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    Summary
    EudraCT Number:2019-004814-32
    Sponsor's Protocol Code Number:YH25448-301
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-06-02
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-004814-32
    A.3Full title of the trial
    A Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Lazertinib versus Gefitinib as the First-line Treatment in Patients with Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    III. fázisú, kettős vak, randomizált vizsgálat a lazertinib vs. gefitinib
    hatásosságának és biztonságosságának értékelésére az epidermális növekedési faktor receptor mutáció
    pozitív, lokálisan előrehaladott vagy metasztatikus, nem kissejtes tüdőkarcinómában szenvedő
    betegeknél elsővonalbeli kezeléseként
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the efficacy and safety of Lazertinib in the treatment of patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    Egy vizsgálat a lazertinib hatásosságának és biztonságosságának tesztelésére lokálisan előrehaladott vagy metasztatikus nem kissejtes tüdőkarcinómában szenvedők betegek kezelésében
    A.3.2Name or abbreviated title of the trial where available
    LASER301
    A.4.1Sponsor's protocol code numberYH25448-301
    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 SponsorYuhan Corporation
    B.1.3.4CountryKorea, Republic of
    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 supportYuhan Corporation
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationYuhan Corporation
    B.5.2Functional name of contact pointClinical Operation Team
    B.5.3 Address:
    B.5.3.1Street Address74, Noryangjin-ro, Dongjak-gu
    B.5.3.2Town/ citySeoul
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number8228280181
    B.5.6E-mailtwan@yuhan.co.kr
    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 namelazertinib
    D.3.2Product code YH25448
    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 INNLazertinib mesylate monohydrate
    D.3.9.1CAS number 2411549-88-5
    D.3.9.2Current sponsor codeYH25448AM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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 Yes
    D.2.1.1.1Trade name Iressa
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameOver-encapsulated gefitinib
    D.3.4Pharmaceutical form Capsule, hard
    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 INNGefitinib
    D.3.9.3Other descriptive nameGefitinib
    D.3.9.4EV Substance CodeSUB20637
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adenocarcinoma of the lung (non-small cell Lung cancer); locally advanced or metastatic, not amenable to curative surgery or radiotherapy
    E.1.1.1Medical condition in easily understood language
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10001165
    E.1.2Term Adenocarcinoma lung stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10001164
    E.1.2Term Adenocarcinoma lung stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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 efficacy of lazertinib compared with gefitinib as measured by progression-free survival
    E.2.2Secondary objectives of the trial
    1) To further assess the efficacy of lazertinib compared with gefitinib
    2) To assess overall survival of lazertinib compared with gefitinib
    3) To characterize the pharmacokinetics of lazertinib
    4) To assess the impact of lazertinib compared with gefitinib on patient’s disease-related symptoms and Health Related Quality of Life
    5) To assess the safety and tolerability profile of lazertinib compared with gefitinib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients must be ≥ 18 years of age and satisfy the legal age of consent in the jurisdiction in which the study is being conducted
    2. Patients with pathologically confirmed adenocarcinoma of the lung (e.g., this may occur as systemic recurrence after prior surgery for early stage disease or patients may be newly diagnosed with Stage IIIB/C or IV disease). Patients with mixed histology are eligible if adenocarcinoma is the predominant histology
    3. Patients with locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
    4. Patients with at least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations, assessed in tissue biopsy by an accredited local laboratory based on the Qiagen- Therascreen® EGFR Mutation Detection Kit RGQ (Scorpions ARMS), the Amoy Diagnostics-the AmoyDx® EGFR Mutation Test Kit, the PANAGENEPANAMutyperTM or the Roche Diagnostics-Cobas® EGFR Mutation Test v2, or by central testing in a designated laboratory
    5. Mandatory provision of an unstained, archived tumor tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status for patients
    6. Patients must be treatment-naïve for locally advanced or metastatic NSCLC. (Note: Prior adjuvant and neo-adjuvant therapy (e.g., chemotherapy, radiotherapy, investigational products) for early stage disease is permitted if completed > 12 months prior to randomization provided all other entry criteria are satisfied
    7. Patients must have a WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization
    8. Patients must have at least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a short axis of ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), and which is suitable for accurate repeated measurements. If only 1 measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and baseline tumor assessment scans are done at least 2 weeks after the screening biopsy is performed
    9. A male patient who has not undergone a vasectomy must agree to follow the contraceptive guidance in Appendix 3 of protocol during the study treatment period and for at least 24 weeks after the last dose of study treatment and refrain from donating sperm during this period
    10. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    • Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 of protocol.
    OR
    • A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 from the time of screening until 24 weeks after the last dose of study treatment.
    • A WOCBP must have a negative serum pregnancy test (beta human chorionic gonadotropin) at screening.
    11. Patient must sign an informed consent form (ICF) prior to any study specific procedures which includes compliance with the requirements and restrictions listed in the ICF and in protocol
    E.4Principal exclusion criteria
    1. Symptomatic and unstable brain metastases.
    2. Leptomeningeal metastases
    3. Symptomatic spinal cord compression. If steroid treatment is not required within at least 2 weeks prior to randomization then the patient may be enrolled.
    4. History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
    5. Any medical conditions requiring chronic continuous oxygen therapy.
    6. History of any malignancy other than the disease under study within 3 years before randomization
    7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator’s opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol.
    8. Any cardiovascular disease as follows:
    • History of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment.
    • History of myocardial infarction or unstable angina within 24 weeks of randomization.
    9. Positive hepatitis B (HBV) surface antigen (HBsAg), Positive hepatitis C antibody (anti-HCV), other clinically active infectious liver disease or confirmed positive human immunodeficiency virus test results.
    10. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of study treatment.
    11. History of hypersensitivity to active or inactive excipients of investigational product(s), or drugs with a similar chemical structure or class to investigational product(s).
    12. Any history of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
    13. Clinically significant chronic infection or significant medical or psychiatric illness.
    14. Undergone a bone marrow or solid organ transplant.
    15. Any condition which would prevent patient compliance with study procedures, restrictions, and requirements, as determined by the Investigator.
    16. Prior treatment with any systemic antineoplastic therapy for locally advanced or metastatic NSCLC (IIIB/C or IV) including chemotherapy, biological therapy, immunotherapy, or any investigational drug.
    17. Any prior treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor.
    18. Major surgery within 4 weeks of randomization.
    19. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of randomization.
    20. Patients currently receiving medications or herbal supplements known to be potent CYP3A4 inhibitors or inducers
    21. Patients receiving unstable doses of warfarin as anticoagulant
    22. Patients who have been treated with alternative anti-cancer treatment within 5 half-lives of the treatment or within 4 weeks (whichever is longer) prior to randomization.
    23. Any unresolved toxicities from prior therapy, greater than CTCAE grade 1 at randomization, with the exception of alopecia and grade 2, prior chemotherapy-induced neuropathy.
    24. Patients who have been treated with an investigational drug within 5 half-lives of the compound or within 4 weeks (whichever is longer) prior to randomization.
    25. Patient has any of following cardiac criteria:
    • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250msec).
    • Mean resting QTc >470 msec obtained from 3 electrocardiograms (ECGs), using the screening ECG machine derived QTc value.
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medications known to prolong QT interval or induce Torsades de Pointes (Appendix 6).
    • Left ventricular ejection fraction <50%
    26. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
    • Absolute neutrophil count <1.5 x 10^9 /L.
    • Platelet count <100 x 10^9 /L.
    • Hemoglobin <90 g/L.
    • Alanine aminotransferase >2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases, or >5x ULN in presence of liver metastases.
    • Aspartate aminotransferase >2.5x ULN if no demonstrable liver metastases or >5x ULN in the presence of liver metastases.
    • Total bilirubin >1.5x ULN if no liver metastases or >3x ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or liver metastases.
    • Serum creatinine >1.5x ULN concurrent with creatinine clearance < 50 ml/min measured by the study site’s standard method (e.g., Cockcroft and Gault equation). Confirmation of creatinine clearance is only required when creatinine is >1.5x ULN
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival according to RECIST v1.1 by Investigator assessment.

    E.5.1.1Timepoint(s) of evaluation of this end point
    October 2022
    E.5.2Secondary end point(s)
    • Objective Response Rate (ORR)
    • Duration of Response (DoR)
    • Disease Control Rate (DCR)
    • Depth of Response
    • Time to Response
    All according to RECIST v1.1 by Investigator assessments.
    • Overall survival (OS)
    • Plasma concentrations of lazertinib at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose
    • Cerebrospinal fluid (CSF) concentrations of lazertinib
    Change from baseline in :
    • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items (EORTC QLQ-C30)
    • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Lung Cancer 13 items (EORTC QLQ-LC13)
    • Euro-Quality of Life-5 Dimension-5 (EQ-5D-5L) level (EQ-5D-5L)EQ-dd
    E.5.2.1Timepoint(s) of evaluation of this end point
    October 2022 and October 2024
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    1. Exploration of resistance mutation types using NGS from longitudinal plasma samples
    2. Relationship between selected efficacy/PK/safety endpoints with the tumor and/or blood-borne biomarkers
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Australia
    Philippines
    Serbia
    Singapore
    Thailand
    Turkey
    China
    Greece
    Hungary
    Korea, Republic of
    Malaysia
    Russian Federation
    Taiwan
    Ukraine
    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
    The last visit of the last patient undergoing the study (last patient last visit LPLV).
    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 months10
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days1
    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: 380
    F.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 380
    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)
    After DB and OL period of treatment post study treatment assessment will be initiated at the time study treatment is permanently discontinued. This may include: discontinuation visit, 28-Day safety follow-up visit, progression follow -up visit (every 6 weeks), survival follow-up visit (every 6 weeks).
    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 Decision2020-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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