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    Clinical Trial Results:
    A Phase I-II evaluation of the safety and efficacy of the oral HSP90 inhibitor Debio 0932 in combination with standard of care in first- and second-line therapy of patients with Stage IIIb or IV Non-small Cell Lung Cancer - the HALO study (HSP90 inhibition And Lung cancer Outcomes)

    Summary
    EudraCT number
    		 2011-005533-39
    Trial protocol
    		 GB   ES   HU  
    Global end of trial date
    11 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Aug 2016
    First version publication date
    11 Aug 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Debio0932-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Debiopharm International, S.A.
    Sponsor organisation address
    Case postale 5911, Chemin Messidor 5-7, Lausanne, Switzerland, 1002
    Public contact
    Vice President Clinical Research & Development, Debiopharm International, S.A., 41 21 321 01 11, info-international@debiopharm.com
    Scientific contact
    Vice President Clinical Research & Development, Debiopharm International, S.A., 41 21 321 01 11, info-international@debiopharm.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
    11 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Part A :To determine the MTD of Debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage IIIb or IV NSCLC and with docetaxel in previously treated patients with Stage IIIb or IV NSCLC. Part B : To compare the effect of adding Debio 0932 to combination chemotherapy with cisplatin/pemetrexed and cisplatin/gemcitabine on the rate of PFS at 6 months in first-line therapy of patients with Stage IIIb or IV NSCLC. Part C : To compare the effect of adding Debio 0932 to docetaxel on the change in tumour size in second-line therapy of patients with Stage IIIb or IV NSCLC.
    Protection of trial subjects
    An independent DMC was established prior to initiation of Part A. The main tasks of the DMC was to perform continuous cardiac safety monitoring (CCSM) and provide recommendations to the Sponsor concerning dose regimens and study continuation/discontinuation. Written approval of the study protocol and the informed consent was obtained from the appropriate independent ethics committees (IECs) prior to initiation of the study. These IECs were also notified of the end of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2014
    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 Kingdom: 3
    Country: Number of subjects enrolled
    Spain: 67
    Country: Number of subjects enrolled
    France: 12
    Worldwide total number of subjects
    82
    EEA total number of subjects
    82
    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)
    55
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 82 patients with Stage IIIb or IV non-small cell lung cancer were recruited to participate in this trial.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Regimen A - Debio 0932/Cisplatin/Pemetrexed
    Arm description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Pemetrexed 500 mg/m2 BSA was to be administered on Day 1 of each 21 day treatment cycle.

    Investigational medicinal product name
    Debio 0932
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Debio 0932 administered as daily oral tablets at a starting dose of 250 mg four times per day (QD).

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Cisplatin 75 mg/m2 body surface area (BSA) administered on Day 1 of each 21-day treatment cycle.

    Arm title
    		 Regimen B: Debio 0932/Cisplatin/Gemcitabine
    Arm description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Debio 0932
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Debio 0932 administered as daily oral tablets at a starting dose of 250 mg four times per day (QD).

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Gemcitabine 1250 mg/m2 BSA administered on Days 1 and 8 of each 21-day treatment cycle.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Cisplatin 75 mg/m2 body surface area (BSA) administered on Day 1 of each 21-day treatment cycle.

    Arm title
    		 Regimen C: Debio 0932/Docetaxel
    Arm description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Debio 0932
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Debio 0932 administered as daily oral tablets at a starting dose of 250 mg four times per day (QD).

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Docetaxel 60 or 75 mg/m2 BSA administered on Day 1 of each 21-day treatment cycle.

    Number of subjects in period 1
    		Regimen A - Debio 0932/Cisplatin/Pemetrexed Regimen B: Debio 0932/Cisplatin/Gemcitabine Regimen C: Debio 0932/Docetaxel
    Started
    28
    19
    35
    Completed
    0
    0
    0
    Not completed
    28
    19
    35
         Lost to follow-up
    28
    19
    35

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Regimen A - Debio 0932/Cisplatin/Pemetrexed
    Reporting group description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.

    Reporting group title
    Regimen B: Debio 0932/Cisplatin/Gemcitabine
    Reporting group description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.

    Reporting group title
    Regimen C: Debio 0932/Docetaxel
    Reporting group description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.

    Reporting group values
    		 Regimen A - Debio 0932/Cisplatin/Pemetrexed Regimen B: Debio 0932/Cisplatin/Gemcitabine Regimen C: Debio 0932/Docetaxel Total
    Number of subjects
    		 28 19 35 82
    Age categorical
    Units: Subjects
        Adults: 18-80 years
    		 28 19 35 82
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.29 ± 9.22 60.89 ± 8.67 57.03 ± 10.77 -
    Gender categorical
    Units: Subjects
        Female
    		 9 3 11 23
        Male
    		 19 16 24 59

    End points

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    End points reporting groups
    Reporting group title
    Regimen A - Debio 0932/Cisplatin/Pemetrexed
    Reporting group description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.

    Reporting group title
    Regimen B: Debio 0932/Cisplatin/Gemcitabine
    Reporting group description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.

    Reporting group title
    Regimen C: Debio 0932/Docetaxel
    Reporting group description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.

    Primary: Number of patients with dose limiting toxicities

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    End point title
    		 Number of patients with dose limiting toxicities [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 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: The limited amount of data for this terminated trial precluded analysis.
    End point values
    		 Regimen A - Debio 0932/Cisplatin/Pemetrexed Regimen B: Debio 0932/Cisplatin/Gemcitabine Regimen C: Debio 0932/Docetaxel
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: Patients
    Notes
    [2] - The limited amount of data for this terminated trial precluded analysis.
    [3] - The limited amount of data for this terminated trial precluded analysis.
    [4] - The limited amount of data for this terminated trial precluded analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 years and three months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Regimen A - Debio 0932/Cisplatin/Pemetrexed
    Reporting group description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.

    Reporting group title
    Regimen C: Debio 0932/Docetaxel
    Reporting group description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.

    Reporting group title
    Regimen B: Debio 0932/Cisplatin/Gemcitabine
    Reporting group description
    		 Debio 0932 administered in conjunction with standard chemotherapy care.

    Serious adverse events
    		 Regimen A - Debio 0932/Cisplatin/Pemetrexed Regimen C: Debio 0932/Docetaxel Regimen B: Debio 0932/Cisplatin/Gemcitabine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 28 (42.86%)
    18 / 35 (51.43%)
    9 / 19 (47.37%)
         number of deaths (all causes)
    5
    5
    4
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    12 / 28 (42.86%)
    18 / 35 (51.43%)
    9 / 19 (47.37%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 26
    0 / 16
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    0 / 3
    Pulmonary oedema
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Investigations
    Thrombocytopenia
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 35 (8.57%)
    3 / 19 (15.79%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 5
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Ischaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Diarrhoea
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    12 / 28 (42.86%)
    18 / 35 (51.43%)
    9 / 19 (47.37%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 28
    0 / 16
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    0 / 3
    Bone pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia viral
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 35 (5.71%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Lung abscess
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Regimen A - Debio 0932/Cisplatin/Pemetrexed Regimen C: Debio 0932/Docetaxel Regimen B: Debio 0932/Cisplatin/Gemcitabine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 28 (100.00%)
    35 / 35 (100.00%)
    19 / 19 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    Epistaxis
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    2
    Thrombosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 35 (5.71%)
    1 / 19 (5.26%)
         occurrences all number
    1
    2
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 28 (0.00%)
    5 / 35 (14.29%)
    0 / 19 (0.00%)
         occurrences all number
    0
    17
    0
    Asthenia
         subjects affected / exposed
    22 / 28 (78.57%)
    24 / 35 (68.57%)
    18 / 19 (94.74%)
         occurrences all number
    80
    75
    49
    Influenza like illness
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Mucosal inflammation
         subjects affected / exposed
    11 / 28 (39.29%)
    8 / 35 (22.86%)
    3 / 19 (15.79%)
         occurrences all number
    16
    10
    5
    Hypothermia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    7 / 28 (25.00%)
    8 / 35 (22.86%)
    10 / 19 (52.63%)
         occurrences all number
    11
    12
    11
    Pain
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 35 (2.86%)
    2 / 19 (10.53%)
         occurrences all number
    2
    1
    4
    Oedema
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 28 (7.14%)
    4 / 35 (11.43%)
    0 / 19 (0.00%)
         occurrences all number
    4
    4
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 28 (28.57%)
    7 / 35 (20.00%)
    9 / 19 (47.37%)
         occurrences all number
    9
    9
    11
    Chest pain
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 35 (2.86%)
    3 / 19 (15.79%)
         occurrences all number
    2
    1
    3
    Dyspnoea-2
         subjects affected / exposed
    3 / 28 (10.71%)
    12 / 35 (34.29%)
    8 / 19 (42.11%)
         occurrences all number
    3
    23
    10
    Dyspnoea exertional
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Haemoptysis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    1
    0
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    2
    0
    1
    Pneumothorax
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Productive cough
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 35 (5.71%)
    3 / 19 (15.79%)
         occurrences all number
    2
    5
    5
    Pulmonary embolism
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 35 (5.71%)
    1 / 19 (5.26%)
         occurrences all number
    1
    3
    1
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Anxiety
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 35 (2.86%)
    2 / 19 (10.53%)
         occurrences all number
    3
    3
    2
    Insomnia
         subjects affected / exposed
    4 / 28 (14.29%)
    4 / 35 (11.43%)
    4 / 19 (21.05%)
         occurrences all number
    4
    4
    5
    Depression
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences all number
    2
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 28 (10.71%)
    4 / 35 (11.43%)
    2 / 19 (10.53%)
         occurrences all number
    4
    19
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 28 (7.14%)
    4 / 35 (11.43%)
    0 / 19 (0.00%)
         occurrences all number
    3
    16
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 28 (3.57%)
    5 / 35 (14.29%)
    1 / 19 (5.26%)
         occurrences all number
    1
    10
    1
    Blood creatinine increased
         subjects affected / exposed
    7 / 28 (25.00%)
    2 / 35 (5.71%)
    1 / 19 (5.26%)
         occurrences all number
    13
    3
    1
    Blood bilirubin increased
         subjects affected / exposed
    0 / 28 (0.00%)
    4 / 35 (11.43%)
    0 / 19 (0.00%)
         occurrences all number
    0
    10
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Ejection fraction decreased
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    2 / 19 (10.53%)
         occurrences all number
    0
    1
    2
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    2
    2
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 28 (10.71%)
    5 / 35 (14.29%)
    3 / 19 (15.79%)
         occurrences all number
    3
    9
    4
    Neutrophil count increased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 28 (3.57%)
    4 / 35 (11.43%)
    1 / 19 (5.26%)
         occurrences all number
    2
    4
    1
    Injury, poisoning and procedural complications
    Neurotoxicity
         subjects affected / exposed
    8 / 28 (28.57%)
    7 / 35 (20.00%)
    3 / 19 (15.79%)
         occurrences all number
    16
    10
    3
    Ototoxicity
         subjects affected / exposed
    7 / 28 (25.00%)
    0 / 35 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    13
    0
    4
    Skin toxicity
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    1 / 19 (5.26%)
         occurrences all number
    0
    14
    4
    Hypothermia-2
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Dyspnoea
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    2 / 19 (10.53%)
         occurrences all number
    0
    1
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 28 (14.29%)
    4 / 35 (11.43%)
    2 / 19 (10.53%)
         occurrences all number
    4
    4
    4
    Dysgeusia
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 35 (5.71%)
    4 / 19 (21.05%)
         occurrences all number
    3
    2
    7
    Ataxia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    5 / 28 (17.86%)
    2 / 35 (5.71%)
    1 / 19 (5.26%)
         occurrences all number
    6
    2
    1
    Headache
         subjects affected / exposed
    5 / 28 (17.86%)
    2 / 35 (5.71%)
    6 / 19 (31.58%)
         occurrences all number
    5
    2
    7
    Neuropathy peripheral
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 35 (8.57%)
    1 / 19 (5.26%)
         occurrences all number
    1
    3
    1
    Somnolence
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    3
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Vision blurred
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Anaemia
         subjects affected / exposed
    14 / 28 (50.00%)
    19 / 35 (54.29%)
    14 / 19 (73.68%)
         occurrences all number
    46
    30
    25
    Febrile neutropenia
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    2
    Neutropenia
         subjects affected / exposed
    12 / 28 (42.86%)
    23 / 35 (65.71%)
    13 / 19 (68.42%)
         occurrences all number
    27
    69
    41
    Leukopenia
         subjects affected / exposed
    0 / 28 (0.00%)
    5 / 35 (14.29%)
    4 / 19 (21.05%)
         occurrences all number
    0
    14
    7
    Lymphopenia
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    8
    3
    0
    Thrombocytopenia
         subjects affected / exposed
    3 / 28 (10.71%)
    3 / 35 (8.57%)
    9 / 19 (47.37%)
         occurrences all number
    3
    9
    30
    Thrombocytosis
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    5
    0
    0
    Vertigo
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    2
    2
    0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
         occurrences all number
    0
    4
    1
    Conjunctivitis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    Eye pain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    4 / 28 (14.29%)
    2 / 35 (5.71%)
    3 / 19 (15.79%)
         occurrences all number
    5
    2
    3
    Diarrhoea
         subjects affected / exposed
    18 / 28 (64.29%)
    27 / 35 (77.14%)
    7 / 19 (36.84%)
         occurrences all number
    35
    70
    9
    Constipation
         subjects affected / exposed
    8 / 28 (28.57%)
    5 / 35 (14.29%)
    7 / 19 (36.84%)
         occurrences all number
    15
    10
    12
    Dyspepsia
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    4
    2
    0
    Haematemesis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Hiccups
         subjects affected / exposed
    5 / 28 (17.86%)
    1 / 35 (2.86%)
    0 / 19 (0.00%)
         occurrences all number
    8
    1
    0
    Stomatitis
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 35 (5.71%)
    1 / 19 (5.26%)
         occurrences all number
    2
    2
    1
    Nausea
         subjects affected / exposed
    20 / 28 (71.43%)
    13 / 35 (37.14%)
    15 / 19 (78.95%)
         occurrences all number
    69
    22
    42
    Reflux gastritis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    13 / 28 (46.43%)
    8 / 35 (22.86%)
    8 / 19 (42.11%)
         occurrences all number
    32
    12
    19
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    1
    6
    0
    Alopecia
         subjects affected / exposed
    0 / 28 (0.00%)
    9 / 35 (25.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    11
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Erythema
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 35 (5.71%)
    1 / 19 (5.26%)
         occurrences all number
    1
    2
    2
    Nail disorder
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Lividity
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 35 (5.71%)
    2 / 19 (10.53%)
         occurrences all number
    1
    7
    7
    Rash maculo-papular
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    4
    0
    Rash
         subjects affected / exposed
    4 / 28 (14.29%)
    4 / 35 (11.43%)
    4 / 19 (21.05%)
         occurrences all number
    4
    7
    4
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    Nocturia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    Renal failure
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 35 (2.86%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    4
    Proteinuria
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 28 (10.71%)
    8 / 35 (22.86%)
    0 / 19 (0.00%)
         occurrences all number
    3
    15
    0
    Back pain
         subjects affected / exposed
    5 / 28 (17.86%)
    2 / 35 (5.71%)
    1 / 19 (5.26%)
         occurrences all number
    5
    2
    2
    Muscle spasms
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Bone pain
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    2
    7
    0
    Musculoskeletal pain
         subjects affected / exposed
    4 / 28 (14.29%)
    3 / 35 (8.57%)
    1 / 19 (5.26%)
         occurrences all number
    6
    3
    1
    Myalgia
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 35 (8.57%)
    0 / 19 (0.00%)
         occurrences all number
    2
    8
    0
    Pain in extremity
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 35 (2.86%)
    2 / 19 (10.53%)
         occurrences all number
    0
    4
    3
    Neck pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 35 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    Candida infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    0
    2
    Gingivitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Device related infection
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 35 (2.86%)
    2 / 19 (10.53%)
         occurrences all number
    1
    1
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    3 / 28 (10.71%)
    5 / 35 (14.29%)
    0 / 19 (0.00%)
         occurrences all number
    5
    5
    0
    Superinfection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    16 / 28 (57.14%)
    13 / 35 (37.14%)
    11 / 19 (57.89%)
         occurrences all number
    34
    28
    26
    Dehydration
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 35 (5.71%)
    3 / 19 (15.79%)
         occurrences all number
    12
    2
    4
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    2
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 35 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    0
    2
    0
    Hypomagnesaemia
         subjects affected / exposed
    4 / 28 (14.29%)
    4 / 35 (11.43%)
    2 / 19 (10.53%)
         occurrences all number
    6
    4
    2
    Hyponatraemia
         subjects affected / exposed
    3 / 28 (10.71%)
    4 / 35 (11.43%)
    2 / 19 (10.53%)
         occurrences all number
    4
    4
    2
    Oedema-2
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 35 (5.71%)
    0 / 19 (0.00%)
         occurrences all number
    3
    2
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Nov 2014
    Trial termination
    -

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