E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced or Metastatic Squamous Non-Small-Cell Lung Cancer (NSCLC) |
Cáncer pulmonar no microcítico (CPNM) epidermoide avanzado o metastásico. |
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E.1.1.1 | Medical condition in easily understood language |
Advanced or Metastatic Squamous Non-Small-Cell Lung Cancer (NSCLC) |
Cáncer pulmonar no microcítico (CPNM) epidermoide avanzado o metastásico. |
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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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025044 |
E.1.2 | Term | Lung cancer |
E.1.2 | System Organ Class | 100000004864 |
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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 |
The primary objective of the study is to assess whether the addition of oral veliparib to carboplatin and paclitaxel will improve overall survival (OS) when compared to the addition of placebo to carboplatin and paclitaxel, in subjects with previously untreated locally advanced and metastatic squamous NSCLC |
El objetivo principal del estudio es evaluar si la adición de veliparib oral al tratamiento con carboplatino y paclitaxel mejorará la supervivencia global (SG) en comparación con la adición de un placebo al tratamiento con carboplatino y paclitaxel, en sujetos con cáncer pulmonar no microcítico (CPNM) epidermoide avanzado o metastásico no tratados previamente. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to assess the effects of veliparib combination therapy on: duration of overall response (DOR), progression-free survival (PFS), and objective response rate (ORR). |
Los objetivos secundarios del estudio son evaluar los efectos del tratamiento combinado con veliparib en: duración de la respuesta global (DRG), supervivencia sin progresión (SSP) y tasa de respuesta objetiva (TRO). |
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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 |
Subestudio farmacogenético ? Muestra de sangre opcional. |
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E.3 | Principal inclusion criteria |
-Subject must be ? 18 years of age. -Life expectancy > 12 weeks -Subject must have cytologically or histologically confirmed squamous NSCLC. -Subject must have advanced or metastatic squamous NSCLC (stage IIIB or IV) that is not amenable to surgical resection or radiation with curative intent at time of study Screening. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible. -Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1). |
- Sujeto ? 18 años de edad. - Esperanza de vida > 12 semanas. - El sujeto debe tener un CPNM epidermoide confirmado por medios citológicos o histológicos. - El sujeto debe tener un CPNM epidermoide avanzado o metastásico (en estadios IIIB o IV) no tratable mediante resección quirúrgica ni radioterapia con fines curativos en el momento de la selección del estudio. Pueden participar en el estudio los sujetos que presenten CPNM epidermoide recidivante tras el tratamiento quirúrgico que no sea tratable mediante resección quirúrgica ni radioterapia con fines curativos. - El sujeto debe tener al menos 1 lesión unidimensional mensurable de CPNM en una imagen de TC conforme a los criterios RECIST (versión 1.1) - |
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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 non-squamous NSCLC, or a known EGFR mutation of exon 19 deletion or L858R mutation in exon 21, or a known ALK gene rearrangement. -Subject has received prior systemic anti-cancer therapy for advanced or metastatic NSCLC. |
- El sujeto presenta hipersensibilidad conocida al paclitaxel o a otros fármacos cuya formulación contiene aceite de ricino polietoxilado (Cremophor). - El sujeto presenta hipersensibilidad conocida a los compuestos de platino. - El sujeto presenta neuropatía periférica de grado ? 2. - El sujeto padece un CPNM no epidermoide, o presenta una mutación conocida del gen EGFR consistente en una deleción del exón 19 o una mutación L858R en el exón 21, o un reordenamiento conocido del gen ALK. - El sujeto ha recibido previamente tratamiento antineoplásico sistémico para el CPNM avanzado o metastásico. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall Survival |
Supervivencia Global |
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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 sujeto se definirá como el número de días transcurridos desde la fecha en que se aleatorizó al sujeto hasta la fecha de su muerte. |
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E.5.2 | Secondary end point(s) |
Duration of Response (DOR); Progression-free Survival (PFS); Objective Response Rate (ORR). |
Duración de la Respuesta Global (DRG); Supervivencia Sin Progresión (SSP); Tasa de Respuesta Objetiva (TRO) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The duration of overall response will be defined as the number of days from CR or PR to PD. PFS will be defined as the number of days from the date of randomization to the date of disease progression or death if disease progression is not reached. Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1). |
Se definirá como duración de la respuesta global el número de días transcurridos desde el día en que se cumplan los criterios de RC o RP hasta el día en que se documente objetivamente la PE. La SSP se definirá como el número de días transcurridos desde la fecha de aleatorización hasta la fecha en que este experimente un acontecimiento de progresión de la enfermedad o muerte si no se alcanza la progresión de la enfermedad. La tasa de respuesta objetiva se define como la proporción de sujetos con respuesta completa o parcial determinada por el investigador conforme a los criterios RECIST (versión 1.1). |
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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 | 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) |
Calidad de vida, Estado Funcional (ECOG) |
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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 | 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 110 |
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 |
Australia |
Austria |
Belarus |
Brazil |
Canada |
Croatia |
Czech Republic |
Denmark |
Finland |
France |
Germany |
Greece |
Hungary |
Ireland |
Israel |
Italy |
Latvia |
Lithuania |
Mexico |
Netherlands |
New Zealand |
Norway |
Poland |
Portugal |
Russian Federation |
Slovakia |
South Africa |
Spain |
Sweden |
Switzerland |
Turkey |
Ukraine |
United Kingdom |
United States |
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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
|
The end-of-study is defined as the date of last subject's last visit. The sponsor may also end the study upon confirmation that the primary endpoint was statistically met. |
Se define como fecha final del estudio la fecha de la última visita del último sujeto. El promotor también podrá finalizar el estudio una vez que se confirme que se ha cumplido estadísticamente el criterio de valoración principal. |
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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 | 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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |