| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Non-Small Cell Lung Cancer |
| Cáncer de pulmón no microcítico |
|
| E.1.1.1 | Medical condition in easily understood language |
| Non-Small Cell Lung Cancer |
| Cáncer de pulmón no microcítico |
|
| 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 | 17.0 |
| 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) |
|
| 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 evaluate the safety and tolerability of RO5479599 in combination with carboplatin and paclitaxel
? To estimate the efficacy of RO5479599 in combination with carboplatin and paclitaxel, as measured by the objective response rate (ORR, defined as complete response [CR] rate + partial response [PR] rate) |
- Evaluar la seguridad y la tolerancia de RO5479599 en combinación con carboplatino y paclitaxel.
- Valorar la eficacia de RO5479599 en combinación con carboplatino y paclitaxel, que se determinará basándose en el índice de respuesta objetiva (IRO, que se define como el índice de respuesta completa [RC] + respuesta parcial [RP]). |
|
| E.2.2 | Secondary objectives of the trial |
? To evaluate patients for progression-free survival (PFS) and overall survival (OS)
? To evaluate disease control rate (DCR, defined as ORR + stable disease [SD] rate)
? To describe the PK of RO5479599 in combination with carboplatin and paclitaxel |
- Evaluar la supervivencia libre de progresión (SLP) y la supervivencia global (SG) en los pacientes
- Evaluar el índice de control de la enfermedad (ICE, que se define como el IRO + índice de estabilización de la enfermedad [EE])
- Describir la FC de RO5479599 en combinación con carboplatino y paclitaxel |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Age >/= 18 years
- ECOG performance status (PS) 0 - 1
- Histologically confirmed squamous NSCLC patients
- Locally advanced or metastatic (stage IIIB or IV) squamous NSCLC
- No prior systemic chemotherapy, targeted therapy for metastatic NSCLC
- Evidence of at least one radiologically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Adequate hematological, liver and renal function
- Use of highly effective contraception |
- Tener >/= 18 años de edad.
- Estado funcional (EF) ECOG 0 - 1.
- Pacientes con CPNM escamoso confirmado histológicamente.
- CPNM de histología escamosa, localmente avanzado y/o metastásico (en estadio IIIB o IV).
- No haber recibido previamente quimioterapia sistémica o terapia dirigida para CPNM.
- Evidencia de al menos una lesión medible radiológicamente, de acuerdo con los criterios RECIST v1.1.
- Función hematológica, función hepática y función renal adecuadas.
- Uso de método anticonceptivo altamente eficaz. |
|
| E.4 | Principal exclusion criteria |
- Concurrent therapy with any other investigational drug
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases
- Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus and/or significant cardiovascular disease or uncontrolled infection
- Any other diseases, metabolic dysfunction, a physical examination finding or a clinical laboratory finding, giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- Major surgery or significant traumatic injury < 28 days prior to the first study treatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
- Pregnant or breast-feeding women
- History of other malignancies that could affect compliance with protocol or interpretation of results. Patients with malignancies diagnosed more than five years prior to study day one, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer are generally eligible |
- Tratamiento simultáneo con cualquier otro fármaco en investigación.
- Antecedentes o evidencia clínica de tumores primarios o metástasis del sistema nervioso central (SNC).
- Evidencia de enfermedades concomitantes significativas, no controladas, que pudieran afectar al cumplimiento con el protocolo o la interpretación de los resultados, incluyendo diabetes mellitus y/o enfermedades cardiovasculares significativas no controladas o infecciones no controladas.
- Cualquier otra enfermedad, alteración metabólica, hallazgo en la exploración física o en las pruebas de laboratorio clínico que lleven a sospechar razonablemente la existencia de una enfermedad o condición para la cual estaría contraindicado el uso de un fármaco en investigación.
- Cirugía mayor (exceptuando biopsias) o traumatismos significativos en los < 28 días previos a la administración de la primera infusión del tratamiento del estudio o en los que esté prevista una intervención de cirugía mayor durante el tratamiento del estudio.
- Mujeres embarazadas o en período de lactancia.
- Antecedentes de otras neoplasias malignas que podrían afectar al cumplimiento del protocolo o a la interpretación de los resultados. Los pacientes con neoplasias diagnosticadas más de cinco años antes del día 1 del estudio, carcinoma in situ de cérvix o carcinoma de piel basocelular o escamocelular tratados adecuadamente son generalmente elegibles para el estudio. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Incidence of adverse events
2. Objective response rate (ORR), defined as complete response (CR) rate + partial response (PR) rate at 6 weeks |
1. Incidencia de acontecimientos adversos.
2. Índice de respuesta objetiva (IRO), que se define como índice de respuesta completa [RC] + respuesta parcial [RP] a las 6 semanas. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to 30 months
2. 6 weeks |
1. Hasta 30 meses.
2. 6 semanas. |
|
| E.5.2 | Secondary end point(s) |
1. Progression-free survival (PFS)
2. Outcome Measure: Overall survival (OS)
3. Outcome Measure: Disease control rate (DCR)
4. Pharmacokinetic parameters derived from serum RO5479599 concentrations |
1. Supervivencia Libre de progresión (SLP).
2. Variable de valoración: Supervivencia Global (SG).
3. Variable de valoración: Índice de control de la enfermedad (ICE).
4. Parámetros farmacocinéticos de las concentraciónes séricas de RO5479599. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Up to 30 months |
| Hasta 30 meses. |
|
| 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 | Yes |
| E.6.13.1 | Other scope of the trial description |
| other exploratory objectives e.g. biomarkers, RCR |
| Otros objetivos exploratorios, p.ej. biomarcadores, RCR |
|
| 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 |
|
| 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.8.2.4 | 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 | 4 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 13 |
| 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 |
| Canada |
| Denmark |
| France |
| Germany |
| Korea, Republic of |
| Netherlands |
| Spain |
| United Kingdom |
| United States |
|
| 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
|
The timepoint for the primary efficacy analysis is defined as the time at which the last patient has completed six cycles of chemotherapy combination and/or RO5479599, or all patients have progressed/died or withdrawn consent or when the study is
terminated by the Sponsor, whichever occurs first. All patients will attend a follow-up visit 28 (± 3) days after receiving the last administration of RO5479599, which is the last study visit. |
| Está previsto realizar el análisis principal de eficacia en el momento en que el último paciente haya completado 6 ciclos de quimioterapia de combinación y/o de RO5479599 o cuando todos los pacientes hayan manifestado progresión de la enfermedad o hayan fallecido o retirado su consentimiento o cuando el promotor concluya el estudio, lo que ocurra primero. Todos los pacientes acudirán a una visita de seguimiento 28(±3) días tras la última dosis de RO5479599, que será la última visita del estudio. |
|
| 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 | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| 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 | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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