E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced or Metastatic Non-squamous Non Small Cell Lung Cancer (NSCLC) |
Cáncer de pulmón no microcítico (CPNM), no epidermoide. |
|
E.1.1.1 | Medical condition in easily understood language |
Advanced or Metastatic Non-squamous Non Small Cell Lung Cancer (NSCLC) |
Cáncer de pulmón no microcítico (CPNM), no epidermoide. |
|
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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029514 |
E.1.2 | Term | Non-small cell lung cancer NOS |
E.1.2 | System Organ Class | 100000004864 |
|
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 |
The primary objective of the study is to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in current smokers with metastatic or advanced NSCLC. |
El objetivo principal del estudio es evaluar si el tratamiento con veliparib más carboplatino y paclitaxel mejora la supervivencia en comparación con el tratamiento quimioterápico habitual elegido por el investigador en pacientes fumadores con CPNM metastásico o avanzado. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in current plus former smokers with metastatic or advanced NSCLC; to compare progression-free survival (PFS) and to compare objective response rate (ORR) between the two treatment arms in current smokers or in current plus former smokers. |
Los objetivos secundarios del estudio son evaluar si el tratamiento con veliparib más carboplatino y paclitaxel mejora la supervivencia en comparación con el tratamiento quimioterápico habitual elegido por el investigador en pacientes fumadores y ex fumadores con CPNM metastásico o avanzado; comparar la supervivencia sin progresión (SSP) y comparar la tasa de respuesta objetiva (TRO) entre los dos grupos de tratamiento de pacientes fumadores o de pacientes fumadores y ex fumadores. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetic substudy - optional blood test |
|
E.3 | Principal inclusion criteria |
- Subject must be ? 18 years of age. Life expectancy > 12 weeks. - Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers. - Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening. - Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1). |
-El paciente debe tener ? 18 años de edad. Esperanza de vida > 12 semanas. -El paciente fumador o ex fumador debe tener un CPNM no epidermoide avanzado o metastásico confirmado por medios citológicos o histológicos -El paciente debe tener un CPNM no tratable mediante resección quirúrgica ni radioterapia con fines curativos en el momento de la selección del estudio. -El paciente debe tener al menos 1 lesión unidimensional mensurable de CPNM en una imagen de TC conforme a los criterios RECIST (versión 1.1). |
|
E.4 | Principal exclusion criteria |
- Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor). - Subject has a known hypersensitivity to platinum compounds. - Subject has peripheral neuropathy ? grade 2. - Subject has squamous NSCLC, or an untreated known EGFR mutation of exon 19 deletion or L858R mutation in exon 21, or a known ALK gene rearrangement. - Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC. |
-El paciente presenta hipersensibilidad conocida a paclitaxel o a otros fármacos cuya formulación contiene aceite de ricino polietoxilado (Cremophor). -El paciente presenta hipersensibilidad conocida a los compuestos de platino -El paciente presenta neuropatía periférica de grado ? 2. -Pacientes con CPNM epidermoide o con una mutación en el EGFR conocida sin tratar (deleción del exón 19 o mutación L858R en el exón 21) o un reordenamiento del gen ALK. -El paciente ha recibido previamente quimioterapia citotóxica o quimiorradioterapia para el CPNM |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Overall Survival (OS) in current smokers |
Supervivencia global (SG) en pacientes fumadores |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death. |
El tiempo hasta la muerte de un paciente seleccionado se definirá como el número de días desde la fecha en que el paciente es randomizado hasta la fecha de la muerte del paciente. |
|
E.5.2 | Secondary end point(s) |
Overall Survival (OS) in current and former smokers Progression Free Survival (PFS) Objective Response Rate (ORR) |
Supervivencia global (SG) en pacientes fumadores y ex fumadores Supervivencia sin progresión (SSP) Tasas de respuestas objetivas (TRO) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
PFS will be defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached. ORR is defined as the proportion of subjects with complete or partial response using measurements according to RECIST (version 1.1). |
SSP se definirá como el número de días desde la fecha de randomización del paciente hasta la fecha que el paciente experimente un evento de progresión de la enfermedad o muerte (todas las causas de mortalidad) si no se ha producido progresión de la enfermedad. La tasa de respuestas objetivas se definirá como la proporción de pacientes con una respuesta parcial o completa conforme a los criterios RECIST (version 1.1). |
|
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 | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Quality of life, Performance Status (ECOG) |
|
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) | 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 | 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) | 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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 81 |
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 |
Canada |
Czech Republic |
Denmark |
Egypt |
Finland |
France |
Germany |
Hungary |
Israel |
Japan |
Korea, Republic of |
Netherlands |
New Zealand |
Russian Federation |
South Africa |
Spain |
Taiwan |
Turkey |
United Kingdom |
United States |
|
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
|
The end-of-study is defined as the date of last subject's last visit. |
|
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 | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |