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    Clinical Trial Results:
    LON-GAS TRIFLURIDINE/TIPIRACIL (FTD/TPI) with or without Bevacizumab in patients with platinum-refractory esophago-gastric adenocarcinoma. A randomized phase III study

    Summary
    EudraCT number
    		 2018-004845-18
    Trial protocol
    		 DK  
    Global end of trial date
    31 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Oct 2024
    First version publication date
    30 Oct 2024
    Other versions
    Summary report(s)
    		 trial publication

    Trial information

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    Trial identification
    Sponsor protocol code
    1.4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, København Ø, Denmark, 2100
    Public contact
    Dept of Oncology,Rigshospitalet, Lene Bæksgaard Jensen, 0045 35455072, lene.baeksgaard.jensen@regionh.dk
    Scientific contact
    Dept of Oncology,Rigshospitalet, Lene Bæksgaard Jensen, 0045 35455072, lene.baeksgaard.jensen@regionh.dk
    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
    01 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and tolerability of Lonsurf with or without bevacizumab in Caucasian patients with platinum-refractory esophago-gastric adenocarcinoma. Primary objective is Progression Free Survival (PFS)
    Protection of trial subjects
    According to protocol.
    Background therapy
    		 NA. No products fit the description.
    Evidence for comparator
    		 FTD/TPI significantly prolonged progressionfree survival and overall survival in patients with metastatic EGA in third or later line compared to placebo, based on the TAGS trial (Shitara K, Doi T, Dvorkin M, et al. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19:1437–1448.)
    Actual start date of recruitment
    01 Mar 2019
    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
    Denmark: 103
    Worldwide total number of subjects
    103
    EEA total number of subjects
    103
    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)
    33
    From 65 to 84 years
    70
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Main inclusion criteria were age at least 18 years, histologically confirmed esophagogastric adenocarcinoma and previous (perioperative or palliative) treatment with combination chemotherapy with a fluoropyrimidine (5- FU, capecitabine or S-1) and a platinum (cisplatin, oxaliplatin, or carboplatin).

    Pre-assignment
    Screening details
    		 153 patients were screened, 50 patients were ineligible, 34 not fulfilling the inclusion criteriae, 16 due to other reasons.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Trifluridine/tipiracil plus bevacizumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    trifluridine and tipiracil
    Investigational medicinal product code
    L01BC59
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Trifluridine and tipiracil 35 mg/m2 orally twice daily on days 1–5 and 8–12 every 28 days.

    Investigational medicinal product name
    bevacizumab
    Investigational medicinal product code
    L01F G01
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab 5 mg/kg intravenously on days 1 and 15 every 28 days.

    Arm title
    		 Control
    Arm description
    		 Control arm with trifluridine and tipiracil
    Arm type
    		 Active comparator

    Investigational medicinal product name
    trifluridine and tipiracil
    Investigational medicinal product code
    L01BC59
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Trifluridine and tipiracil 35 mg/m2 orally twice daily on days 1–5 and 8–12 every 28 days.

    Number of subjects in period 1
    		Intervention Control
    Started
    50
    53
    Completed
    50
    53

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Trifluridine/tipiracil plus bevacizumab

    Reporting group title
    Control
    Reporting group description
    		 Control arm with trifluridine and tipiracil

    Reporting group values
    		 Intervention Control Total
    Number of subjects
    		 50 53 103
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 64 (56 to 71) 66 (61 to 71) -
    Gender categorical
    Units: Subjects
        Female
    		 39 10 49
        Male
    		 11 43 54
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized and treated patients.

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    103
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    21
        Male
    82

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Trifluridine/tipiracil plus bevacizumab

    Reporting group title
    Control
    Reporting group description
    		 Control arm with trifluridine and tipiracil

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized and treated patients.

    Primary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    End point type
    Primary
    End point timeframe
    Progression-free survival calculated from the date of randomisation to the first date of radiological or clinical progression, time till death, or censored on cut-off date.
    End point values
    		 Intervention Control
    Number of subjects analysed
    50
    53
    Units: months
        median (confidence interval 95%)
    3.9 (3.0 to 6.3)
    3.1 (2.0 to 4.3)
    Statistical analysis title
    		 Kaplan-Meier
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Oct 1, 2019 to March 1st, 2023
    Adverse event reporting additional description
    Adverse events were evaluated before each cycle and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Nadir hematology was measured on day 14 on cycle one and two.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 -

    Reporting group title
    control
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 50 (44.00%)
    21 / 53 (39.62%)
         number of deaths (all causes)
    49
    51
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    hospitalisation
    Additional description: Serious adverse events, that all were due to hospitalisations, were observed in 21 patients (40%) in the FTD/TPI group and in 22 patients (44%) in the group receiving FTD/TPI plus bevacizumab
         subjects affected / exposed
    22 / 50 (44.00%)
    21 / 53 (39.62%)
         occurrences causally related to treatment / all
    5 / 22
    4 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Experimental control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 50 (100.00%)
    53 / 53 (100.00%)
    General disorders and administration site conditions
    non-serious adverse event
    Additional description: attached publication for further details on non-serious adverse events
         subjects affected / exposed
    50 / 50 (100.00%)
    53 / 53 (100.00%)
         occurrences all number
    50
    53

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    None reported
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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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