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    Summary
    EudraCT Number:2022-000131-23
    Sponsor's Protocol Code Number:CA116-003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-10-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2022-000131-23
    A.3Full title of the trial
    A Phase 2 Open-label Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants with Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    -
    A.3.2Name or abbreviated title of the trial where available
    Phase 2 Study of MORAb-202 in Previously Treated Metastatic NSCLC AC
    A.4.1Sponsor's protocol code numberCA116-003
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1273-2077
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol -Myers Squibb International Corporation Belgium
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol -Myers Squibb International Corporation
    B.5.2Functional name of contact pointHead of the GSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine - l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameMORAb-202
    D.3.2Product code BMS-986445
    D.3.4Pharmaceutical form Lyophilisate 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 INNFarletuzumab ecteribulin
    D.3.9.2Current sponsor codeBMS-986445
    D.3.9.4EV Substance CodeSUB215766
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Non-Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Non-Small Cell Cancer that has spread (metastasized) beyond the lung
    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
    1. To assess safety and tolerability of MORAb-202 in participants with previously treated, metastatic non-small cell lung cancer (NSCLC) adenocarcinoma (AC)
    2. To assess tumor response of MORAb-202 in participants with previously treated, metastatic NSCLC AC
    E.2.2Secondary objectives of the trial
    1. To evaluate progression-free survival (PFS) of MORAb-202 in participants with previously treated, metastatic NSCLC AC
    2. To evaluate disease control rate (DCR) of MORAb-202 in participants with previously treated, metastatic NSCLC AC
    3. To evaluate duration of response (DoR) of MORAb-202 in participants with previously treated, metastatic NSCLC AC who achieved a complete response (CR) or partial response (PR)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Participants or legally acceptable representatives who signed Written Informed Consent
    2) Participants (male or female) must be 18 years or older at the time of signing the informed consent
    3) Participants with histologically or cytologically documented metastatic NSCLC adenocarcinoma (AC)
    4) Investigator-assessed radiologically documented disease progression during or after last treatment
    5) Measurable target disease assessed by the investigator according to RECIST 1.1.
    6) Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of disease progression based on RECIST 1.1 to be deemed a target lesion.
    7) ECOG PS of 0 or 1
    8) Participants must have received prior treatment, including platinum based chemotherapy
    and:
    i) If without actionable genetic alterations or unknown genetic
    alterations status,
    treatment with anti-PD-1/PD-L1
    OR
    ii) If with known actionable genetic alterations, treatment with at least 1
    targeted therapy
    9) Participants must have received no more than 3 prior lines of systemic therapy in the metastatic setting
    NOTE: Participants with resectable or stage 3 locally advanced disease that has recurred or progressed within 1 year from the start of treatment with platinum based chemotherapy and anti-PD-1/PD-L1 are not required to be retreated in the metastatic
    setting to be eligible.
    10) Either FFPE tissue block (preferred), newly cut unstained slides or newly obtained biopsies must be available for assessment by IHC at a central laboratory prior to treatment assignment.
    E.4Principal exclusion criteria
    Medical Conditions
    -NSCLC histologies other than adenocarcinoma (AC)
    -Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed >12 months before treatment
    -Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted if chest radiation is documented >6 months before starting study treatment
    -Current infectious pneumonia (including COVID-19-related infection), history of viral pneumonia with evidence of persistent radiologic abnormalities
    -Investigator assessed current ILD/pneumonitis or ILD/pneumonitis is suspected at Screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anticancer therapy
    -Participants with an active, known or suspected autoimmune disease, connective tissue, or inflammatory disorders with documented pulmonary involvement

    Prior/Concomitant Therapy
    -Participants who have received prior investigational treatment with FRα-targeting agent, or FRα-targeting ADCs including MORAb-202.
    -Any condition requiring folate supplementation (eg, folate deficiency).
    -Any major surgery within 4 weeks of the first dose of study treatment

    Physical and Laboratory Test Findings
    -Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of adverse events (AEs)/serious AEs (SAEs),
    treatment related AEs/SAEs, AEs leading to discontinuation, AEs of
    special interest (AESI), deaths and laboratory abnormalities.
    Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after last patient completed a maximum of 2 year study treatment or the date of discontinuation, whichever occurred first.
    E.5.2Secondary end point(s)
    -Incidence and severity of adverse events (AEs)/serious AEs (SAEs), treatment related AEs/SAEs, AEs of special interest (AESI), deaths and laboratory abnormalities.

    -PFS by RECIST 1.1 per investigator assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    -30 days after last patient completed a maximum of 2 year study treatment or the date of discontinuation, whichever occurred first.


    -All participants have been followed up for a minimum of 6 months.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA16
    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
    Chile
    United States
    Belgium
    France
    Spain
    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
    End of study is defined as all randomized participants who complete their last visit or scheduled procedure.
    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 months0
    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 months0
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 30
    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)
    Since this is a dose-optimizing study, at the end of the study, BMS will not continue to provide BMS supplied study intervention to participants or investigators unless BMS chooses to extend the study. The investigator should ensure that the participant receives appropriate standard of care to treat the condition under study.
    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 Decision2022-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
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