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    Summary
    EudraCT Number:2022-001088-29
    Sponsor's Protocol Code Number:CJDQ443B12201
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-09-30
    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 ConcernedBulgarian Drug Agency
    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: Отворено изпитване фаза 2 за оценка на действието и безопасността на
    монотерапия с JDQ443 като първа линия на лечение при пациенти с локално авансирал или метастатичен недребноклетъчен рак на белия дроб с KRAS G12C мутация с експресия на PD-L1 < 1% или с експресия на PD-L1 ≥ 1 и съпътстваща мутация в 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.
    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 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 Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number004161 3241 111
    B.5.5Fax number004161 3248 001
    B.5.6E-mailclinicaltrial.enquiries@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
    E.1.1.1Medical condition in easily understood language
    locally advanced or metastatic KRAS G12C- mutated non-small cell lung cancer
    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).
    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.
    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.
    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
    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).
    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.
    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
    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%.
    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
    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 concerned3
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days15
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 120
    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 Decision2022-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
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