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    Summary
    EudraCT Number:2020-005191-35
    Sponsor's Protocol Code Number:J2G-MC-JZJX
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-20
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-005191-35
    A.3Full title of the trial
    LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib in RET fusion-Positive NSCLC
    A.3.2Name or abbreviated title of the trial where available
    LIBRETTO-432
    A.4.1Sponsor's protocol code numberJ2G-MC-JZJX
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Yes
    D.2.1.1.1Trade name Retsevmo
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V. Papendorpseweg 83, 3528BJ Utrecht, the Netherlands
    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 nameSELPERCATINIB
    D.3.2Product code SUB193120
    D.3.4Pharmaceutical form Capsule
    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 INNSelpercatinib
    D.3.9.3Other descriptive nameRetsevmo
    D.3.9.4EV Substance CodeSUB193120
    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 Retsevmo
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V. Papendorpseweg 83, 3528BJ Utrecht, the Netherlands
    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 nameSELPERCATINIB
    D.3.2Product code SUB193120
    D.3.4Pharmaceutical form Capsule
    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 INNSelpercatinib
    D.3.9.3Other descriptive nameRetsevmo
    D.3.9.4EV Substance CodeSUB193120
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCapsule
    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
    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
    Adjuvant Selpercatinib following definitive locoregional treatment in male or female patients with stage IB-IIIA RET fusion positive NSCLC
    E.1.1.1Medical condition in easily understood language
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare EFS of participants in the primary analysis population with
    Stage II-IIIA RET fusion-positive NSCLC treated with selpercatinib versus placebo.
    E.2.2Secondary objectives of the trial
    -To compare EFS of participants in the overall population with Stage IB-IIIA RET fusion-positive NSCLC treated with selpercatinib versus placebo
    -To compare other efficacy outcomes achieved with selpercatinib versus placebo in the primary analysis and overall populations
    -To evaluate the safety and tolerability of selpercatinib versus placebo in the primary analysis and overall populations
    -To assess/evaluate performance of RET tests from investigator- identified laboratories compared to a single Lilly-designated RET test.
    -To compare onset or worsening of NSCLC symptoms in participants
    treated with selpercatinib versus placebo
    -To compare physical functioning in participants treated with selpercatinib versus placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Must have histologically confirmed Stage IB, II, or IIIA NSCLC. Staging will be according to the Tumor, Node, Metastasis staging system for lung cancer
    -Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR) or next generation sequencing (NGS)
    -Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC
    a. Participants must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion.
    -Patients must have completely recovered from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy at the time of randomization
    -Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
    -Adequate hematologic, hepatic and renal function
    -Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 2 weeks after. Men must refrain from donating sperm and must agree to using condom. Women of child-bearing potential must not be breastfeeding during treatment and for at least 2 weeks after the last dose of study drug
    -Written informed consent.
    E.4Principal exclusion criteria
    -Additional oncogenic driver mutations of NSCLC, e.g., ALK fusion, or
    activating mutations of EGFR
    -Evidence of small cell lung cancer
    -Clinical or radiologic evidence of disease recurrence or progression following definitive therapy
    -Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids
    -Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of study treatment or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) >470 msec on more than 1 ECG obtained during the baseline period
    -Uncontrolled human immunodeficiency virus (HIV)-1/2 infection
    -Has known active Hepatitis B or C
    -Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment (e.g., hypertension, diabetes, clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis, pericardial effusion, or pleural effusion). Screening for chronic conditions is not required
    -Major surgery, excluding placement of vascular access, within 4 weeks of study drug
    -Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
    -Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers, or a malignancy diagnosed ≥2 years previously and not currently active
    -Have a known hypersensitivity to any of the excipients of selpercatinib
    -Prior treatment with selpercatinib or pralsetinib
    -Taking a concomitant medication that is known to cause QTc prolongation
    -Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
    -have participated, within the last 30 days; (3 months in the UK), in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (3 months in the UK),whichever is longer, should have passed.
    E.5 End points
    E.5.1Primary end point(s)
    EFS by investigator assessment in the primary analysis population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Randomization to disease recurrence/progression or death from any cause (Estimated at up to 7 years)
    E.5.2Secondary end point(s)
    1. Time to distant disease recurrence in the CNS by investigator assessment and BICR
    2. PFS2 by investigator assessment
    3. OS
    4. Safety per CTCAE v5.0 (including, but not limited to): incidence and
    severity of TEAEs, SAEs, deaths, and clinical laboratory abnormalities
    5. The positive predictive value of RET tests from investigator-identified laboratories with respect to the Lilly-designated RET test
    6. Mean change from baseline over time in NSCLC symptoms as measured by NSCLC-SAQ.
    7. Time to onset or worsening of NSCLC symptoms as measured by
    NSCLC-SAQ.
    8. Mean change from baseline overtime in physical functioning as measured by EORTC-IL19 or Physical Functioning Scale (items 1-5) of the EORTC QLQ-C30.
    9. Time to deterioration of physical functioning as measured by 'EORTC-IL19' or Physical Functioning Scale (items 1-5) of the EORTC QLQ-C30
    10. EFS by investigator assessment in overall population as secondary endpoint
    11. EFS by BICR
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Randomization to disease recurrence/progression or death from any cause (Estimated at up to 7 years)
    2. Randomization to Second Disease Progression or Death from Any Cause (Estimated at up to 9 years)
    3. Randomization to Date of Death from Any Cause (Estimated at up to 9 years)
    4. Baseline to study discontinuation (Estimated at up to 3 years)
    5. Baseline
    6. Baseline to study discontinuation (Estimated at up to 3 years)
    7. Baseline to study discontinuation (Estimated at up to 3 years)
    8. Baseline to study discontinuation (Estimated at up to 3 years)
    9. Baseline to study discontinuation (Estimated at up to 3 years)
    10. Randomization to disease recurrence up to 7 years
    11. Randomization to disease recurrence up to 7 years
    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 No
    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) No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Singapore
    Ukraine
    Hong Kong
    Taiwan
    Australia
    Brazil
    Canada
    China
    India
    Israel
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Turkey
    United Kingdom
    United States
    Austria
    Belgium
    Czechia
    Denmark
    France
    Germany
    Greece
    Italy
    Netherlands
    Norway
    Poland
    Romania
    Spain
    Sweden
    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
    Per protocol LVLS or last scheduled procedure.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years11
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days14
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 170
    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)
    The numbers and percentages of participants receiving post-study-treatment anticancer therapies will be provided by type of therapy (surgery, radiotherapy, or systemic therapy), and by drug class and/or name, overall, and by line of therapy
    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 Decision2021-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-22
    P. End of Trial
    P.End of Trial StatusOngoing
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