Clinical Trials Register

Summary
EudraCT Number:	2015-005605-36
Sponsor's Protocol Code Number:	SCI-Ta1-NSCLC-CHEMOP2-001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-01-18
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

2015-005605-36

A.3

Full title of the trial

Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type

Studio di Fase II per valutare l’attività della Timosina alfa 1 aggiunta alla chemioterapia standard di mantenimento (più cisplatino o carboplatino) in pazienti con carcinoma polmonare
non a piccole cellule metastatico, EGFR wild type

A.3.1

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

Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type.

A.3.2

Name or abbreviated title of the trial where available

SCI-Ta1-NSCLC-CHEMO P2-001

A.4.1

Sponsor's protocol code number

SCI-Ta1-NSCLC-CHEMOP2-001

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	SCICLONE PHARMACEUTICALS ITALY S.R.L.
B.1.3.4	Country	Italy
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	SciClone Pharmaceuticals Italy
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sciclone Pharmaceuticals Italy Srl
B.5.2	Functional name of contact point	Procuratore Speciale
B.5.3	Address:
B.5.3.1	Street Address	Via di Tiglio 126
B.5.3.2	Town/ city	Lucca
B.5.3.3	Post code	55100
B.5.3.4	Country	Italy
B.5.4	Telephone number	05831913257
B.5.5	Fax number	058391457
B.5.6	E-mail	francesco.dicostanzo@icloud.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	Yes
D.2.1.1.1	Trade name	ZADAXIN - 1.6 MG/ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 1 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	SCICLONE PHARMACEUTICALS ITALY 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	ZADAXIN
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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

metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type

carcinoma polmonare non a piccole cellule metastatico con EGFR non mutato

E.1.1.1

Medical condition in easily understood language

metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type

carcinoma polmonare non a piccole cellule metastatico con EGFR non mutato

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10064049
E.1.2	Term	Lung adenocarcinoma metastatic
E.1.2	System Organ Class	100000004864

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 evaluate the activity/efficacy in terms of PFS of SoC chemotherapy with cisplatin (or carboplatin) and either Pemetrexed, Paclitaxel, Gemcitabine, or Bevacizumab+Thymosin alpha 1
in patients with advanced EGFR wild type NSCLC as compared to a control group of patients
receiving SoC chemotherapy alone.

Valutare l’attività/efficacia (in termini di progression free survival - PFS) della Timosina alfa 1
in associazione alla chemioterapia standard + cisplatino (o carboplatino) confrontata con la sola chemioterapia+ cisplatino (o carboplatino) in pazienti con tumore polmonare non a piccole
cellule che non presentino mutazioni sensibilizzanti dell’ EGFR.

E.2.2

Secondary objectives of the trial

Overall Survival (OS);
Quality of Life (QoL);
Organ failure free days;
Safety;
Biomarkers of immunity and inflammation.

Sopravvivenza globale;
Qualità della vita;
I giorni senza insufficienza d’organo;
I biomarcatori di immunità e dell’infiammazione;
Sicurezza;

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age 18 years or older;
Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples will be enrolled;
Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy ;
Measurable disease by Response Evaluation Criteria In Solid Tumours (RECIST) in a
lesion not previously irradiated or non-measurable disease;
Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2;
Absolute neutrophil count (ANC) > 1.5 x 10 9 /liter (L) and platelets > 100 x 10 9 /L ;
Bilirubin level either normal or <1.5 x ULN;
AST (SGOT) and ALT (SGPT) <2.5 x ULN (≤5 x ULN if liver metastases are present);
Serum creatinine <1.5 x ULN;
Effective contraception for both, male and female pts, if the risk of conception exists;
Recovery from all acute toxicities of prior therapies;
Provision of written informed consent to the analysis of biological markers (registration).

Età >= 18 anni;
Conferma istologica o citologica di NSCLC;
NSCLC localmente avanzato o metastatico, non sottoponibile a resezione chirurgica o radioterapia;
Malattia misurabile secondo RECIST in una lesione non precedentemente trattata con radioterapia o malattia non misurabile;
ECOG-PS 0-2;
Neutrofili Assoluti> 1.5 x 10 9/L e piastrine > 100 x 10 9/L ;
Bilirubina livelli normali o <1.5 x ULN;
AST (SGOT) and ALT (SGPT) <2.5 x ULN (≤5 x ULN se presenti metastasi epatiche);
Creatinina sierica <1.5 x ULN;
Efficaci metodi contraccettivi per entrambi i sessi (maschi e femmine), se esiste potenziale rischio di concepimento;
Recupero da effetti tossici di precedenti terapie;
Consenso Informato scritto.

E.4

Principal exclusion criteria

Prior therapy with Thymosin alpha-1;
Prior therapy with a study drug ;
Newly diagnosed central nervous system (CNS) metastases that have not yet been treated
with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or
spinal cord compression may be considered if they have evidence of clinically stable
disease (SD) (no steroid therapy or steroid dose being tapered) for at least 28 days;
Pregnancy or suspected pregnancy;
Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of
the investigator, makes it inappropriate for the patient to be enrolled in the study;
Known severe hypersensitivity to a study drug or anyof the excipients of this product;
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the
exception of basal cell carcinoma or cervical cancer in situ;
Any evidence of clinically active interstitial lung disease (ILD) (patients with chronic,
stable, radiographic changes who are asymptomatic or patients with uncomplicated
progressive lymphangiticcarcinomatosis need not be excluded);
As judged by the investigator, any evidence of severe or uncontrolled systemic disease
(e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
As judged by the investigator, any inflammatory changes of the surface of the eye;
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.

Precedente terapia con Timosina alfa-1;
Precedente terapia con un nuovo farmaco;
Recente diagnosi di metastasi a livello CNS che non sono state ancora trattate chirurgicamente e/o con radioterapia. Pazienti con precedente diagnosi e trattamento di metastasi al CNS o compressione del midollo spinale possono essere considerati per lo Studio, se ci sono evidenze che la malattia é clinicamente stabile (SD) per almeno 28 giorni;
Gravidanza o sospetta gravidanza;
Non risolta tossicità cronica per precedenti trattamenti anti-cancro che secondo giudizio clinico rendono il paziente non elegibile allo Studio;
Conosciuta serie ipersensibilità al principio attivo in Studio o a qualunque eccipiente;
Oltra neoplasia concomitante o diagnosticata negli ultimi 5 anni ad eccezione del basalioma o del cancro alla cervice in situ;
qualsiasi evidenza di malattia interstiziale polmonare clinicamente attiva;
qualsiasi evidenza, secondo il giudizio clinico, di severa o incontrollata malattia sistemica;
qualsiasi cambiamento infiammatorio oculare secondo il giudizio clinico;
qualsiasi evidenza di altro disturbo clinico o di parametro di laboratorio che rende il paziente non elegibile allo studio.

E.5 End points

E.5.1

Primary end point(s)

Time to PSF

Tempo alla PSF

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.5.2

Secondary end point(s)

Time to Overall Survival (OS)

Tempo di Soppravvivenza Globale

E.5.2.1

Timepoint(s) of evaluation of this end point

Approximately at 26 months follow up

Approssimativamente a 26 mesi di Follow-up

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

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.8.2.4

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

140

F.4.2

For a multinational trial

F.4.2.1

In the EEA

140

F.4.2.2

In the whole clinical trial

140

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)

At the end of participation in the study, it will be proposed to the patient the therapy considered most suitable based on available knowledge.

Al termine della partecipazione allo studio, sarà proposta al paziente la terapia considerata più adeguata sulla base delle conoscenze disponibili.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	IRCCS San Raffaele
G.4.3.4	Network Country	Italy

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-05-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-07-07

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

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