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 | No |
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 | No |
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 |
|
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 | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |