pembrolizumab)
12. DOR per RECIST 1.1 by investigator assessment (with or without
pembrolizumab)
13. DCR per RECIST 1.1 by investigator assessment (with
pembrolizumab)
14. DCR per RECIST 1.1 by investigator assessment (with or without
pembrolizumab)
15. Intracranial response per RECIST 1.1 by investigator assessment
(with pembrolizumab)
16. Intracranial response per RECIST 1.1 by investigator assessment
(with or without pembrolizumab)
17. PFS2 (with pembrolizumab)
18. PFS2 (with or without pembrolizumab)
19. OS (with pembrolizumab)
20. OS (with or without pembrolizumab)
21. Time to deterioration in pulmonary symptoms per NSCLC SAQ (with
pembrolizumab)
22. Time to deterioration in pulmonary symptoms per NSCLC SAQ (with
or without pembrolizumab)
23. Safety, including but not limited to SAEs, AEs, deaths, and clinical
laboratory abnormalities per CTCAE v5.0 (with pembrolizumab)
24. Safety, including but not limited to SAEs, AEs, deaths, and clinical
laboratory abnormalities per CTCAE v5.0 (with and without
pembrolizumab)
25. RET fusion status

. PFS per RECIST 1.1 secondo la valutazione dello sperimentatore (con pembrolizumab)
2. PFS secondo RECIST 1.1 secondo la valutazione dello sperimentatore (con o senza pembrolizumab)
3. ORR secondo RECIST 1.1 secondo BICR (con pembrolizumab)
4. ORR secondo RECIST 1.1 secondo BICR (con o senza pembrolizumab)
5. DOR secondo RECIST 1.1 di BICR (con pembrolizumab)
6. DOR secondo RECIST 1.1 di BICR (con o senza pembrolizumab)
7. DCR per RECIST 1.1 da BICR (con pembrolizumab)
8. DCR per RECIST 1.1 da BICR (con o senza pembrolizumab)
9. ORR per RECIST 1.1 dalla valutazione dello sperimentatore (con
pembrolizumab)
10. ORR per RECIST 1.1 dalla valutazione dello sperimentatore (con o senza
pembrolizumab)
11. DOR per RECIST 1.1 dalla valutazione dello sperimentatore (con
pembrolizumab)
12. DOR per RECIST 1.1 dalla valutazione dello sperimentatore (con o senza
pembrolizumab)
13. DCR per RECIST 1.1 dalla valutazione dello sperimentatore (con
pembrolizumab)
14. DCR per RECIST 1.1 dalla valutazione dello sperimentatore (con o senza
pembrolizumab)
15. Risposta intracranica secondo RECIST 1.1 dalla valutazione dello sperimentatore
(con pembrolizumab)
16. Risposta intracranica secondo RECIST 1.1 dalla valutazione dello sperimentatore
(con o senza pembrolizumab)
17. PFS2 (con pembrolizumab)
18. PFS2 (con o senza pembrolizumab)
19. OS (con pembrolizumab)
20. OS (con o senza pembrolizumab)
21. Tempo al deterioramento dei sintomi polmonari per NSCLC SAQ (con
pembrolizumab)
22. Tempo al deterioramento dei sintomi polmonari per NSCLC SAQ (con
o senza pembrolizumab)
23. Sicurezza, inclusi ma non limitati a SAE, AE, decessi e clinici
anomalie di laboratorio secondo CTCAE v5.0 (con pembrolizumab)
24. Sicurezza, inclusi ma non limitati a SAE, AE, decessi e clinici
anomalie di laboratorio per CTCAE v5.0 (con e senza
pembrolizumab)
25. Stato di fusione RET

E.5.2.1

Timepoint(s) of evaluation of this end point

1. + 2. Baseline to Progressive Disease or Death from Any Cause (up to 24 Months)
3. Baseline to Second Disease Progression or Death from Any Cause (up to 36 Months)
4. + 5. Baseline through Disease Progression or Death (up to 24 Months)
6. Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (up to 24 Months)
7. Baseline through Disease Progression or Death (up to 24 Months)
8. + 9. Baseline to Date of Death from Any Cause (up to 48 Months)
10. + 11. Baseline through Disease Progression or Death (up to 24 Months)
12. + 13. Baseline to Deterioration of Pulmonary Symptoms (up to 24 Months)
14. Baseline through Disease Progression or Death (up to 24 Months)

1. + 2. Baseline per malattia progressiva o morte per qualsiasi causa (fino a 24 mesi)
3. Dal basale alla seconda progressione della malattia o morte per qualsiasi causa (fino a 36 mesi)
4. + 5. Baseline attraverso progressione della malattia o morte (fino a 24 mesi)
6. Data di CR o PR fino a Data di progressione della malattia o decesso per qualsiasi causa (fino a 24 mesi)
7. Baseline attraverso progressione della malattia o morte (fino a 24 mesi)
8. + 9. Baseline fino alla data di decesso per qualsiasi causa (fino a 48 mesi)
10. + 11. Baseline attraverso progressione della malattia o morte (fino a 24 mesi)
12. + 13. Baseline per il deterioramento dei sintomi polmonari (fino a 24 mesi)
14. Baseline attraverso progressione della malattia o morte (fino a 24 mesi)

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

Yes

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.8.2.4

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

Australia

Brazil

Canada

China

Hong Kong

Israel

Japan

Korea, Republic of

Mexico

Russian Federation

Singapore

Taiwan

Turkey

Ukraine

Belgium

France

Germany

Greece

Italy

Netherlands

Poland

Romania

Spain

United Kingdom

Czechia

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:

125

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

125

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

164

F.4.2.2

In the whole clinical trial

250

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

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

2020-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-01-08

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

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IMP with orphan designation in the indication
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