E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage III Non-Small Cell Lung Cancer |
Estadio III Cáncer de Pulmón de Células no pequeñas |
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E.1.1.1 | Medical condition in easily understood language |
Stage III Non-Small Cell Lung Cancer |
Estadio III Cáncer de Pulmón de Células no pequeñas |
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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 | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029519 |
E.1.2 | Term | Non-small cell lung cancer stage III |
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 whether the addition of oral veliparib versus placebo to Paclitaxel/Carboplatin-based chemoradiotherapy with Paclitaxel/Carboplatin consolidation will improve progression-free survival (PFS) in patients with Stage III non-small cell lung cancer |
Evaluar si la adición de veliparib ora,l en comparación con placebo, a la quimiorradioterapia basada en paclitaxel/carboplatino con consolidación con paclitaxel/carboplatino mejora la supervivencia libre de progresión en pacientes con cáncer de pulmón no microcítico en estadio III |
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E.2.2 | Secondary objectives of the trial |
To assess overall survival (OS), objective response rate (ORR), duration of overall response (DOR), safety and tolerability of veliparib versus placebo added to standard therapy |
Evaluar la supervivencia global (SG), la tasa de respuesta objetiva (TRO), la duración de la respuesta global (DRG), la seguridad y la tolerabilidad de veliparib añadido al tratamiento convencional, en comparación con placebo |
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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 |
Optional genetic sub-study - to determine if a subject's genetic information has any relation veliparib, non-small cell lung cancer (NSCLC) and/or other cancers, and to determine if genetic information affects how NSCLC and other cancers develop and progress, how they can be diagnosed or treated, and their causes and symptoms. |
Sub-estudio genético opcional – Determinar si la información genética del sujeto tiene alguna relación con veliparib, con el cáncer de pulmón no mircrocitico y otros canceres y determinar si la información genética afecta como el cáncer de pulmón no microcitico crece y progresa, como pueden ser diagnosticados y las causas y síntomas |
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E.3 | Principal inclusion criteria |
1. Participants with Histologically or cytologically confirmed Stage III non-small cell lung cancer (NSCLC). 2. Participants in the randomized portion of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria. 3. Participants must have V20 (volume of lung to receive 20 Gy radiotherapy according to simulation) < 35%. 4. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 – 1. 5. Participant must have adequate hematologic, renal, hepatic, and lung function. |
1. El sujeto deben tener un Cáncer de Pulmón no microcitico (CPNM) de estadío III confirmado mediante examen histológico o citológico 2. Los sujetos de la parte aleatorizada del estudio deben tener enfermedad medible según los criterios RECIST, versión 1.1 3 El sujeto debe tener un V20 (volumen de pulmón que recibirá 20 Gy de radioterapia según simulación) < 35%.
4. El sujeto debe tener una puntuación del estado funcional del ECOG (Eastern Cooperative Oncology Group) de 0-1
5. El sujeto debe tener una función hematológica, renal, hepática y pulmonar adecuada |
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E.4 | Principal exclusion criteria |
1. Participants with prior chemotherapy or radiotherapy (RT) for current NSCLC. Participants curatively treated for past early stage NSCLC greater than 3 years ago may be included. 2. Participants with prior exposure to poly-ADP-ribose polymerase (PARP) inhibitors. 3. Participants with known hypersensitivity to carboplatin, paclitaxel, or formulations containing polyethoxylated castor oil (Cremophor). 4. Participants with prior mediastinal or thoracic radiotherapy. Prior tangential RT to prior breast cancer is acceptable. 5. Participants with major surgery in the 4 weeks prior to randomization (Video-assisted thoracoscopic surgery (VATS) and/or mediastinoscopy is not considered major surgery). |
1. Sujetos tratados con quimioterapia o radioterapia previa para el CPNM actual; podrá incluirse a sujetos tratados para un CPNM de estadio precoz anterior hace más de 3 años. 2. Sujetos con exposición previa a inhibidores de la PARP. 3. Sujetos con hipersensibilidad conocida a carboplatino, paclitaxel o formulaciones que contengan aceite de ricino polietoxilado (Cremophor). 4. Sujetos tratados previamente con radioterapia mediastínica o torácica. Se acepta la RT tangencial para cáncer de mama previo 5. Sujeto sometido a una intervención de cirugía mayor durante las 4 semanas previas a la aleatorización (la cirugía torácica videoasistida [VATS] y la mediastinoscopía no se consideran intervenciones de cirugía mayor). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-free survival |
Supervivencia libre de enfermedad |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Tumor Assessments conducted at baseline, prior to consolidation chemotherapy, at 24 weeks after start of treatment, every 8 weeks until one year after beginning therapy, then every 12 weeks. |
La evaluación tumoral se realizara antes de la quimioterapia de consolidación las 24 semanas después del inicio del tratamiento, cada 8 semanas hasta un año después del inicio del tratamiento y posteriormente cada 12 semanas |
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E.5.2 | Secondary end point(s) |
Overall survival, Duration of Response, Objective response rate |
La supervivencia global, duración de la respuesta, Tasa de respuesta objetiva |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Survival assessment conducted every 8 weeks following progression |
La evaluación de la supervivencia se llevara a cabo cada 8 semanas después de la progresión |
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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 | 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 | 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 |
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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 | 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 | 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 | 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
Czech Republic |
France |
Greece |
Hungary |
Russian Federation |
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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |