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    Clinical Trial Results:
    Immunotherapy by Nivolumab after prior Chemotherapy for HIV+ patients with Advanced non-small cell lung cancer (NSCLC): IFCT-CHIVA2 phase IIa trial

    Summary
    EudraCT number
    		 2016-003796-22
    Trial protocol
    		 FR  
    Global end of trial date
    18 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Oct 2022
    First version publication date
    22 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IFCT-1602
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03304093
    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 156811045, contact@ifct.fr
    Scientific contact
    Contact , IFCT, 33 156811045, 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 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Feb 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Efficacy of the anti-PD1 antibody (nivolumab) as measured by DCR.
    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
    12 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
    France: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    13
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Sixteen patients were enrolled between December 2017 and July 2019 in 7 centers.

    Pre-assignment
    Screening details
    		 Patients with combined (c)ART-controlled HIV-1 infection (VL <200 copies/mL), regardless of their CD4+ T-cell count, and histologically/cytologically proven NSCLC stage IIIB or IV at diagnosis or after relapse post-surgery were included. Patients had received at least one prior platinum-based doublet chemotherapy regimen

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

    Arms
    Arm title
    		 Nivolumab
    Arm description
    		 Nivolumab was administered intravenously over 30 minutes at 3 mg/kg every 2 weeks, until disease progression or limiting toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab was administered intravenously over 30 minutes at 3 mg/kg every 2 weeks, until disease progression or limiting toxicity.

    Number of subjects in period 1
    		Nivolumab
    Started
    16
    Completed
    0
    Not completed
    16
         Adverse event, serious fatal
    4
         Patient refusal
    1
         Adverse event, non-fatal
    1
         Lack of efficacy
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 13 13
        From 65-84 years
    		 3 3
    Age continuous
    Units: years
        median (full range (min-max))
    		 58.4 (44.0 to 70.9) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 14 14
    Smoking status
    Units: Subjects
        Yes
    		 16 16
        No
    		 0 0
    WHO performance status
    Measure Description: The WHO performance status (PS) classification categorizes patients as: 0: able to carry out all normal activity without restriction 1: restricted in strenuous activity but ambulatory and able to carry out light work 2 : ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours 3: symptomatic and in a chair or in bed for greater than 50% of the day but not bedridden 4: completely disabled; cannot carry out any self-care; totally confined to bed or chair.
    Units: Subjects
        PS 0
    		 5 5
        PS 1
    		 7 7
        PS 2
    		 4 4
    Histology
    Units: Subjects
        Adenocarcinoma
    		 10 10
        Unspecified NSCLC
    		 1 1
        Squamous cell carcinoma
    		 5 5
    Stage
    Units: Subjects
        IIIB
    		 1 1
        IVA
    		 4 4
        IVB
    		 11 11
    Cancer history
    Units: Subjects
        Yes, AIDS-related
    		 1 1
        Yes, Non-AIDS-related
    		 5 5
        No
    		 10 10
    Infection history
    Units: Subjects
        Yes
    		 11 11
        No
    		 5 5
    Comorbidity
    Units: Subjects
        Yes
    		 8 8
        No
    		 7 7
        Unknown
    		 1 1
    Significant pathology
    Units: Subjects
        Yes
    		 10 10
        No
    		 5 5
        Unknown
    		 1 1
    EGFR baseline tumour mutation
    Measure Description: Genetic mutations were not tested in the patients with squamous cell carcinoma (n=5).
    Units: Subjects
        Yes
    		 0 0
        No
    		 9 9
        Not applicabe
    		 5 5
        Not done
    		 2 2
    KRAS baseline tumour mutation
    Measure Description: Genetic mutations were not tested in the patients with squamous cell carcinoma (n=5).
    Units: Subjects
        Yes
    		 3 3
        No
    		 7 7
        Not applicable
    		 5 5
        Not done
    		 1 1
    BRAF baseline tumour mutation
    Measure Description: Genetic mutations were not tested in the patients with squamous cell carcinoma (n=5).
    Units: Subjects
        Yes
    		 1 1
        No
    		 9 9
        Not applicable
    		 5 5
        Not done
    		 1 1
    HER2 baseline tumour mutation
    Measure Description: Genetic mutations were not tested in the patients with squamous cell carcinoma (n=5).
    Units: Subjects
        Yes
    		 0 0
        No
    		 6 6
        Not applicable
    		 5 5
        Not done
    		 5 5
    PI3KCA baseline tumour mutation
    Measure Description: Genetic mutations were not tested in the patients with squamous cell carcinoma (n=5).
    Units: Subjects
        Yes
    		 0 0
        No
    		 5 5
        Not determinated
    		 1 1
        Not applicable
    		 5 5
        Not done
    		 5 5
    ALK baseline tumour mutation
    Measure Description: Genetic mutations were not tested in the patients with squamous cell carcinoma (n=5).
    Units: Subjects
        Yes
    		 0 0
        No
    		 11 11
        Not applicable
    		 5 5
    ROS1 baseline tumour mutation
    Measure Description: Genetic mutations were not tested in the patients with squamous cell carcinoma (n=5).
    Units: Subjects
        Yes
    		 0 0
        No
    		 8 8
        Not determinated
    		 1 1
        Not applicable
    		 5 5
        Not done
    		 2 2
    PD-L1
    Units: Subjects
        Less than 1%
    		 9 9
        Between 1-49%
    		 2 2
        50% or more
    		 3 3
        Not available
    		 2 2
    Smocking status
    Units: Pack Year
        median (full range (min-max))
    		 40 (13 to 90) -
    Nadir CD4
    Units: mm3
        median (full range (min-max))
    		 201.0 (32 to 534) -
    CD4 T cell count
    Units: mm3
        median (full range (min-max))
    		 384.5 (187 to 778) -
    HIV viral load
    Units: copy/mL
        median (full range (min-max))
    		 25 (0 to 44) -

    End points

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    End points reporting groups
    Reporting group title
    Nivolumab
    Reporting group description
    		 Nivolumab was administered intravenously over 30 minutes at 3 mg/kg every 2 weeks, until disease progression or limiting toxicity.

    Primary: Disease Control Rate

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    End point title
    		 Disease Control Rate [1]
    End point description
    Patients who have achieved complete response (disappearance of all target lesions), partial response (at least a 30% decrease in the sum of diameters of target lesions since inclusion) and stable disease (between less than 30% decrease and less than 20% increase) as evaluated with Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).
    End point type
    Primary
    End point timeframe
    8 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
    		 Nivolumab
    Number of subjects analysed
    16
    Units: % of participants
    number (confidence interval 95%)
        Disease control
    62.5 (38.8 to 86.2)
        Progressive disease
    31.3 (8.5 to 54.0)
        Not evaluable/Not done
    6.3 (0.0 to 18.1)
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of response is defined as the time from the date of the first documented response (complete response (CR) or partial response(PR)) or disease stability (SD) to the earliest date of disease progression or death due to any cause. If a patient with a CR, PR or SD has neither progressed nor died at the time of the analysis cut-off, the patient will be censored at the date of last adequate tumour assessment.
    End point type
    Secondary
    End point timeframe
    Up to 1 year
    End point values
    		 Nivolumab
    Number of subjects analysed
    16
    Units: months
        median (full range (min-max))
    3.52 (0.7 to 28.6)
    No statistical analyses for this end point

    Secondary: Responses Rate According to Tissue PD-L1 Expression

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    End point title
    		 Responses Rate According to Tissue PD-L1 Expression
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Nivolumab
    Number of subjects analysed
    16
    Units: % of participants
    number (confidence interval 95%)
        PD-L1 positive - partial response
    20.0 (0.0 to 55.1)
        PD-L1 positive - stable disease
    80.0 (44.9 to 100.0)
        PD-L1 positive - progressive disease
    0 (0 to 0)
        PD-L1 negative - partial response
    11.1 (0.0 to 31.6)
        PD-L1 negative - stable disease
    33.3 (2.5 to 64.1)
        PD-L1 negative - progressive disease
    44.4 (12.0 to 76.9)
        PD-L1 negative - Not evaluable/Not done/missing
    11.1 (0.0 to 31.6)
    No statistical analyses for this end point

    Secondary: Progression Free Survival

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    End point title
    		 Progression Free Survival
    End point description
    Time between the date of inclusion and the first date of documented progression or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum since inclusion or a n unequivocal increase of a non-target lesion, or the appearance of new lesion(s).
    End point type
    Secondary
    End point timeframe
    Up to 1 year
    End point values
    		 Nivolumab
    Number of subjects analysed
    14
    Units: months
        median (confidence interval 95%)
    3.4 (1.8 to 5.5)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Time elapsed between the date of inclusion and death. Subjects who did not die will be censored on the last date a subject was known to be alive.
    End point type
    Secondary
    End point timeframe
    Up to 1 year
    End point values
    		 Nivolumab
    Number of subjects analysed
    16
    Units: month
        median (confidence interval 95%)
    10.9 (2.17 to 9999)
    No statistical analyses for this end point

    Secondary: Quality of Life Measured by LCSS Questionnaire

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    End point title
    		 Quality of Life Measured by LCSS Questionnaire
    End point description
    Quality of life is assessed by Lung Cancer Symptom Scale (LCSS). Changes from baseline to the 9 items of the scale are classified into 3 categories: improvement (decrease of at least 1 point), deterioration (increase of at least 1 point) and stabilization.
    End point type
    Secondary
    End point timeframe
    After 2 cycles
    End point values
    		 Nivolumab
    Number of subjects analysed
    11
    Units: Participants
        Anorexia - improvment
    2
        Anorexia - Stability
    1
        Anorexia - Deterioration
    8
        Fatigue - Improvement
    0
        Fatigue - Stability
    4
        Fatigue - Deterioration
    7
        Cough - Improvement
    4
        Cough - Stability
    4
        Cough - Deterioration
    3
        Dyspnea - Improvement
    2
        Dyspnea - Stability
    4
        Dyspnea - Deterioration
    5
        Hemoptysis - Improvement
    1
        Hemoptysis - Stability
    10
        Hemoptysis - Deterioration
    0
        Pain - Improvement
    3
        Pain - Stability
    4
        Pain - Deterioration
    4
        Symptom distress - Improvement
    5
        Symptom distress - Stability
    2
        Symptom distress - Deterioration
    4
        Activity level - Improvement
    5
        Activity level - Stability
    1
        Activity level - Deterioration
    5
    No statistical analyses for this end point

    Secondary: 6-month Overall Survival

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    End point title
    		 6-month Overall Survival
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Nivolumab
    Number of subjects analysed
    16
    Units: percent
        number (confidence interval 95%)
    68.7 (40.5 to 85.6)
    No statistical analyses for this end point

    Secondary: 12-month survival rate

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    End point title
    		 12-month survival rate
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Nivolumab
    Number of subjects analysed
    16
    Units: percent
        number (confidence interval 95%)
    48.1 (22.4 to 69.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected for a patient from the date of signature of inform consent form, during treatment period and until 100 days after the last dose of study treatment. Deaths were collected until data analysis.
    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
    21
    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
    9 / 16 (56.25%)
         number of deaths (all causes)
    10
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant ascites
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Neoplasm progression
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hypoxia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Pemphigoid
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    1 / 16 (6.25%)
         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 population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 16 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant ascites
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Neoplasm progression
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    4
    Pallor
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Peripheral coldness
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    10 / 16 (62.50%)
         occurrences all number
    46
    Chest pain
         subjects affected / exposed
    4 / 16 (25.00%)
         occurrences all number
    10
    Pain
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Death
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Gait disturbance
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Xerosis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    8 / 16 (50.00%)
         occurrences all number
    17
    Cough
         subjects affected / exposed
    6 / 16 (37.50%)
         occurrences all number
    15
    Haemoptysis
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    4
    Productive cough
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    4
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Dysphonia
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    3
    Epistaxis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Hypoxia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Delirium
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    8
    Weight decreased
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    4
    Blood alkaline phosphatase decreased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Breath sounds abnormal
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    CD4 lymphocytes decreased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    CD8 lymphocytes increased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Tlymphocyte count decreased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Skin injury
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    2
    Tachycardia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2
    Paraesthesia
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    5
    Hypokinesia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Motor dysfunction
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Neuralgia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    4
    Sciatica
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    3
    Sensorimotor disorder
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    30
    Somnolence
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 16 (25.00%)
         occurrences all number
    18
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 16 (50.00%)
         occurrences all number
    11
    Constipation
         subjects affected / exposed
    4 / 16 (25.00%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed
    4 / 16 (25.00%)
         occurrences all number
    9
    Vomiting
         subjects affected / exposed
    4 / 16 (25.00%)
         occurrences all number
    9
    Abdominal pain
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    9
    Aphthous ulcer
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    6
    Ascites
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Dry mouth
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    2
    Pancreatitis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 16 (25.00%)
         occurrences all number
    16
    Rash
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    7
    Alopecia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    5
    Alopecia areata
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    2
    Madarosis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    2
    Onycholysis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    7
    Pemphigoid
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    12
    Skin exfoliation
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    Hypothyroidism
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    20
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 16 (31.25%)
         occurrences all number
    15
    Back pain
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    9
    Bone pain
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    8
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    3
    Muscle spasms
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    2
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    5
    Hypercalcaemia
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    6
    Hyperkalaemia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Hypercreatinaemia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 16 (6.25%)
         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
    11 Feb 2019
    A substantial modification was done in order: - clarify which hospitalization were not to be reported as SAEs - increase inclusion duration

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    31 Jan 2020
    Due to difficulties in recruiting patients with the rare HIV-NSCLC combination, the study independent data monitoring committee recommended that patient inclusion be stopped in January 2020.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Our study is limited by the small sample size, which was due to difficulties in recruiting patients with the rare HIV-NSCLC combination.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34217967
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