E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non Small Cell Lung Cancer stage IIB/IV or recurrent |
tumore del polmone non a piccole cellule, in stadio IIIB/IV o recidivante |
|
E.1.1.1 | Medical condition in easily understood language |
Non Small Cell Lung Cancer stage IIIB/IV or recurrent |
Tumore Polmonare Non a piccole cellule stadio IIIB/IV o recidivante |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 |
Progression Free Survival PFS |
Sopravvivenza senza progressione di malattia |
|
E.2.2 | Secondary objectives of the trial |
Overall Survival OS |
sopravvivenza complessiva |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
patients> 18 years; ECOG PS 0-1; disease stage IIIB / IV according to the classification RECIST 1.1 with a cytotoxic or histo-logical diagnosis of NSCLC (non-squamous) and who have previously received only chemotherapy (except for treatment neo-adjuvant or adjuvant, from which must be spent at least 12 months compared to study entry); the presence of at least one measurable lesion according to RECIST (version 1.1). |
pazienti con età > 18 anni; PS secondo ECOG 0-1; malattia in stadio IIIB/IV secondo la classificazione RECIST 1.1 con diagnosi cito- o istologica di NSCLC (non squamoso) e che abbiano precedentemente ricevuto un solo trattamento chemioterapico (fatta eccezione per trattamento neo-adiuvante o adiuvante, dal quale devono essere trascorsi almeno 12 mesi rispetto all'arruolamento nello studio); la presenza di almeno una lesione misurabile secondo i criteri RECIST (versione 1.1). |
|
E.4 | Principal exclusion criteria |
are excluded patients with a previous diagnosis of oncologic pathology , except for non-melanoma skin cancers, carcinoma in situ of the cervix or other forms of cancer from which the patient must, however, be free from at least 3 years prior to study enrollment; patients with known positivity for molecular studies such as EGFR and ALK; previous treatment with TKIs or inhibitors of ALK; presence of brain metastases unstable (defined as stable if spent four weeks from a previous radiation therapy); previous chemotherapy with docetaxel or VEGFR inhibitors (except for Avastin, which is allowed by the study); more than one line of chemotherapy treatment (with the exception above to neoadjuvant or adjuvant treatment); persistent and non-hematological toxicities in reference to previous treatments carried out; presence of cavitations in the lung or evidence on CT or MRI of tumors central or local invasion of the major vessels, or a recent history (<3 months) of hemoptysis or bleeding or thrombotic event more important in the previous six months; anticoagulant therapy (except heparin bpm) or antiplatelet therapy (except aspirin dosage <325mg daily); significant cardiac disease (unstable angina, myo |
sono esclusi i pazienti con precedente diagnosi di patologia/e oncologica/he precedente/i, fatta eccezione per i carcinomi cutanei nonmelanoma, i carcinomi in situ della cervice o altre forme tumorali dalle quali il paziente dovrà, tuttavia, risultare libero da almeno 3 anni prima dell'arruolamento nello studio; pazienti con nota positività per indagini molecolari quali EGFR ed ALK; precedente trattamento con TKI o inibitori di ALK; presenza di metastasi cerebrali instabili (definite stabili se trascorse 4 settimane da un precedente trattamento radioterapico); precedenti trattamenti chemioterapici con docetaxel o inibitori di VEGFR (eccezione per bevacizumab, che è consentito dallo studio); più di una linea di trattamento chemioterapico (con l'eccezione sopra riportata per trattamento adiuvante o neoadiuvante); persistere di tossicità ematologiche e non- in riferimento ai precedenti trattamenti effettuati; presenza di cavitazioni a livello polmonare o evidenza alla TC o RMN di tumori centrali o invasione locale dei maggiori vasi, o una recente storia (< 3 mesi) di emottisi o evento trombotico maggiore o sanguinamenti importanti nei precedenti 6 mesi; terapia anticoagulante (eccetto eparina a bpm) o terapia antiaggregante (eccetto acido acetilsalicilico con dosaggio <325mg al dì); patologie cardiologiche significative (angina instabile; infarto del miocardio negli ultimi 6 mesi, scompenso cardiaco con NYHA II); diabete mellito scompensato o necessità di alti dosaggi di steroide. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival PFS |
Sopravvivenza senza progressione di malattia |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Overall Survival OS |
sopravvivenza complessiva |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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 | No |
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) | No |
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 | 15 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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
|
February 2017 |
Febbraio 2017 |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |