E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with extensive-stage small-cell lung cancer (SCLC) who have refractory or resistant disease from prior platinum-based chemotherapy. |
Pacientes con cáncer de pulmón microcítico (CPM) en estadío extendido con enfermedad refractaria o resistente tras la quimioterapia basada en el platino previa. |
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E.1.1.1 | Medical condition in easily understood language |
patients with Small Cell Lung Cancer whose cancer worsened during or after 90 days of platinum based chemotherapy |
Pacientes con cáncer de pulmón microcítico que hayan presentado progresión de la enfermedad (PE) durante o después de 90 días de la quimioterapia basada en platino |
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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 | 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 preliminary efficacy of each treatment arm in terms of Overall Response Rate. ORR will be evaluated using Investigator assessments according to RECIST 1.1 |
Evaluar la eficacia preliminar de cada grupo de tratamiento por medio de la TRO. TRO utilizando la evaluación del investigador conforme a los criterios RECIST 1.1 |
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E.2.2 | Secondary objectives of the trial |
1. To further assess the preliminary efficacy of each treatment arm in terms of DoR, DCR, TTR, PFS, and overall survival (OS) 2. To assess the pharmacokinetics (PK) of novel combination treatments |
1. Evaluar con más detalle la eficacia preliminar de cada grupo de tratamiento por medio de la DR, TCE, THR, SLP y supervivencia global (SG) 2. Para evaluar la farmacocinética (PK) de los nuevos tratamientos combinados |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically or cytologically documented extensive disease American Joint Committee on Cancer Stage IV SCLC (T any, N any, M1 a/b), including patients with: • T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. • Biopsy-proven mixed SCLC and NSCLC histology • Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment. Patients with suspected brain metastases at screening should have a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry. 2. Patients must have demonstrated progressive disease (PD) either during first-line platinum-based chemotherapy (platinum refractory) or within 90 days of completing platinum-based chemotherapy (platinum resistant), and have not received further treatment apart from first-line platinum-based chemotherapy. |
1. Pacientes con enfermedad extendida documentada histológica o citológicamente (CPM en estadio IV según el American Joint Committee on Cancer [T cualquiera, N cualquiera, M1 a/b]), incluyendo pacientes que: •T3-4 debido a múltiples nódulos pulmonares que son demasiado extensos o que tienen el volumen del tumor / nódulo demasiado grande para ser abarcado en una radiación tolerable. • Comprobado por biopsia mixta SCLC e histológica NSCLC • Metástasis cerebrales; deben ser asintomáticas o tratadas y estables sin esteroides ni anticonvulsivos durante al menos 1 mes antes de tratamiento del estudio. Los pacientes con metástasis cerebrales sospechosos en el cribado deben tener una tomografía computarizada (TC) / imágenes de resonancia magnética (MRI) del cerebro antes del ingreso al estudio. 2. Pacientes que hayan presentado progresión de la enfermedad (PE) durante la quimioterapia basada en el platino de primera línea (refractarios al platino) o PE en los 90 días siguientes a la finalización de la quimioterapia basada en el platino de primera línea (resistentes al platino) y que no han recibido tratamiento adicional, aparte de la quimioterapia basada en platino de primera línea. |
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E.4 | Principal exclusion criteria |
1. Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of patient safety or study results, including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from the study medications, or compromise the ability of the patient to give written informed consent. 2. Past medical history of interstitial lung disease, drug-induced pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease. |
1. Cualquier condición que, en opinión del investigador, pudiera interferir con la evaluación del IP o la interpretación de la seguridad de los pacientes o los resultados del estudio, incluyendo pero no limitado a la infección activa en curso, insuficiencia cardíaca congestiva sintomática, hipertensión no controlada, angina de pecho inestable, arritmia cardíaca, o enfermedad psiquiátricas/situaciones sociales que limiten el cumplimiento de los requisitos del estudio, aumentando sustancialmente el riesgo de incurrir en los AA de los medicamentos del estudio, o comprometer la capacidad del paciente para dar su consentimiento informado por escrito.
2. Antecedentes personales de enfermedad pulmonar intersticial, neumonitis inducida por fármacos, neumonitis por radiación que requiere tratamiento con esteroides, o cualquier evidencia de enfermedad pulmonar intersticial clínicamente activa. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall Response rate evaluated by using Investigator assessments according to RECIST 1.1 |
Eficacia preliminar de cada grupo de tratamiento basada en la TRO según la evaluación del investigador conforme a los criterios RECIST 1.1. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary analysis of ORR will occur approximately 12 weeks after the last patient has initiated treatment. |
El corte de los datos para el análisis intermedio tendrá lugar aproximadamente 12 semanas después de que el décimo paciente haya empezado el tratamiento. |
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E.5.2 | Secondary end point(s) |
1. To further assess the preliminary efficacy of each treatment arm in terms of DoR, DCR, TTR, PFS, and overall survival (OS) |
1. Evaluar con más detalle la eficacia preliminar de cada grupo de tratamiento por medio de la DR, TCE, THR, SLP y supervivencia global (SG) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The primary analysis of ORR will occur approximately 12 weeks after the last patient has initiated treatment. All study endpoints will be analyzed at this time with the exception of OS. A final analysis of OS will take place when approximately 75% maturity for OS events is achieved or as determined by the Sponsor. |
El análisis principal de la TRO se realizará unas 12 semanas después de que el último paciente haya empezado el tratamiento. Todas las variables de valoración del ensayo, excepto la SG, se analizarán en este momento. Se realizará un análisis final de la SG cuando se alcance una madurez aproximada del 75 % para los acontecimientos de SG o cuando lo determine el promotor. |
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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 | 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) | 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) | 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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 |
Germany |
Hungary |
Poland |
Spain |
Ukraine |
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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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Due to Overall Survival as the Secondary Objective the Study will continue until the OS of last patient is evaluated or the Sponsor decides otherwise. |
Debido a la supervivencia global como el objetivo secundario, el estudio continuará hasta que la SG del último paciente sea evaluado o el promotor decida otra cosa. |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | |
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 |