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    Summary
    EudraCT Number:2013-004371-12
    Sponsor's Protocol Code Number:U31287-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:2014-05-14
    Trial results View 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 number2013-004371-12
    A.3Full title of the trial
    Phase 3, Randomized, Placebo-Controlled, Double-blind, Multi-Center, Two-Part Study of Patritumab (U3-1287) in Combination with Erlotinib in EGFR Wild-type Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Systemic Therapy
    A patritumab (U3-1287) erlotinibbal való kombinációjának III. fázisú, randomizált, placebo-kontrollált, kettős-vak, többközpontú, kétrészes vizsgálata olyan helyileg előrehaladott vagy áttétes állapotú, nem-kissejtes tüdőrákban (non-small cell lung cancer, NSCLC) szenvedő vad típusú epidermális növekedési faktor receptor (epidermal growth factor receptor, EGFR) betegeknél, akik állapota legalább egy megelőző szisztémás terápia során súlyosbodott
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate Patritumab in combination with Erlotinib in patients with lung cancer.
    A.4.1Sponsor's protocol code numberU31287-A-U301
    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 Development Limited
    B.1.3.4CountryUnited Kingdom
    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 Pharma Development
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportDaiichi Sankyo Development Limited
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportDaiichi Sankyo Company, Limited
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Limited
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross, Buckinghamshire
    B.5.3.3Post codeSL9 0BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1753 482800
    B.5.5Fax number+44 1753 899107
    B.5.6E-maileuregaffairs@dsd-eu.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
    D.3.2Product code U3-1287
    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
    D.3.9.1CAS number 1262787-83-6
    D.3.9.2Current sponsor codeU3-1287
    D.3.9.3Other descriptive nameAnti-HER3 Monoclonal Antibody
    D.3.9.4EV Substance CodeSUB59906
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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 17.0
    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
    The primary objective for Part A of the study is to confirm that the combination regimen of patritumab with erlotinib will improve PFS in HRG-high, EGFR-inhibitor–naïve, EGFR-wild type subjects with locally advanced or metastatic NSCLC who progressed on at least one prior systemic therapy.

    The primary objective for Part B of the study is to determine if the combination regimen of patritumab with erlotinib will improve OS in EGFR-inhibitor–naïve subjects with locally advanced or metastatic, HRG-high, EGFR-wild type NSCLC who have progressed on at least one prior systemic therapy.
    E.2.2Secondary objectives of the trial
    Secondary objectives for Part A are:
    - To evaluate overall survival (OS) and objective response rate (ORR)
    - To further characterize the safety of patritumab in combination with erlotinib, including incidence of HAHA formation
    - To refine the cut-off for HRG-high tumors that will be used to select subjects in Part B
    - To evaluate the population pharmacokinetics of patritumab

    Secondary objectives for Part B are:
    - To evaluate OS in the pre-defined narrower subset of HRG-high subjects (the “extremely high-HRG” stratum) after the primary objective of Part B is achieved
    - To evaluate PFS
    - To further characterize the safety of patritumab in combination with erlotinib, including incidence of HAHA formation
    - To evaluate population pharmacokinetics of patritumab
    - To evaluate TTD on the LCS of the FACT-L and on the total FACT-L
    - To evaluate ORR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must satisfy all of the following criteria to be included in the study:
    1. Must be ≥ 20 years of age
    2. Must have histologically confirmed NSCLC with either:
    a) Metastatic disease (Stage IV) OR
    b) Stage IIIB disease not amenable to surgery or curative intent.
    Note: It is permissible to use either AJCC Version 6.0 or the AJCC Version 7.0 staging system. For sites that use AJCC Version 7.0, T4M0 patients with other ipsilateral nodules and N0-N2 are still eligible.
    3. If tumor histology is adenocarcinoma, must have wild-type EGFR genotype as assessed by a validated assay that includes the exon 19 deletion and the exon 21 (L858R) substitution.
    - Historical locally generated EGFR results may be acceptable if assay details are available. Historical EGFR test results for all subjects with adenocarcinoma must be provided to the Sponsor’s designee for confirmation prior to randomization. See Laboratory Manual for details.
    - Archived tumor samples from patients without a verified historical result will be tested by the sponsor at the central testing lab. See Laboratory Manual for instructions on archived tumor sample submission.
    4. Must have received one or two prior lines of systemic anticancer therapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy
    - Patients who received only adjuvant systemic treatment will be eligible only if disease progression occurred <6 months after completion of adjuvant therapy.
    - For patients who received adjuvant systemic therapy and subsequent systemic therapy for metastatic disease, the adjuvant treatment counts as a line of therapy only if disease progression occurred < 6 months after its completion.
    - Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen.
    5. Must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months).
    6. Must have available recent (before treatment start) or archival tumor specimen meeting these criteria:
    - Part A subjects: Recent or archival tumor specimens must be determined by the central pathology laboratory to be HRG high or low using the validated IUO-1 assay. (Refer to the Laboratory Manual for details on specimen requirements). Subjects with undetermined HRG expression will be excluded.
    - Part B subjects: Recent or archival tumor specimens must be HRG high as determined by the central pathology laboratory using IUO-2. (Refer to the Laboratory Manual for details on specimen requirements). Subjects with undetermined HRG expression will be excluded.
    7. Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines Version 1.1 for Part A; for Part B, must have measurable disease or non-measurable disease per RECIST
    8. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    9. Must have adequate hematological function, as follows:
    - ANC ≥ 1.5 x 109/L
    - Platelet count ≥ 100 x 109/L
    - Hemoglobin ≥ 9 g/dL
    10. Must have adequate renal function, as follows:
    - Calculated creatinine clearance ≥ 60 mL/min using the modified Cockroft-Gault equation
    - Serum creatinine ≤ 1.5 x ULN
    11. Must have adequate hepatic function, as follows:
    - AST ≤ 2.5 x ULN (if liver metastases are present, < 5 x ULN)
    - ALT ≤ 2.5 x ULN (if liver metastases are present, < 5 x ULN)
    - Alkaline phosphatase ≤ 2.5 x ULN (if bone or liver metastases are present, < 5 x ULN)
    - Bilirubin ≤ 1.5 x ULN
    12. Must have adequate prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 x ULN
    13. If female, must be either postmenopausal (no menstrual period for a minimum of 12 months), surgically sterile, or if of childbearing potential, must have a negative urine or serum pregnancy test upon entry into this study; and must be willing to use maximally effective birth control during the period of therapy and contraception for 6 months following the last investigational drug dose
    14. If male, must be surgically sterile or willing to use a double-barrier contraception method upon enrollment, during the course of the study, and for 6 months following the last investigational drug dose
    15. Must have provided informed consent for study participation (see Section 1.5.2)
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria will be disqualified from entering the study:
    1. Lung adenocarcinoma with an ALK gene rearrangement. Test results for all subjects with adenocarcinoma must be provided to the Sponsor’s designee for confirmation prior to randomization. Refer to the Laboratory Manual for further details on sample and testing requirements.
    a. Historical locally generated results may be acceptable if assay details are available. Historical ALK test results for all subjects with adenocarcinoma must be provided to the Sponsor’s designee for confirmation prior to randomization. See Laboratory Manual for details.
    b. Archived tumor samples from patients without a verified historical result will be tested by the sponsor at the central testing lab. See laboratory manual for instructions on archived tumor sample submission.
    2. Left ventricular ejection fraction (LVEF) < 45%
    3. Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy
    4. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
    5. History of corneal disease
    6. History of interstitial lung disease (ILD)
    7. Clinically active brain metastases, defined as untreated symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy and have no evidence of disease progression on imaging studies (MRI/CT scan). A minimum of 4 weeks (2 weeks for subjects with a solitary brain lesion amenable to stereotactic radiosurgery) must have elapsed between the end of radiotherapy and study enrollment.
    8. Uncontrolled hypertension (diastolic > 100 mmHg or systolic > 140 mmHg). It is permissible for the subject to receive treatment with antihypertensive medication to maintain blood pressure within required parameters.
    9. Clinically significant ECG changes that obscure the ability to assess the RR, PR, QT, QTc, and QRS intervals.
    10. Clinically significant (any grade) ascites or pleural effusion requiring chronic medical intervention
    11. Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure (New York Heart Association > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
    12. Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment; treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment; or treatment with small molecule TKIs within 2 weeks before study drug treatment
    Prior and concurrent use of hormone replacement therapy is permitted.
    13. Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment. No target lesion should be selected within the previously irradiated field unless there was progression at that lesion following radiation.
    14. Participation in clinical drug trials within 4 weeks (2 weeks for small molecule TKIs) before study drug treatment, or current participation in other investigational procedures
    15. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Subjects should be tested for HIV prior to randomization if required by local regulations or ethics committee.
    16. History of hypersensitivity to any of the study drugs or to any excipients.
    17. Prior or ongoing clinically significant 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 impair the assessment of study results.
    18. Psychological, social, familial, or geographical factors that would interfere with study participation or follow-up.
    E.5 End points
    E.5.1Primary end point(s)
    Part A primary efficacy endpoint: PFS
    Part B primary efficacy endpoint: OS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various timepoints
    E.5.2Secondary end point(s)
    Part A secondary efficacy endpoints: OS; ORR.
    Part B secondary efficacy endpoints: PFS; TTD on the LCS; TTD on the total FACT-L; ORR

    Safety Endpoints: (Part A and Part B)
    - Frequency and severity of treatment-emergent AEs
    - Incidence of human anti-human antibody (HAHA) formation

    Population Pharmacokinetic (PK) Endpoints (Part A and Part B):
    - Serum patritumab concentrations
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker Assessment
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA106
    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
    Brazil
    Canada
    European Union
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Serbia
    Switzerland
    Taiwan
    Turkey
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    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: 312
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 468
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 429
    F.4.2.2In the whole clinical trial 780
    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)
    Return to routine clinical care
    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 Decision2014-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-18
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