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    Summary
    EudraCT Number:2021-005879-40
    Sponsor's Protocol Code Number:U31402-A-U301
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-08
    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 ConcernedNorway - NOMA
    A.2EudraCT number2021-005879-40
    A.3Full title of the trial
    HERTHENA–Lung02: A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
    A.3.2Name or abbreviated title of the trial where available
    HERTHENA–Lung02
    A.4.1Sponsor's protocol code numberU31402-A-U301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05338970
    A.5.4Other Identifiers
    Name:IND Number:Number: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 organisationDaiichi Sankyo, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Contact
    B.5.3 Address:
    B.5.3.1Street Address211 Mt. Airy Road
    B.5.3.2Town/ cityBasking Ridge, New Jersey
    B.5.3.3Post codeNJ 07920
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1908992 6400
    B.5.6E-maileu_cta@dsi.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
    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.3.9.1CAS number 1262787-83-6
    D.3.9.2Current sponsor codeU3-1402
    D.3.9.3Other descriptive nameanti-HER3 IgG1 monoclonal antibody conjugated to deruxtecan
    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.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.2.5The 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 namePemetrexed
    D.3.2Product code NA
    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 INNPemetrexed
    D.3.9.1CAS number 137281-23-3
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namePemetrexed disodium
    D.3.9.4EV Substance CodeSUB09655MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 3
    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.2.5The 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 nameCisplatin
    D.3.2Product code NA
    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 INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameTransplatin
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 4
    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.2.5The 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 nameCarboplatin
    D.3.2Product code NA
    D.3.4Pharmaceutical form 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 INNCARBOPLATIN
    D.3.9.1CAS number 41575-94-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameCarboplatinum
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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: 5
    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.2.5The 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 nameCarboplatin
    D.3.2Product code NA
    D.3.4Pharmaceutical form 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 INNCARBOPLATIN
    D.3.9.1CAS number 41575-94-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameCarboplatinum
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC)
    E.1.1.1Medical condition in easily understood language
    Non-small Cell Lung Cancer (NSCLC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10079440
    E.1.2Term Non-squamous non-small cell 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 compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy, as measured by progression-free survival (PFS), in subjects with metastatic or locally advanced nonsquamous non-small cell lung cancer (NSCLC) with an EGFR-activating mutation (exon 19 deletion or L858R)
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    - To compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy, as measured by OS, in subjects with metastatic or locally advanced nonsquamous NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R)

    Other Secondary Objectives:
    - To further evaluate the efficacy of patritumab deruxtecan compared with platinum-based chemotherapy in subjects with metastatic or locally advanced nonsquamous NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R)

    - To evaluate symptoms, functioning and global health for patritumab deruxtecan compared with platinum-based chemotherapy in subjects with metastatic or locally advanced nonsquamous NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) based on PROs.

    Please refer to the protocol for full list of secondary objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sign and date the main ICF, prior to the start of any study-specific qualification procedures. Consent for the optional samples for EOT tumor biopsy and/or pharmacogenetic analysis will be covered in the main ICF. A separate tissue screening consent will be obtained from all subjects to meet the baseline biopsy requirement.
    2. Is a male or female subject aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
    3. Has histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation.
    4. Has documentation of an EGFR-activating mutation detected from tumor tissue or from a blood sample: exon 19 deletion or L858R at diagnosis or thereafter.
    5. Received 1 or 2 prior line(s) of an approved EGFR TKI treatment in the metastatic or locally advanced setting, which must include a third-generation EGFR TKI (ie, approved therapies designed with higher preferential activity for mutant vs. EGFRwt and that address acquired resistance to first- and second-generation EGFR TKI [eg, osimertinib, lazertinib, aumolertinib, alflutinib, and others in consultation with Medical Monitor]). If a subject has received 2 prior lines of EGRF TKI therapy, administration of the third-generation EGRF TKI must have been in the most recent line and in the setting of NSCLC with a demonstrated T790M mutation. Enrollment of subjects receiving third-generation EGFR TKIs other than osimertinib will be a maximum of approximately 20% of the enrolled population in each treatment arm.
    6. May have received either neoadjuvant and/or adjuvant treatment if progression to metastatic or locally advanced disease occurred at least 12 months after the last dose of such therapy and subsequently experienced disease progression on or after third-generation EGFR TKI treatment administered in the metastatic or locally advanced setting.
    a. To provide an example, a patient who received osimertinib as adjuvant therapy after tumor resection, then progressed to having metastatic disease over a year following completion of adjuvant therapy must have also received a third-generation EGFR TKI as treatment for metastatic disease to be considered eligible for this study.
    7. Has not received any other prior systemic therapies in the metastatic or locally advanced setting (including chemotherapy, immunotherapy etc) (even if administered in combination with EGFR TKI).
    8. Has documentation of radiographic disease progression while receiving or after a third-generation EGFR TKI for metastatic or locally advanced disease.
    9. Has at least 1 measurable lesion as per RECIST v1.1 by Investigator assessment.
    10. Is willing to provide sufficient quantity and quality of tumor tissue content.
    11. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.
    12. Has adequate bone marrow reserve and organ function based on local laboratory data within 14 days prior to randomization as described in the protocol.
    13. If the subject is a female of childbearing potential, must have a negative serum pregnancy test at Screening and must be willing to use highly effective birth control upon randomization, during the Treatment Period, and for 7 months following the last dose of patritumab deruxtecan. A female is considered to be of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) or if permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) with surgery at least 1 month before randomization or confirmed by follicle stimulating hormone (FSH) test. For comparator drugs, the investigators should follow local practice guidelines and/or label approved in their country.
    14. 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 patritumab deruxtecan administration. For comparator drugs, the investigators should follow local practice guidelines and/or label approved in their country.
    15. If male, must be surgically sterile or willing to use highly effective birth control upon randomization, during the Treatment Period, and for at least 4 months following the last dose of patritumab deruxtecan. For comparator drugs, the investigators should follow local practice guidelines and/or label approved in their country.
    16. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period and at least 4 months after the final patritumab deruxtecan administration. For comparator drugs, the investigators should follow local practice guidelines and/or label approved in their country.
    17. 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. Has any previous histologic or cytologic evidence of small cell OR combined small cell/non-small cell disease in the archival tumor tissue or pretreatment tumor biopsy, or squamous NSCLC histology.
    2. Has any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during Screening.
    3. Has clinically severe respiratory compromise (based on the Investigator’s assessment) resulting from intercurrent pulmonary illnesses as described in the protocol.
    4. Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to randomization. Subjects who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.
    5. Has evidence of any leptomeningeal disease.
    6. Has evidence of clinically active spinal cord compression or brain metastases, defined as being symptomatic and untreated, 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 but must have a stable neurologic status for at least 2 weeks prior to randomization.
    7. Has had inadequate washout period prior to randomization defined as follows:
    a. Whole brain radiation therapy <14 days or stereotactic brain radiation therapy <7 days.
    b. Major surgery (excluding placement of vascular access) <28 days.
    c. Radiotherapy treatment to >30% of the bone marrow or with a wide field of radiation <28 days or palliative radiation therapy <14 days.
    d. Chloroquine or hydroxychloroquine ≤14 days.
    e. Live virus vaccination ≤28 days.
    8. Has had prior treatment with the following:
    a. Any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase I.
    b. HER3 antibody.
    c. Any systemic therapies (other than EGFR TKIs) in the metastatic or locally advanced setting, including chemotherapy or any other systemic therapy in combination with an EGFR TKI.
    9. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), Grade ≤1 or baseline. Subjects with chronic Grade 2 toxicities [defined as no worsening to Grade >2 for at least 3 months prior to randomization and managed with standard of care treatment]) that the Investigator deems related to previous anticancer therapy may be randomized.
    10. Has history of other active malignancy within 3 years prior to randomization, except the following:
    a. Adequately resected nonmelanoma skin cancer.
    b. Adequately treated intraepithelial carcinoma of the cervix.
    c. Any other curatively treated in situ disease.
    11. Has uncontrolled or significant cardiovascular disease prior to randomization as described in the protocol.
    12. Has active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of active viral infection within 28 days of randomization.
    13. Has a known HIV infection that is not well controlled. All the following criteria are required to define an HIV infection that is well controlled: undetectable viral ribonucleic acid (RNA) load, CD4+ counts/levels of >350 cells/μL, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 3 weeks on same anti-HIV retroviral medications. If an HIV infection meets the above criteria, the subject’s viral RNA load and CD4+ cell count should be monitored per local standard of care (e.g., every 3 months).
    14. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active infection) psychiatric illness/social situations, geographical factors, substance abuse, or other factors that, in the Investigator’s opinion, make it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Screening for chronic conditions is not required for eligibility.
    15. Has known hypersensitivity to either the drug substance or inactive ingredients in any of the drug products.
    16. Is a female who is pregnant or breastfeeding or intends to become pregnant during the study.
    17. Has 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.
    18. Has clinically significant corneal disease.

    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) as assessed by blinded independent central review (BICR) based on RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS is defined as the time from the date of randomization to the earlier of the dates of the
    first documentation of objective progression of disease or death due to any cause.
    E.5.2Secondary end point(s)
    - Overall survival (OS)
    - Progression-free survival (PFS) as assessed by the Investigator per RECIST v1.1
    - Progression-free survival on the next line of therapy (PFS2) as assessed by local standard clinical practice
    - Objective response rate (ORR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1
    - Duration of response (DoR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1
    - Clinical benefit rate (CBR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1
    - Disease control rate (DCR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1
    - Time to response (TTR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1
    - Patient-reported outcome (PRO) of disease-related symptoms, functioning scales, and general health status and overall quality of life
    E.5.2.1Timepoint(s) of evaluation of this end point
    - OS is defined as the time from the date of randomization to the date of death due to any cause.
    - PFS is defined as the time from the date of randomization to the earlier of the dates of the first documentation of objective progression of disease or death due to any cause.
    - ORR must be confirmed at least 4 weeks later (e.g., generally at the next tumor assessment time point).
    - DoR, CBR, DCR and TTR must be confirmed from the time of randomization until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject.
    - PRO: Data are collected from before randomization (i.e., the Screening visit) up to 90 days after EOT.
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity, biomarker assessments and QOL
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 EEA63
    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
    Switzerland
    Hong Kong
    Taiwan
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    China
    Denmark
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Norway
    Poland
    Portugal
    Serbia
    Spain
    Sweden
    United Kingdom
    United States
    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 overall EOS will occur when
    - 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 drug is offered to these subjects
    - or the study is discontinued by the Sponsor for other reasons (administrative, program-level or class-related).
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 532
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 188
    F.4.2.2In the whole clinical trial 560
    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)
    An alternative study may be available for subjects continuing to derive benefit from treatment with patritumab deruxtecan where the drug is offered to these subjects.
    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 Decision2022-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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