E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Extensive stage disease small cell lung cancer who have completed first line chemotherapy |
Cáncer microcítico de pulmón con enfermedad extendida (CMP-EEx) después de terminar la quimioterapia de primera línea basada en platino |
|
E.1.1.1 | Medical condition in easily understood language |
Lung cancer |
Cáncer de pulmón |
|
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 | 18.1 |
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) |
|
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 |
The purpose of this study is to show that maintenance therapy with nivolumab, or nivolumab plus ipilimumab followed by nivolumab alone, will prolong Overall Survival or Progression Free Survival compared with placebo in subjects with extensive stage disease small cell lung cancer who have completed first line chemotherapy |
El objetivo de este ensayo es mostrar que el tratamiento de mantenimiento con nivolumab o nivolumab más ipilimumab seguido de nivolumab solo prolongará la Supervivencia global (SG) o la Supervivencia libre de progresión (SLP) frente a placebo en sujetos con CMP-EEx que han completado una primera linea de quimioterapia. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate (descriptively) Overall Survival and BICR (Blinded Independent Central Review)-assessed Progression-Free Survival of nivolumab combined with ipilimumab versus nivolumab monotherapy. |
Evaluar (descriptivamente) la SG y la SLP evaluada mediante la RCIE (Revisión Central Independiente Enmascarada) e nivolumab en combinación con ipilimumab frente a nivolumab en monoterapia |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Subjects with histologically or cytologically confirmed extensive stage disease SCLC -Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy -ECOG performance status of 0 or 1 |
- Sujetos con CMP-EEx confirmada mediante histología o - Los sujetos deben haber recibido 4 ciclos de quimioterapia de primera línea basada en platino y deben tener una respuesta que se mantiene después de terminar la quimioterapia - Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) de 0 o 1. |
|
E.4 | Principal exclusion criteria |
-Subjects with untreated central nervous system metastases are excluded -Subjects with active, known, or suspected autoimmune disease are excluded -All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline |
-Pacientes con Metástasis del SNC.sin tratamiento -Pacientes con enfermedad autoinmunitaria activa, conocida o sospechada -Todos los efectos adversos atribuidos al tratamiento oncológico previo deben haberse resuelto a grado 1 o nivel basal |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Overall Survival - Progression-free survival |
Supervivencia Global Supervivencia libre de progresión |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
- OS: Approximately 30 months after the first subject is randomized - PFS: Approximately 6 months after the last subject is randomized |
-SG: aproximadamente 30 meses después de que el primer paciente se haya aleatorizado. -SLP: aproximadamente 6 meses después de que el primer paciente se haya aleatorizado |
|
E.5.2 | Secondary end point(s) |
-Descriptive analysis of PFS and OS to evaluate nivolumab monotherapy to nivolumab with ipilimumab treatment regimen |
- Análisis descriptivo de SG y PFS para evaluar el tratamiento con nivolumab monoterapia o el tratamiento de combinación de nivolumab con ipilimumab |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Approximately 30 months |
Aproximadamente 30 meses |
|
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 |
Biomarker Assessments, Outcomes Research Assessments, Blinded Independent Central Review, immunogenicity assessment |
Evaluaciones de biomarcador, Evaluaciones de resultados de investigación, Revisión central independiente enmascarada, Evaluaciones de inmunogenicidad. |
|
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 | 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 | 61 |
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 |
Argentina |
Australia |
Austria |
Belgium |
Brazil |
Canada |
Colombia |
Denmark |
Finland |
France |
Germany |
Greece |
Hong Kong |
Ireland |
Israel |
Italy |
Japan |
Korea, Republic of |
Mexico |
Netherlands |
Peru |
Poland |
Romania |
Russian Federation |
Singapore |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
United Kingdom |
United States |
|
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 patient |
Última visita de seguimiento del último paciente |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
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 | 3 |