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    Summary
    EudraCT Number:2020-004643-80
    Sponsor's Protocol Code Number:DS1062-A-U301
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-22
    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 number2020-004643-80
    A.3Full title of the trial
    Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer without Actionable Genomic Alterations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer Without Genomic Alterations
    A.3.2Name or abbreviated title of the trial where available
    TROPION-LUNG01
    A.4.1Sponsor's protocol code numberDS1062-A-U301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04656652
    A.5.4Other Identifiers
    Name:INDNumber:136626
    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
    B.5.3.3Post codeNJ 07920
    B.5.3.4CountryUnited States
    B.5.4Telephone number1908992 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 nameDS-1062a
    D.3.2Product code DS-1062a
    D.3.4Pharmaceutical form Powder for 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 INNADC of a MAb, MAAP-9001a, conjugated with a drug-linker, MAAA-1162a (datopotamab deruxtecan)
    D.3.9.1CAS number 2238831-60-0
    D.3.9.2Current sponsor codeDS-1062a
    D.3.9.3Other descriptive nameHumanised immunoglobulin G1-kappa against tumor associated calcium signal transducer 2 monoclonal antibody conjugated to deruxtecan
    D.3.9.4EV Substance CodeSUB213761
    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.2.1.1.1Trade name Docetaxel AqVida 20 mg / ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAqVida GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of DS-1062a with that of docetaxel, as measured by PFS and OS, for subjects with NSCLC without actionable genomic alterations previously treated with platinum-based chemotherapy and an α-PD- 1/α-PD-L1 monoclonal antibody
    E.2.2Secondary objectives of the trial
    - To further evaluate the efficacy of DS-1062a compared with docetaxel
    - To further evaluate the safety of DS-1062a compared with docetaxel
    - To assess the PK of DS-1062a
    - To assess the immunogenicity of DS-1062a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has the ability to provide written informed consent by signing and dating the ICF prior to the start of any study-specific qualification procedures
    2. Adults ≥18 years
    3. Has a life expectancy ≥3 months based on Investigator’s opinion and has pathologically documented NSCLC (please see further details in the protocol)
    5. Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC
    6. Subject must meet ONE of the following prior therapy requirements for advanced or metastatic NSCLC:
    a. Received platinum-based chemotherapy in combination with α-PD-1/α-PD-L1 monoclonal antibody as the only prior line of therapy
    OR
    b. Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy
    7. Must undergo a pre-treatment tumor biopsy procedure
    OR
    If available, tumor tissue previously retrieved from a biopsy procedure
    performed within 2 years prior to the subject signing informed consent
    and that has a minimum of 10 × 4 micron sections or a tissue block
    equivalent of 10 × 4 micron sections may be substituted for the pre
    treatment
    biopsy procedure during Screening. If a documented law or
    regulation prohibits (or does not approve) sample collection, then such
    samples will not be collected/submitted.
    Note: Results from the TROP2 testing of the pre-treatment tumor biopsy
    will not be used to determine eligibility for the study.
    8. Inclusion Criterion removed
    9. Has measurable disease based on local imaging assessment using RECIST v1.1
    10. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or1 at Screening
    11. Within 7 days before randomization, has adequate bone marrow function as detailed in the study protocol
    12. Within 7 days before randomization, has adequate hepatic function as detailed in the study protocol
    13. Within 7 days before randomization, has adequate renal function, including mild or moderate renal function, as detailed in the study protocol
    14. Has left ventricular ejection fraction (LVEF) ≥50% by either ECHO or MUGA scan within 28 days before randomization
    15. Has adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × ULN
    16. Has an adequate treatment washout period before randomization, as defined in the study protocol

    For the full list of inclusion criteria, please see protocol section 5.1
    E.4Principal exclusion criteria
    1. Has mixed small-cell lung cancer and NSCLC histology
    2. Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Please see additional details in the protocol
    3. Has leptomeningeal carcinomatosis or metastasis
    4. Had prior treatment with:
    a. Any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase I
    b. TROP2-targeted therapy
    c. Docetaxel as monotherapy or in combination with other agents
    5. Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting the prior therapy requirements for Stage III or metastatic NSCLC disease as described in Inclusion Criterion 6
    6. Has NSCLC disease that is eligible for definitive local therapy alone
    7. Uncontrolled or significant cardiac disease as described in detail in the protocol
    8. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
    9. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement, or prior pneumonectomy
    10. Has significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage
    11. Clinically significant corneal disease
    12. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections
    13. Has known human immunodeficiency virus (HIV) infection that is not well controlled
    14. Has an active or uncontrolled hepatitis B and/or hepatitis C infection,
    is positive for hepatitis B or C virus based on the evaluation of results of
    tests for hepatitis B (hepatitis B surface antigen [HBsAg], anti-hepatitis
    B surface antibody [anti-HBs], anti-hepatitis B core antibody [anti-HBc],
    or hepatitis B virus [HBV] DNA), and/or hepatitis C infection (as per
    hepatitis C virus [HCV] RNA) within 28 days of randomization. See
    section 5.2 of protocol for details.
    15. Has a history of malignancy, other than NSCLC except a) adequately resected non melanoma skin cancer, b) curatively treated in situ disease, or c) or other solid tumors curatively treated, with no evidence of disease for ≥3 years
    16. Concomitant medical condition that would increase the risk of toxicity in the opinion of the Investigator
    17. Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline
    18. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients (including but not limited to polysorbate 80) of DS-1062a or docetaxel
    19. History of severe hypersensitivity reactions to other monoclonal antibodies
    20. Is pregnant or breastfeeding or planning to become pregnant

    For the full list of exclusion criteria, please see protocol section 5.2.
    E.5 End points
    E.5.1Primary end point(s)
    - PFS assessed by BIRC: defined as the time from randomization to the earlier of the dates of the first radiographic disease progression or death due to any
    cause.
    - OS: defined as the time from randomization to death due to any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the pre-determined timepoints as described in the protocol.
    E.5.2Secondary end point(s)
    - PFS assessed by investigator
    - ORR
    - DoR
    - TTR
    - DCR
    - EORTC-QLQLC13 (except questions 36 and 37)
    - TEAEs and other safety parameters during the study
    - PK
    - Immunogenicity
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the pre-determined timepoints as described in the protocol.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA88
    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
    Hong Kong
    Mexico
    Singapore
    Argentina
    Belgium
    Brazil
    Canada
    Czechia
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Switzerland
    Taiwan
    United Kingdom
    United States
    France
    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
    The overall EOS will occur after all subjects have discontinued the study or have died; or an alternative study becomes available for subjects continuing to derive benefit from treatment with DS-1062a where the drug is offered to these subjects.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 443
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 147
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 188
    F.4.2.2In the whole clinical trial 590
    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)
    In the event of early termination of the study, the sponsor will consider providing DS-1062a to subjects who benefit from treatment according to legal regulations in the corresponding countries. Alternatively, these subjects may also be treated with standard of care per investigator's decision.
    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 Decision2021-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
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