E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed Small Cell Lung Cancer |
Carcinoma polmonare a piccole cellule in recidiva |
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E.1.1.1 | Medical condition in easily understood language |
Relapsed Small Cell Lung Cancer |
Carcinoma polmonare a piccole cellule in recidiva |
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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 | 10041068 |
E.1.2 | Term | Small cell lung cancer extensive stage |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 | 10041070 |
E.1.2 | Term | Small cell lung cancer recurrent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 | 10041069 |
E.1.2 | Term | Small cell lung cancer limited stage |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 the overall survival (OS) of nivolumab versus chemotherapy in subjects with relapsed SCLC after platinum-based, first-line chemotherapy |
Confrontare la sopravvivenza globale (Overall Survival) con nivolumab rispetto a chemioterapia in soggetti affetti da SCLC in recidiva dopo chemioterapia di prima linea a base di platino |
|
E.2.2 | Secondary objectives of the trial |
- To compare the progression free survival (PFS) of nivolumab versus chemotherapy - To compare the objective response rate (ORR) of nivolumab versus chemotherapy |
• Confrontare la sopravvivenza libera da progressione (progression free survival, PFS) con nivolumab rispetto a chemioterapia • Confrontare il tasso di risposta obiettiva (objective response rate, ORR) con nivolumab rispetto a chemioterapia
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult men and women with histologically or cytologically confirmed SCLC that recurred or progressed after platinum-based, first-line chemotherapy or chemoradiation therapy. Subjects must have had at least 4 cycles of platinum-based, first-line chemotherapy for either limited or extensive stage disease or if less than 4 cycles, must have had a BOR of at least partial or complete response. |
Uomini e donne adulti affetti da SCLC confermato istologicamente o citologicamente in recidiva o progressione dopo chemioterapia o chemio-radioterapia di prima linea a base di platino. I soggetti devono aver ricevuto almeno 4 cicli di chemioterapia di prima linea a base di platino per malattia in stadio limitato o esteso, oppure, nel caso in cui abbiano ricevuto meno di 4 cicli, devono aver avuto come BOR una risposta almeno parziale oppure una risposta completa. |
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E.4 | Principal exclusion criteria |
Untreated or symptomatic central nervous system (CNS) metastases, documented carcinomatous meningitis, active, known or suspected autoimmune disease, and prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways), topotecan, or amrubicin. |
Metastasi non trattate o sintomatiche del sistema nervoso centrale, meningite carcinomatosa documentata, malattia autoimmune in fase attiva, nota o sospetta, e precedente trattamento con anticorpo anti-PD-1, anti-PD-L1, anti PD L2, anti-CD137 o anti-CTLA-4 (incluso ipilimumab o qualsiasi altro anticorpo o farmaco specificamente diretto contro vie di co-stimolazione o di “checkpoint” delle cellule T), topotecan o amrubicina. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival (OS) in subjects with relapsed SCLC |
Sopravvivenza globale (Overall Survival, OS) in soggetti con SCLC in recidiva |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Approximately 12 months. Additional survival follow-up may continue for up to 5 years from the completion of the study |
Circa 12 mesi. Follow Up aggiuntivi sulla sopravvivenza possono continuare fino a 5 anni dopo il completamento dello studio. |
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E.5.2 | Secondary end point(s) |
1-progression free survival (PFS) 2-objective response rate (ORR) |
1)Sopravvivenza libera da progressione (Progression Free Survival, PFS) 2) Tasso di risposta obiettiva (Objective Response Rate, ORR) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Tumor response will be assessed every 6 weeks until Week 30, and every 12 weeks until disease progression or treatment discontinuation |
La risposta tumorale verrà valutata ogni 6 settimane fino alla settimana 30 e quindi ogni 12 settimane fino a progressione di malattia o discontinuazione dal trattamento. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Outcomes Research Assessments, Immunogenicity Assessments |
Valutazioni sugli esiti della ricerca, Valutazioni sull’Immunogenicità |
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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 | 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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 95 |
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 |
Chile |
Israel |
Japan |
Korea, Republic of |
Russian Federation |
Taiwan |
United States |
Austria |
Belgium |
Denmark |
Finland |
France |
Germany |
Greece |
Hungary |
Italy |
Netherlands |
Norway |
Poland |
Romania |
Spain |
Switzerland |
United Kingdom |
Czechia |
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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
|
Last follow-up visit of the last subject |
Ultima Visita di Follow Up dell’ultimo soggetto |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 5 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 15 |