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    Clinical Trial Results:
    Expression/DNA methylation of cancer testis antigens may predict response to pembrolizumab in pretreated NSCLC patients

    Summary
    EudraCT number
    2017-000689-30
    Trial protocol
    AT  
    Global end of trial date
    01 Jun 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Jul 2024
    First version publication date
    03 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Pem-NSCLC
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Wien, Austria, 1090
    Public contact
    Sabine Zoechbauer-Mueller, Med. Univ. Wien, +43 14040073783, sabine.zoechbauer-mueller@meduniwien.ac.at
    Scientific contact
    Sabine Zoechbauer-Mueller, Med. Univ. Wien, +43 14040073783, sabine.zoechbauer-mueller@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Oct 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objectives of this study are to determine DNA methylation as well as expression of CTAs in lung adenocarcinoma patients whose tumor cells do express PD-L1 (≥ 1%) as well as in patients whose tumor cells do not express PD-L1. These results will be compared with the outcome of the patients after treatment with the combination of chemotherapy and pembrolizumab. In addition, expression of selected CTAs will be investigated in serum samples from these patients. We hypothesize that in lung adenocarcinomas expression of CTAs may be upregulated by loss of DNA methylation which may result in an enhanced immune response and finally in an enhanced tumor response and in a better clinical outcome of some patients.
    Protection of trial subjects
    Confidentiality of Data The investigator affirms that information furnished to the investigator will be maintained in confidence, and such information will be divulged to the institutional review board, ethics review committee (IRB/ERC) or similar or expert committee; affiliated institution and employees, only under an appropriate understanding of confidentiality with such board or committee, affiliated institution and employees. Data generated by this trial will be considered confidential by the investigator, except to the extent that it is included in a publication as provided in the Publications section of this protocol. Confidentiality of Subject Records The investigator agrees that IRB/ERC, or regulatory authority representatives may consult and/or copy trial documents in order to verify worksheet/case report form data. By signing the consent form, the subject agrees to this process. If trial documents will be photocopied during the process of verifying worksheet/case report form information, the subject will be identified by unique code only; full names/initials will be masked prior to transmission to the Sponsor. The investigator agrees to treat all subject data used and disclosed in connection with this trial in accordance with all applicable privacy laws, rules and regulations. Confidentiality of Investigator Information The investigator recognizes that certain personal identifying information with respect to the investigator, and all subinvestigators and trial site personnel, may be used and disclosed for trial management purposes, as part of a regulatory submissions, and as required by law. This information may include: 1. name, address, telephone number and e-mail address; 2. hospital or clinic address and telephone number; 3. curriculum vitae or other summary of qualifications and credentials; and 4. other professional documentation.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    3
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients with advanced lung adenocarcinoma, without an EGFR mutation or ALK translocation, pretreated with at least 1 platin-based chemotherapy regimen and with by a CT scan documented tumor progression will be included.

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    40 [1]
    Number of subjects completed
    11

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Protocol deviation: 29
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: From the 40 pre-assigned patients only 11 could finally be recruited due to protocol deviations.
    Period 1
    Period 1 title
    Sample collection (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    In this single-center, phase II, single-arm, open-label study in total 42 patients (21 with ≥ 1% expression of the Programmed Death ligand 1 [PD-L1] on tumor cells and 21 without PD-L1 expression on tumor cells) with advanced NSCLC (adenocarcinoma), without an EGFR mutation or ALK translocation, pretreated with at least 1 platin-based chemotherapy regimen and with by a computertomography (CT) scan documented tumor progression were planned to be included.

    Arms
    Arm title
    Study
    Arm description
    In this single-center, phase II, single-arm, open-label study in total 42 patients (21 with ≥ 1% expression of the Programmed Death ligand 1 [PD-L1] on tumor cells and 21 without PD-L1 expression on tumor cells) with advanced NSCLC (adenocarcinoma), without an EGFR mutation or ALK translocation, pretreated with at least 1 platin-based chemotherapy regimen and with by a computertomography (CT) scan documented tumor progression were planned to be included.
    Arm type
    Active comparator

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    MK-3475
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2 mg/kg Q3W or 200 mg Q3W

    Number of subjects in period 1
    Study
    Started
    11
    Completed
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sample collection
    Reporting group description
    -

    Reporting group values
    Sample collection Total
    Number of subjects
    11 11
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    3 3
        From 65-84 years
    8 8
    Gender categorical
    Units: Subjects
        Female
    6 6
        Male
    5 5
    PD-L1 expression
    ≥ 1% PD-L1 expression on tumor cells versus without PD-L1 expression on tumor cells
    Units: Subjects
        PD-L1 pos
    7 7
        PD-L1 neg
    4 4

    End points

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    End points reporting groups
    Reporting group title
    Study
    Reporting group description
    In this single-center, phase II, single-arm, open-label study in total 42 patients (21 with ≥ 1% expression of the Programmed Death ligand 1 [PD-L1] on tumor cells and 21 without PD-L1 expression on tumor cells) with advanced NSCLC (adenocarcinoma), without an EGFR mutation or ALK translocation, pretreated with at least 1 platin-based chemotherapy regimen and with by a computertomography (CT) scan documented tumor progression were planned to be included.

    Primary: CTA methylation

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    End point title
    CTA methylation [1]
    End point description
    End point type
    Primary
    End point timeframe
    2018-2022
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study was prematurely stopped and no statistical analysis was calculated.
    End point values
    Study
    Number of subjects analysed
    0 [2]
    Units: percent
        number (not applicable)
    Notes
    [2] - The study was prematurely stopped.
    No statistical analyses for this end point

    Secondary: Treatment response

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    End point title
    Treatment response
    End point description
    End point type
    Secondary
    End point timeframe
    2018-2022
    End point values
    Study
    Number of subjects analysed
    0 [3]
    Units: Subjects
    number (not applicable)
        Stable disease
        Progressive disease
        Partial remission
        NA
    Notes
    [3] - The study was prematurely stopped.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    2018-2022
    Adverse event reporting additional description
    No adverse event reached the 5% threshold.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Study
    Reporting group description
    No adverse event reached the 5% threshold.

    Serious adverse events
    Study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse event reached the 5% threshold.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2019
    We initially planned to include with chemotherapy pretreated patients with advanced lung adenocarcinoma who received pembrolizumab monotherapy after tumor progression. Since the approval of pembrolizumab monotherapy and the combination of pembrolizumab/platin/pemetrexed by the EMA for the first-line treatment of NSCLC patients with adenocarcinoma subtype the vast majority of patients already receives pembrolizumab in the first line setting. Thus, the number of patients meeting our initial inclusion criteria drastically decreased and we decided to change the study cohort to untreated patients who will receive the EMA approved combination of pembrolizumab/platin/pemetrexed. This change of the project plan was communicated with and approved by Merck, the ethics committee of the Medical University of Vienna and the Austrian Agency for Health and Food Safety.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Challenges were: ineligibility/unwillingness of patients for a tumor re-biopsy; tumor necrosis; SARS-CoV-2 pandemia.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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