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    Summary
    EudraCT Number:2022-002736-31
    Sponsor's Protocol Code Number:ETOP22-22
    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:2023-01-16
    Trial 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 number2022-002736-31
    A.3Full title of the trial
    A multicentre, single-arm phase II trial of adagrasib in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status
    Estudio de fase II, con un grupo y multicéntrico de adagrasib en pacientes con CPNM con mutación de KRASG12C, incluidos ancianos (≥ 70 años) o pacientes con un mal estado funcional
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of adagrasib for patients with KRASG12C-mutant non-small cell lung cancer (NSCLC), who are elderly or who are unwell because of their lung cancer.
    Un estudio de adagrasib para pacientes con cáncer de pulmón de células no pequeñas (CPCNP) con mutación KRASG12C, que son ancianos o que no se encuentran bien debido a su cáncer de pulmón.
    A.3.2Name or abbreviated title of the trial where available
    ADEPPT
    ADEPPT
    A.4.1Sponsor's protocol code numberETOP22-22
    A.5.4Other Identifiers
    Name:MiratiNumber:849-ISR-006
    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 IBCSG Partners Foundation
    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 supportMirati Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationETOP IBCSG Partners Foundation
    B.5.2Functional name of contact pointCoordinating Center
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 33
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041315119400
    B.5.5Fax number0041315119401
    B.5.6E-mailetop-regulatory@etop.ibcsg.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 nameAdagrasib
    D.3.2Product code MRTX849
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAdagrasib
    D.3.9.1CAS number 2326521-71-3
    D.3.9.2Current sponsor codeMRTX849
    D.3.9.4EV Substance CodeSUB218270
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Patients with KRASG12C-mutant stage IV NSCLC that had prior chemotherapy and/or immune-checkpoint inhibition or both.
    Pacientes con NSCLC en estadio IV con mutación KRASG12C que recibieron quimioterapia previa y/o inhibición del punto de control inmunitario o ambos.
    E.1.1.1Medical condition in easily understood language
    Patients with ‘non-small cell lung cancer’ (NSCLC) that has grown again during/after previous treatment. A change (mutation) in a gene called KRAS was found, which causes the lung cancer to grow.
    Pacientes con cáncer de pulmón de células no pequeñas que ha vuelto a crecer durante/después del tratamiento anterior. Tiene mutación en un gen llamado KRAS, que hace que crezca el cáncer de pulmón.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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
    The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).
    El objetivo principal de este ensayo es evaluar la eficacia clínica del tratamiento con adagrasib, en términos de respuesta objetiva, en pacientes con NSCLC con mutación KRASG12C, incluidos pacientes de edad avanzada (≥70 años) o pacientes con un estado funcional deficiente (ECOG PS = 2) .
    E.2.2Secondary objectives of the trial
    The secondary objectives refer to the evaluation of measures of clinical efficacy including durable clinical benefit (DCB), time-to-progression (TTP), progression-free survival (PFS), overall survival (OS), overall safety and patient-related outcomes.
    Los objetivos secundarios se refieren a la evaluación de medidas de eficacia clínica, incluido el beneficio clínico duradero (DCB), el tiempo hasta la progresión (TTP), la supervivencia libre de progresión (PFS), la supervivencia general (OS), la seguridad general y los resultados relacionados con el paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically confirmed stage IV NSCLC
    - KRASG12C-mutation by local testing (by tissue or ctDNA)
    - Prior treatment with at least one line of systemic therapy for NSCLC (e.g., platinum-based doublet chemotherapy and/or immune-checkpoint inhibition or both).
    - Life expectancy ≥12 weeks
    - Measurable disease according to RECIST v1.1
    - Age ≥18 years with ECOG PS 2 (cohort 1), or age ≥70 years with ECOG PS 0-1 (cohort 2)
    - Adequate haematological, renal and liver function
    - Negative pregnancy test for patients of childbearing potential
    - Ability to comply with the trial protocol, in the investigator's judgment.
    -Written informed consent for protocol treatment must be signed and dated by the patient and the investigator prior to any trial-related intervention, including the submission of mandatory biomaterial.
    - CPCNP en estadio IV confirmado histológica o citológicamente
    - Mutación KRASG12C por pruebas locales (por tejido o ctDNA)
    - Tratamiento previo con al menos una línea de terapia sistémica para NSCLC (p. ej., quimioterapia doble basada en platino y/o inhibición del punto de control inmunitario o ambos).
    - Esperanza de vida ≥12 semanas
    - Enfermedad medible según RECIST v1.1
    - Edad ≥18 años con ECOG PS 2 (cohorte 1), o edad ≥70 años con ECOG PS 0-1 (cohorte 2)
    - Función hematológica, renal y hepática adecuada
    - Prueba de embarazo negativa para pacientes en edad fértil
    - Capacidad para cumplir con el protocolo del ensayo, a juicio del investigador.
    -El paciente y el investigador deben firmar y fechar el consentimiento informado por escrito para el protocolo de tratamiento antes de cualquier intervención relacionada con el ensayo, incluida la presentación del biomaterial obligatorio.
    E.4Principal exclusion criteria
    -Prior investigational therapy within 28 days or at least 5 half-lives before enrolment
    -Prior treatment with an agent targeting KRASG12C
    -Leptomeningeal disease or untreated brain metastases:
    – Patient should be neurologically stable for at least 2 weeks before enrolment, without the need for corticosteroids, except for prednisone (or its equivalent) at a dose of ≤10 mg daily
    – For patients with definitively treated brain metastases, a minimum of 2 weeks must have elapsed from the last day of radiotherapy
    - History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications.
    Any of the following cardiac abnormalities:
    – Unstable angina pectoris or myocardial infarction within 6 months prior to enrolment.
    – Symptomatic or uncontrolled atrial fibrillation within 6 months prior to enrolment.
    – Congestive heart failure ≥NYHA Class 3 within 6 months prior to enrolment.
    – Prolonged QTc interval >480 ms or family or medical history of congenital Long QT Syndrome
    -History of stroke or transient ischemic attack within 6 months prior to enrolment
    -Ongoing need for treatment with concomitant medication with any of the following characteristics: known risk of Torsades de Pointes; substrate of CYP3A with narrow therapeutic index; strong inducer of CYP3A and/or P-gp; strong inhibitor of BCRP; and proton pump inhibitors that cannot be switched to alternative treatment prior to enrolment
    -Known human immunodeficiency virus (HIV) infection
    -Acute or chronic hepatitis B or C infection. Note that the following are permitted:
    a. Patients treated for hepatitis C (HCV) with no detectable viral load at screening;
    b. Patients treated for HIV with no detectable viral load for at least 1 month prior to enrolment; and
    c. Patients with hepatitis B (HBV) receiving prophylaxis against reactivation of hepatitis B (either [HBsAg-positive with normal ALT and HBV DNA <2,000 IU/mL or <10,000 copies/mL] or [HBsAg-negative and anti-HBcAg-positive])
    -Women who are pregnant or in the period of lactation
    -Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study
    -Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
    -Terapia en investigación previa dentro de los 28 días o al menos 5 vidas medias antes de la inclusión
    -Tratamiento previo con un agente dirigido a KRASG12C
    -Enfermedad leptomeníngea o metástasis cerebrales no tratadas:
    – El paciente debe estar neurológicamente estable durante al menos 2 semanas antes de la inclusión, sin necesidad de corticoides, excepto prednisona (o su equivalente) a una dosis de ≤10 mg diarios
    – Para pacientes con metástasis cerebrales tratadas definitivamente, deben haber transcurrido un mínimo de 2 semanas desde el último día de radioterapia
    - Antecedentes de enfermedad intestinal o cirugía gástrica mayor que pueda alterar la absorción del tratamiento del estudio o incapacidad para tragar medicamentos orales.
    Cualquiera de las siguientes anomalías cardíacas:
    – Angina de pecho inestable o infarto de miocardio en los 6 meses anteriores a la inclusión.
    – Fibrilación auricular sintomática o no controlada en los 6 meses anteriores a la inclusión.
    – Insuficiencia cardíaca congestiva ≥NYHA Clase 3 en los 6 meses anteriores a la inclusión.
    – Intervalo QTc prolongado >480 ms o antecedentes médicos o familiares de síndrome de QT prolongado congénito
    -Antecedentes de accidente cerebrovascular o ataque isquémico transitorio dentro de los 6 meses anteriores a la inclusión
    -Necesidad continua de tratamiento con medicación concomitante con alguna de las siguientes características: riesgo conocido de Torsades de Pointes; sustrato de CYP3A con índice terapéutico estrecho; fuerte inductor de CYP3A y/o P-gp; fuerte inhibidor de BCRP; e inhibidores de la bomba de protones que no se pueden cambiar a un tratamiento alternativo antes de la inclusión
    -Infección conocida por el virus de la inmunodeficiencia humana (VIH)
    -Infección aguda o crónica por hepatitis B o C. Tenga en cuenta que lo siguiente está permitido:
    una. Pacientes tratados por hepatitis C (VHC) sin carga viral detectable en la selección;
    b. Pacientes tratados por VIH sin carga viral detectable durante al menos 1 mes antes de la inclusión; y
    C. Pacientes con hepatitis B (VHB) que reciben profilaxis contra la reactivación de la hepatitis B (ya sea [HBsAg positivo con ALT normal y ADN del VHB <2000 UI/mL o <10 000 copias/mL] o [HBsAg negativo y anti-HBcAg positivo] )
    -Mujeres embarazadas o en periodo de lactancia
    -Hombres y mujeres en edad fértil sexualmente activos que no estén dispuestos a utilizar un método anticonceptivo eficaz durante el estudio
    -Juicio por parte del investigador de que el paciente no debe participar en el estudio si es poco probable que cumpla con los procedimientos, restricciones y requisitos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR) per RECIST v1.1, assessed at 12 weeks.
    Tasa de respuesta objetiva (ORR) según RECIST v1.1, evaluada a las 12 semanas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    final analysis
    Análisis final
    E.5.2Secondary end point(s)
    - Durable clinical benefit (DCB)
    - Time to progression (TTP)
    - Progression-free Survival (PFS)
    - Overall Survival (OS)
    - Safety
    - Patient-related outcomes
    - Beneficio clínico duradero
    - Tiempo hasta la progresión
    - Supervivencia sin progresión
    - Supervivencia global
    - Seguridad
    - Resultados percibidos por el paciente
    E.5.2.1Timepoint(s) of evaluation of this end point
    - DCB: final analysis
    - TTP: final analysis
    - PFS: final analysis
    - OS: final analysis
    - Safety: every 3 month and at final analysis
    -Patient-related outcomes: final analysis
    - DCB: análisis final
    - TTP: análisis final
    - SLP: análisis final
    - SO: análisis final
    - Seguridad: cada 3 meses y en el análisis final
    -Resultados relacionados con el paciente: análisis final
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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 EEA23
    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
    Spain
    Italy
    Belgium
    Ireland
    United Kingdom
    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
    LPLV
    Ultimo visita del última paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 53
    F.4.2.2In the whole clinical trial 68
    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 Decision2023-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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