E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non Small Cell Lung Cancer |
Tumore polmonare non a piccole cellule |
|
E.1.1.1 | Medical condition in easily understood language |
Non Small Cell Lung Cancer |
Tumore 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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066490 |
E.1.2 | Term | Progression of 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 | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate Progression Free Survival (PFS) in patients who have ''acquired resistance'' to first line gefitinib |
L’obiettivo primario dello studio è valutare la sopravvivenza libera da progressione (PFS) in pazienti che hanno acquisito resistenza al trattamento di prima linea con gefitinib. |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate overall survival (OS) 2. To evaluate Objective Response Rate (ORR) and Disease Control Rate (DCR) 3. To evaluate symptoms and Health related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire 4. To evaluate gefitinib safety and tolerability. |
• Valutare la sopravvivenza globale (OS) in pazienti che hanno acquisito resistenza al trattamento con gefitinib
• Valutare il tasso di risposta obiettiva (ORR) e il tasso di controllo della malattia (DCR)
• Valutare i sintomi e la qualità della vita correlata alla salute (Health Related Quality of Life HRQOL) mediante i questionari FACT-L (Functional Assessment of Cancer Therapy for Lung Cancer)
• Valutare sicurezza e tollerabilità di gefitinib. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1)-Male or female patients aged 18 years or older 2)-Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally 3)-Patients with documented 'acquired resistance' on first line gefitinib 4)-Patients suitable to start cisplatin based pemetrexed combination chemotherapy. 5)-Provision of informed consent prior to any study specific procedures. |
1)Soggetti di sesso femminile o maschile di almeno 18 anni di età.
2)Conferma citologica o istologica di carcinoma polmonare non a piccole cellule (NSCLC) ad eccezione dell’istologia predominantemente squamosa, con una mutazione attivante del recettore tirosin-chinasico del fattore di crescita epidermico (EGFR TK) ottenuta tramite esame eseguito localmente.
3) “Resistenza acquisita” ad una prima linea di trattamento con gefitinib, come da definizioni nel protocollo.
4) Pazienti idonei ad iniziare chemioterapia combinata con cisplatino e pemetrexed.
5) Consenso informato firmato e datato dal paziente prima di qualsiasi procedura studio specifica. |
|
E.4 | Principal exclusion criteria |
1)-Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib). 2)-Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease 3)-Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer 4)-Any evidence of severe of uncontrolled systemic disease 5)-Treatment with an investigational drug within 4 weeks before randomization |
1)Precedente chemioterapia o altre terapie anti-neoplastiche sistemiche (escluso gefitinib)
2) Storia medica di malattia interstiziale polmonare, malattia interstiziale farmaco-indotta, polmonite da radiazioni che richieda trattamento steroideo o qualsiasi evidenza di malattia interstiziale polmonare clinicamente attiva.
3) Altre neoplasie maligne co-esistenti o neoplasie maligne diagnosticate nell’arco degli ultimi 5 anni, con l’eccezione di carcinoma a cellule basali o cancro cervicale in situ o cancro intramucosale gastrico completamente asportato.
4)A giudizio del ricercatore, qualunque evidenza di malattia sistemica grave non controllata (es. malattia respiratoria, cardiaca, renale o epatica, instabile o non compensata).
5) 10. Trattamento con un farmaco sperimentale nelle 4 settimane precedenti la randomizzazione (è concessa la somministrazione di un trattamento di prima linea con gefitinib mediante uno studio clinico o un altro programma di accesso). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival (PFS) |
sopravvivenza libera da progressione |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
for the study: until 190 PFS events |
fino a 190 eventi PFS |
|
E.5.2 | Secondary end point(s) |
1) Overall survival (OS) 2) Object Response Rate (ORR) 3) Disease Control Rate (DCR) 4) Symptoms and HRQOL as measured by the FACT-L Trial Outcome Index (TOI) 5) Safety and tolerability |
1) Sopravvivenza globale (OS)
2) Tasso di risposta obiettiva (ORR)
3) Tasso di controllo della malattia (DCR)
4) Sintomi e la qualità della vita correlata alla salute (Health Related Quality of Life HRQOL) mediante i questionari FACT-L (Functional Assessment of Cancer Therapy for Lung Cancer)
5) Sicurezza e tollerabilità |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) for the study: until 125 OS events 2) until progression or last evaluable assessment in absence of progression 3) until 6 weeks following progression 4) from randomization until treatment discontinuation 5) from consent to 30 days after discontinuation of study treatment |
1) per lo studio: fino a 125 eventi OS 2) fino a preogressione o all'ultimo assesment valutabile in assenza di progressione di malattia
3) fino a 6 settimane successive a progressione
4) dalla randomizzazione fino alla discontinuazione dle trattamento
5) dal comsemso a 30 gg dopo la discontinuazione del trattamento |
|
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 | Yes |
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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | No |
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 |
China |
Hong Kong |
Japan |
Russian Federation |
Taiwan |
|
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 | 4 |
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 | 4 |
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 |