E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Extensive-Stage Small Cell Lung Cancer |
Cáncer microcítico de pulmón en estadio extendido |
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E.1.1.1 | Medical condition in easily understood language |
Lung Cancer |
Cáncer de pulmón |
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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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-Part 1 and 2: To assess the safety, tolerability, and maximum tolerated dose (MTD) or maximum administered dose (MAAD) of BMS-986012 given in combination with 4 cycles of cisplatin/etoposide (Part 1) and carboplatin/etoposide (Part 2), and then continuing as BMS-986012 monotherapy until disease progression. -Part 3: To compare the PFS of subjects randomized to receive BMS 986012 in combination with platinum and etoposide for 4 cycles and then continuing as BMS-986012 monotherapy until disease progression (Arm 3A) to that of subjects randomized to receive platinum and etoposide alone (Arm 3B) in subjects with newly diagnosed extensive-stage SCLC. |
- Partes 1 y 2: evaluar la seguridad, tolerabilidad y dosis máxima tolerada (DMT) o dosis máxima administrada (DMA) de BMS-986012 administrado en combinación con 4 ciclos de cisplatino/etopósido (Parte 1) o carboplatino/etopósido (Parte 2) y luego continuando con BMS-986012 en monoterapia hasta la progresión de la enfermedad. - Parte 3: comparar la SLP de los sujetos aleatorizados a recibir BMS-986012 en combinación con platino y etopósido durante 4 ciclos y luego continuando con BMS-986012 en monoterapia hasta la progresión de la enfermedad (Grupo 3A) con la de los sujetos aleatorizados a recibir platino y etopósido solos (Brazo 3B) en sujetos con CMP en estadio extendido recién diagnosticado. |
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E.2.2 | Secondary objectives of the trial |
-To characterize the pharmacokinetics of BMS-986012 -To characterize the immunogenicity of BMS-986012 |
- Caracterizar la farmacocinética (FC) de BMS-986012 - Caracterizar la inmunogenicidad de BMS-986012 |
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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 |
Additional Research Collection (section 5.10)
This protocol will include residual sample storage for additional research. This collection for additional research is intended to expand the translational R&D capability at Bristol-Myers Squibb, and will support as yet undefined research aims that will advance our understanding of disease and options for treatment. It may also be used to support health authority requests for analysis, and advancement of pharmacodiagnostic development to better target drugs to the right patients. This may also include genetic/genomic exploration aimed at exploring disease pathways, progression and response to treatment etc. |
Sección 5.10: Additional Research Collection Este protocolo incluirá el almacenamiento de muestras residuales para investigaciones adicionales. Esta colección de muestras para investigación adicional está destinada a ampliar la capacidad de I + D en Bristol-Myers Squibb y dará soporte a los objetivos de investigación todavía sin definir, que hagan avanzar nuestra comprensión de la enfermedad y las opciones de tratamiento. También se puede utilizar para dar soporte a las solicitudes presentadas a las autoridades sanitarias para el análisis y el avance del desarrollo fármacodiagnóstico a mejores medicamentos diana para los pacientes adecuados. Esto también puede incluir la exploración genética/genómica con el objetivo de explorar vías de la enfermedad, la progresión y la respuesta al tratamiento, etc. |
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E.3 | Principal inclusion criteria |
- Pulmonary SCLC documented by histology or cytology - Extensive disease (Stage IV) Small Cell Lung Cancer - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Male and Females 18 years of age or older |
- Cáncer microcítico de pulmón confirmado por histología o citología - Estadio extendido (estadio IV) de cáncer microcítico de pulmón - Estado funcional 0 o 1 según Eastern Cooperative Oncology Group (ECOG) - Hombre s y mujeres de 18 años o mayores |
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E.4 | Principal exclusion criteria |
- Prior systemic therapy for lung cancer - Symptomatic brain metastases - Grade 2 peripheral neuropathy - Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) - Other active malignancies or prior malignancy within 2 years |
- Tratamiento previo sistémico para cáncer de pulmón - Metástasis cerebrales sintomáticas - Grado 2 de neuropatía periférica - Infección activa o crónica con virus de la inmunodeficiencia humana (VIH), virus de la hepatitis B (VHB), o virus de la hepatitis C (VHC) - Otras neoplasias o neoplasias previas en un plazo de 2 años |
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E.5 End points |
E.5.1 | Primary end point(s) |
1- Number of participants with adverse events (AEs) 2-Number of participants with serious adverse events (SAEs) 3- Discontinuations due to AEs 4- Number of participants who died due to AEs 5-Number of participants with laboratory toxicity grade shift from baseline 6- Progression Free Survival |
1- Número de participantes con acontecimientos adversos (AA) 2-Número de participantes con acontecimientos adversos graves (AAG) 3- Los abandonos debidos a acontecimientos adversos 4- Número de participantes que murieron debido a acontecimientos adversos 5-Número de participantes con cambio de grado de toxicidad de laboratorio respecto a los niveles basales 6- Supervivencia libre de progresión |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1- Cycle 1, Day 1 up to approximately 26 months 2- Date of enrollment up to approximately 26 months 3- Cycle 1, Day 1 up to approximately 26 months 4- Cycle 1, Day 1 up to approximately 26 months 5- Cycle 1, Day 1 up to approximately 26 months 6- From date of first dose or randomization until date of confirmed disease progression, up to 2 years |
1- Ciclo 1, Día 1 hasta aproximadamente 26 meses 2- Fecha de reclutamiento hasta aproximadamente 26 meses 3- Ciclo 1, Día 1 hasta aproximadamente 26 meses 4- Ciclo 1, Día 1 hasta aproximadamente 26 meses 5- Ciclo 1, Día 1 hasta aproximadamente 26 meses 6- A partir de la fecha de la primera dosis o la aleatorización hasta la fecha de progresión de la enfermedad confirmada, hasta 2 años |
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E.5.2 | Secondary end point(s) |
1- Maximum observed serum concentration(Cmax) 2- Time of maximum observed serum concentration(Tmax) 3- Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T)) 4- Observed serum concentration at the end of a dosing interval(Ctau) 5- Area under the concentration-time curve in 1 dosing interval(AUC(TAU)) 6- Characterization of Immunogenicity |
1- Máxima concentración sérica observada (Cmax) 2- Tiempo de concentración máxima sérica observada (Tmax) 3- El área bajo la curva de concentración plasmática-tiempo desde el inicio (tiempo 0) al tiempo de la última concentración cuantificable (AUC (0-T)) 4- Concentración sérica observada al final de un intervalo de dosificación (Ctau) 5- El área bajo la curva de concentración-tiempo un intervalo de dosificación (AUC (TAU)) 6- Caracterización de la inmunogenicidad |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-6: Cycle 1 Day 1 up to 60 days after last dose |
1-6: Ciclo 1 Día 1 hasta 60 días después de la última dosis |
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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 | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker Assessments |
Evaluaciones de biomarcadroes |
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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 |
identify a potential MTD (or MAAD) of BMS-986012 in combination with Platinum and Etoposide |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Note: Part 3 of the trial is "controlled" |
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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 | Yes |
E.8.2.3.1 | Comparator description |
Platinum/etopside alone versus Platinum/etopside in combination with BMS-986012 |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 |
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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 the study will occur after the last treated subject has been followed for at least 12 months from his/her first treatment date or all subjects have met the primary end point. |
El fin de ensayo ocurrirá después de que al último paciente tratado del estudio se le haya seguido durante al menos 12 meses desde de su primera cita tratamiento o todos los sujetos hayan cumplido con 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 | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 |