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    Clinical Trial Results:
    An open-label, randomised, multicentre, phase II clinical study of panitumumab plus pemetrexed and cisplatin (PemCisP) versus PemCis in the first-line treatment of patients with stage IIIB or IV primary nonsquamous non-small cell lung cancer, with particular regard to the KRAS status

    Summary
    EudraCT number
    		 2009-014677-41
    Trial protocol
    		 DE  
    Global end of trial date
    30 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2022
    First version publication date
    16 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AG47/GMIHO-006/2008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01088620
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GMIHO, Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
    Sponsor organisation address
    Almstadtstraße 7, Berlin, Germany, 10119
    Public contact
    Medical Consulting, GWT-TUD GmbH, +49 35125933100, info@gmiho.de
    Scientific contact
    Medical Consulting, GWT-TUD GmbH, +49 35125933100, info@gmiho.de
    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
    16 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to estimate the efficacy of the combination consisting of cisplatin/pemetrexed and panitumumab in patients with wild-type KRAS (non-mutated status). The progression-free survival rate at 6 months was compared to expectations derived from historical data, which were verified by a randomized control group without the antibody.
    Protection of trial subjects
    The conduct of this study was in compliance with the Good Clinical Practice Guidelines and under the guiding principles detailed in the Declaration of Helsinki. The study was also carried out in keeping with applicable local law(s) and regulation(s). Participants were monitored losely for toxicity, especially myelosuppression, renal, and gastrointestinal toxicity. An interim analysis of safety was presented to the Data Safety and Monitoring Board (DSMB) after documentation of the first 10 randomized patients in each arm. The DSMB received regular information on safety results of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Apr 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 96
    Worldwide total number of subjects
    96
    EEA total number of subjects
    96
    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)
    61
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From the 26th Apr 2010 through 11th Jan 2013, a total of 98 patients were randomised at 13 participating centers in Germany. The assumption of 67 patients with KRAS wild type per arm (in total 134 patients) was not achieved.

    Pre-assignment
    Screening details
    		 Out of 98 randomized patients, 96 patients were included in the full analysis set. One patient had to be excluded because of the violation of inclusion criteria. Another patient withdrew his consent after randomisation but before the first cycle of combination therapy. Randomization was stratified by participating center.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was performed in a non-blinded design because this was considered adequate to meet the study objectives.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Pemetrexed plus Cisplatin plus Panitumumab (PemCisP)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Alimta®
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed was administered at a dose of 500 mg/m² as a 10 minute infusion, before the application of cisplatin on day 1 of each three-week cycle for up to 4 cycles or until diagnosis of disease progression if occurring earlier.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 75 mg/m² was applied i.v. on day 1 of each three-week cycle, after the administration of pemetrexed, according to routine procedures for up to 4 cycles or until diagnosis of disease progression if occurring earlier.

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Vectibix®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Panitumumab 9 mg/kg b.w. qw3 as infusion was administered on Day 1 of each three-week cycle for up to 4 cycles or until diagnosis of disease progression if occurring earlier.

    Arm title
    		 Arm B
    Arm description
    		 Pemetrexed plus Cisplatin (PemCis)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Alimta®
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed was administered at a dose of 500 mg/m² as a 10 minute infusion, before the application of cisplatin on day 1 of each three-week cycle for up to 4 cycles or until diagnosis of disease progression if occurring earlier.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 75 mg/m² was applied i.v. on day 1 of each three-week cycle, after the administration of pemetrexed, according to routine procedures for up to 4 cycles or until diagnosis of disease progression if occurring earlier.

    Number of subjects in period 1
    		Arm A Arm B
    Started
    49
    47
    Completed
    23
    33
    Not completed
    26
    14
         Adverse event, non-fatal
    5
    -
         Refusal by patient (not associated with toxicity)
    2
    -
         Lack of efficacy
    15
    12
         Protocol deviation
    1
    -
         not specified
    3
    2

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Pemetrexed plus Cisplatin plus Panitumumab (PemCisP)

    Reporting group title
    Arm B
    Reporting group description
    		 Pemetrexed plus Cisplatin (PemCis)

    Primary: Progression Free Survival (PFS) Rate

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    End point title
    		 Progression Free Survival (PFS) Rate
    End point description
    End point type
    Primary
    End point timeframe
    after 6 months
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    46
    46
    Units: patients
        number (not applicable)
    14
    24
    Statistical analysis title
    		 Efficacy analysis
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Logrank
    Parameter type
    		 Mean difference (final values)
    Point estimate
    173.915
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 133.43
         upper limit
    		 214.399
    Variability estimate
    Standard error of the mean
    Dispersion value
    20.656

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    at the time when the subject is enrolled into the study (date of signature of the informed consent) until the End of Treatment Visit has been performed or 30 days after the last dose of study treatment
    Adverse event reporting additional description
    The investigator was responsible for ensuring that all AEs observed by the investigator or reported by subjects were properly captured in the subjects’ medical records.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 WHO-ART
    Dictionary version
    2013AA
    Frequency threshold for reporting non-serious adverse events: 0%
    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: In total, 40 patients experienced one or more SAE, 24 patients of Arm A and 16 patients of Arm B. Among them, 14 patients of Arm A and 8 patients of Arm B reported SAEs that were assessed as being drug related. With 24 versus 16 the number of patients with one or more SAEs was higher within the panitumumab arm as compared to the control arm. Furthermore, the total number of SAEs was also higher in the panitumumab arm as compared to the control arm (33 in Arm A versus 22 in Arm B).

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Oct 2012
    Protocol Version 1.9-2 dated 13.08.2012: CRO change
    12 Jul 2013
    Protocol Version 2.1 dated 08.04.2013: in consequence of the premature stop of the patient recruitment only the data sets of 98 patients were evaluable

    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.
    A futility analysis was performed to support the safety assessment of the DSMB. On the basis of interim toxicity data and the futility analysis of PFS the DSMB recommended to immediately stop patient recruitment.
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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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