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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-000730-17
    Sponsor's Protocol Code Number:U31402-A-U201
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-11
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-000730-17
    A.3Full title of the trial
    HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer(NSCLC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Patritumab Deruxtecan in Subjects with Metastatic or Locally Advanced EGFR-mutated NSCLC
    A.4.1Sponsor's protocol code numberU31402-A-U201
    A.5.4Other Identifiers
    Name:IND NumberNumber:133343
    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 SponsorDAIICHI SANKYO, INC
    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 supportDaiichi Sankyo, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyneos Health LLC
    B.5.2Functional name of contact pointShruti Aggarwal
    B.5.3 Address:
    B.5.3.1Street Address1 Pinehurst Road Farnborough
    B.5.3.2Town/ cityHampshire
    B.5.3.3Post codeGU14 7BF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441276481091
    B.5.5Fax number+44 1276713000
    B.5.6E-mailshruti.aggarwal@syneoshealth.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 namePatritumab Deruxtecan for Injection 100 mg
    D.3.2Product code U3-1402
    D.3.4Pharmaceutical form Powder 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 INNPatritumab deruxtecan
    D.3.9.2Current sponsor codeU3-1402
    D.3.9.4EV Substance CodeSUB204104
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Metastatic or Locally Advanced EGFR mutated Non-Small Cell Lung Cancer (NSCLC)
    E.1.1.1Medical condition in easily understood language
    Metastatic or Locally Advanced 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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080083
    E.1.2Term Advanced lung cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the antitumor activity of patritumab deruxtecan in subjects with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R)
    E.2.2Secondary objectives of the trial
    - To investigate the durability of patritumab deruxtecan antitumor activity in subjects with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R)
    - To further investigate the antitumor activity of patritumab deruxtecan in subjects with metastatic or
    locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R)
    - To assess the safety and tolerability of patritumab deruxtecan in subjects with metastatic or locally
    advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R)
    - To evaluate HER3 protein expression in tumor tissue and its relationship with efficacy
    - To assess the immunogenicity incidence against patritumab deruxtecan
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sign and date the tissue ICF and the main ICF, prior to the start of any study-specific qualification procedures.
    2. Male or female subjects aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
    3. Histologically or cytologically documented locally advanced or metastatic NSCLC not amenable to curative surgery or radiation.
    4. Documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease. Subjects must have received both of the following:
    a. Prior treatment with osimertinib. Subjects receiving an EGFR TKI at the time of signing informed consent should continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1.
    b. Systemic therapy with at least 1 platinum-based chemotherapy regimen.
    5. Documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R.
    6. At least 1 measurable lesion confirmed by BICR as per RECIST v1.1
    7. Consented and willing to provide required tumor tissue of sufficient quantity (as defined in the Laboratory Manual) and of adequate tumor tissue content (as confirmed by H&E staining at the central laboratory). Required tumor tissue can be provided as either:
    a. Pretreatment tumor biopsy from at least 1 lesion not previously irradiated and amenable to core biopsy
    OR
    b. Archival tumor tissue collected from a biopsy performed within 3 months prior to signing of the tissue consent and since progression while on or after treatment with the most recent cancer therapy regimen.
    8. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.
    9. Has adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1 Day 1 as defined in the protocol.
    10. If the subject is a female of childbearing potential, she must have a negative serum pregnancy test at Screening and must be willing to use highly effective birth control, upon enrollment, during the Treatment Period, and for 7 months following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period
    for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose or confirmed by follicle stimulating hormone (FSH) test.
    11. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.
    12. If male, the subject must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for at least 4 months following the last dose of study drug.
    13. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and at least 4 months after the final study drug administration.
    14. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
    E.4Principal exclusion criteria
    1. Any previous or current histologic or cytologic evidence of small cell OR combined small cell/non-small cell disease in the archival tumor tissue or pretreatment tumor biopsy.
    2. Any history of interstitial lung disease (including pulmonary fibrosis or radiation pneumonitis), has current interstitial lung disease (ILD), or is suspected to have such disease by imaging during screening.
    3. Clinically severe respiratory compromise (based on Investigator’s assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
    a. Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months prior to the study enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion);
    b. Any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis);
    OR prior complete pneumonectomy.
    4. Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory or any form of immunosuppressive therapy prior to enrollment. Subjects who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.
    5. Evidence of any leptomeningeal disease
    6. Evidence of clinically active spinal cord compression or brain metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive or treated brain metastases who are asymptomatic (i.e., without neurologic signs or symptoms and not requiring treatment with corticosteroids or anticonvulsants) may be included in the study. Subjects must have a stable neurologic status for at least 2 weeks prior to Cycle 1 Day 1.
    7. Inadequate washout period prior to Cycle 1 Day 1 as defined in the protocol points a/b/c/d/e/f (page 53).
    8. Prior treatment with an anti-HER3 antibody or single-agent topoisomerase I inhibitor.
    9. Prior treatment with an ADC that consists of any topoisomerase I inhibitor
    10. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Grade ≤1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible at the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee.
    11. Has history of other active malignancy within 3 years prior to enrollment, except:
    a. Adequately treated non-melanoma skin cancer;
    b. Superficial bladder tumors (Ta, Tis, T1);
    c. Adequately treated intraepithelial carcinoma of the cervix uteri;
    d. Low risk non-metastatic prostate cancer (with Gleason score <7, and following local treatment or ongoing active surveillance);
    e. Any other curatively treated in situ disease.
    12. Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day 1 as defined in the protocol points a/b/c/d/e/f/g (page 64).
    13. Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1 as defined in the protocol points a/b (page 64).
    14. Subject with any human immunodeficiency virus (HIV) infection.
    15. Any evidence of severe or uncontrolled diseases including active bleeding diatheses, active infection, psychiatric illness/social situations, geographical factors, substance abuse, or other factors which in the Investigator’s opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required.
    16. History of hypersensitivity to either the drug substance or any excipients in patritumab deruxtecan.
    17. Female who is pregnant or breast-feeding or intends to become pregnant during the study.
    18. Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator’s opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism or excretion of the study drug; or confound the assessment of study results.
    19. Has clinically significant corneal disease.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR: Data are collected at baseline, then from the start of study treatment until documented disease progression or other protocol defined reason.
    E.5.2Secondary end point(s)
    - Duration of Response (DoR)
    - Progression-free Survival (PFS)
    - Objective Response Rate (ORR)
    - Disease Control Rate (DCR)
    - Time to Response (TTR)
    - Best percentage change in the sum of diameters (SoD) of measurable tumors
    - Overall Survival (OS)
    - Safety parameters (AEs, ECOG PS, vital signs, clinical laboratory parameters, ECG etc.)
    - Correlation between HER3 protein expression and efficacy
    - Anti-drug antibody (ADA) status at baseline and post-baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    DoR, PFS, ORR, DCR, TTR, Changes in SoD: Data are collected at baseline, then from the start of study treatment until documented disease progression, death, lost to follow-up, or withdrawal by subject or other protocol defined reason. Tumor response as assessed by BICR per RECIST v1.1 and death date reported by investigator.
    OS: Death date is collected until the subject discontinues the study.
    Safety parameters: From the time the subject signs the main study ICF and up to 40 (+ 7) days after the last dose of study drug
    HER3 data are collected at baseline (biopsy), at Cycle 2, and EOT (optional)
    ADA Status: Data are collected from the start of study treatment until documented disease progression.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker assessment (HER3 expression data), Immunogenicity
    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 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 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 Yes
    E.8.2.3.1Comparator description
    Different dose of the same product
    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
    Australia
    Japan
    Korea, Republic of
    Singapore
    Taiwan
    United States
    Austria
    France
    Poland
    Bulgaria
    Netherlands
    Spain
    Germany
    Italy
    Belgium
    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
    Overall End of Study (EOS) will occur when:
    - after the last subject last visit;
    - all subjects have discontinued treatment and discontinued long-term survival follow-up or have died;
    - an alternative study becomes available, for subjects continuing to derive benefit from treatment with patritumab deruxtecan, where the study drug is offered to these subjects;
    - the study is discontinued by the Sponsor for other reasons
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 390
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 420
    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 end of study, an alternative study will be available for subjects continuing to derive benefit from treatment with patritumab deruxtecan.
    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 Decision2021-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
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