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    Summary
    EudraCT Number:2021-002605-10
    Sponsor's Protocol Code Number:CJDQ443B12301
    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:2022-04-27
    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 number2021-002605-10
    A.3Full title of the trial
    KontRASt-02: A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer
    KontRASt-02: Estudio de fase III, aleatorizado, controlado y abierto que evalúa la seguridad y la eficacia de JDQ443 frente a docetaxel en pacientes con cáncer de pulmón de células no pequeñas localmente avanzado o metastásico con mutación KRAS G12C previamente tratados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of JDQ443 in comparison with docetaxel in participants with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer
    Estudio de la eficacia y seguridad de JDQ443 en comparación con docetaxel en participantes con cáncer de pulmón de células no pequeñas localmente avanzado o metastásico con mutación KRAS G12C.
    A.4.1Sponsor's protocol code numberCJDQ443B12301
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+3490 0353036
    B.5.5Fax number+3493 2479903
    B.5.6E-maileecc.novartis@novartis.com
    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 nameJDQ443
    D.3.2Product code JDQ443
    D.3.4Pharmaceutical form 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 INNNot established yet.
    D.3.9.2Current sponsor codeJDQ443
    D.3.9.3Other descriptive nameJDQ443
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Docetaxel - Taxotere and other docetaxel containing medicinal products
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Mature IP, 54 rue La Boeti, 75008 Paris, France
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 namedocetaxel
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDocetaxel
    D.3.9.1CAS number 114977-28-5
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 non-small cell lung cancer harboring the KRAS G12C mutation
    Cáncer de pulmón de células no pequeñas avanzado con mutación KRAS G12C.
    E.1.1.1Medical condition in easily understood language
    Advanced lung cancer with a specific mutation (G12C) in the KRAS gene
    Cáncer de pulmón avanzado con una mutación específica (G12C) en el gen KRAS
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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 compare the progression-free survival (PFS) of JDQ443 versus docetaxel
    - Comparar la supervivencia libre de progresión (PFS) de JDQ443 frente a docetaxel.
    E.2.2Secondary objectives of the trial
    ● To compare overall survival (OS) in the two treatment arms (key secondary objective)
    ● To assess the anti-tumor activity of JDQ443 compared to docetaxel
    ● To assess PFS2 in the two treatment arms
    ● To characterize the safety profile of JDQ443
    ● To assess the effect of JDQ443 vs docetaxel on PROs (NSCLC-SAQ, EORTC QLQ-C30, lung-specific module QLQ-LC13, and EQ-5D-5L) including lung cancer symptoms, health-related quality of life, and health status
    ● To characterize the pharmacokinetics of JDQ443
    ● To assess the effect of JDQ443 vs docetaxel on ECOG performance status
    ● To assess the safety of JDQ443 in participants who crossover from docetaxel
    - Comparar la supervivencia global (OS) en los dos grupos de tratamiento (objetivo secundario principal).
    - Evaluar la actividad antitumoral de JDQ443 en comparación con docetaxel.
    - Evaluar PFS2 en los dos grupos de tratamiento.
    - Caracterizar el perfil de seguridad de JDQ443.
    - Evaluar los efectos de JDQ443 frente a docetaxel en PROs (NSCLC-SAQ, EORTC QLQ-C30, módulo específico de pulmón QLQ-LC13, y EQ-5D-5L) incluyendo los síntomas del cáncer de pulmón, la calidad de vida relacionada con la salud y el estado de salud.
    - Caracterizar la farmacocinética de JDQ443.
    - Evaluar el efecto de JDQ443 frente a docetaxel en el estado funcional del ECOG.
    - Evaluar la seguridad de JDQ443 en participantes que cambian de docetaxel a JDQ443
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● Participants are male and female, aged 18 or older
    ● Histologically confirmed locally advanced stage IIIB/IIIC (and not eligible for definitive chemo-radiation curative therapy or complete surgical resection) or stage IV previously treated NSCLC. Presence of a KRAS G12C mutation by central laboratory testing using tissue samples.
    ● Participants have received one prior platinum-based chemotherapy and one prior immune checkpoint inhibitor therapy either in combination or in sequence.
    ● Participants with ECOG performance status from 0 to 2
    - Participantes de ambos sexos, de 18 años o más.
    - NSCLC localmente avanzado en estadio IIIB/IIIC (y no apto para tratamiento curativo definitivo con quimiorradiación o resección quirúrgica completa) o en estadio IV confirmado histológicamente y tratado previamente. Presencia de una mutación KRAS G12C determinada mediante pruebas analíticas de muestras de tejido realizadas en un laboratorio central.
    - Participantes que hayan recibido anteriormente quimioterapia basada en platino y terapia con un inhibidor de puntos de control inmunitario, ya sea en secuencia o en combinación.
    - Participantes con estado funcional del ECOG de 0 a 2.
    E.4Principal exclusion criteria
    ● Participants who have previously received docetaxel, KRAS G12C inhibitor, or any other systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior immune checkpoint inhibitor therapy.
    ● Participants with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) rearrangement by local testing. Participants with other known druggable alterations will be
    excluded, if required by local guidelines.
    ● History of severe hypersensitivity reaction to taxanes or any excipients of these study treatments.
    - Participantes que hayan recibido previamente docetaxel, un inhibidor de KRAS G12C o cualquier otro tratamiento sistémico para su NSCLC localmente avanzado o metastásico que no sea quimioterapia basada en platino ni terapia con un inhibidor de puntos de control inmunitario.
    - Participantes con mutación sensibilizante del receptor del factor de crecimiento epidérmico (EGFR) o reordenamiento de la quinasa de linfoma anaplásico (ALK) determinados mediante pruebas locales. Se excluirá a los participantes con otras alteraciones conocidas que pueden ser tratadas con fármacos, si se indica en las guías locales.
    - Antecedentes de reacción de hipersensibilidad grave a los taxanos o a cualquier excipiente de estos tratamientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    ● Progression-free survival (PFS) per Blinded Independent Review Committee (BIRC) according to RECIST 1.1.
    - Supervivencia libre de progresión (PFS) por un comité de revisión independiente ciego (BIRC) mediante RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary PFS analysis for the randomized part of the study will be performed after observing approximately 269 centrally confirmed PFS events, in the full analysis set (FAS) or based on the PFS interim analysis data in case the study is futile at that analysis. If PFS is statistically significant, the final OS analysis will be performed after observing approximately 228 deaths in the FAS or earlier if OS meets statistical significance at the planned interim analysis
    El análisis principal para la supervivencia libre de progresión (SLP) de la parte randomizada del estudio, se realizará cuando se hayan observado aproximadamente 269 eventos de PFS, confirmados centralmente en el conjunto de análisis completo o basado en los datos el Análisis Intermedio (AI) de la SLP en el caso de que el estudio sea positivo a futilidad. Si la SLP es estadísticamente significativa, el análisis final de la supervivencia global (SG), se realizara después de observar aproximadamente 228 muertes en el conjunto de análisis completo o antes, si la SG alcanza significación estadística en el momento del Análisis Intermedio.
    E.5.2Secondary end point(s)
    ● OS
    ● ORR, DCR, TTR, and DOR per RECIST 1.1 (by BIRC and local Investigator's assessment)
    ● PFS2 based on local investigator's assessment
    ● Type, frequency and severity of adverse events, changes in laboratory values, vital signs, ECGs
    ● Time to definitive 10-point deterioration symptom scores of chest pain, cough, and dyspnea per QLQ-LC13 questionnaire are primary PRO variables of interest
    ● Time to definitive deterioration in global health status/QoL, shortness of breath, and pain per QLQ-C30 are secondary PRO variables of interest
    ● Change from baseline in EORTC-QLQ C30 LC13, EQ-5D-5L, and NSCLC-SAQ
    ● The concentration of JDQ443 in plasma and pharmacokinetic
    parameters for a subgroup of participants in mainland China.
    ● Time to definitive deterioration of the ECOG performance status.
    ● Type, frequency and severity of adverse events, changes in laboratory values, vital signs, ECGs
    -OS
    - ORR, DCT, TTR y DOR mediante RECIST 1.1 (evaluación por BIRC e investigador local)
    - PFS2 basada en evaluación del investigador local
    - Tipo, frecuencia y severidad de los efectos adversos, cambios en los valores de laboratorio, signos vitales, ECGs.
    - Tiempo hasta el deterioro en 10 puntos en puntuación de síntomas como dolor de pecho, tos y disnea según el cuestionario QLQ-LC13.
    - Tiempo hasta el deterioro del estatus de salud general, dificultad para respirar, y dolor, segun el cuestionario QLQ-C30.
    - Cambio desde basal en EORTC-QLQ C30 LC13, EQ-5D-5L, y NSCLC-SAQ
    - La contentración de JDQ443 en plasma y parámetros farmacocinéticos para un subgrupo de participantes en China continental.
    - Tiempo hasta el deterioro del ECOG.
    - Tipo, frecuencia y gravedad de los acontecimientos adversos, cambios en valores de laboratorio, constantes vitales, ECGs
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Efficacy: pre specified time-points as per protocol
    • Safety/tolerability: continuously during on-treatment period
    • PK: as defined per protocol and Statistical Analysis Plan
    - Eficacia: tiempos preestablecidos según protocolo
    - Seguridad y Tolerabilidad: continuamente durante el periodo de tratamiento
    - PK: como está definido en el protocolo y el Plan de Análisis estadístico.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Docetaxel
    Docetaxel
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Argentina
    Brazil
    Canada
    Chile
    China
    Colombia
    Hong Kong
    India
    Jordan
    Korea, Republic of
    Lebanon
    Malaysia
    Mexico
    Russian Federation
    Serbia
    Taiwan
    Thailand
    Viet Nam
    Croatia
    Czechia
    Denmark
    Estonia
    Finland
    Greece
    Hungary
    Iceland
    Italy
    Norway
    Poland
    Portugal
    Slovenia
    United Kingdom
    Bulgaria
    Romania
    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
    LVLS
    LVLS
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    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: 360
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 360
    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)
    There are currently no specific plans.
    Actualmente no hay planes específicos
    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 Decision2022-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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