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    Clinical Trial Results:
    A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat with Platinum Doublet Chemotherapy versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

    Summary
    EudraCT number
    		 2017-003304-43
    Trial protocol
    		 ES  
    Global end of trial date
    22 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2018
    First version publication date
    29 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 24360-309 (CA2099NC)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03348904
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cut-Off, Wilmington, DE, United States, 19803
    Public contact
    Incyte Corporation, Incyte Corporation Call Center, +44 (0)330 100 3677, globalmedinfo@incyte.com
    Scientific contact
    Incyte Corporation, Incyte Corporation Call Center, +44 (0)330 100 3677, globalmedinfo@incyte.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
    22 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare overall survival (OS) and progression-free survival (PFS) per blinded independent central review (BICR) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) to chemotherapy (Arm B) in NSCLC participants whose tumors express programmed death-ligand 1 (PD-L1) at 0 to 49%.
    Protection of trial subjects
    The study was conducted in compliance with the ethical principles derived from the Declaration of Helsinki and the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of study participants were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Dec 2017
    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
    United States: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    0
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In this study, 2 participants were randomized to the chemotherapy only (Arm B) treatment.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Double-blind for arms A and C (no participants enrolled); open-label for Arm B.

    Arms
    Arm title
    		 Arm B
    Arm description
    		 Platinum doublet chemotherapy
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

    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 administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine administered intravenously at the protocol-defined dose on days 1 and 8 of a 3 week cycle.

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.

    Number of subjects in period 1
    		Arm B
    Started
    2
    Completed
    1
    Not completed
    1
         Administrative reason
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Period
    Reporting group description
    		 All randomized participants.

    Reporting group values
    		 Overall Period Total
    Number of subjects
    		 2 2
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Arm B
    Reporting group description
    		 Platinum doublet chemotherapy

    Primary: Overall survival (OS) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B)

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    End point title
    		 Overall survival (OS) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B) [1]
    End point description
    Defined as the time from randomization to the date of death from any cause.
    End point type
    Primary
    End point timeframe
    Month 38
    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: No statistical analyses have been provided as analysis was not completed for early termination.
    End point values
    		 Arm B
    Number of subjects analysed
    0 [2]
    Units: months
        number (not applicable)
    Notes
    [2] - Study was terminated; there were no participants enrolled in Arms A and C - no analysis completed.
    No statistical analyses for this end point

    Primary: Progression-free survival (PFS) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B)

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    End point title
    		 Progression-free survival (PFS) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B) [3]
    End point description
    Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.
    End point type
    Primary
    End point timeframe
    Approximately 25 months
    Notes
    [3] - 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: No statistical analyses have been provided as analysis was not completed for early termination.
    End point values
    		 Arm B
    Number of subjects analysed
    0 [4]
    Units: days
        number (not applicable)
    Notes
    [4] - Study was terminated; there were no participants enrolled in Arms A and C - no analysis completed.
    No statistical analyses for this end point

    Secondary: Objective response rate (ORR) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B)

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    End point title
    		 Objective response rate (ORR) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B)
    End point description
    Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria.
    End point type
    Secondary
    End point timeframe
    Approximately 25 months
    End point values
    		 Arm B
    Number of subjects analysed
    0 [5]
    Units: percentage of participants
        number (not applicable)
    Notes
    [5] - Study was terminated; there were no participants enrolled in Arms A and C - no analysis completed.
    No statistical analyses for this end point

    Secondary: Duration of response (DOR) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B)

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    End point title
    		 Duration of response (DOR) of nivolumab plus epacadostat in combination with chemotherapy (Arm A) compared to chemotherapy (Arm B)
    End point description
    Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    Approximately 25 months
    End point values
    		 Arm B
    Number of subjects analysed
    0 [6]
    Units: months
        number (not applicable)
    Notes
    [6] - Study was terminated; there were no participants enrolled in Arms A and C - no analysis completed.
    No statistical analyses for this end point

    Secondary: Estimate of overall survival (OS) of nivolumab and placebo in combination with chemotherapy (Arm C)

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    End point title
    		 Estimate of overall survival (OS) of nivolumab and placebo in combination with chemotherapy (Arm C)
    End point description
    Defined as the time from randomization to the date of death from any cause.
    End point type
    Secondary
    End point timeframe
    Approximately 38 months
    End point values
    		 Arm B
    Number of subjects analysed
    0 [7]
    Units: days
        number (not applicable)
    Notes
    [7] - Study was terminated; there were no participants enrolled in Arms A and C - no analysis completed.
    No statistical analyses for this end point

    Secondary: Estimate of PFS of nivolumab and placebo in combination with chemotherapy (Arm C)

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    End point title
    		 Estimate of PFS of nivolumab and placebo in combination with chemotherapy (Arm C)
    End point description
    Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    Approximately 25 months
    End point values
    		 Arm B
    Number of subjects analysed
    0 [8]
    Units: days
        number (not applicable)
    Notes
    [8] - Study was terminated; there were no participants enrolled in Arms A and C - no analysis completed.
    No statistical analyses for this end point

    Secondary: Estimate of ORR of nivolumab and placebo in combination with chemotherapy (Arm C)

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    End point title
    		 Estimate of ORR of nivolumab and placebo in combination with chemotherapy (Arm C)
    End point description
    Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.
    End point type
    Secondary
    End point timeframe
    Approximately 25 months
    End point values
    		 Arm B
    Number of subjects analysed
    0 [9]
    Units: percentage of participants
        number (not applicable)
    Notes
    [9] - Study was terminated; there were no participants enrolled in Arms A and C - no analysis completed.
    No statistical analyses for this end point

    Secondary: Estimate of DOR of nivolumab and placebo in combination with chemotherapy (Arm C)

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    End point title
    		 Estimate of DOR of nivolumab and placebo in combination with chemotherapy (Arm C)
    End point description
    Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    Approximately 25 months
    End point values
    		 Arm B
    Number of subjects analysed
    0 [10]
    Units: months
        number (not applicable)
    Notes
    [10] - Study was terminated; there were no participants enrolled in Arms A and C - no analysis completed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the initiation of study treatment until 30 days after last dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Arm B
    Reporting group description
    		 Platinum doublet chemotherapy.

    Serious adverse events
    		 Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Osteomyelitis
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    2 / 2 (100.00%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 2 (50.00%)
         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
    23 Oct 2017
    *ALK and ROS1 testing are mandatory for participants with nonsquamous histology. *Table for expected toxicities from study drugs added.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    22 May 2018
    Following an interim analysis of a pivotal Phase 3 study with epacadostat and an PD-1 inhibitor that concluded the pre-specified co-primary endpoints would not be met, the strategic decision was made to discontinue, stop enrollment and close the Checkmate 9NC/ECHO-309 study.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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