E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER |
CÁNCER DE PULMÓN NO MICROCÍTICO POSITIVO PARA PD-L1 LOCALMENTE AVANZADO O METASTÁSICO |
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E.1.1.1 | Medical condition in easily understood language |
Treatement of advanced lung cancer which has spread to other part of the body. |
Tratamiento del cáncer de pulmón avanzado que se ha extendido a otras partes del cuerpo. |
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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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
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 |
The primary objective for this study is to evaluate the efficacy of MPDL3280A in patients with programmed cell death?1 ligand 1 (PD-L1)?positive locally advanced or metastatic non?small cell lung cancer (NSCLC), as measured by: ? Independent review facility (IRF)-assessed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 ? Investigator-assessed ORR according to modified RECIST. |
El objetivo principal para este estudio es evaluar la eficacia de MPDL3280A en pacientes con cancer de pulmón no microcítico (NSCLC) positivo para el ligando 1 del receptor de muerte celular programada-1 (PD-L1) localmente avanzado o metastásico, determinado mediante: ? Tasa de respuesta objetiva (TRO) según los «Criterios de evaluación de la respuesta en tumores sólidos» (RECIST) v1.1 evaluada por el centro de evaluación independiente (IRF) ? la TRO evaluada por el investigador según los RECIST modificados. |
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E.2.2 | Secondary objectives of the trial |
? To evaluate progression-free survival (PFS) and duration of response (DOR) according to RECIST v1.1 as assessed by IRF and according to modified RECIST as assessed by the investigators ? To evaluate ORR, DOR, and PFS according to RECIST v1.1 as assessed by the investigators ? To evaluate overall survival (OS) |
?Evaluar la supervivencia sin progresión (SSP) y duración de la respuesta (DR) según RECIST v1.1 los RECIST determinado por IRF y de acuerdo con los RECIST modificados evaluados por el investigador ? Evaluar la TRO, DR y SSP según RECIST v. 1.1 evaluadas por el investigador. ? Evaluar la supervivencia global (SG). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Histologically or cytologically documented Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC ? PD-L1-positive status as determined by an IHC assay performed by a central laboratory ? ECOG performance status of 0 or 1 ? Life expectancy > 12 weeks ? Measurable disease, as defined by RECIST v1.1 |
? NSCLC en estadio IIIB (no elegible para quimiorradioterapia definitiva), estadio IV o recurrente, histológica o citológicamente documentado ?Estado PD-L1 positivo según se determina mediante pruebas de IHQ realizadas por un laboratorio central ?Grado de actividad ECOG de 0 ó 1 ? Expectativa de vida > 12 weeks ?Enfermedad mensurable, según se define en los RECIST v. 1.1 |
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E.4 | Principal exclusion criteria |
? Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment ? Known CNS disease, including treated brain metastases ? Leptomeningeal disease ? History of auto-immune disease |
? Tratamiento con cualquier otro fármaco en investigación o participación en otro ensayo clínico con fines terapéuticos en los 28 días previos a la inclusión en el estudio ? Enfermedad del SNC conocida, incluso metástasis cerebrales tratadas ? Enfermedad leptomeníngea ?Historia de enfermedad auto-inmune |
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E.5 End points |
E.5.1 | Primary end point(s) |
The co-primary endpoints of this study will be IRF-assessed ORR according to RECIST v1.1 and investigator-assessed ORR according to modified RECIST criteria . |
La variable principal co-primaria de este estudio será la evaluación por el centro de evaluación independiente de la TRO según RECIST v1.1 y la evaluación por el investigador de la TRO según los criterios RECIST modificados |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Please refer to section E.5.1 |
Por favor, consulte la sección E.5.1 |
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E.5.2 | Secondary end point(s) |
? PFS assessed by IRF per RECIST v1.1 ? PFS assessed by investigator per modified RECIST ? OS |
? SSP evaluada por IRF por RECIST V1.1 ? SSP evaluada por el investigador por RECIST modificados ? SG |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Please refer to section E.5.2 |
Por favor, consulte la sección E.5.2 |
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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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 |
Belgium |
Bulgaria |
Canada |
France |
Italy |
Netherlands |
Germany |
Spain |
Slovenia |
Switzerland |
Turkey |
United Kingdom |
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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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The end of study is defined as the date of the last follow-up visit of the last patient enrolled and is expected to occur approximately 12 months after the last patient enrolls in the study. |
El final del estudio se define como la fecha de la última visita de seguimiento del último paciente incluido y se prevé que tenga lugar aproximadamente 12 meses después de que el último paciente entre en el estudio. |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |