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    Summary
    EudraCT Number:2021-002605-10
    Sponsor's Protocol Code Number:CJDQ443B12301
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-27
    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 ConcernedDenmark - DHMA
    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
    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
    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 Pharma AG
    B.1.3.4CountrySwitzerland
    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 Healthcare A/S
    B.5.2Functional name of contact pointMedical information
    B.5.3 Address:
    B.5.3.1Street AddressEdvard Thomsens Vej 14
    B.5.3.2Town/ cityKøbenhavn S
    B.5.3.3Post code2300
    B.5.3.4CountryDenmark
    B.5.6E-mailsrkiv.til@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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    E.1.1.1Medical condition in easily understood language
    Advanced lung cancer with a specific mutation (G12C) in the KRAS gene
    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
    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 cancer 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.
    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 not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) previously treated KRAS G12C-mutant NSCLC. Presence of a KRAS G12C mutation by central laboratory testing using tissue or blood samples, or assessed locally with GuardantHealth Guardant360® CDx liquid biopsy test or by a local laboratory utilizing the QIAGEN therascreen® KRAS RGQ PCR kit.
    ● Participants have received at least 1, but not more than 3, previous lines of treatment including 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
    E.4Principal exclusion criteria
    ● Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other, KRAS G12C inhibitor.
    ● Participants whose tumors harbor an 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.
    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.
    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
    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 in chest pain, coughing and dyspnea per QLQ-LC13 questionnaire are primary PRO variables of interest
    ● Time to definitive 10-point deterioration in global health status/QoL, shortness of breath, and pain per QLQ-C30 are secondary PRO variables of interest
    ● Observed values and changes from baseline for EORTC-QLQ C30 scales, QLQ-LC13 scales, NSCLC-SAQ domain and total scores, and EQ-5D-5L health state utility values (HSUVs) and visual analog scale (VAS) scores.
    ● 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
    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
    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
    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 Yes
    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
    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 concerned2
    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
    Chile
    Colombia
    Malaysia
    Hong Kong
    Taiwan
    Australia
    Brazil
    Canada
    China
    India
    Jordan
    Korea, Republic of
    Lebanon
    Mexico
    Russian Federation
    Serbia
    Thailand
    Turkey
    United Kingdom
    United States
    Viet Nam
    Bulgaria
    Croatia
    Czechia
    Denmark
    Estonia
    Finland
    Greece
    Hungary
    Iceland
    Italy
    Norway
    Poland
    Portugal
    Romania
    Slovenia
    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
    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 days12
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days16
    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: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 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.
    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 Decision2022-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-10
    P. End of Trial
    P.End of Trial StatusOngoing
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