E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Extensive-Stage Small Cell Lung Cancer |
Carcinoma polmonare a piccole cellule in stadio esteso |
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E.1.1.1 | Medical condition in easily understood language |
Extensive-Stage Small Cell Lung Cancer |
Carcinoma polmonare a piccole cellule in stadio esteso |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the safety of rovalpituzumab tesirine when administered in combination with nivolumab or nivolumab and ipilimumab in adult subjects with extensive-stage small cell lung cancer (SCLC) |
Valutare la sicurezza di rovalpituzumab tesirina quando somministrato in associazione con nivolumab o nivolumab e ipilimumab in soggetti adulti affetti da carcinoma polmonare a piccole cellule (SCLC) a stadio esteso |
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E.2.2 | Secondary objectives of the trial |
To explore the efficacy of rovalpituzumab tesirine when administered in combination with nivolumab or nivolumab and ipilimumab in adult subjects with extensive-stage SCLC |
Esplorare l’efficacia di rovalpituzumab tesirina quando somministrato in associazione con nivolumab o nivolumab e ipilimumab in soggetti adulti affetti da SCLC a stadio esteso |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Minimum of 18 years old - Participants with histologically confirmed extensive-stage small cell lung cancer (SCLC) with progressive disease after at least one platinum-based chemotherapeutic regimen and with evaluable or measurable disease - Eastern Cooperative Oncology Group (ECOG) 0-1 - Adequate hematologic, hepatic, and renal function |
- Minimo di 18 anni - Partecipanti con SCLC in grado esteso confermato istologicamente con PD dopo almeno un regime chemioterapico a base di platino e con malattiva valutabile o misurabile - Stato di validità ECOG 0-1 - Funzioni ematologiche, epatice e renali soddisfacenti |
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E.4 | Principal exclusion criteria |
- Has active, known, or suspected autoimmune disease - Had prior exposure to an immuno-oncology or pyrrolobenzodiazapine (PBD)-based drug |
- Malattia autoimmune attiva nota o sospetta - Precedente esposizione ad un farmaco immuno-oncologico a base di pyrrolobenzodiazapine (PBD) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety Endpoints - analysis of the safety endpoints will include the following measurements or assessments: Adverse events (Aes) and dose-limiting toxicities (DLTs), vital signs, body weight, laboratory abnormalities, electrocardiographic parameters, echocardiography, Eastern Cooperative Oncology Group (ECOG) performance status, monitoring of concomitant medications. Efficacy Endpoints - response assessments as per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, including ORR and CBR, Duration of Response (DOR), Progression-free survival (PFS), PFS status after 6 months from the initiation of study treatment, OS. Radiographic imaging, pharmacokinetics, biomarker, and pharmacodynamic endpoints - Specific PK parameters of all drugs, ATA incidence and timing, Tumor DLL3 and PD-L1 expression, inflammatory markers, blood tumor markers, immune markers, biomarkers, including soluble DLL3, circulating tumor cells (CTCs) |
Valutazioni di sicurezza - Le valutazioni sulla sicurezza includeranno le misure dei seguenti test: eventi avversi (AE) e tossicità dose-limitanti (DLT), parametri vitali, peso corporeo, alterazioni di laboratorio, elettrocardiogrammi (ECG), ecocardiogramma, stato di validità ECOG, monitoraggio dei medicinali concomitanti. Valutazioni di efficacia: le valutazioni delle risposte saranno classificate con i criteri RECIST (Response Evaluation Criteria in Solid Tumors) v1.1, incluse ORR e CBR, Duration of Response (DOR), Progression-free survival (PFS), stato PFS dopo 6 mesi dall'inizio del trattamento in studio, OS. Valutazioni di immagini radiografiche, farmacocinetica, biomarcatori e farmacodinamica: parametri PK specifici per tutti i farmaci, incidenza e tempo di ATA, espressione tumorale di DLL3 e PD-L1, marcatori infiammatori, marcatori tumorali ematici, marcatori immunitari, biomarcatori inclusi DLL3 solubile, cellule tumorali circolanti (CTC) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
To assess the safety of Rova-T administered in combo with nivolumab, or nivolumab and ipilimumab. |
Valutare la sicurezza di rovalpituzumab tesirine somministrato in combinazione con nivolumab o con n |
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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 | No |
E.8.1.2 | Open | No |
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 | 3 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 |
France |
Germany |
Italy |
Spain |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
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
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Treatment will continue for all subjects until they withdraw consent, experience an AE that warrants them coming off study, death, investigator decision, they become lost to follow-up, they have significant protocol non-compliance, the study is terminated by the sponsor. Since nivolumab may be given indefinitely, the study will continue until the last subject undergoing treatment has experienced one of the above. |
Il trattamento continuerà per tutti i soggetti fino al ritiro del consenso, occorrenza di un EA che garantisca l'uscita dallo studio, morte, decisione dello sperimentatore, lost to follow-up, non-compliance al protocollo significativa, studio interrotto dallo sponsor. Poiché nivolumab può essere somministrato senza limiti, lo studio proseguirà fino a quando l'ultimo soggetto in trattamento si troverà in una delle condizioni sopra riportate. |
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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 | 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 |