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    Clinical Trial Results:
    An open-label, non-randomized, single dose, exploratory Phase II trial of FG001 (an imaging agent) for localization of biopsy-proven primary non-small cell lung cancer (NSCLC)

    Summary
    EudraCT number
    		 2021-004389-37
    Trial protocol
    		 DK  
    Global end of trial date
    02 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 May 2024
    First version publication date
    31 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FG001-CT-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fluoguide A/S
    Sponsor organisation address
    Ole Maaløes vej 3, København N, Denmark, 2200
    Public contact
    Director Regulatory Affairs, FluoGuide A/S, alk@fluoguide.com
    Scientific contact
    Director Regulatory Affairs, FluoGuide A/S, alk@fluoguide.com
    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
    02 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate FG001 for the detection of NSCLC
    Protection of trial subjects
    The trial was conducted, in compliance with the protocol, regulatory requirements, Good Clinical Practice (GCP) and the ethical principles of the latest revision of the Declaration of Helsinki as adopted by the World Medical Association. All subjects provided written informed consent to participate in the trial prior to being screened. All subjects received written and verbal information regarding the trial. The given information emphasized that participation in the trial was voluntary and that the subjects could withdraw from the trial at any time and for any reason. All subjects were given the opportunity to ask questions about the trial and were given sufficient time to decide whether to participate in the trial. A subject was discontinued from the trial at any time if the subject, the Investigator, or the FluoGuide A/S evaluated that it was not in the subject´s best interest to continue. The following were possible reasons for trial treatment discontinuation: • Subject withdrawal of consent. • Subject was not compliant with trial procedures. • AE that in the opinion of the Investigator was in the best interest of the subject to discontinue trial participation. • Protocol violation requiring discontinuation. • Lost to follow-up. • FluoGuide A/S request for early termination of trial. • Subject death. All subjects could withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. Reasonable attempts were made by the Investigator to provide a reason for the subject’s withdrawal. The reason for the subject’s withdrawal from the trial was specified in the subject’s journal and the eCRF. If a subject was withdrawn from treatment due to an AE, the subject was followed and treated by the Investigator until the abnormal parameter or symptom has resolved or stabilized. Although subjects could withdraw from the trial at any time and for any reason, subject withdrawal was avoided to the extent possible.
    Background therapy
    		 None
    Evidence for comparator
    		 None
    Actual start date of recruitment
    24 May 2022
    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: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at Copenhagen University Hospital, Rigshospitalet, Denmark. A total of 18 subjects were screened, 17 subjects received trial drug as a 36 mg single administration, 1 subject withdrew before dosing.

    Pre-assignment
    Screening details
    		 At the screening visit the subject´s medical history and concomitant illnesses were obtained, and the previous and concomitant medication documented.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The trial was not blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 36 mg of FG001, administered day before surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    FG001
    Investigational medicinal product code
    FG001
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    36 mg of FG001, slow intravenous infusion

    Arm title
    		 Cohort 2
    Arm description
    		 36 mg of FG001, administered 2 days prior to surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    FG001
    Investigational medicinal product code
    FG001
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    36 mg of FG001, slow intravenous infusion

    Number of subjects in period 1 [1]
    		Cohort 1 Cohort 2
    Started
    9
    8
    Completed
    8
    8
    Not completed
    1
    0
         Adverse event, serious fatal
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The disparity is due to 1 screening failure (withdrawal of consent) - a total of 18 subjects underwent screening, and a total of 17 subjects received trial drug (Cohort 1: N=9; Cohort 2: N=8). One subject in Cohort 1 died during the trial. This subject had a fatal TEAE of arterial rupture that was considered not related to the trial drug. 16 subjects completed the trial.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 17 17
    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))
    		 72 (58 to 83) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 8 8
    Fertility Status
    Units: Subjects
        Post-menopausal
    		 9 9
        NA
    		 8 8
    Ethnicity
    Units: Subjects
        White
    		 17 17
    Tumor location
    Units: Subjects
        Peripheral
    		 17 17
    Tumor size
    (cm, longest diameter)
    Units: centimetre
        arithmetic mean (standard deviation)
    		 3.84 ( 1.337 ) -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Full Analysis Set (FAS) or Intent-to-Treat Population: All subjects who were exposed to trial drug irrespective of their compliance to the planned course of treatment. All enrolled subjects dosed with FG001 and with any valid imaging information were included in the FAS. Note: The FAS/ITT Population was removed from the analysis in a post database lock statistical analysis plan (SAP) addendum.

    Subject analysis set title
    Per-Protocol (PP) Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per-Protocol (PP) Set: The set of FAS subjects who had at least 80% of the trial drug administered, and who did not have any major protocol violations that may affect the assessment of efficacy endpoints. Note: The PP Set was redefined as a subset of the Safety Analysis Set in a post database lock SAP addendum.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set: All subjects who received trial drug.

    Subject analysis sets values
    		 Full Analysis Set (FAS) Per-Protocol (PP) Set Safety Analysis Set
    Number of subjects
    17
    17
    17
    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))
    72 (58 to 83)
    72 (58 to 83)
    72 (58 to 83)
    Gender categorical
    Units: Subjects
        Female
    9
    9
    9
        Male
    8
    8
    8
    Fertility Status
    Units: Subjects
        Post-menopausal
    9
    9
    9
        NA
    8
    8
    8
    Ethnicity
    Units: Subjects
        White
    17
    17
    17
    Tumor location
    Units: Subjects
        Peripheral
    17
    17
    17
    Tumor size
    (cm, longest diameter)
    Units: centimetre
        arithmetic mean (standard deviation)
    3.84 ( 1.337 )
    3.84 ( 1.337 )
    3.84 ( 1.337 )

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 36 mg of FG001, administered day before surgery

    Reporting group title
    Cohort 2
    Reporting group description
    		 36 mg of FG001, administered 2 days prior to surgery

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Full Analysis Set (FAS) or Intent-to-Treat Population: All subjects who were exposed to trial drug irrespective of their compliance to the planned course of treatment. All enrolled subjects dosed with FG001 and with any valid imaging information were included in the FAS. Note: The FAS/ITT Population was removed from the analysis in a post database lock statistical analysis plan (SAP) addendum.

    Subject analysis set title
    Per-Protocol (PP) Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per-Protocol (PP) Set: The set of FAS subjects who had at least 80% of the trial drug administered, and who did not have any major protocol violations that may affect the assessment of efficacy endpoints. Note: The PP Set was redefined as a subset of the Safety Analysis Set in a post database lock SAP addendum.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set: All subjects who received trial drug.

    Primary: Sensitivity for detection of NSCLC

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    End point title
    		 Sensitivity for detection of NSCLC [1]
    End point description
    The primary efficacy endpoint (sensitivity measured as the proportion of biopsies encompassing active tumor tissue that were fluorescent and TBR values based on in vivo and ex vivo images) was challenging to achieve as the fluorescence signal was weak, resulting in mean TBR values between 1 and 2. Consequently, the surgeon could not be guided by the fluorescent light to sample the biopsies, and this is why these biopsies were not evaluated for fluorescence on the back table. A subjective evaluation of in vivo and ex vivo images was performed by the Sponsor team and identified that 11/15 subjects had a tumor that was fluorescent with FG001.
    End point type
    Primary
    End point timeframe
    Duration of the trial
    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 primary efficacy endpoint (sensitivity measured as the proportion of biopsies encompassing active tumor tissue that were fluorescent and TBR values based on in vivo and ex vivo images) was challenging to achieve as the fluorescence signal was weak. Subjective evaluation of in vivo and ex vivo images was performed by the Sponsor team and no statistical analyses were thus performed.
    End point values
    		 Per-Protocol (PP) Set
    Number of subjects analysed
    15
    Units: tumours that were fluorescent with FG001
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Duration of the trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Safety Analysis Set
    Reporting group description
    		 Safety Analysis Set: All subjects who received trial drug. All subjects in the Safety Analysis Set received a 36.0 mL administration of trial drug

    Serious adverse events
    		 Safety Analysis Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 17 (11.76%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Arterial rupture
    Additional description: Arterial rupture and bleeding during surgery
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Hemothorax
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Analysis Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2022
    Protocol Version 2.0: Removed “single site” wording throughout. Update to inclusion criterion 1 to include subjects with squamous-cell carcinoma. Update to inclusion criterion 3 to include subjects with tumor size ≥1.5 cm. Update the time window for PK sample collection at +44 hours post FG001 administration. Add new section describing financial aspects of the study including site payments.
    23 Nov 2022
    Protocol version 3.0: GCP statement was removed. Study visit structure updated to include an EoT visit at Day 4 from FG001 administration. Risk assessment information updated. Secondary efficacy endpoints were separated for Cohorts 1 and 2 and updated to include “Demonstrate exposure of FG001 after 1 hour and prior to surgery” for Cohort 2. Exploratory endpoint was updated to “To evaluate the correlation between the normalized FG001 intensities and the uPAR expression as determined by IHC”. Exploratory endpoint was added “To explore the impact on normalized intensity level for surrounding benign tissue such as but not constrained to anthracosis and atelectasis”. Correction to exclusion criterion 4. Planned number of subjects changed from “20 to 24” to “16 up to 44”. Study design revised to allow up to 5 cohorts each including 8 subjects, with FG001 administration 2 days prior to surgery. Details of safety monitoring updated. PK sample timing updated, with an updated PK sampling schedule for Cohort 2. Vital signs timing updated. Sample size calculation updated.

    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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