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    Summary
    EudraCT Number:2022-001088-29
    Sponsor's Protocol Code Number:CJDQ443B12201
    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:2022-08-03
    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 number2022-001088-29
    A.3Full title of the trial
    KontRASt-06: An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation.
    KontRASt-06: Ensayo de fase II abierto en el que se evalúan la actividad y la seguridad de JDQ443 en monoterapia como tratamiento de primera línea para pacientes con cáncer de pulmón de células no pequeñas localmente avanzado o metastásico KRAS G12C mutado con expresión de PD-L1 <1 % o con expresión de PD-L1 >=1 % y mutación adicional de STK11
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C- mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation.
    Estudio de eficacia y seguridad de JDQ443 en monoterapia como tratamiento de primera línea para pacientes con cáncer de pulmón de células no pequeñas localmente avanzado o metastásico KRAS G12C mutado con expresión de PD-L1 <1 % o con expresión de PD-L1 >=1 % y mutación adicional de STK11.
    A.4.1Sponsor's protocol code numberCJDQ443B12201
    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.3.9.4EV Substance CodeSUB218494
    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.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
    locally advanced or metastatic KRAS G12C- mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation
    Cáncer de pulmón de células no pequeñas localmente avanzado o metastásico KRAS G12C mutado con expresión de PD-L1 <1 % o con expresión de PD-L1 >=1 % y mutación adicional de STK11.
    E.1.1.1Medical condition in easily understood language
    locally advanced or metastatic KRAS G12C- mutated non-small cell lung cancer
    Cáncer de pulmón de células no pequeñas localmente avanzado o metastásico KRAS G12C mutado
    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 assess the antitumor activity of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic NSCLC whose tumors harbor a KRAS G12C mutation and a PD-L1 expression < 1%, regardless of STK11 mutation status (cohort A).
    Evaluar la actividad antitumoral de JDQ443 en monoterapia como tratamiento de primera línea para participantes con CPCNP localmente avanzado o metastásico cuyos tumores presentan mutación KRAS G12C y expresión de PD-L1 <1 %, independientemente del estado de mutación de STK11 (cohorte A).
    E.2.2Secondary objectives of the trial
    • To assess the antitumor activity of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic NSCLC whose tumors harbor a KRAS G12C mutation, a PD-L1 expression ≥1% and an STK11 co-mutation (cohort B).
    • To assess duration of response (DOR) in both cohorts.
    - Evaluar la actividad antitumoral de JDQ443 en monoterapia como tratamiento de primera línea para participantes con CPCNP localmente avanzado o metastásico cuyos tumores presentan mutación KRAS G12C, expresión de PD-L1 >=1 % y mutación adicional de STK11 (cohorte B).
    - Evaluar la duración de la respuesta (DOR) en ambas cohortes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) NSCLC without previous systemic treatment for metastatic disease. Prior (neo)adjuvant treatment with chemotherapy and/or immunotherapy, or prior radiotherapy administered sequentially or concomitantly with chemotherapy and/or immunotherapy for localized or locally advanced disease are accepted if the time between therapy completion and enrollment is > 12 months.
    • Presence of a KRAS G12C mutation (all participants) and:
    • Cohort A: PD-L1 expression < 1%, regardless of STK11 mutation status
    • Cohort B: PD-L1 expression ≥ 1% and an STK11 co-mutation
    • At least one measurable lesion per RECIST 1.1.
    • ECOG performance status ≤ 1.
    • Participants capable of swallowing study medication.
    - CPCNP, confirmado histológicamente, localmente avanzado (en estadio IIIb/IIIc y no apto para recibir quimiorradiación definitiva ni resección quirúrgica con intención curativa) o metastásico (en estadio IV) sin tratamiento sistémico previo para la enfermedad metastásica. Se acepta el tratamiento (neo)adyuvante previo con quimioterapia o inmunoterapia, o la radioterapia previa administrada de forma secuencial o concomitante con quimioterapia o inmunoterapia para la enfermedad localizada o localmente avanzada si el tiempo transcurrido entre la finalización del tratamiento y el reclutamiento es >12 meses.
    - Presencia de mutación KRAS G12C (en todos los participantes) y:
    - Cohorte A: expresión de PD-L1 <1 %, independientemente del estado de mutación de STK11.
    - Cohorte B: expresión de PD-L1 >=1 % y mutación adicional de STK11.
    - Al menos una lesión medible según RECIST 1.1.
    - Estado funcional ECOG <=1.
    - Participantes capaces de tragar la medicación del estudio.
    E.4Principal exclusion criteria
    • Participants whose tumors harbor an EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other known druggable alterations will be excluded, if required by local guidelines
    • Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC.
    • A medical condition that results in increased photosensitivity (i.e. solar urticaria, lupus erythematosus, etc).
    • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
    • Participants who are taking a prohibited medication (strong CYP3A inducers) that cannot be discontinued at least seven days prior to the first dose of study treatment and for the duration of the study
    - Participantes cuyos tumores presenten una mutación sensibilizante del EGFR o un reordenamiento de ALK determinados mediante pruebas de laboratorio locales. Se excluirá a los participantes con otras alteraciones conocidas que pueden ser tratadas con fármacos, si se indica en las guías locales.
    - Uso previo de un inhibidor de KRAS G12C o tratamiento sistémico previo para el CPCNP metastásico.
    - Una enfermedad que conlleve una mayor fotosensibilidad (es decir, urticaria solar, lupus eritematoso, etc.).
    - Metástasis activas en el sistema nervioso central (SNC) o meningitis carcinomatosa conocidas.
    - Participantes que tomen medicación prohibida (inductores potentes de CYP3A) que no pueda discontinuarse al menos siete días antes de la primera dosis del tratamiento del estudio ni durante el transcurso de este.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR), defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent review committee (BIRC).
    Tasa de respuesta global (ORR), definida como la proporción de participantes con una respuesta completa (RC) o una respuesta parcial (RP) confirmadas como la mejor respuesta global (BOR) según la versión 1.1 de los Criterios de evaluación de respuesta en tumores sólidos (RECIST 1.1) por el comité de revisión independiente ciego (BIRC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint of the study is ORR, defined as the proportion of participants with a confirmed CR/PR as BOR. BOR is defined as the best response recorded from the start of the treatment until disease progression per RECIST 1.1 by BIRC. CR and PR must be confirmed by repeat assessments that should be performed not less than 4 weeks after the criteria for response were first met. Responses documented after the use of any new anti-neoplastic therapy will be considered as non-response.
    La variable principal del estudio es ORR, definida como la proporción de participantes con una RC/RP confirmadas como BOR. BOR es definida como la mejor respuesta global registrada desde el inicio de tratamiento hasta la progresión de la enfermedad por RECIST 1.1 según el comité de revisión independiente ciego (BIRC). Respuesta completa (RC) y respuesta parcial (RP) tienen que ser confirmadas en repetidas evaluaciones que deberían realizarse no menos de 4 semanas después de alcanzar el criterio de respuesta por primera vez. Las respuestas documentadas después del uso de cualquier nueva terapia antineoplásica no serán consideradas como respuestas.
    E.5.2Secondary end point(s)
    • ORR per RECIST 1.1 by BIRC.
    • DOR, defined as the time from the first occurrence of a PR or a CR per RECIST 1.1 by BIRC to the occurrence of disease progression or death due to any cause.
    • PFS, defined as the time from the date of enrollment to the date of the first documented disease progression per RECIST 1.1 by BIRC or date of death due to any cause.
    • OS, defined as the time from the date of enrollment to the date of death due to any cause.
    • Disease control rate (DCR), defined as the proportion of participants with a BOR of confirmed CR, PR and stable disease (SD) per RECIST 1.1 by BIRC.
    Time to response (TTR), defined as the time from the date of enrollment to the first documented response of either CR or PR per RECIST 1.1 by BIRC.
    • ORR, DOR, DCR, TTR and PFS per RECIST 1.1 by local radiology assessment.
    • ORR, DOR, DCR and TTR per RECIST 1.1 by BIRC and by local radiology assessment.
    • PFS and OS
    • Type, frequency and severity of adverse events, changes in laboratory values, vital signs, electrocardiograms (ECGs).
    • Concentration of JDQ443 in plasma and derived PK parameters, as appropriate.
    • Time to definitive deterioration (TTD) in the NSCLC-SAQ total score, and TTD in the physical functioning (PF) scale of the EORTC QLQ-C30
    • Change from baseline to each treatment visit and EOT for NSCLC-SAQ total score, pain, cough, dyspnea and items.
    • Change from baseline to each treatment visit and EOT for all EORTC-QLQ C30 domains, subscales and items
    • Change from baseline to each treatment visit and to EOT for the FACT GP5
    - ORR según RECIST 1.1 determinada por el BIRC.
    - DOR, definida como el tiempo transcurrido desde la primera aparición de una RP o una RC según RECIST 1.1 determinada por el BIRC hasta la aparición de la progresión de la enfermedad o la muerte por cualquier causa.
    - PFS, definida como el tiempo transcurrido desde la fecha del reclutamiento hasta la fecha de la primera progresión de la enfermedad según RECIST 1.1 documentada por el BIRC o la fecha de la muerte por cualquier causa.
    - OS, definida como el tiempo transcurrido desde la fecha del reclutamiento hasta la fecha de la muerte por cualquier causa.
    - Tasa de control de la enfermedad (DCR), definida como la proporción de participantes con una BOR de la RC y la RP confirmadas y con enfermedad estable (EE) según RECIST 1.1 determinada por el BIRC. Tiempo hasta la repuesta (TTR) definido como el tiempo transcurrido desde la fecha del reclutamiento hasta la primera RC o RP según RECIST 1.1 documentada y determinada por el BIRC .
    - ORR, DOR, DCR, TTR y PFS según RECIST 1.1 determinados mediante evaluación radiológica local.
    - ORR, DOR, DCR y TTR según RECIST 1.1 determinados por el BIRC y mediante evaluación radiológica local.
    - PFS y OS
    - Tipo, frecuencia y gravedad de los acontecimientos adversos, cambios en los
    valores analíticos, constantes vitales y electrocardiogramas (ECG).
    - Concentración de JDQ443 en plasma y parámetros de PK derivados, según proceda.
    - Tiempo hasta el deterioro definitivo (TTD) en la puntuación total obtenida en el NSCLC-SAQ y TTD en la escala de funcionamiento físico (FF) del QLQ-C30 de la EORTC.
    - Cambio desde la basal hasta cada visita de tratamiento y el EOT en la puntuación total obtenida en el NSCLC-SAQ considerando los síntomas de dolor, tos y disnea y los ítems.
    - Cambio desde la basal hasta cada visita de tratamiento y el EOT en todos los dominios, subescalas e ítems del QLQ-C30 de la EORTC.
    - Cambio desde la basal hasta cada visita de tratamiento y el EOT en FACT GP5.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the key secondary endpoint, ORR per RECIST 1.1 by BIRC in cohort B, the same definition as in the Protocol, Section 9.3.1 applies. Treatment with JDQ443 will be considered to have clinically relevant efficacy in cohort B if an ORR of ≥ 40% is observed with the lower bound of the 95% confidence interval ≥ 20%.
    Para el Objetivo secundario, ORR por RECIST 1.1. según el comité de revisión independiente ciego (BIRC) en la cohorte B, será la misma definición que la que aplica en el Protocolo en la Sección 9.3.1. El tratamiento con JDQ443 se considerará que tiene eficacia clinica relevante en la cohorte B, si se observa una ORR de >= 40% con un limite inferior del intervalo de confianza del 95% de >= 20%.
    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 Yes
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    China
    India
    Malaysia
    Singapore
    Thailand
    United States
    Austria
    France
    Bulgaria
    Netherlands
    Spain
    Germany
    Greece
    Italy
    Belgium
    Hungary
    Portugal
    Turkey
    United Kingdom
    E.8.7Trial 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
    LVLS
    última visita del último paciente (LVLS)
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days10
    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: 120
    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 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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 57
    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.
    No hay actualmente 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 Decision2022-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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