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    Clinical Trial Results:
    Phase II trial evaluating the efficacy and safety of carboplatin plus pemetrexed in Human Immunodeficiency Virus positive (HIV+) patients with stage III (not amenable to radiation or inoperable) or stage IV non-squamous Non Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2010-023676-48
    Trial protocol
    		 FR  
    Global end of trial date
    03 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Feb 2023
    First version publication date
    11 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IFCT-1001 CHIVA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01296113
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IFCT
    Sponsor organisation address
    10 Rue de la Grange Batelière , Paris, France, 75009
    Public contact
    Contact, IFCT, 33 1.56.81.10.46, contact@ifct.fr
    Scientific contact
    Contact, IFCT, 33 1.56.81.10.46, contact@ifct.fr
    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
    30 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Disease control rate (DCR) (stable, partial and complete response) of at least 30% after 4 cycles (12 weeks).
    Protection of trial subjects
    Algorithms for management of adverse events were provided in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2011
    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
    France: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    56
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between May 2011 and July 2015, 61 patients were enrolled. 60 patients received at least one first-line Carboplatin-Pemetrexed cycle. The full planned induction regimen (four cycles) was completed in 38 patients (62.3%). Among the 38 four-cycle completers, 31 patients (50.8% of efficacy population) started pemetrexed-maintenance.

    Pre-assignment
    Screening details
    		 To be eligible, People Living with HIV (PLHIV) were diagnosed with histological or cytological confirmed non-squamous NSCLC, stage III–IV, and had no previous administration of chemotherapy, age between 18 and 75 years, an ECOG-PS 0–2, patients with symptomatic or asymptomatic brain metastases could be included without prior treatment.

    Period 1
    Period 1 title
    Induction
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 Carboplatin-Pemetrexed
    Arm description
    		 Patients received first-line intravenous chemotherapy with pemetrexed, 500 mg/m, bolus infused in 10 min, every 3 weeks, combined with carboplatin bolus infusion, with a target AUC5 on day 1 for a maximum of four cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    AUC5 every 3 weeks on day 1 for a maximum of four 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 every 3 week, 500 mg/m, bolus infused in 10 min, on day 1 for a maximum of four cycles.

    Number of subjects in period 1
    		Carboplatin-Pemetrexed
    Started
    61
    Completed
    38
    Not completed
    23
         not received treatment (death)
    1
         Lack of efficacy
    22
    Period 2
    Period 2 title
    Maintenance Pemetrexed
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 Pemetrexed
    Arm description
    		 After the four-cycle induction, patients achieving disease control ( partial responses or stable diseases) and ECOG-PS ⩽2 were continued on pemetrexed.
    Arm type
    		 Experimental

    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 every 3 week, 500 mg/m, bolus infused in 10 min, on day 1 for a maximum of four cycles.

    Number of subjects in period 2 [1]
    		Pemetrexed
    Started
    31
    Completed
    31
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: After the four-cycle induction, 7/38 patients didn't achieve disease control (partial response or stable) and were not allowed to continued on maintenance pemetrexed.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Induction
    Reporting group description
    		 -

    Reporting group values
    		 Induction Total
    Number of subjects
    		 61 61
    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))
    		 52.9 (36.6 to 67.5) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 46 46
    HIV viral load
    Units: Subjects
        Undectectable
    		 48 48
        Detectable
    		 12 12
        Missing
    		 1 1
    Antiretroviral therapy at study entry
    Units: Subjects
        Yes
    		 58 58
        No
    		 3 3
    ECOG performans status (PS)
    Units: Subjects
        PS 0
    		 17 17
        PS 1
    		 32 32
        PS 2
    		 12 12
    Smocking status
    Units: Subjects
        Current
    		 54 54
        Former
    		 3 3
        Never
    		 4 4
    Histology
    Units: Subjects
        Adenocarcinoma
    		 56 56
        Sarcomatoïd
    		 1 1
        Non-squamous cell predominant NSCLC
    		 4 4
    Disease stage
    Units: Subjects
        III
    		 6 6
        IV
    		 55 55
    Brain metastasis
    Units: Subjects
        Symptomatic
    		 9 9
        Asymptomatic
    		 10 10
        No brain metastasis
    		 42 42
    History of cancer
    Units: Subjects
        AIDS related
    		 3 3
        Non-AIDS related
    		 6 6
        No history of cancer
    		 52 52
    History of AIDS-related infectio,
    Units: Subjects
        Yes
    		 44 44
        No
    		 17 17
    History of Hepatitis C
    Units: Subjects
        Yes
    		 24 24
        No
    		 37 37
    History of Hepatitis B
    Units: Subjects
        Yes
    		 7 7
        No
    		 54 54
    Comorbidity: arterial hypertension
    Units: Subjects
        Yes
    		 10 10
        No
    		 51 51
    Comorbidity: Dyslipidemia
    Units: Subjects
        Yes
    		 7 7
        No
    		 54 54
    Comorbidity: diabetes
    Units: Subjects
        Yes
    		 3 3
        No
    		 58 58
    Comorbidty: cardiopathy
    Units: Subjects
        Yes
    		 8 8
        No
    		 53 53
    Genetic status
    Units: Subjects
        Wild type
    		 44 44
        KRAS mutation
    		 7 7
        ALK mutation
    		 2 2
        BRAF V600 mutation
    		 2 2
        EGFR mutation L858R exon 21
    		 1 1
        Missing
    		 5 5
    CD4 count
    Units: cells/microlitre
        median (full range (min-max))
    		 418.0 (18 to 1230) -
    Nadir CD4 count
    Units: cells/microlitre
        median (full range (min-max))
    		 169.5 (1 to 822) -
    Duration of HIV infection
    Units: years
        median (full range (min-max))
    		 20.7 (0.1 to 29) -
    Number of pack-year
    Units: Pack-years
        median (full range (min-max))
    		 36 (6 to 120) -
    Median known duration of HIV infection
    Units: year
        median (full range (min-max))
    		 20.7 (0.1 to 29) -

    End points

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    End points reporting groups
    Reporting group title
    Carboplatin-Pemetrexed
    Reporting group description
    		 Patients received first-line intravenous chemotherapy with pemetrexed, 500 mg/m, bolus infused in 10 min, every 3 weeks, combined with carboplatin bolus infusion, with a target AUC5 on day 1 for a maximum of four cycles.
    Reporting group title
    Pemetrexed
    Reporting group description
    		 After the four-cycle induction, patients achieving disease control ( partial responses or stable diseases) and ECOG-PS ⩽2 were continued on pemetrexed.

    Primary: 12-week disease control rate

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    End point title
    		 12-week disease control rate [1]
    End point description
    Number of patient with complete or partial responses and stable diseases at 12 weeks
    End point type
    Primary
    End point timeframe
    After 4 cycles of induction chemotherapy (12 weeks)
    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: Not applicable as the study was single arm.
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: Subjects
    31
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS was defined as the time between patient’s inclusion and disease progression, relapse or death of any cause.
    End point type
    Secondary
    End point timeframe
    45.5 months (median follow-up)
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: months
        median (confidence interval 95%)
    3.5 (2.7 to 4.4)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    OS as the time between inclusion and death from any cause.
    End point type
    Secondary
    End point timeframe
    45.5 months (median follow-up)
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: months
        median (confidence interval 95%)
    7.6 (5.7 to 12.8)
    No statistical analyses for this end point

    Secondary: Best overall response at 12 weeks

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    End point title
    		 Best overall response at 12 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    At 12 weeks
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: Subjects
        Partial response
    13
        Stable disease
    18
        Progressive disease
    30
    No statistical analyses for this end point

    Secondary: Number of opportunistic infections

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    End point title
    		 Number of opportunistic infections
    End point description
    End point type
    Secondary
    End point timeframe
    45.5 months (median follow-up)
    End point values
    		 Carboplatin-Pemetrexed Pemetrexed
    Number of subjects analysed
    60 [2]
    31 [3]
    Units: Number of opportunistic infections
    0
    0
    Notes
    [2] - Safety population includes all patients who received at least one cycle of study chemotherapy (N=60)
    [3] - Safety population includes all patients who received at least one cycle of maintenance (N=31).
    No statistical analyses for this end point

    Secondary: Death due to sepsis or infections

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    End point title
    		 Death due to sepsis or infections
    End point description
    Number of death due to sepsis or infections.
    End point type
    Secondary
    End point timeframe
    45.5 months (median follow-p)
    End point values
    		 Carboplatin-Pemetrexed Pemetrexed
    Number of subjects analysed
    60 [4]
    31 [5]
    Units: Number of death
    2
    0
    Notes
    [4] - Safety population includes all patients who received at least one cycle of study chemotherapy (N=60)
    [5] - Safety population includes all patients who received at least one cycle of maintenance (N=31).
    No statistical analyses for this end point

    Other pre-specified: Prognosis Analysis of PFS

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    End point title
    		 Prognosis Analysis of PFS
    End point description
    End point type
    Other pre-specified
    End point timeframe
    At 12 weeks
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: Hazard ratio
    number (confidence interval 95%)
        Cancer history : yes
    1.69 (0.79 to 3.60)
        PS 2
    2.67 (1.31 to 5.43)
        Brain metastasis : yes
    1.52 (0.86 to 2.67)
        History of AIDS : yes
    1.07 (0.58 to 1.97)
    No statistical analyses for this end point

    Other pre-specified: Prognosis Analysis of OS

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    End point title
    		 Prognosis Analysis of OS
    End point description
    End point type
    Other pre-specified
    End point timeframe
    At 12 weeks
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: Hazard ration
    number (confidence interval 95%)
        Cancer history : yes
    1.56 (0.70 to 3.46)
        PS 2
    4.44 (1.93 to 10.22)
        Brain metastatis : yes
    1.75 (0.95 to 3.22)
        highly active antiretroviral therapy : yes
    0.44 (0.09 to 2.23)
        History of AIDS : yes
    1.06 (0.56 to 2.0)
    No statistical analyses for this end point

    Other pre-specified: PFS according to PS at inclusion

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    End point title
    		 PFS according to PS at inclusion
    End point description
    End point type
    Other pre-specified
    End point timeframe
    45.5 months (median follow-up)
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: months
    median (confidence interval 95%)
        PS 0-1
    4.3 (3.1 to 5.2)
        PS 2
    1.7 (1.3 to 2.9)
    No statistical analyses for this end point

    Other pre-specified: PFS according to brain metastasis at inclusion

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    End point title
    		 PFS according to brain metastasis at inclusion
    End point description
    End point type
    Other pre-specified
    End point timeframe
    45 months (median follow-up)
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: months
    median (confidence interval 95%)
        Without brain metastasis
    4.0 (2.9 to 5.3)
        With brain metastasis
    2.6 (1.3 to 4.4)
    No statistical analyses for this end point

    Other pre-specified: OS according to PS at inclusion

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    End point title
    		 OS according to PS at inclusion
    End point description
    End point type
    Other pre-specified
    End point timeframe
    45.5 months (median follow-up)
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: months
    median (confidence interval 95%)
        PS 0-1
    11.9 (6.4 to 14.3)
        PS 2
    2.4 (0.7 to 5.4)
    No statistical analyses for this end point

    Other pre-specified: OS According to brain metastasis at inclusion

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    End point title
    		 OS According to brain metastasis at inclusion
    End point description
    End point type
    Other pre-specified
    End point timeframe
    45.5 months (median follow-up)
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: months
    median (confidence interval 95%)
        Without brain metastasis
    11.9 (5.9 to 16.6)
        With brain metastasis
    6.2 (1.9 to 8.8)
    No statistical analyses for this end point

    Post-hoc: Risk factor of grade 3-4 haematologic toxicity of carboplatin-pemetrexed in patient treated with antiretroviral therapy

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    End point title
    		 Risk factor of grade 3-4 haematologic toxicity of carboplatin-pemetrexed in patient treated with antiretroviral therapy
    End point description
    End point type
    Post-hoc
    End point timeframe
    At 12 weeks
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    58 [6]
    Units: % of subjects
    number (not applicable)
        Grade 3-4 hematologic toxicity if no AIDS-history
    60.6
        Grade 3-4 hematologic toxicity if AIDS-history
    39.4
        No gr 3-4 hematologic toxicity if no AIDS-history
    84.0
        No gr 3-4 hematologic toxicity if AIDS-history
    16.0
    Notes
    [6] - 58 patients treated with antiretroviral therapy at inclusion
    No statistical analyses for this end point

    Post-hoc: Quality of Life Evaluated With the Lung Cancer Symptom Scale (LCSS)

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    End point title
    		 Quality of Life Evaluated With the Lung Cancer Symptom Scale (LCSS)
    End point description
    The quality of life was described by the sum of the score of all domains of LCSS questionnaire, at the end of each first-line chemotherapy cycle compared to the baseline value. Declined : mean score increased by at least 10 points from baseline. Improved : mean score decreased by at least 10 points from baseline.
    End point type
    Post-hoc
    End point timeframe
    At 12 weeks
    End point values
    		 Carboplatin-Pemetrexed
    Number of subjects analysed
    61
    Units: % of subjects
    number (not applicable)
        C1 vs baseline : declined
    12.8
        C1 vs baseline : stable
    71.8
        C1 vs baseline : improved
    15.4
        C2 vs baseline : declined
    9.4
        C2 vs baseline : stable
    65.6
        C2 vs baseline : improved
    25.0
        C3 vs baseline : declined
    20.8
        C3 vs baseline : stable
    50.0
        C3 vs baseline : improved
    29.2
        C4 vs baseline : declined
    12.2
        C4 vs baseline : stable
    58.2
        C4 vs baseline : improved
    29.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse events have to be reported from inclusion to 30 day following the end of administration of study treatments.
    Adverse event reporting additional description
    The maximal grade of adverse events was collected by cycle of treatment.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 -

    Serious adverse events
    		 Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 60 (53.33%)
         number of deaths (all causes)
    55
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Progression of bronchial carcinoma
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 4
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Thromboembolism NOS
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Reduced general condition
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences causally related to treatment / all
    2 / 6
         deaths causally related to treatment / all
    0 / 3
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchopneumopathy
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COAD exacerbated
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Hemoptysis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumopathy
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Productive cough
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Hemoglobin decreased
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Cerebral oedema management
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Confusion
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hemiparesis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neuropathic pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Aplasia bone marrow
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    Febrile aplasia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    Hemolysis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Eye disorder
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Colitis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Diarrhea
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Nausea
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    Vomiting
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute renal failure
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Fracture NOS
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    1 / 1
    Catheter related infection
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Localized infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Septic shock
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Spastic bronchitis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 3
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 60 (100.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    9 / 60 (15.00%)
         occurrences all number
    27
    Aspartate aminotransferase increased
         subjects affected / exposed
    10 / 60 (16.67%)
         occurrences all number
    25
    Blood alkaline phosphatase increased
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences all number
    16
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    8 / 60 (13.33%)
         occurrences all number
    21
    Weight decreased
         subjects affected / exposed
    13 / 60 (21.67%)
         occurrences all number
    31
    Vascular disorders
    Haemoptysis
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 60 (15.00%)
         occurrences all number
    19
    Paraesthesia
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    9
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    54 / 60 (90.00%)
         occurrences all number
    264
    Febrile neutropenia
         subjects affected / exposed
    7 / 60 (11.67%)
         occurrences all number
    8
    Leukopenia
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    7
    Neutropenia
         subjects affected / exposed
    49 / 60 (81.67%)
         occurrences all number
    186
    Thrombocytopenia
         subjects affected / exposed
    43 / 60 (71.67%)
         occurrences all number
    190
    General disorders and administration site conditions
    Abdominal pain
         subjects affected / exposed
    8 / 60 (13.33%)
         occurrences all number
    14
    Asthenia
         subjects affected / exposed
    47 / 60 (78.33%)
         occurrences all number
    173
    Chest pain
         subjects affected / exposed
    9 / 60 (15.00%)
         occurrences all number
    18
    General physical health deterioration
         subjects affected / exposed
    11 / 60 (18.33%)
         occurrences all number
    18
    Oedema peripheral
         subjects affected / exposed
    9 / 60 (15.00%)
         occurrences all number
    21
    Pyrexia
         subjects affected / exposed
    10 / 60 (16.67%)
         occurrences all number
    21
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    10 / 60 (16.67%)
         occurrences all number
    15
    Diarrhoea
         subjects affected / exposed
    11 / 60 (18.33%)
         occurrences all number
    17
    Dysphagia
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    9
    Nausea
         subjects affected / exposed
    31 / 60 (51.67%)
         occurrences all number
    74
    Stomatitis
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    20 / 60 (33.33%)
         occurrences all number
    41
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    17 / 60 (28.33%)
         occurrences all number
    36
    Dysphonia
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    9
    Dyspnoea
         subjects affected / exposed
    25 / 60 (41.67%)
         occurrences all number
    50
    Productive cough
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    22
    Rash
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    6
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    7 / 60 (11.67%)
         occurrences all number
    27
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    14
    Back pain
         subjects affected / exposed
    8 / 60 (13.33%)
         occurrences all number
    15
    Bone pain
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    8
    Musculoskeletal chest pain
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences all number
    20
    Neck pain
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    7
    Pain in extremity
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    3
    Infections and infestations
    Catheter site infection
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    7
    Lung infection
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    6
    Oral candidiasis
         subjects affected / exposed
    10 / 60 (16.67%)
         occurrences all number
    13
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    24 / 60 (40.00%)
         occurrences all number
    67
    Hypokalaemia
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 May 2015
    Modification was made in order to add growth factors to prevent febrile neutropenia.
    13 Jun 2017
    Modification was made in order to reduce the frequency of tumour evaluation after the 5th assessment and to extend the duration of the study.

    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.
    The trial suffers from a bias related to the potential heterogeneity of patients living with HIV; however, the option of a restricted population of patients without PS 2 and without symptomatic brain metastases could have affected the recruitment.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32444410
    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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