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    Summary
    EudraCT Number:2017-002063-17
    Sponsor's Protocol Code Number:ETOP12-17
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-002063-17
    A.3Full title of the trial
    A single arm phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC
    Estudio Fase II con un solo grupo que evalúa la actividad de alectinib para el tratamiento de CNPM avanzado con reordenamiento de RET en pacientes previamente tratados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to evaluate the activity of alectinib for the Treatment of pretreated patients with advanced NSCLC that have confirmed RET-rearrangement.
    Un estudio de investigación para evaluar la actividad de alectinib para el tratamiento de pacientes pretratados con NSCLC avanzado que han confirmado el reordenamiento RET.
    A.3.2Name or abbreviated title of the trial where available
    ALERT-lung
    A.4.1Sponsor's protocol code numberETOP12-17
    A.5.4Other Identifiers
    Name:Roche NumberNumber:MO30176
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorETOP (European Thoracic Oncology Platform)
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationETOP
    B.5.2Functional name of contact pointETOP Coordinating Office
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 40
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4131 511 94 00
    B.5.5Fax number+4131 511 94 01
    B.5.6E-mailALERT-lung@etop-eu.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAlectinib
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALECTINIB HYDROCHLORIDE
    D.3.9.1CAS number 1256589-74-8
    D.3.9.2Current sponsor codeRO542-482/F03,RO542-4802/F16
    D.3.9.3Other descriptive nameALECTINIB HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB177048
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced stage RET-rearranged NSCLC
    Pacientes con CNPM avanzado con reordenamiento de RET
    E.1.1.1Medical condition in easily understood language
    Lung cancer called "non-small cell lung cancer (NSCLC)" that has spread to other parts of the Body (metastatic) and that has a rearrangment in the RET gene
    Cáncer de pulmón llamado "cáncer de pulmón no microcítico (CPNM)" que haya progresado y se haya extendido a otras partes del cuerpo y que tiene una reordenación en el gen RET
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST 1.1.
    Evaluar la eficacia de alectinib en cuanto a la mejor respuesta global (RG) según RECIST v1.1.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate secondary measures
    of clinical efficacy including disease control, progression-free survival (PFS), and overall survival (OS) as well as to assess safety and tolerability of the treatment and to describe the
    association of primary and secondary outcomes with tumour characteristics.
    Los objetivos secundarios son analizar las mediciones secundarias de la eficacia clínica como el control de la enfermedad, la supervivencia sin progresión (SSP) y la supervivencia global (SG), así como evaluar la seguridad y la tolerabilidad del tratamiento y describir la asociación de los resultados principales y secundarios con las características del tumor.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically-documented non-small cell lung carcinoma
    - Advanced disease defined as recurrent stage IV (according to 8th TNM classification) or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical
    resection, or definitive chemo-radiation therapy for locally advanced disease)
    - RET rearrangement detected by FISH, Nanostring or by parallel-sequencing on FFPE tumour tissue (biopsy, resection or cytoblock) assessed locally.
    - Availability of FFPE tumour material for central confirmation of RET-rearrangement
    - At least one prior platinum-based systemic regimen: Adjuvant or neoadjuvant or definitive platinum-based chemo-radiotherapy treatments are considered as a line of treatment only if completed less than 6 months before enrolment. Maintenance therapy following platinum doublet-based chemotherapy is not considered a separate regimen of therapy.
    - Measurable or non-measurable, but radiologically evaluable (except for skin lesions) disease according to RECIST v1.1 criteria
    - Adequate haematological, renal and liver function
    - ECOG Performance Status 0-2
    - Carcinoma no microcítico de pulmón comprobado por el análisis histológico o citológico
    - Enfermedad avanzada definida como de estadio IV recurrente (según la 8ª clasificación TNM) o enfermedad recurrente o progresiva tras tratamiento multimodal (radioterapia, extirpación quirúrgica o quimiorradioterapia definitiva para una enfermedad localmente avanzada)
    - Reordenamiento de RET detectado por FISH, Nanostring o por secuenciación paralela de tejido tumoral FFPE (biopsia, resección o citobloque) analizado localmente.
    - Disponibilidad de material tumoral FFPE para la confirmación central del reordenamiento de RET
    - Al menos un tratamiento sistémico basado en platino previo Los tratamientos adyuvantes o neoadyuvantes o de quimiorradioterapia con platino definitiva se consideran una línea de tratamiento solo si concluyeron menos de 6 meses antes de la inclusión. El tratamiento de mantenimiento tras la biquimioterapia antineoplásica con platino no se considera un tratamiento distinto
    - Enfermedad mensurable o no mensurable pero evaluable radiológicamente (excepto las lesiones cutáneas) según los criterios de RECIST v1.1
    - Función hematológica, renal y hepática adecuada
    - Categoría funcional ECOG 0-2
    E.4Principal exclusion criteria
    - Untreated, active CNS metastases
    - Carcinomatous meningitis
    - Baseline symptomatic bradycardia
    - Prior treatment with any RET TKI or RET targeted therapy
    - Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
    - History of hypersensitivity to any of the additives in the alectinib drug formulation
    - Pregnant or lactating women
    - Known HIV positivity or AIDS-related illness
    - Any concurrent systemic anticancer therapy
    - Metástasis activa en el SNC no tratada
    - Meningitis carcinomatosa
    - Bradicardia sintomática previa
    - Tratamiento previo con cualquier TKI de RET o tratamiento selectivo de RET
    - Cualquier trastorno GI que pueda afectar a la absorción de medicamentos orales, como el síndrome de intolerancia o pacientes sometidos a resección intestinal mayor
    - Antecedentes de hipersensibilidad a cualquiera de los aditivos en la formulación del medicamento alectinib
    - Mujeres embarazadas o lactantes
    - Infección por el VIH o enfermedad relacionada con el SIDA conocidas
    - Cualquier tratamiento sistémico concomitante contra el cáncer
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response (OR = CR or PR), per investigator assessment, according to RECIST 1.1.
    Mejor respuesta global (RG = RC o RP), por la evaluación del investigador, según RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from the start of trial treatment across all time points until the end of trial
    treatment.
    desde el inicio del tratamiento del estudio, pasando por todos los momentos de evaluación, hasta el final del tratamiento del estudio
    E.5.2Secondary end point(s)
    -Best Overall (OR) response per independent review
    -Disease control (DC): best overall response of CR or PR, or SD (or non-CR/non-PD in the case of non-measurable disease only)
    -Progression-free survival (PFS)
    -Overall survival (OS)
    -Safety and tolerability
    - Mejor respuesta global por la revisión independiente
    - Control de la enfermedad: mejor respuesta global de RC o RP, o EE (o no RC/no EP solo en el caso de enfermedades no mensurables)
    - Supervivencia sin progresión
    - Supervivencia global
    - Seguridad y tolerabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    -OR: from the start of trial treatment across all time points until the end of trial Treatment
    -DC: measured at 24 weeks
    -PFS: time from the date of enrolment until documented progression or death, if progression is not documented
    -OS: time from the date of enrolment until death from any cause
    -Safety and tolerability: from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication
    - OR: desde el inicio del tratamiento del estudio, pasando por todos los momentos de evaluación, hasta el final del tratamiento del estudio.
    - DC: mesurado tras 24 semanas
    - PFS: tiempo transcurrido desde la fecha de inclusión hasta la progresión comprobada o el fallecimiento, si la progresión no está comprobada
    - OS: tiempo transcurrido desde la fecha de la inclusión hasta el fallecimiento por cualquier causa
    - Seguridad y tolerabilidad: desde la fecha de firma del consentimiento informado hasta 30 días después de la interrupción del tratamiento de estudio, independientemente de su relación con el medicamento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    single-arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other 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.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Ireland
    Italy
    Netherlands
    Spain
    E.8.7Trial has a data monitoring committee Yes
    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 trial ends when both of the following criteria are satisfied:
    - The trial is mature for the analysis of the primary endpoint, according to protocol specifications.
    - The cleaning procedure of the database is completed and database is ‘frozen’.

    The total duration of the trial is expected to be 5 years, including a run-in period of 6 months and an additional 6 months for the final analysis report.
    en ensayo clínico finaliza cuando se cumplen los dos criterios siguientes:
      - El ensayo clínicos está listo para el análisis del objetivo l primario, de acuerdo con las especificaciones del protocolo.
      - Se completa el procedimiento de limpieza de la base de datos y la base de datos se 'congela'.

    Se espera que la duración total del ensayo sea de 5 años, incluido un período inicial de 6 meses y 6 meses adicionales para el informe de análisis final.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    No
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-18
    P. End of Trial
    P.End of Trial StatusOngoing
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