E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer |
Cáncer de pulmón no microcítico en estadio IV o cáncer de mama metastásico con receptores hormonales positivos y HER2 negativo |
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E.1.1.1 | Medical condition in easily understood language |
Lung Cancer or Breast Cancer |
Cáncer de pulmón o cáncer de mama |
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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 | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006202 |
E.1.2 | Term | Breast cancer stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025055 |
E.1.2 | Term | Lung cancer non-small cell stage IV |
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 characterize further the safety profile of the combination of abemaciclib and pembrolizumab |
Caracterizar en mayor medida el perfil de seguridad de la politerapia con abemaciclib y pembrolizumab. |
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E.2.2 | Secondary objectives of the trial |
-To characterize further the safety profile of the combination of abemaciclib and pembrolizumab -To assess the preliminary efficacy of abemaciclib in combination with pembrolizumab -To characterize the PK of abemaciclib and pembrolizumab when given in combination |
-Caracterizar en mayor medida el perfil de seguridad de la politerapia con abemaciclib y pembrolizumab. -Evaluar la eficacia preliminar de abemaciclib en combinación con pembrolizumab. -Caracterizar la FC de abemaciclib y pembrolizumab cuando se administran en politerapia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Part A: NSCLC, KRASmt, PD-L1+; Chemotherapy naïve for metastatic NSCLC Part B: NSCLC, squamous subtype; Must have received 1 prior therapy containing platinum based chemotherapy for metastatic NSCLC Part C: HR+, HER2- breast cancer; Must have received at least 1 but no more than 2 chemotherapy regimens for metastatic breast cancer All patients: amendable to provide tumor tissue prior to treatment and during treatment; ECOG PS <= 1; |
Parte A: CPNM, KRASmt, PD-L1+; no haber recibido anteriormente quimioterapia para el CPNM metastásico Parte B: CPNM, subtipo escamoso; deben haber recibido 1 tratamiento quimioterápico previo que incluya un derivado del platino para el CPNM metastásico Parte C: cáncer de mama HR+, HER2-; deben haber recibido al menos 1 y como máximo 2 tratamientos quimioterápicos para el cáncer de mama metastásico Para todos los pacientes: deben estar dispuestos a proporcionar tejido tumoral antes del tratamiento y durante este; CF ECOG <= 1; |
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E.4 | Principal exclusion criteria |
-Have CNS metastasis with associated neurological changes 14 days prior to receiving study drug -QTc interval of >470msec on screening ECG -History of interstitial lung disease or pneumonitis -Active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years -Recently treated with an anti-PD-1 or PD-L1 or anti-CTLA-4 agent -Previously received treatment with any CDK4 or CDK6 inhibitor |
-Presentar metástasis en el SNC con cambios neurológicos asociados, 14 días antes de recibir el fármaco del estudio -Presentar un intervalo QTc > 470 ms en el ECG que se realice durante la selección -Antecedentes de enfermedad pulmonar intersticial o neumonitis -Haber experimentado una enfermedad autoinmunitaria activa u otro síndrome que requiera la administración de corticosteroides sistémicos u otros fármacos autoinmunitarios durante los 2 últimos años -Haber recibido tratamiento recientemente con un fármaco anti-PD-1 o PD-L1 o anti-CTLA-4 -Haber recibido tratamiento anteriormente con un inhibidor de la CDK4 o de la CDK6 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The safety endpoints per CTCAE v 4.0, NCI 2009 and will include but are not limited to the following: ?TEAEs, ECIs, SAEs, and hospitalizations ?Clinical laboratory tests, vital signs, and physical examinations |
Entre los criterios de valoración de la seguridad (de acuerdo con los CTCAE, v 4.0, NCI 2009) que se evaluarán se incluyen: -Los AAST, los AIC, los AAG y las hospitalizaciones. -Los análisis clínicos, las constantes vitales y las exploraciones físicas. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Safety evaluations will occur at each study visit |
Las evaluaciones de la seguridad se realizarán en cada visita del estudio |
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E.5.2 | Secondary end point(s) |
?ORR per tumor assessment using RECIST v1.1 and irRECIST ?PFS rate at 24 weeks per RECIST v1.1 and irRECIST ?DoR per RECIST v1.1 and irRECIST ?DCR per RECIST v1.1 and irRECIST ?OS Abemaciclib and pembrolizumab concentrations in plasma or serum Pain and disease-related symptoms assessed by MDASI |
-La TRO, basada en las evaluaciones tumorales que se realizarán de acuerdo con los criterios RECIST v1.1 y los criterios irRECIST. - La tasa de SSP al cabo de 24 semanas, de acuerdo con los criterios RECIST v1.1y los criterios irRECIST. -La DdR, de acuerdo con los criterios RECIST v1.1y los criterios irRECIST. - La TCE, de acuerdo con los criterios RECIST v1.1y los criterios irRECIST. - La SG. La concentración plasmática o sérica de abemaciclib y pembrolizumab. El dolor y los síntomas relacionados con la enfermedad, de acuerdo con el cuestionario MDASI*. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Radiologic assessment is done every 6 weeks for 48 weeks, then every 9 weeks thereafter. |
Las evaluaciones radiológicas se realizarán cada 6 semanas durante las primeras 48 semanas, y posteriormente cada 9 semanas |
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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 |
Pain and disease-related symptoms |
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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) | 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 | No |
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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
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 |
France |
Italy |
Spain |
Taiwan |
Turkey |
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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date of the last visit or last scheduled procedure for the last patient |
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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 | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 20 |